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-0917-2023 | Class II | 6.5 cm Adult Craniotome, Thin Foot Plate Attachment. Use with XMax, microMax, and eMax... | The Anspach Effort, Inc. | HBC | |
| Z-0916-2023 | Class II | 6.5 cm Adult Rotating Craniotome Attachment. Use with XMax, microMax, and eMax... | The Anspach Effort, Inc. | HBC | |
| Z-0877-2023 | Class I | MAHURKAR 13.5Fr High Flow Dual Lumen Acute Dialysis Catheter, Sterile, Single Use, Rx... | Medtronic, Inc. | NIE | |
| Z-1234-2023 | Class II | Patient-Fitted Temporomandibular (TMJ) Reconstruction Prosthesis | Stryker Leibinger GmbH & Co. KG | LZD | |
| Z-1016-2023 | Class II | Future Diagnostics STAT-IntraOperative-Intact-PTH (STAT-IO-I-PTH) Immunoassay kit REF... | Future Diagnostics Solutions B.V. | CEW | |
| Z-0471-2023 | Class II | NexGen Option Stemmed Tibial Component Size 8, Item Number 00-5986-057-02 | Zimmer GmbH | JWH | |
| Z-0470-2023 | Class II | NexGen Option Stemmed Tibial Component Size 7, Item Number 00-5986-057-01 | Zimmer GmbH | JWH | |
| Z-0469-2023 | Class II | NexGen Option Stemmed Tibial Component Size 6, Item Number 00-5986-047-02 | Zimmer GmbH | JWH | |
| Z-0468-2023 | Class II | NexGen Option Stemmed Tibial Component Size 5, Item Number 00-5986-047-01 | Zimmer GmbH | JWH | |
| Z-0467-2023 | Class II | NexGen Option Stemmed Tibial Component Size 4, Item Number 00-5986-037-02 | Zimmer GmbH | JWH | |
| Z-0466-2023 | Class II | NexGen Option Stemmed Tibial Component Size 3, Item Number 00-5986-037-01 | Zimmer GmbH | JWH | |
| Z-0926-2023 | Class I | SHIP KIT, LIFESPARC, CONTROLLER AND ACCESSORIES - 5900-0000; SHIP KIT, LIFESPARC... | Cardiac Assist, Inc | DWA | |
| Z-1004-2023 | Class II | Agfa HealthCare Enterprise Imaging XERO Viewer | AGFA Healthcare Corp. | LLZ | |
| Z-1017-2023 | Class II | Invisalign Express 10 REF 8512 Invisalign System Comprehensive REF 9000 Invisalign... | Align Technology, Inc. | PNN | |
| Z-1038-2023 | Class II | Turbett Surgical Container, TS1000: Indicated for enclosing other medical devices that... | TURBETT SURGICAL, Inc | FRG | |
| Z-1037-2023 | Class II | Turbett Surgical Container, TS1200: Indicated for enclosing other medical devices that... | TURBETT SURGICAL, Inc | FRG | |
| Z-0719-2023 | Class II | Oncentra Brachy radiation therapy planning system software. | Elekta Limited | MUJ | |
| Z-0725-2023 | Class III | Denticator PICK-A-DENT, periodontal aid - intradental pick, REF 621714 | Young Dental Manufacturing Co 1, LLC. | JET | |
| Z-0915-2023 | Class II | Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems for pain... | Medtronic Neuromodulation | LGW | |
| Z-0914-2023 | Class II | Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems for pain... | Medtronic Neuromodulation | LGW | |
| Z-0913-2023 | Class II | Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems for pain... | Medtronic Neuromodulation | LGW | |
| Z-0912-2023 | Class II | Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems for pain... | Medtronic Neuromodulation | LGW | |
| Z-0911-2023 | Class II | Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems for pain... | Medtronic Neuromodulation | LGW | |
| Z-1182-2023 | Class II | Custom Suture Pack Product Description: US1638 CUSTOM SUTURE PACK US1756 CUSTOM SUTURE... | Medtronic, Inc. | GAT | |
| Z-1181-2023 | Class II | Ti-Cron Coated Braided Polyester Suture Product Description 88862775-31 TICRON* 4-0 BLU... | Medtronic, Inc. | GAT | |
| Z-1180-2023 | Class II | Surgipro II Monofilament Polypropylene Sutures Product Description Model Number VP-421X... | Medtronic, Inc. | GAW | |
| Z-1179-2023 | Class II | Surgipro Monofilament Polypropylene Sutures Product Description CP-535 SURGIPRO* 1 BLU... | Medtronic, Inc. | GAW | |
| Z-1178-2023 | Class II | Surgilon Braided Nylon suture Product Description: 88861883-51 SURGILON* 2-0 BLK 75CM... | Medtronic, Inc. | GAR | |
| Z-1177-2023 | Class II | Surgidac Uncoated Braided Polyester suture Product Description D-1764K SURGIDAC*... | Medtronic, Inc. | GAT | |
| Z-1176-2023 | Class II | Sofsilk Coated Braided Silk Suture Product Description CS-211 SOFSILK* 4-0 BLK... | Medtronic, Inc. | GAP | |
| Z-1175-2023 | Class II | Novafil Monofilament Polybutester Suture Product Description: 8886 4002-41 NOVAFIL 3-0... | Medtronic, Inc. | GAT | |
| Z-1174-2023 | Class II | Monosof Monofilament Nylon sutures: Product Description CN-724 MONOSOF* 1 BLK 100CM GS25... | Medtronic, Inc. | GAR | |
| Z-1173-2023 | Class II | Monofilament Nylon Suture (McKesson Branded) and Coated Braided Silk Suture (McKesson... | Medtronic, Inc. | GAR | |
| Z-1172-2023 | Class II | Dermalon Monofilament Nylon Suture: (1) 88861741-11 DERMALON* 6-0 BLU 45CM C1 (2)... | Medtronic, Inc. | GAR | |
| Z-0909-2023 | Class II | Codman Surgical Patties, Part number 801400; SURG PATXRAY 1/2X1/2-200; Lot 6396457 | Integra LifeSciences Corporation | HBA | |
| Z-0771-2023 | Class II | Remington MEDICAL, Automatic Cutting Needle, 18ga (1.3mm) x 20cm, REF NAC-1820M (1) | Remington Medical | KNW | |
| Z-0766-2023 | Class II | Lamaze Chill Teether, Fluid-Filled Teething Ring, Model No. Y5288L | TOMY International | KKO | |
| Z-0880-2023 | Class II | ActiveAid 922, Shower/Commode Chair | Altimate Medical, Inc. | INN | |
| Z-0910-2023 | Class II | Source Administration Set (SAS) used with the Medrad Intego PET Infusion System... | Medrad, Inc. | FRN | |
| Z-0782-2023 | Class II | Beaver EdgeAhead Stiletto/MVR Knife .90mm Straight (20G)-for ocular paracentesis... | Becton Dickinson & Co | HNN | |
| Z-1036-2023 | Class II | OSS Modular Arthrodesis Nail, 7 Degree Collar Assembly with Locking Bolts-For use in the... | Zimmer GmbH | HSB | |
| Z-0750-2023 | Class II | HeartWare HVAD Pump Kit, REF MCS1705PU | HeartWare, Inc. | DSQ | |
| Z-0749-2023 | Class II | HeartWare HVAD Pump Kit, REF 1205 | HeartWare, Inc. | DSQ | |
| Z-0748-2023 | Class II | HeartWare HVAD Pump Kit, REF 1104JP | HeartWare, Inc. | DSQ | |
| Z-0747-2023 | Class II | HeartWare HVAD Pump Kit, REF 1104CA-CLIN | HeartWare, Inc. | DSQ | |
| Z-0746-2023 | Class II | HeartWare HVAD Pump Kit, REF 1104 | HeartWare, Inc. | DSQ | |
| Z-0745-2023 | Class II | HeartWare HVAD Pump Kit, REF 1103 | HeartWare, Inc. | DSQ | |
| Z-0744-2023 | Class II | HeartWare Model 1102 | HeartWare, Inc. | DSQ | |
| Z-0743-2023 | Class II | HeartWare Model 1101 | HeartWare, Inc. | DSQ | |
| Z-0742-2023 | Class II | HeartWare Model 1100 | HeartWare, Inc. | DSQ |