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-0353-05 | AMPLATZER Delivery System 45-degree curve, order no. 9-DEL-8F-45/60. Product is labeled... | Abbott Medical | GBK | ||
| Z-0352-05 | AMPLATZER Delivery System 45-degree curve, order no. 9-DEL-7F-45/80. Product is labeled... | Abbott Medical | GBK | ||
| Z-0351-05 | AMPLATZER Delivery System 45-degree curve, order no. 9-DEL-7F-45/60. Product is labeled... | Abbott Medical | GBK | ||
| Z-0350-05 | Amplatzer Delivery Systems (45-degree curve). order no. 9-DEL-6F-45/60. Product is... | Abbott Medical | GBK | ||
| Z-0111-06 | Lysus Infusion System - Lysus Drug Delivery Catheter: The Lysus Infusion System... | EKOS Corporation | KRA | ||
| Z-0241-06 | Gamma3 Long Nail Kit, 120 degree, 11 x 320mm Right. And 125 degree Nail. | Howmedica Osteonics Corp | NDH | ||
| Z-0577-05 | Cold Therapy Blanket | DeRoyal Industries, Inc. | ILO | ||
| Z-0410-05 | PASV PICC, 3F, single lumen, CUSTOM KIT - VANDERBILT UNIVERSITY MEDICAL CENTER. Catalog... | Boston Scientific Corporation | LJS | ||
| Z-0409-05 | VAXCEL WITH PASV PICC, 3F, single lumen. CUSTOM KIT - UNIVERSITY OF NEW MEXICO HOSPITAL... | Boston Scientific Corporation | LJS | ||
| Z-0408-05 | PASV PICC CUSTOM KIT, 3F, single lumen - CHILDREN''S HEALTHCARE OF ATLANTA, Catalog #... | Boston Scientific Corporation | LJS | ||
| Z-0407-05 | VAXCEL PASV Peripherally Inserted Central Catheter, 3F, single lumen: CUSTOM KIT... | Boston Scientific Corporation | LJS | ||
| Z-0406-05 | VAXCEL PASV Peripherally Inserted Central Catheter, 3F, single lumen, sold in kits... | Boston Scientific Corporation | LJS | ||
| Z-0405-05 | VAXCEL PASV Peripherally Inserted Central Catheter, 3F, single lumen, sold in a kit... | Boston Scientific Corporation | LJS | ||
| Z-0404-05 | VAXCEL PASV Peripherally Inserted Central Catheter, 3F, single lumen, sold in a kit... | Boston Scientific Corporation | LJS | ||
| Z-0403-05 | VAXCEL PASV Peripherally Inserted Central Catheter, 3F, single lumen. Catalog #45-450... | Boston Scientific Corporation | LJS | ||
| Z-0387-05 | Vitros CRP (C-Reactive Protein) Slides. Catalog #192 6740 contains 250 slides; Catalog... | Ortho-Clinical Diagnostics, Inc. | DCK | ||
| Z-0462-05 | Endopath EZ45 No Knife Linear Stapler (NK45G). | Ethicon Endo-Surgery Inc | GDW | ||
| Z-0461-05 | Endopath EZ45 Endoscopic Linear Cutter (ET45G). | Ethicon Endo-Surgery Inc | GDW | ||
| Z-0460-05 | Endopath EZ45 Endoscopic Linear Cutter (ET45B). | Ethicon Endo-Surgery Inc | GDW | ||
| Z-0459-05 | Endopath EZ45 Endoscopic Linear Cutter (EZ45G). | Ethicon Endo-Surgery Inc | GDW | ||
| Z-0458-05 | Endopath EZ45 No Knife Linear Stapler (NK45B). | Ethicon Endo-Surgery Inc | GDW | ||
| Z-0457-05 | Endopath EZ45 Endoscopic Linear Cutter (EZ45B) | Ethicon Endo-Surgery Inc | GDW | ||
| Z-0306-05 | EMBOL-X Slim Access Device / Aortic Cannula 24 Fr X 11''. | Edwards Lifesciences LLC | DWF | ||
| Z-0324-05 | Immulite 2500 insulin Kit | Siemens Healthcare Diagnostics Inc. | CFP | ||
| Z-0386-05 | Sabraset Administration Sets with AutoClamp; for use with model 6060 multi-therapy pumps... | Baxter Healthcare Corporation | FPA | ||
| Z-0296-05 | Universal Cable Adaptor (Part #17765-001and labeled on outer package as part no... | Pulmonetic Systems, Inc. | NOU | ||
| Z-0295-05 | Universal Cable Adaptor (Part #17765-001and labeled on outer package as part no... | Pulmonetic Systems, Inc. | NOU | ||
| Z-0294-05 | Universal Cable Adaptor (Part #17765-001and labeled on outer package as part no... | Pulmonetic Systems, Inc. | NOU | ||
| Z-0274-05 | Universal Cable Adaptor (Part #17765-001 and labeled on outer package as part no... | Pulmonetic Systems, Inc. | NOU | ||
| Z-0385-05 | Baxter labeled 6060 Solution Sets with AutoClamp; For use with model 6060 multi-therapy... | Baxter Healthcare Corporation | FPA | ||
| Z-0391-05 | Model 8561 Lioresal (Baclofen injection) Intrathecal Refill Kit is designed for refilling... | Medtronic Neuromodulation | LKK | ||
| Z-0372-05 | ACCU-CHEK Inform meter; catalog No. 3035123. | Roche Diagnostics GmbH | NBW | ||
| Z-0846-05 | Altaire, Magnetic Resonance Imaging Device. | FUJIFILM Healthcare Americas Corporation | LNH | ||
| Z-0555-05 | Cypher Sirolimus-eluting Coronary Stent on Raptor Over-the-Wire Delivery System... | Cordis US Corp. | NIQ | ||
| Z-0309-05 | Titanium Orthos Bracket | Ormco/Sybronendo | EJF | ||
| Z-0239-2008 | Stryker Renaissance Series PACU wheeled stretcher, Model 1731, Stryker Medical, Portage... | Stryker Medical | FPO | ||
| Z-0238-2008 | Stryker Renaissance Series PACU wheeled stretcher, Model 1711, Stryker Medical, Portage... | Stryker Medical | FPO | ||
| Z-0237-2008 | Stryker Renaissance Series PACU wheeled stretcher, Model 1710, Stryker Medical, Portage... | Stryker Medical | FPO | ||
| Z-0236-2008 | Stryker Renaissance Series/Advantage Series PACU wheeled stretcher, Model 1509, Stryker... | Stryker Medical | FPO | ||
| Z-0235-2008 | Stryker Renaissance Series/Advantage Series PACU wheeled stretcher, Model 1501, Stryker... | Stryker Medical | FPO | ||
| Z-0234-2008 | Stryker Renaissance Series Emergency Care wheeled stretcher, Model 1231, Stryker Medical... | Stryker Medical | FPO | ||
| Z-0233-2008 | Stryker Renaissance Series Emergency Care wheeled stretcher, Model 1211, Stryker Medical... | Stryker Medical | FPO | ||
| Z-0232-2008 | Stryker Renaissance Series Emergency Care wheeled stretcher, Model 1210, Stryker Medical... | Stryker Medical | FPO | ||
| Z-0231-2008 | Stryker Eye Surgery (Head/Neck Surgery) wheeled stretcher, Model 1069, Stryker Medical... | Stryker Medical | FPO | ||
| Z-0230-2008 | Stryker M-series powered patient transport stretcher, Model 1025 (SM304), Stryker... | Stryker Medical | FPO | ||
| Z-0229-2008 | Stryker Trauma wheeled stretcher, Model 1020, Stryker Medical, Portage, MI 49002 | Stryker Medical | FPO | ||
| Z-0228-2008 | Stryker M-Series wheeled stretcher, Model 1015 (SM204), Stryker Medical, Portage, MI 49002 | Stryker Medical | FPO | ||
| Z-0227-2008 | Stryker Advantage Series Emergency Care wheeled stretcher, Model 1009, Stryker Medical... | Stryker Medical | FPO | ||
| Z-0226-2008 | Stryker M-Series wheeled stretcher, Model 1005 (SM104), Stryker Medical, Portage, MI 49002 | Stryker Medical | FPO | ||
| Z-0225-2008 | Stryker Trauma wheeled stretcher, Model 1002, Stryker Medical, Portage, MI 49002 | Stryker Medical | FPO |