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-0421-2011 | Smith & Nephew FAST FIX 360, REVERSE CURVED NEEDLE Catalog Number; 72202469. Intended... | Smith & Nephew, Inc. | GAT | ||
| Z-0420-2011 | Smith & Nephew FAST FIX 360, CURVED NEEDLE Catalog Number; 72202468. Intended for use... | Smith & Nephew, Inc. | GAT | ||
| Z-0419-2011 | Smith & Nephew FAST FIX 360, STRAIGHT NEEDLE Catalog Number; 72202467. Intended for use... | Smith & Nephew, Inc. | GAT | ||
| Z-0401-2011 | Millar Disposable Angiographic Catheter (Left Heart), manufactured for Millar... | Millar LLC. | DQO | ||
| Z-2912-2011 | ***REF MCA5-08SD, QTY: 1***0.8 mm Diamond Ball, 5.6 cm. Use with Micro Curved... | The Anspach Effort, Inc. | HBE | ||
| Z-2911-2011 | ***REF MCA5-07SD, QTY: 1***0.7 mm Diamond Ball, 5.6 cm. Use with Micro Curved... | The Anspach Effort, Inc. | HBE | ||
| Z-2910-2011 | ***REF MCA5-06SD, QTY: 1***0.6 mm Diamond Ball, 5.6 cm. Use with Micro Curved... | The Anspach Effort, Inc. | HBE | ||
| Z-2909-2011 | ***REF MCA5-05SD, QTY: 1***0.5 mm Diamond Ball, 5.6 cm. Use with Micro Curved... | The Anspach Effort, Inc. | HBE | ||
| Z-2908-2011 | ***REF MCA5-2SD, QTY: 1***2 mm Diamond Ball, 5.6 cm. Use with Micro Curved Attachment... | The Anspach Effort, Inc. | HBE | ||
| Z-2907-2011 | ***REF MCA5-1SD, QTY: 1***1 mm Diamond Ball, 5.6 cm. Use with Micro Curved Attachment... | The Anspach Effort, Inc. | HBE | ||
| Z-2906-2011 | ***REF MCA5-2SB, QTY: 1***2 mm Fluted Ball, 5.6 cm. Use with Micro Curved Attachment... | The Anspach Effort, Inc. | HBE | ||
| Z-2905-2011 | ***REF MCA5-1SB, QTY: 1***1 mm Fluted Ball, 5.6 cm. Use with Micro Curved Attachment... | The Anspach Effort, Inc. | HBE | ||
| Z-2904-2011 | ***REF MCA5-15SD, QTY: 1***1.5 mm Diamond Ball, 5.6 cm. Use with Micro Curved... | The Anspach Effort, Inc. | HBE | ||
| Z-2903-2011 | "***REF MCA5-15SB QTY: 1***1.5 mm Fluted Ball, 5.6 cm. Use with Micro Curved Attachment... | The Anspach Effort, Inc. | HBE | ||
| Z-1849-2012 | Class II | Medtronic 0-arm Imaging System with Software Version 3.1.1, Catalog Numbers... | Medtronic Navigation, Inc | IZL | |
| Z-0969-2011 | Percutaneous Insertion Tray For Use with: Arrow Ultra 8 IAB (Intra Aortic Balloon)... | Arrow International LLC (subsidiary of Teleflex Incorporated) | DSP | ||
| Z-1824-2011 | Calcium Reagent, Calcium Test System for cobas c 111, Part number 04718933190... | Roche Diagnostics GmbH | CIC | ||
| Z-1823-2011 | Calcium Reagent, Calcium Test System for COBAS INTEGRA 400, 400 PLUS, 800, 800 CTS... | Roche Diagnostics GmbH | CIC | ||
| Z-0430-2011 | Medtronic Dual Chamber Temporary Pacemaker, model 5388. Manufacturer: Medtronic, Inc... | Medtronic, Inc. | LWP | ||
| Z-0793-2011 | FiberOptix IAB Ultra 8 Fr, 40cc Model: IAB-05840-LWS | Arrow International LLC (subsidiary of Teleflex Incorporated) | DSP | ||
| Z-0792-2011 | FiberOptix IAB Sheath, Ultra 8 Fr, 30cc. Model: IAB-05830-LWS | Arrow International LLC (subsidiary of Teleflex Incorporated) | DSP | ||
| Z-0791-2011 | Arrow Ultra 8 IAB (Intra-Aortic Balloon) Catheter, 8 Fr, 40cc. Model: IAB-05840-U | Arrow International LLC (subsidiary of Teleflex Incorporated) | DSP | ||
| Z-0790-2011 | Arrow Ultra 8 IAB (Intra-Aortic Balloon) Catheter, 8 Fr, 30cc. Model: IAB-05830-U | Arrow International LLC (subsidiary of Teleflex Incorporated) | DSP | ||
| Z-0359-2011 | Power supply boards on Dash 3000, 4000 and 5000 Monitors. GE Healthcare, 8200 West Tower... | GE Healthcare | MHX | ||
| Z-0400-2013 | Class II | 00780304001 MIS 12/14 Slotted Femoral Head Provisional -3.5X36 00780304002 MIS 12/14... | Zimmer GmbH | HWT | |
| Z-0399-2013 | Class II | 00780303601 MIS 12/14 Slotted Femoral Head Provisional -3.5X36 00780303602 MIS 12/14... | Zimmer GmbH | HWT | |
| Z-0398-2013 | Class II | 00780303201 MIS 12/14 Slotted Femoral Head Provisional -3.5X32 00780303202 MIS 12/14... | Zimmer GmbH | HWT | |
| Z-0397-2013 | Class II | 00780302801 MIS 12/14 Slotted Femoral Head Provisional -3.5X28 00780302802 MIS 12/14... | Zimmer GmbH | HWT | |
| Z-0396-2013 | Class II | 00780302601 MIS 12/14 Slotted Femoral Head Provisional -3.5X26 00780302602 MIS 12/14... | Zimmer GmbH | HWT | |
| Z-0395-2013 | Class II | 00780302201 MIS 12/14 Slotted Femoral Head Provisional -2X22 00780302202 MIS 12/14... | Zimmer GmbH | HWT | |
| Z-0394-2013 | Class II | 00789504001 VerSys Femoral Head Provisional 40mm -3.5 00789504002 VerSys Femoral Head... | Zimmer GmbH | HWT | |
| Z-0393-2013 | Class II | . 00789503601 VerSys Femoral Head Provisional 36mm -3.5 00789503602 VerSys Femoral Head... | Zimmer GmbH | HWT | |
| Z-0392-2013 | Class II | 00789503201 VerSys Femoral Head Provisional 32mm -3.5 00789503202 VerSys Femoral Head... | Zimmer GmbH | HWT | |
| Z-0391-2013 | Class II | . 00789502801 VerSys Femoral Head Provisional 28mm -3.5 00789502802 VerSys Femoral Head... | Zimmer GmbH | HWT | |
| Z-0390-2013 | Class II | 00789502601 VerSys Femoral Head Provisional 26mm -3.5 00789502602 VerSys Femoral Head... | Zimmer GmbH | HWT | |
| Z-0389-2013 | Class II | Product 100789502202 VerSys Femoral Head Provisional 22mm +0 00789502203 VerSys Femoral... | Zimmer GmbH | HWT | |
| Z-0464-2011 | DX-G Digitizer, manufactured by Agfa-Gevart NV, Mortsel, Belgium. | AGFA Healthcare Corp. | MQB | ||
| Z-0491-2011 | AdvanDx EK/P. aeruginosa PNA FISH- Culture Identification Kit for identification of E... | Advandx, Inc. | JSS | ||
| Z-2852-2011 | "***REF: 24-4050 TMJ SYSTEM ArthroSimplicity KIT***STERILE PRODUCT***STERILE EO***KIT... | Biomet Microfixation | KDD | ||
| Z-2851-2011 | "***REF: 922090 TMJ SYSTEM InnerVue SCOPE PROCEDURE KIT***STERILE PRODUCT***STERILE... | Biomet Microfixation | KDD | ||
| Z-2850-2011 | "***REF: 24-3050 TMJ SYSTEM OnPoint SCOPE PROCEDURE KIT***STERILE PRODUCT***STERILE... | Biomet Microfixation | KDD | ||
| Z-2849-2011 | "***REF: 922070 TMJ SYSTEM ARTHROSIMPLICITY KIT***STERILE PRODUCT***STERILE... | Biomet Microfixation | KDD | ||
| Z-1657-2011 | Philips OmniDiagnost Eleva, a diagnostic-imaging device intended for radiographic... | Philips North America LLC | IZI | ||
| Z-1656-2011 | Philips MultiDiagnost Eleva system, a diagnostic-imaging device intended for... | Philips North America LLC | IZI | ||
| Z-1655-2011 | Philips Allura Integris Systems with OMCP Generator, x-ray diagnostic system... | Philips North America LLC | IZI | ||
| Z-1654-2011 | Philips Allura Xper Systems with Velara Generator, x-ray system. FCO72200184. | Philips North America LLC | IZI | ||
| Z-1849-2011 | HEMOCUE AB Hb 201 DM ANALYZER, in vitro diagnostic device for quantitative hemoglobin... | Hemo Cue, Inc. | GKR | ||
| Z-1848-2011 | HEMOCUE AB GLUCOSE 201 DM ANALYZER, in vitro diagnostic device for quantitative... | Hemo Cue, Inc. | CGA | ||
| Z-0391-2011 | Sorin OptiPack, Perfusion Tubing Set, Sterile EO, REF 084504800, Manufactured by Sorin... | LivaNova USA, Inc. | DWF | ||
| Z-0390-2011 | Sorin OptiPack, Perfusion Tubing Set, Sterile EO, REF 084504500, Manufactured by Sorin... | LivaNova USA, Inc. | DWF |