Device recalls
Recall records from FDA, newest initiation date first.
Every device recall MDM has ingested. The recall record supplies the product, the reason and the product code; the matching enforcement report supplies the Class I, II or III classification. Where the two have not been joined, the class is left blank rather than assumed.
Data as of , the FDA export date. FDA medical device recall database
| Recall number | Class | Product | Recalling firm | Product code | Initiated |
|---|---|---|---|---|---|
| Z-0620-2018 | Class II | ELAN 4 Drill: ELAN 4 1-RING TWIST DRILL D1.5 ELAN 4 1-RING TWIST DRILL D2.0 ELAN 4 2-RING... | Aesculap Inc | HBE | |
| Z-0619-2018 | Class II | ELAN 4 Burr: ELAN 4 1-RING ROSEN BURR+ D0.6 ELAN 4 1-RING ROSEN BURR+ D0.8 ELAN 4 1-RING... | Aesculap Inc | HBE | |
| Z-1951-2018 | Class II | Respire Pink H/S Oral Sleep Apnea Device | Respire Medical | LRK | |
| Z-1950-2018 | Class II | Respire Pink H/S Oral Sleep Apnea Device | Respire Medical | LRK | |
| Z-1949-2018 | Class II | Respire Pink+ Hard Oral Sleep Apnea Device | Respire Medical | LRK | |
| Z-1948-2018 | Class II | Respire Pink+ Hard/Soft Oral Sleep Apnea Device | Respire Medical | LRK | |
| Z-1947-2018 | Class II | Respire Pink Series EF+ Oral Sleep Apnea Device. | Respire Medical | LRK | |
| Z-0623-2018 | Class II | The ELAN 4 Air System is intended for high speed cutting, sawing and drilling of bone in... | Aesculap Inc | HBB | |
| Z-0691-2018 | Class III | Biofinity XR Toric contact lenses 8.7/14.5 - 6PK Biofinity XR Toric (comfilcon A) Soft... | CooperVision, Inc. | LPM | |
| Z-0234-2018 | Class II | Elekta ERGO++ Product Usage: ERGO is often used for stereotactic treatments. | Elekta Limited | MUJ | |
| Z-3133-2017 | Class II | Baxter Amia Automated Peritoneal Dialysis Set with Cassette, REF 5C5479 | Baxter Healthcare Corporation | FKX | |
| Z-0006-2018 | Class II | Electric Wheelchair bases: a) C300 b) C350 c) C400 d) C500 | Permobil, AB | ITI | |
| Z-0005-2018 | Class II | Electric Wheelchairs: a) C300 CORPUS II b) C350 CORPUS II c) C400 CORPUS II d) C400... | Permobil, AB | ITI | |
| Z-0071-2018 | Class II | AERO IOL Injection System containing 10 Z28 Cartridges per box, Part #003500-0025-282... | Aaren Scientific Inc. | MSS | |
| Z-0973-2018 | Class II | LCSU 4, Laerdal Compact Suction Unit The LCSU 4 is a portable, electrically powered... | Laerdal Medical a/S | JCX | |
| Z-0808-2018 | Class II | Syngo.via systems with SW VB20A | Siemens Medical Solutions USA, Inc. | LLZ | |
| Z-0695-2018 | Class II | 1113 Gravity Tube Set Pk/24 -SH Product Usage: The FMS Gravity Tube Set is intended to... | DePuy Mitek, Inc. | JCY | |
| Z-0834-2018 | Class II | DELTA XTEND" Reverse Shoulder System Modular Centered and Eccentric Epiphysis Implants... | Depuy Orthopaedics Inc. | KWS | |
| Z-0833-2018 | Class II | DELTA XTEND" Reverse Shoulder System Modular Centered and Eccentric Epiphysis Implants... | Depuy Orthopaedics Inc. | HSD | |
| Z-0415-2018 | Class II | Equinoxe Cage, Glenoid, Alpha, Medium Product Usage: The Equinoxe Shoulder System is... | Exactech, Inc. | KWS | |
| Z-0414-2018 | Class II | Equinoxe Cage, Glenoid, Alpha, Small Product Usage: The Equinoxe Shoulder System is... | Exactech, Inc. | KWS | |
| Z-0261-2018 | Class II | Mobile Mini C-arm system Part # 1000-0004-FD. Intended to provide the physician with... | Orthoscan, Inc. | OXO | |
| Z-0260-2018 | Class II | Mobile Mini C-arm system Part # 1000-0005. Intended to provide the physician with... | Orthoscan, Inc. | OXO | |
| Z-0259-2018 | Class II | Mobile Mini C-arm system Part # 1000-0004. Intended to provide the physician with... | Orthoscan, Inc. | OXO | |
| Z-0258-2018 | Class II | Mobile Mini C-arm system Part # 1000-0001. Intended to provide the physician with... | Orthoscan, Inc. | OXO | |
| Z-0106-2018 | Class II | SURPLUG MICRO CONNECTOR Item No. 066-C3352; 111" (282 cm) Appx 13.9 ml, 15 Drop Admin... | Abbott Medical | FMG | |
| Z-0001-2018 | Class II | Carl Zeiss INTRABEAM PRS 500, product #304534-0000-500. The firm name on the label is... | Carl Zeiss Meditec Inc | JAD | |
| Z-0968-2018 | Class II | BD Vacutainer K2 EDTA (K2E) 3.6mg Blood Collection Tube (13 x 75 mm x 2.0 mL). Catalog... | Becton Dickinson & Co | JKA | |
| Z-0596-2018 | Class II | Persona Partial Knee System Product Usage: The Persona Partial Knee System instruments... | Zimmer GmbH | HWA | |
| Z-0038-2018 | Class II | PM3544 QUADRA RELIEVE and PM3562 QUADRA ALLURE MP These low voltage (LV) devices are... | Abbott Medical | NKE | |
| Z-0037-2018 | Class II | PM 1260 ASSURITY + These low voltage (LV) devices are implantable pacemaker pulse... | Abbott Medical | DXY | |
| Z-0036-2018 | Class II | PM 1250 and PM 2250 ZENEX; PM1282 and PM2282 ZENEX MRI These low voltage (LV) devices... | Abbott Medical | DXY | |
| Z-0035-2018 | Class II | PM1226 ACCENT ST MRI SR RF and PM2222 ACCENT ST These low voltage (LV) devices are... | Abbott Medical | LWP | |
| Z-0034-2018 | Class II | PM1214 NUANCE SR RF; PM1230 and PM2230 NUANCE MRI; PM2214 NUANCE DR RF These low voltage... | Abbott Medical | NKE | |
| Z-0033-2018 | Class II | Merlin@Home Software Model EX2000 v8.2.2 for Merlin@Home Transmitter Models EX1150... | Abbott Medical | OSR | |
| Z-0032-2018 | Class II | Merlin PCS 3650 Programmer with Model 3330 Software Version 23.1.1 The Merlin Patient... | Abbott Medical | NIK | |
| Z-0031-2018 | Class II | Assurity MRI Model Numbers: PM1272, PM2272 Implantation of a single-chamber pulse... | Abbott Medical | DXY | |
| Z-0030-2018 | Class II | Assurity Model Numbers: PM1240, PM2240; Assurity + Model Number: PM2260; Accent Model... | Abbott Medical | DXY | |
| Z-0029-2018 | Class II | Anthem Model Numbers: PM3210, PM3212; Allure/Relieve Model Numbers: PM3222, PM3242... | Abbott Medical | NKE | |
| Z-0004-2018 | Class I | Unify, Model Numbers: CD3231-40 and CD3231-40Q; Unify Quadra, Model Numbers: CD3249-40... | Abbott Medical | NIK | |
| Z-0003-2018 | Class I | Fortify VR - Model Numbers: CD1231-40 and CD1231-40Q; Fortify ST VR, Model Numbers... | Abbott Medical | LWS | |
| Z-0727-2018 | Class II | Stage-1 RDS Indexed Abutment for RDS Stage-1 Single Stage Implants Keystone s... | Keystone Dental Inc. | DZE | |
| Z-0626-2018 | Class II | G7 DUAL MOBILITY LINER 44MM F Product Usage: Intended for use in hip arthroplasty cases... | Zimmer GmbH | KWY | |
| Z-0628-2018 | Class II | AGC 2000 LP Patella, labeled as AGC Porous Patellar Med, Model Number 150804. Product... | Zimmer GmbH | JWH | |
| Z-0627-2018 | Class II | AGC 2000 LP Patella, labeled as AGC Porous Patellar SM, Model Number 150802. Product... | Zimmer GmbH | JWH | |
| Z-3134-2017 | Class II | VITEK(R) 2 GP, REF 21342, IVD, UDI 03573026131920, bioMerieux, Inc. VITEK(R) 2 is an... | bioMerieux, Inc. | LQL | |
| Z-0508-2018 | Class II | AArtis Q/ Q.Zen biplane Artis zee biplane Product Usage: Artis is a family of dedicated... | Siemens Medical Solutions USA, Inc. | OWB | |
| Z-0497-2018 | Class II | Graseby 3300 Pump and Graseby 3000 Series Pump Accessories Patient controlled syringe... | Abbott Medical | MEA | |
| Z-0605-2018 | Class II | Lyophilized Chemistry Calibrator Level 1 Product Usage: Beckman Coulter Chemistry... | Siemens Healthcare Diagnostics Inc. | JIX | |
| Z-3239-2017 | Class II | IVEA Product Part Number 16100 Model 500A | Firefly Medical, Inc. | FOX |