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-2270-2021 | Class II | Arcos Modular Revision Hip System High Offset Cone Prox Body, Size A, 70 MM Item... | Zimmer GmbH | KWA | |
| Z-2269-2021 | Class II | Arcos Modular Revision Hip System Standard Cone Prox Body, Size E, 70 MM Item... | Zimmer GmbH | KWA | |
| Z-2268-2021 | Class II | Arcos Modular Revision Hip System Standard Cone Prox Body, Size B, 70 MM Item Number... | Zimmer GmbH | KWA | |
| Z-2267-2021 | Class II | Arcos Modular Revision Hip System Standard Cone Prox Body, Size A, 70 MM Item... | Zimmer GmbH | KWA | |
| Z-2266-2021 | Class II | Arcos Modular Revision Hip System High Offset Cone Prox Body, Size E, 60 MM Item... | Zimmer GmbH | KWA | |
| Z-2265-2021 | Class II | Arcos Modular Revision Hip System High Offset Cone Prox Body, Size D, 60 MM Item... | Zimmer GmbH | KWA | |
| Z-2264-2021 | Class II | Arcos Modular Revision Hip System High Offset Cone Prox Body, Size B, 60 MM Item Number... | Zimmer GmbH | KWA | |
| Z-2263-2021 | Class II | Arcos Modular Revision Hip System High Offset Cone Prox Body, Size A, 60 MM Item Number... | Zimmer GmbH | KWA | |
| Z-2262-2021 | Class II | Arcos Modular Revision Hip System High Offset Cone Prox Body, Size A, 50 MM Item Number... | Zimmer GmbH | KWA | |
| Z-2261-2021 | Class II | Arcos Modular Revision Hip System Standard Cone Prox Body, Size B, 60 MM Item Number... | Zimmer GmbH | KWA | |
| Z-2260-2021 | Class II | Arcos Modular Revision Hip System Standard Cone Prox Body, Size A, 60 MM Item Number... | Zimmer GmbH | KWA | |
| Z-2259-2021 | Class II | Arcos Modular Revision Hip System Standard Cone Prox Body, Size A, 50 MM Item Number... | Zimmer GmbH | KWA | |
| Z-2228-2021 | Class II | Medtronic StimLoc Burr Hole Cover, Part Numbers: a) 3387S-40 b) 3389S-28 c) 3389S-40 d)... | Medtronic Neuromodulation | GXR | |
| Z-2081-2021 | Class II | ANCILLARY ADULT 140-DOSE CONVENIENCE KIT, ITEM #1189482, for the administration of the... | Mckesson Medical-Surgical Inc. Corporate Office | QMT | |
| Z-2224-2021 | Class II | CODMAN RANEY SCALP CLIPS-Disposable cylindrical clips designed to provide hemostasis to... | Integra LifeSciences Corporation | HBO | |
| Z-2102-2021 | Class II | Medtronic Reveal LINQ LNQ11 / PA96000 | Medtronic, Inc. | MXD | |
| Z-1896-2021 | Class II | OSSUR MIAMI J SELECT COLLAR - Product Usage: is intended to provide gross immobilization... | Ossur Americas | IQK | |
| Z-2375-2021 | Class II | Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch... | Medtronic, Inc. | MSD | |
| Z-2374-2021 | Class II | Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch... | Medtronic, Inc. | MSD | |
| Z-2373-2021 | Class II | Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch... | Medtronic, Inc. | MSD | |
| Z-2372-2021 | Class II | Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch... | Medtronic, Inc. | MSD | |
| Z-2371-2021 | Class II | Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch... | Medtronic, Inc. | MSD | |
| Z-2370-2021 | Class II | Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch... | Medtronic, Inc. | MSD | |
| Z-2369-2021 | Class II | Palindrome RT Repair Kit 15 FR TAL 55cm, Sterile, Item Code 8888541155 | Medtronic, Inc. | MSD | |
| Z-2368-2021 | Class II | Palindrome RT Repair Kit 15 FR TAL 44cm, Sterile, Item Code 8888541144 | Medtronic, Inc. | MSD | |
| Z-2367-2021 | Class II | Palindrome RT Repair Kit 15 FR TAL 33cm, Sterile, Item Code 8888541133 | Medtronic, Inc. | MSD | |
| Z-2366-2021 | Class II | Palindrome RT Repair Kit 15 FR TAL 28cm, Sterile, Item Code 8888541128 | Medtronic, Inc. | MSD | |
| Z-2365-2021 | Class II | Palindrome RT Repair Kit 15 FR TAL 23cm, Sterile, Item Code 8888541123 | Medtronic, Inc. | MSD | |
| Z-2364-2021 | Class II | Palindrome RT Repair Kit 15 FR TAL 19cm, Sterile, Item Code 8888541119 | Medtronic, Inc. | MSD | |
| Z-2363-2021 | Class II | Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x... | Medtronic, Inc. | MSD | |
| Z-2362-2021 | Class II | Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x... | Medtronic, Inc. | MSD | |
| Z-2361-2021 | Class II | Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x... | Medtronic, Inc. | MSD | |
| Z-2360-2021 | Class II | Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x... | Medtronic, Inc. | MSD | |
| Z-2359-2021 | Class II | Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x... | Medtronic, Inc. | MSD | |
| Z-2358-2021 | Class II | Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x... | Medtronic, Inc. | MSD | |
| Z-2156-2021 | Class II | Affinity Four Birthing Bed-used as a birthing bed for women of child bearing age in an... | Hill-Rom Inc. | KNC | |
| Z-2109-2021 | Class II | Stimulen Collagen Moisturizing Lotion, ST9555B | Southwest Technologies Inc | KGN | |
| Z-2072-2021 | Class II | HeartWare, HVAD Pump Implant Kit, REF MCS1705PU - Product Usage: indicated for... | HeartWare, Inc. | DSQ | |
| Z-2025-2021 | Class II | Aequalis Ascend Flex Shoulder System Reversed Platform (Reversed Tray component) Rx Only... | TORNIER Inc. | KWS | |
| Z-2323-2021 | Class II | Cytocell LPH019-A E2A (TCF3) Breakapart Probe- In Vitro Diagnostic Analyte specific... | Cytocell Limited | MVU | |
| Z-2198-2021 | Class II | Straumann SCS Screwdriver, driver, for ratchet, short, L 21mm, stainless steel Article... | Straumann USA, LLC | NDP | |
| Z-2171-2021 | Class II | Nail Insertion Sleeve, elastic T2 Tibia SPI 8-11 (SPI Elast. Sleeve 8-11), Catalog Number... | Stryker Corp. | HSB | |
| Z-2170-2021 | Class II | Nail Insertion Sleeve, elastic T2 Tibia SPI 8-13 (SPI Elast. Sleeve 8-13), Catalog Number... | Stryker Corp. | HSB | |
| Z-2029-2021 | Class II | ARTIS pheno- angiography systems developed for single and biplane diagnostic imaging and... | Siemens Medical Solutions USA, Inc. | OWB | |
| Z-2108-2021 | Class III | 3AA battery cradle (Part Number 045-001699-01) used with BeneVision TD60 Telepack (Model... | Datascope Corp. | MSX | |
| Z-2106-2021 | Class II | Cell Marque Antibodies, MSH6 (44), Mouse Monoclonal Antibody, REF: 287M-10, IVD, CE... | Cell Marque Corp. | MVU | |
| Z-2105-2021 | Class II | Cell Marque, RabMAb,CD17, c-kit (YR145) Rabbit Monoclonal Primary Antibody, REF: 117R-18... | Cell Marque Corp. | MVU | |
| Z-0886-2022 | Class II | Azurion systems with software release R1.x | Philips Medical Systems Nederland B.V. | OWB | |
| Z-0734-2022 | Class II | Azurion systems with software release R2.0.x | Philips North America LLC | OWB | |
| Z-2155-2021 | Class II | Proteus 235-Proton Therapy System | Ion Beam Applications S.A. | LHN |
