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-0204-2023 | Class II | CareFusion V.Mueller GENESIS QTR-LENGTH CONTAINER 12 X 8" (30.3X20.3CM) 4" (10.2CM) DEEP... | Medtronic, Inc. | KCT | |
| Z-0203-2023 | Class II | CareFusion V.Mueller GENESIS MINI CONTAINER 10-1/2 X 7-1/2" (26.7X19.0CM) 3" (7.6CM) DEEP... | Medtronic, Inc. | KCT | |
| Z-1290-2023 | Class II | GaGa Pro Lighting Equipment Co. Ltd. manufactures Class IV Laser Light Show... | Gaga Pro Lighting Equipment Co. | REA | |
| Z-0135-2023 | Class III | LumiraDx SARS-CoV-2 Antigen (Ag) Liquid Quality Control Kit Catalog #: L016080109002... | LumiraDx | QKP | |
| Z-0267-2023 | Class II | Hamilton-C6 | Hamilton Medical AG | CBK | |
| Z-0118-2023 | Class II | AutoPulse Li-ion Battery used on the AutoPulse Resuscitation System Model 100. used as... | ZOLL Circulation, Inc. | DRM | |
| Z-0170-2023 | Class II | WEB Detachment Controller, REF: WDC-2, WDC, MV-WDC2. Component of WEB Aneurysm... | Terumo Cardiovascular Systems Corporation | OPR | |
| Z-0136-2023 | Class II | GORE CARDIOFORM ASD Occluder. cardiovascular implant. | W. L. Gore & Associates, Inc. | MLV | |
| Z-0227-2023 | Class II | Teleflex Medical RUSCH Pocket Pac i.c. Closed System Intermittent Catheter Kit, 14 Fr... | Teleflex Medical | KOD | |
| Z-0132-2023 | Class II | Vortex MP Port Titanium Low Profile Implanted Port with 5F attached Silicone Catheter and... | Boston Scientific Corporation | LJT | |
| Z-0194-2023 | Class II | Insulin Pump/Model: MiniMed 620G/ MMT-1750 MiniMed 640G/ MMT-1711, MMT-1712, MMT-1751... | Medtronic, Inc. | OYC | |
| Z-0193-2023 | Class II | Insulin Pump/Model: MiniMed 630G/ MMT-1715, MMT-1755, MMT-1754; MiniMed 670G/ MMT-1780... | Medtronic, Inc. | OZP | |
| Z-0119-2023 | Class II | ARTIS pheno, Interventional fluoroscopic x-ray system, Model No. 10849000 | Siemens Medical Solutions USA, Inc. | JAA | |
| Z-0150-2023 | Class II | STRATAFIX SPIRAL PGA-PCL UNI UD 20CM USP2-0(M3) S/A SH. indicated for use in soft tissue... | Ethicon, Inc | GAM | |
| Z-0180-2023 | Class II | Simple Clamp, US/EURO Rails, UPPER EXTREMITY DISTRACTION CMPT, REF F-40018, #800101. To... | Baxter Healthcare Corporation | GDC | |
| Z-0179-2023 | Class II | Allen Life Assist Beach Chair, BCSSP-BEACH CHAIR , REF A-91501, #104002. For use with... | Baxter Healthcare Corporation | GDC | |
| Z-0178-2023 | Class II | Beach Chair Clamp, BEACH CHAIR SHLDER POSITIONER CMPT, REF A-90013, #800104. Component... | Baxter Healthcare Corporation | GDC | |
| Z-0177-2023 | Class II | Allen Standard Starburst, Mayfield/Doro, STANDARD SPINE POSITIONERS CMPT, REF A-70710... | Baxter Healthcare Corporation | GDC | |
| Z-0176-2023 | Class II | C-Flex Polar Head Positnr-Device Only, SSP-NEUROSURGICAL HEADREST, REF A-70701, #103001, | Baxter Healthcare Corporation | GDC | |
| Z-0175-2023 | Class II | Allen Advance Table, RSP-ADVANCE TABLE: a) REF A-71100-US, #107003, b) A-71101-EU... | Baxter Healthcare Corporation | GDC | |
| Z-0133-2023 | Class II | da Vinci X (IS4200) and Xi (IS4000) systems, which consists of finished devices Surgeon... | Intuitive Surgical, Inc. | NAY | |
| Z-0229-2023 | Class II | 125 series iGO2 Portable Oxygen Concentrator-indicated for the administration of... | Sunrise Medical, Inc. | CAW | |
| Z-0105-2023 | Class II | Atellica CH Lithium (Li), Siemens Material Number 11097535. in vitro diagnostic assay | Siemens Healthcare Diagnostics Inc. | NDW | |
| Z-0104-2023 | Class II | Atellica CH Lithium_2 (LITH_2), Siemens Material Number 11532401. in vitro diagnostic... | Siemens Healthcare Diagnostics Inc. | NDW | |
| Z-1282-2024 | Class II | LVP software of the Ivenix Infusion System (IIS), LVP-SW-0004 | Fresenius Kabi USA, LLC | FRN | |
| Z-0925-2023 | Class II | Prep-Fill Guarded Luer Connector (GLC): a. Part Number 57-400, Female Lock - Female... | Intl. Medical Industries | LHI | |
| Z-0078-2023 | Class II | Berkeley VC-10 Vacuum Curettage System, Model No. VC-10. For transcervical aspiration of... | OLYMPUS Corporation of the Americas | HHK | |
| Z-0265-2023 | Class II | B. Braun CARESITE Port Access Kit w/Tegaderm, REF 375214, Central Venous (cardiac)... | Medical Action Industries, Inc. 306 | OFF | |
| Z-0092-2023 | Class II | CARESITE SMALLBORE EXT SET T-PORT 5 IN., Product Code 470114, 100 units per carton. The... | B Braun Medical Inc | FPA | |
| Z-0091-2023 | Class II | Extension Set, EXT SET W/CARESITE, 6IN., Product Code 470169, 50 units per carton. A6... | B Braun Medical Inc | FPA | |
| Z-0090-2023 | Class II | ULTRASITE US04TL Smallbore T-Port Extension Set, Product Code 474515, 100 units per... | B Braun Medical Inc | FPA | |
| Z-0095-2023 | Class II | BD Vacutainer Tube Sodium Fluoride: 100 mg, Potassium Oxalate: 20 mg, Catalog Number... | Becton Dickinson & Co | JKA | |
| Z-0195-2023 | Class II | Y-CONNECTOR: 6" Small Kink Resistant Tubing Bifurcated Connector /2 Male Luer Locks, 1... | Halyard Health | FPA | |
| Z-0196-2023 | Class II | Disc Preparation instruments contained in the following... | Alphatec Spine, Inc. | OLO | |
| Z-0134-2023 | Class II | ARIES SARS-CoV-2 Assay, REF: 50-10047 | Luminex Corporation | QJR | |
| Z-0102-2023 | Class II | ARROW Pressure Injectable Arrowg+ard Blue Advance Two-Lumen Midline Kit, 5.5 Fr, 15 cm... | Arrow International LLC (subsidiary of Teleflex Incorporated) | PND | |
| Z-0085-2023 | Class II | Prismaflex HF20 Set (product code 109841). For use in providing continuous fluid... | Baxter Healthcare Corporation | KDI | |
| Z-0084-2023 | Class II | Prismaflex ST Set: ST60 (product code 107643), ST100 (product code 107636), ST150... | Baxter Healthcare Corporation | KDI | |
| Z-0083-2023 | Class II | Prismaflex HF Set: HF1000 (product code 107140), HF1400 (product code 107142). For use... | Baxter Healthcare Corporation | KDI | |
| Z-0082-2023 | Class II | Prismaflex M Set: M150 (product code 109990). For use in providing continuous fluid... | Baxter Healthcare Corporation | KDI | |
| Z-0081-2023 | Class II | Prismaflex M Set: M60 (product code 106696), M100 (product code 106697). For use in... | Baxter Healthcare Corporation | KDI | |
| Z-0456-2024 | Class II | NovoTHOR Gen 2.5 XL whole body red light therapy bed, model S2184. | Thor Photomedicine Inc. | ILY | |
| Z-0455-2024 | Class II | NovoTHOR Gen 2.5 Regular whole body red light therapy bed, model S2183 | Thor Photomedicine Inc. | ILY | |
| Z-0454-2024 | Class II | G041 POD, THOR NOVO GEN 2.0 XL whole body red light therapy bed, model S1177 | Thor Photomedicine Inc. | ILY | |
| Z-0453-2024 | Class II | NovoTHOR Gen 2.0 whole body red light therapy bed, model S1176 | Thor Photomedicine Inc. | ILY | |
| Z-0277-2023 | Class II | Orthex Large Bone Shoulder Bolt, model no. AS-17 | Orthopediatrics Corp | OSN | |
| Z-0124-2023 | Class II | MEDLINE PRE-OP CHG BATHING KIT Reorder #: P164756 | MEDLINE INDUSTRIES, LP - Northfield | LRO | |
| Z-0123-2023 | Class II | MEDLINE 24 BLOOD CLUTURE KIT, Reorder #: DYNDH1632 | MEDLINE INDUSTRIES, LP - Northfield | LRO | |
| Z-0122-2023 | Class II | MEDLINE BLOOD CLUTURE KIT, Reorder #: DYNDH1592 | MEDLINE INDUSTRIES, LP - Northfield | LRO | |
| Z-0121-2023 | Class II | MEDLINE PHERIPHERAL BLOOD CULTURE DRAW, Reorder #: DYNDH1561 | MEDLINE INDUSTRIES, LP - Northfield | LRO |