STERIS Corporation
Montgomery, AL, US
STERIS CORPORATION appears in FDA device records in Montgomery, AL. FDA records list 227 510(k) clearances between and , no PMA records and 14 registered establishments. As of , FDA records show 147 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
2 namesFDA records resolved to STERIS Corporation carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Steris Corporation Hopkins Facilityenforcement report, recall
- Steris Corportionrecall
510(k) clearance history
Showing 50 of 227FDA records hold 227 510(k) clearances for STERIS Corporation between 1997 and 2026. The busiest year on record is 2018, with 26. The most recent is 2026, with 4.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1997 | 2 |
| 1998 | 3 |
| 1999 | 2 |
| 2000 | 2 |
| 2001 | 3 |
| 2002 | 1 |
| 2003 | 1 |
| 2004 | 3 |
| 2007 | 9 |
| 2008 | 7 |
| 2009 | 13 |
| 2010 | 8 |
| 2011 | 14 |
| 2012 | 6 |
| 2013 | 5 |
| 2014 | 6 |
| 2015 | 1 |
| 2016 | 6 |
| 2017 | 12 |
| 2018 | 26 |
| 2019 | 18 |
| 2020 | 8 |
| 2021 | 10 |
| 2022 | 12 |
| 2023 | 23 |
| 2024 | 14 |
| 2025 | 8 |
| 2026 | 4 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K261055 | AMSCO 700 Steam Sterilizer | FLE | Substantially Equivalent | |
| DEN240075 | Prolystica Pass Thru Disinfectant Wipes | SHM | Unknown | |
| K260766 | Celerity 5 HP Biological Indicator (LCB052) | FRC | Substantially Equivalent | |
| K251666 | SYSTEM 1E Liquid Chemical Sterilant Processing System, Model P6700; SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900 | MED | Substantially Equivalent | |
| K252680 | Celerity™ 20 HP Biological Indicator | FRC | Substantially Equivalent | |
| K251452 | Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059); Celerity 20 HP Biological Indicator (LCB044); Celerity 20 HP Challenge Pack (LCB045) | FRC | Substantially Equivalent | |
| K251048 | Rapicide PA High-Level Disinfection Test Strip Model Ref # = ML02-0118 | JOJ | Substantially Equivalent | |
| K243876 | VERIFY STEAM Integrating Indicator | JOJ | Substantially Equivalent | |
| K250842 | PADLOCK CLIP EFTR Kit (00713229) | PKL | Substantially Equivalent | |
| K242773 | Electro Lube NXT | GEI | Substantially Equivalent | |
| K250061 | Celerity Incubator | FRC | Substantially Equivalent | |
| K250044 | Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059); Celerity 20 HP Biological Indicator (LCB044); Celerity 20 HP Challenge Pack (LCB045) | FRC | Substantially Equivalent | |
| K243475 | Chemical Indicator for enspire CLCSPS (LCC015) | JOJ | Substantially Equivalent | |
| K243433 | enspire 3000 Cleaning and Liquid Chemical Sterilant Processing System | FEB | Substantially Equivalent | |
| DEN230085 | VERIFY RESI-TEST SLIDE-THRU Cleaning Process Protein (CPP) Indicator | SDC | Unknown | |
| K243075 | Defendo Single Use Cleaning Adapter for Olympus Endoscopes (100322, 100323, 4000096, 4003269, 4003280) | ODC | Substantially Equivalent | |
| K242742 | DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS EUS (00711900) | ODC | Substantially Equivalent | |
| K240274 | PADLOCK CLIP EFTR Kit (00713229) | PKL | Substantially Equivalent | |
| K242189 | CELERITY HP Indicator Tape (PCC077) | JOJ | Substantially Equivalent | |
| K241344 | MetriCide™ OPA Plus Solution Test Strip | JOJ | Substantially Equivalent | |
| K241055 | Electro Lube NXT | GEI | Substantially Equivalent | |
| K240032 | Celerity Chemical Indicator for enspire 3000 CLCSPS | JOJ | Substantially Equivalent | |
| K240760 | CELERITY HP Indicator Tape | JOJ | Substantially Equivalent | |
| K232826 | Articulator Injection Needle (00711807), Articulator Injection Needle (00711810), Articulator Injection Needle - enteroscope (00711808), Carr-Locke Injection Needle (00711811), Carr-Locke Injection Needle (00711812), Carr-Locke Injection Needle (00711813), Carr-Locke Injection Needle (00711814), Carr-Locke Injection Needle (00711822), Carr-Locke Injection Needle (00711823), Carr-Locke Injection Needle (00711824) | FBK | Substantially Equivalent | |
| K240352 | Defendo Single Use Cleaning Adapter for Olympus Endoscopes | ODC | Substantially Equivalent | |
| K240098 | DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS EUS (00711900) | ODC | Substantially Equivalent | |
| K233682 | VERIFY SPORE TEST STRIP for S40 STERILANT CONCENTRATE | OVY | Substantially Equivalent | |
| K233681 | ConFirm 20 Minute Incubator | FRC | Substantially Equivalent | |
| K233654 | VERIFY® Chemical Indicator for SYSTEM 1E® and SYSTEM 1® endo Liquid Chemical Sterilant Processing Systems | JOJ | Substantially Equivalent | |
| K233187 | Celerity Vaporized VH2O2 Process Indicator Adhesive Label (PCC078) | JOJ | Substantially Equivalent | |
| K233065 | V-PRO maX 2 Low Temperature Sterilization System | MLR | Substantially Equivalent | |
| K232951 | BioShield Biopsy Valve (00711124); BioShield Biopsy Valve (00711125); BioShield Biopsy Valve (00711126); BioShield Biopsy Valve (00711127); BioShield Biopsy Valve (00711129); BioShield Biopsy Valve (00711135); BioShield Biopsy Valve (00711136); BioShield Biopsy Valve - sterile (00711128); BioShield Irrigator (00711133); BioShield Irrigator (00711137); BioShield Irrigating Adaptor (00711131); BioShield Irrigator - extension tubing (00711134) | ODC | Substantially Equivalent | |
| K232918 | enspire 300 Series Automated Endoscope Reprocessor | NZA | Substantially Equivalent | |
| K232914 | SYSTEM 1E Liquid Chemical Sterilant Processing System (P6500); SYSTEM 1 endo Liquid Chemical Sterilant Processing System (P6800); SYSTEM 1 endo Liquid Chemical Sterilant Processing System (P6900) | MED | Substantially Equivalent | |
| K232485 | AMSCO 600 Steam Sterilizer | FLE | Substantially Equivalent | |
| K231746 | VERIFY Spore Test Strip for S40 Sterilant Concentrate | OVY | Substantially Equivalent | |
| K231501 | PRO-LITE Sterilization Tray | KCT | Substantially Equivalent | |
| K231500 | Vis-U-All Low Temperature Sterilization Pouches | FRG | Substantially Equivalent | |
| K231490 | Celerity 20 HP Biological Indicator; VERIFY V24 Self-Contained Biological Indicator | FRC | Substantially Equivalent | |
| K231488 | Celerity™ HP Chemical Indicator; Celerity™ HP Multivariable Chemical Indicator; VERIFY HPU Chemical Indicator; VERIFY VH2O2 Indicator Tape | JOJ | Substantially Equivalent | |
| K223476 | V-PRO maX 2 Low Temperature Sterilization System | MLR | Substantially Equivalent | |
| K231878 | Uretero1 Single-Use Digital Flexible Ureteroscope (standard deflection), PN UROSD101, Uretero1 Single-Use Digital Flexible Ureteroscope (reverse deflection), PN URORD101, Vision1 Imaging Console and Display System, PN VIS101 | FGB | Substantially Equivalent | |
| K230560 | enspire 300 Series Automated Endoscope Reprocessor System | NZA | Substantially Equivalent | |
| K230558 | Revital-Ox PAA High Level Disinfectant Chemical Indicator | JOJ | Substantially Equivalent | |
| K230930 | enspire 3000 Cleaning and Liquid Chemical Sterile Processing System | FEB | Substantially Equivalent | |
| K223717 | Celerity 5 HP Biological Indicator; Celerity 5 HP Challenge Pack | FRC | Substantially Equivalent | |
| K223715 | Celerity Incubator | FRC | Substantially Equivalent | |
| K230582 | SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900 | MED | Substantially Equivalent | |
| K223466 | Uretero1 Single-Use Digital Flexible Ureteroscope (standard deflection), PN UROSD101; Uretero1 Single-Use Digital Flexible Ureteroscope (reverse deflection), PN URORD101; Vision1 Imaging Console and Display System, PN VIS101 | FGB | Substantially Equivalent | |
| K223369 | truFreeze Console, PN CC301; Aire PV Passive Venting Catheter, PN CO840703; 16 Fr CDT 5 Pack, PN 2000181; 20Fr CDT 5 Pack, PN ACCCC3CDT05; Active Venting Spray Kit, 20 Fr CDT, PN 2000177; Active Venting Spray Kit 16 Fr CDT, PN 20000516; Rapid AV Catheter 5 Pack, PN 2000184 | GEH | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3014680834 | 3014680834 | STERIS | 701 Cornell Dr Bldg F Unit 1 2 & 3, Wilmington, DE 19801 US | 2026 | |
| 1043572 | 1043572 | STERIS CORPORATION | 2720 GUNTER PARK DRIVE EAST, MONTGOMERY, AL 36109 US | 2026 | and 30 more, listed in full below |
| 1527821 | 1527821 | STERIS CORPORATION | 5960 Heisley Road, Mentor, OH 44060 US | 2026 | |
| 1933443 | 1000510740 | STERIS CORPORATION | 8525 Page Ave, Breckenridge Hills, MO 63114 US | 2026 | |
| 1937531 | 1937531 | STERIS CORPORATION | 7501 Page Ave, Saint Louis, MO 63133 US | 2026 | |
| 3004080920 | 3004080920 | STERIS CORPORATION | 9325 Pinecone Drive, Mentor, OH 44060 US | 2026 | and 2 more, listed in full below |
| 1526531 | 1526531 | STERIS Corporation | 17820 ENGLEWOOD DR., CLEVELAND, OH 44130 US | 2026 | |
| 1923569 | 1923569 | STERIS Corporation | 5 SUNNEN DR., Saint Louis, MO 63143 US | 2026 | and 202 more, listed in full below |
| 3000251274 | 3000251274 | STERIS Corporation | 6515 HOPKINS RD., Mentor, OH 44060 US | 2026 | |
| 3003950207 | 3003950207 | STERIS Corporation | 6100 Heisley Rd, Mentor, OH 44060 US | 2026 | |
| 3007412809 | 3007412809 | STERIS Corporation | 11457 MELROSE AVE, FRANKLIN PARK, IL 60131 US | 2026 | |
| 3030125044 | 3030125044 | STERIS S.p.A. | Monza Via Parco, 47, Biassono Monza e Brianza 20853 IT | 2026 | |
| 3002806470 | 3002806470 | STERIS SPA | 29, VIA CA BERTONCINA, SERIATE Bergamo 24068 IT | 2026 | and 17 more, listed in full below |
| 3002806603 | 3002806603 | STERIS SPA | 3, 5, 7, 9, VIA EINAUDI, CALCINATE Bergamo 24050 IT | 2026 | and 76 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- FEBAccessories, Cleaning, For Endoscope
- FERAnoscope And Accessories
- EHOBar, Preformed
- FCGBiopsy Needle
- FAXBougie, Urological
- BSOCatheter, Conduction, Anesthetic
- DQYCatheter, Percutaneous
- FGICatheter, Urethrographic, Male
- EMMChisel, Osteotome, Surgical
- FFNClamp, Non-Electrical
- FHAClamp, Penile
- DXCClamp, Vascular
- BYDCondenser, Heat And Moisture (Artificial Nose)
- EMKCurette, Surgical, Dental
- EXQCystometer, Electrical Recording
- FENDevice, Cystometric, Hydraulic
- DWPDilator, Vessel, Surgical
- DZIDrill, Bone, Powered
- ERLDrill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
- EMJElevator, Surgical, Dental
- FBKEndoscopic Injection Needle, Gastroenterology-Urology
- EMIFile, Bone, Surgical
- DTMFilter, Blood, Cardiopulmonary Bypass, Arterial Line
- FCLForceps, Biopsy, Non-Electric
- EMGForceps, Tooth Extractor, Surgical
- BWBForceps, Tube Introduction
- DTRHeat-Exchanger, Cardiopulmonary Bypass
- FHQHolder, Needle, Gastroenterologic
- DXYImplantable Pacemaker Pulse-Generator
- DXTInjector And Syringe, Angiographic
- DZNInstruments, Dental Hand
- DWSInstruments, Surgical, Cardiovascular
- EMFKnife, Surgical
- FHRNeedle, Gastro-Urology
- DTZOxygenator, Cardiopulmonary Bypass
- FHOPneumoperitoneum Needle
- FGMProbe And Director, Gastro-Urology
- FEQPump, Air, Non-Manual, For Endoscope
- DTNReservoir, Blood, Cardiopulmonary Bypass
- EIGRetractor, All Types
- FDGRetractor, Fiberoptic
- FGNRetractor, Non-Self-Retaining
- FFORetractor, Self-Retaining
- FHLScoop
- EAKScreen, Leaded, Operator Radiation Protector
- FDISnare, Flexible
- FBXSound, Urethral, Metal Or Plastic
- EPYSpeculum, Ent
- FLESterilizer, Steam
- EYDStirrups
- EZBStylet For Catheter, Gastro-Urology
- DTSSucker, Cardiotomy Return, Cardiopulmonary Bypass
- CCXSupport, Patient Position
- FFXSystem, Gastrointestinal Motility (Electrical)
- DWJSystem, Thermal Regulating
- BWNTable And Attachments, Operating-Room
- BYXTubing, Pressure And Accessories
- BWAUnit, Electrosurgical And Coagulation, With Accessories
- FGBUreteroscope And Accessories, Flexible/Rigid
- EZOUrethrotome
Recall records
Showing 25 of 147| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2450-2026 | ALYON Surgical Lighting System | The the plus and minus buttons (+/-) used to control light intensity on the light heads may detach. | Class II | Open, Classified | |
| Z-2449-2026 | HarmonyAIR A-Series Surgical Lighting System | The the plus and minus buttons (+/-) used to control light intensity on the light heads may detach. | Class II | Open, Classified | |
| Z-2448-2026 | HarmonyAIR A-Series Surgical Lighting System | There is a potential for paint delamination (chipping/peeling) on the lighting system's light heads. | Class II | Open, Classified | |
| Z-0910-2026 | AMSCO 7053HP Washer/Disinfector Model/Catalog Number: 7053HP Product Description: The AMSCO 7053HP Washer/Disinfector is intended for use in the cleaning and intermediate-level disinfection of soiled reusable simple hard-surfaced rigid surgical instruments (such as forceps and clamps), utensils (such as bedpans, urinals, trays, bowl, basin and kidney dishes), rubber and plastic goods, theatre shoes and other similar and related articles found in healthcare facilities. | Wire connected to the electrical box may shift out of its intended position, which may result in electrical arcing. Electrical arcing remains internal within the unit (no risk of shock to users). | Class II | Open, Classified | |
| Z-0909-2026 | AMSCO 7052HP Washer/Disinfector Model/Catalog Number: 7052HP Product Description: The AMSCO 7052HP Washer/Disinfector is intended for use in the cleaning and intermediate-level disinfection of soiled reusable simple hard-surfaced rigid surgical instruments (such as forceps and clamps), utensils (such as bedpans, urinals, trays, bowl, basin and kidney dishes), rubber and plastic goods, theatre shoes and other similar and related articles found in healthcare facilities. | Wire connected to the electrical box may shift out of its intended position, which may result in electrical arcing. Electrical arcing remains internal within the unit (no risk of shock to users). | Class II | Open, Classified | |
| Z-2178-2025 | Dual Flat Panel Monitor (DFPM) accessories for HarmonyAIR E-Series Surgical Lighting Systems | The DFPM yoke assembly ("yoke assembly") may detach from the spring arm. Should the yoke assembly detach from the spring arm, the yoke assembly would not be expected to fully detach but rather hang from the wiring within the yoke assembly. | Class II | Open, Classified | |
| Z-2177-2025 | Dual Flat Panel Monitor (DFPM) accessories for HarmonyAIR A-Series Surgical Lighting Systems | The DFPM yoke assembly ("yoke assembly") may detach from the spring arm. Should the yoke assembly detach from the spring arm, the yoke assembly would not be expected to fully detach but rather hang from the wiring within the yoke assembly. | Class II | Open, Classified | |
| Z-1361-2026 | Barco MNA with the HexaVue IP Integration System, Model/Catalog Number: MNA-6x0-H | This is a sub-recall of event RES 96885. The supplier identified that during their manufacturing process for a limited batch of MNA-6x0 (adapter) components the incorrect configuration file was used. | Class II | Open, Classified | |
| Z-2539-2024 | Hookup Model/Catalog Number: DSD-110-HU0163 Product Description: Hookups provide the interface between DSD Automated Endoscope Reprocessors ( AER ) and endoscopes, which allow perfusion of liquids dispensed by the AER to contact and high-level disinfect the channels of flexible endoscopes. Component: N/A | IFU for hookup were incorrectly reflected within hookup IFUs and online reference system, Hookup Lookup (HULU). Use of an incorrect hookup connection and/or parameter set may prevent an endoscope from being properly disinfected, which may present a risk of patient contamination or infection | Class II | Open, Classified | |
| Z-2538-2024 | Hookup Model/Catalog Number: 2-8-540CAS Product Description: Hookups provide the interface between an Advantage Plus" Automated Endoscope Reprocessor and Advantage Plus" Pass-Thru Automated Endoscope Reprocessor ( AER ) and endoscopes, which allow perfusion of liquids dispensed by the AER to contact and high-level disinfect the channels of flexible endoscopes. | IFU for hookup were incorrectly reflected within hookup IFUs and online reference system, Hookup Lookup (HULU). Use of an incorrect hookup connection and/or parameter set may prevent an endoscope from being properly disinfected, which may present a risk of patient contamination or infection | Class II | Open, Classified | |
| Z-2537-2024 | Hookup Model/Catalog Number: 2-8-540HAN Product Description: Hookups provide the interface between an Advantage Plus" Automated Endoscope Reprocessor and Advantage Plus" Pass-Thru Automated Endoscope Reprocessor ( AER ) and endoscopes, which allow perfusion of liquids dispensed by the AER to contact and high-level disinfect the channels of flexible endoscopes. | IFU for hookup were incorrectly reflected within hookup IFUs and online reference system, Hookup Lookup (HULU). Use of an incorrect hookup connection and/or parameter set may prevent an endoscope from being properly disinfected, which may present a risk of patient contamination or infection | Class II | Open, Classified | |
| Z-2536-2024 | Hookup Model/Catalog Number: 2-8-540 Product Description: Hookups provide the interface between an Advantage Plus" Automated Endoscope Reprocessor and Advantage Plus" Pass-Thru Automated Endoscope Reprocessor ( AER ) and endoscopes, which allow perfusion of liquids dispensed by the AER to contact and high-level disinfect the channels of flexible endoscopes. | IFU for hookup were incorrectly reflected within hookup IFUs and online reference system, Hookup Lookup (HULU). Use of an incorrect hookup connection and/or parameter set may prevent an endoscope from being properly disinfected, which may present a risk of patient contamination or infection | Class II | Open, Classified | |
| Z-0984-2024 | Dual Articulating Headrest, Velcro P/N P141210813, REF BF753 | Dual-articulating head rest may not stay in place or may fail to lock into position during a patient procedure which could result in an injury to the patient or a procedural delay. | Class II | Open, Classified | |
| Z-0983-2024 | Dual Articulating Headrest, Pad Ret P/N P141210805, REF BF754 | Dual-articulating head rest may not stay in place or may fail to lock into position during a patient procedure which could result in an injury to the patient or a procedural delay. | Class II | Open, Classified | |
| Z-0737-2024 | V. Mueller Universal Bandage Scissors Black Plastic Handles Heavy-Duty, Autoclavable, Overall Length 7 (18 cm)- Intended to cut through tape and bandages Model: SU2014-001 | Bandage Scissors handle cover component contains an incorrect color masterbatch resin carrier. This may allow a pink dye/residue to appear on the Bandage Scissors and/or sterilization pouches after processing. | Class II | Open, Classified | |
| Z-0617-2024 | Hookup Accessories used with MEDIVATORS ADVANTAGE PLUS and ADVANTAGE PLUS Pass Thru Automated Endoscope Reprocessors Model # Model Description 2-8-001 HU ZERO CHANNEL NO LT 2-8-010 ASSY, HOOK-UP, OLYMPUS 2-8-014 HOOKUP, OPTIM LT 2-8-030 ASSY, HOOKUP, PENTAX-0K 2-8-040 ASSY, HKUP STORZ 0K 2-8-070 ASSY, HU VISION SCIENCE 2-8-112 ASSY, HOOKUP OLMPUS 1K 2-8-120 ASSY, HOOKUP FUJI 1K 2-8-210 ASSY, HOOK-UP OLYMPUS 2K 2-8-213 ASSY, HOOKUP, OLYMPUS-2K 2-8-218 ASSY HOOKUP OLY 2K 2-8-236 ASSY, HOOKUP FUJINON 2K 2-8-244 ASSY, HOOKUP, STORZ 2K 2-8-245 ASSY, HOOK-UP, STORZ 2K 2-8-246 ASSY, HKUP, PENTAX-2K 2-8-260 ASSY, HOOK-UP WOLF 2-K 2-8-280 ASSY HOOKUP 2-8-312 ASSY, HOOK-UP OLYMPUS-3K 2-8-330 ASSY, HOOK-UP, PENTAX-3K 2-8-332 ASSEMBLY, HOOK-UP, PENTAX 2-8-334 ASSEMBLY, HOOK-UP, PENTAX 2-8-335 ASSY, HOOKUP, OLYMPUS, 3K 2-8-336 ASSY,HKUP FUJI 70 BRONC 2-8-338 ASSY, HU, FUJI BRONCH U/S 2-8-421 ASSY, HOOKUP, FUJIFILM 2-8-428 ASSY, ED-580XX 2-8-431 ASSY, HOOKUP, PENTAX 2-8-432 ASSY, HOOK-UP, PENTAX 2-8-460 HOOKUP, ASSY WOLF 4K 2-8-511 ASSY, HOOK-UP, OLY 2-8-513 ASSY HOOKUP OLY 4K ESOPHA 2-8-522 ASSY, FUJINON 4K-JET 2-8-523 ASSY, HKUP, FUJI 4K SER 5 2-8-526 ASSY, HOOKUP FUJI 4K+JET 2-8-527 ASSY, FUJI 700 NO FWJ 2-8-528 HOOK, EI-580BT 2-8-534 ASSY, HOOK-UP, PEN-4K+JET 2-8-537 ASSY, HKUP, PTX90 4K+JET 2-8-539 HOOK, PTX I20 FWJ 2-8-540 ASSY-HOOK-UP,STORZ,5K 2-8-611 ASSY, HOOK-UP, OLY 2-8-612 ASSY, HOOKUP, PENTAX 2-8-614 ASM HU OLY TGF-UC180J 2-8-617 ASSY, HKUP, OLY 2 BIOPSY 2-8-623 ASSY,HKUP,FUJI-5 4K+JET 2-8-625 ASSY, HOOKUP, EG-580UT 2-8-626 ASSY, HOOKUP, EG-580UR 2-8-627 ASSY, HKUP, FUJI 700 SER 2-8-634 ASSY, HOOKUP PENTAX DUAL 2-8-639 HOOK, EG3X-J10 2-8-640 ASSY,HOOK-UP STORZ 6K 2-8-711 ASSY, HOOKUP, OLYMPUS 5K 2-8-718 ASSY, HOOKUP, OLY 160/180 2-8-740 ASSY, HOOK-UP, STORZ 2-8-811 ASSY HKUP OLY-ECHO+LIFT 2-8-901 KIT TEE/TOE/RUS HU ADV+ 5-8-010 ASSY, HOOKUP DBL LT 5-8-030 ASSY, HOOKUP 5-8-040 ASSY HOOKUP STORZ 0K DBL 5-8-050 ASSY, HOOKUP, DILATOR 5-8-112 HOOKUP 2-SCOPE 1-K 5-8-190 HOOK DBL, IS, ION 5-8-210 ASSY, HOOKUP 5-8-245 HOOKUP KARLSTORZ-2K 2-8-001HAN HU ZERO CHANNEL NO LT 2-8-002HAN ADVANTAGE TEST BLOCK 2-8-010HAN ASSEMBLY, HOOK-UP,OLYMPUS 2-8-030HAN ASSY,HOOKUP,PENTAX-OK 2-8-112HAN ASSY, HOOK-UP OLYMPUS 1K 2-8-160HAN ASSY, ADV HOOKUP, WOLF 2-8-210HAN ASSY, HOOK-UP OLYMPUS 2K 2-8-213HAN ASSY, HOOKUP, OLYMPUS-2K 2-8-218HAN ASSY HOOKUP OLY 2K 2-8-245HAN ASSY, HOOKUP, STORZ-2K 2-8-330HAN ASSY, HOOK-UP, PENTAX-3K 2-8-334HAN ASSEMBLY, HOOK-UP, PENTAX 2-8-335HAN ASSY,HOOKUP,OLYMPUS 2-8-336HAN ASSY,HKUP FUJI 70 BRONC 2-8-338HAN ASSY, HU, FUJI BRONCH U/S 2-8-421HAN ASSY, HOOKUP, FUJINON 2-8-428CAS HOOK, CAS, ED-580XX 2-8-428HAN HOOK, HAN, ED-580XX 2-8-431CAS ASSY, CASSETTE, PENTAX 2-8-431HAN ASSY, HOOK-UP, PENTAX 2-8-511HAN ASSY, HOOK-UP, OLY 2-8-526HAN ASSY, HOOKUP FUJI 4K+JET 2-8-536HAN HOOKUP,PENTAX,70ULT, 5K 2-8-537CAS ASSY,CASS,PTX 90 4K+JET 2-8-537HAN ASSY HKUP,PTX90 4K+JET 2-8-611HAN ASSY, HOOK-UP, OLY 2-8-626CAS ASSY, CASS, FUJINON 580UR 2-8-627HAN ASSY, HAN, FUJI 700 SER 2-8-634CAS ASSY,CASS PENTAX DUAL CH 2-8-634HAN ASSY,HOOKUP PENTAX DUAL 2-8-640HAN ASSY, HOOK-UP STORZ 6K 2-8-711HAN ASSY, HOOKUP, OLYMPUS-5K 2-8-718HAN ASSY,HOOK-UP, OLY 160/180 2-8-811HAN ASSY HKUP OLY-ECHO W/LIFT 2-8-902H HU BLOCK ULTRASOUND PROBE 5-8-030HAN ASSY, HOOKUP 5-8-050HAN ASSY,HOOKUP, DILATOR 5-8-112HAN ASSY, HOOKUP 2-SCOPE 1-K 5-8-244HAN ASSY, HKUP 2K DBL | Identification label on affected hookups could become illegible over time due to the label's ink coming off. This may potentially prevent users from being able to effectively identify the hookup and may ultimately result in postponement of patient procedures. | Class II | Open, Classified | |
| Z-1595-2023 | Reliance Vision Multi-Chamber Washer/Disinfector, Reference Number FH83062 | In the remote occurrence in which the electrical contactor component present in the drying chambers of the Reliance Vision Multi-Chamber Washer/Disinfector malfunctions, the heating elements in the drying chamber could overheat, eventually resulting in smoke and/or fire. | Class II | Open, Classified | |
| Z-1476-2023 | Steris Lighting and Visualization Systems, Sterile Light handle Cover LB44 -Sterilizable consumables (disposable, single use) used to drape the lighthandle of STERIS surgical lighting systems for the purpose of maintaining a sterile surgical environment. REF: LB44 | Light handle covers may separate from the light handle (detach and fall off) during use, this could result in a procedure delay and/or impact the sterile field which could result in an injury to the patient | Class II | Open, Classified | |
| Z-1475-2023 | Steris Lighting and Visualization Systems, Sterile Light Handle Cover (LB53)- Surgical light handle covers, including disposable surgical light handle covers are designed to fit over surgical light handles for sterile surgeon control. REF: LB53 | Light handle covers may separate from the light handle (detach and fall off) during use, this could result in a procedure delay and/or impact the sterile field which could result in an injury to the patient | Class II | Open, Classified | |
| Z-0781-2023 | VERIFY Steam Test Pack (20 Tests and 20 controls) Item Number: S3069 Intended for use in installation testing and routine monitoring of steam and ethylene oxide sterilization processes | Biological indicator (BI) used to promote growth of the G. stearothermophilus and B. atrophaeus spores was inconsistent in promoting growth throughout lot , some BIs within the lot performed as intended while others did not. When used to monitor steam and ethylene oxide sterilization cycles, the potential hazard is that the BI will show no growth indicating that the cycle was effective, even if it may not have been. | Class II | Open, Classified | |
| Z-0780-2023 | VERIFY Steam Test Pack (20 Tests and 5 controls) Item Number: S3065 Intended for use in installation testing and routine monitoring of steam and ethylene oxide sterilization processes | Biological indicator (BI) used to promote growth of the G. stearothermophilus and B. atrophaeus spores was inconsistent in promoting growth throughout lot , some BIs within the lot performed as intended while others did not. When used to monitor steam and ethylene oxide sterilization cycles, the potential hazard is that the BI will show no growth indicating that the cycle was effective, even if it may not have been. | Class II | Open, Classified | |
| Z-0779-2023 | VERIFY Dual Species Self-Contained Biological Indicators, 100 per box Item Number: S3061 Intended for use in installation testing and routine monitoring of steam and ethylene oxide sterilization processes | Biological indicator (BI) used to promote growth of the G. stearothermophilus and B. atrophaeus spores was inconsistent in promoting growth throughout lot , some BIs within the lot performed as intended while others did not. When used to monitor steam and ethylene oxide sterilization cycles, the potential hazard is that the BI will show no growth indicating that the cycle was effective, even if it may not have been. | Class II | Open, Classified | |
| Z-0778-2023 | VERIFY Dual Species Self-Contained Biological Indicators, 50 per box Item Number: S3060 Intended for use in installation testing and routine monitoring of steam and ethylene oxide sterilization processes | Biological indicator (BI) used to promote growth of the G. stearothermophilus and B. atrophaeus spores was inconsistent in promoting growth throughout lot , some BIs within the lot performed as intended while others did not. When used to monitor steam and ethylene oxide sterilization cycles, the potential hazard is that the BI will show no growth indicating that the cycle was effective, even if it may not have been. | Class II | Open, Classified | |
| Z-0241-2023 | GI4000 Electrosurgical Unit - intended to deliver electrosurgical outputs to perform cutting and/or coagulation and coagulation with or without delivery of argon gas, in flexible endoscopic applications. MODEL #(s): G1110001 | Two electronic diode components (D1 & D4) placed in the reverse orientation on the controller printed circuit board assembly may result in premature wear of the power regulator, leading to the regulators failure which could cause a full power loss. If the regulator failure were to occur during a patient procedure, a procedural delay may result | Class II | Terminated | |
| Z-0079-2023 | Hu-Friedy K360 Scalpel Handle, 360 Degree Scalpel Handle, REF K360 | The scalpel holder may separate from the handle for certain lots. If the tip falls off during use, it could fall into the patient's mouth which may result in a cut to the patient's mouth and also presents a choking hazard. | Class II | Terminated |
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