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-2133-2021 | Class II | Exactech Connexion GXL acetabular polyethylene liners used in the following systems... | Exactech, Inc. | LPH | |
| Z-2132-2021 | Class II | Exactech Connexion GXL acetabular polyethylene liners used in the following systems... | Exactech, Inc. | LZO | |
| Z-2131-2021 | Class II | Exactech Connexion GXL acetabular polyethylene liners used in the following systems... | Exactech, Inc. | LPH | |
| Z-2130-2021 | Class II | Exactech Connexion GXL acetabular polyethylene liners used in the following systems... | Exactech, Inc. | LPH | |
| Z-2129-2021 | Class II | Exactech Connexion GXL acetabular polyethylene liners used in the following systems... | Exactech, Inc. | LZO | |
| Z-2128-2021 | Class II | Exactech Connexion GXL acetabular polyethylene liners used in the following systems... | Exactech, Inc. | LZO | |
| Z-2127-2021 | Class II | Exactech Connexion GXL acetabular polyethylene liners used in the following systems... | Exactech, Inc. | LZO | |
| Z-2126-2021 | Class II | Exactech Connexion GXL acetabular polyethylene liners used in the following systems... | Exactech, Inc. | LZO | |
| Z-2125-2021 | Class II | Exactech Connexion GXL acetabular polyethylene liners used in the following systems... | Exactech, Inc. | LPH | |
| Z-2124-2021 | Class II | Exactech Connexion GXL acetabular polyethylene liners used in the following systems... | Exactech, Inc. | LPH | |
| Z-2123-2021 | Class II | Exactech Connexion GXL acetabular polyethylene liners used in the following systems... | Exactech, Inc. | LPH | |
| Z-2122-2021 | Class II | Exactech Connexion GXL acetabular polyethylene liners used in the following systems... | Exactech, Inc. | LPH | |
| Z-2121-2021 | Class II | Exactech Connexion GXL acetabular polyethylene liners used in the following systems... | Exactech, Inc. | LPH | |
| Z-2120-2021 | Class II | Exactech Connexion GXL acetabular polyethylene liners used in the following systems... | Exactech, Inc. | LPH | |
| Z-2119-2021 | Class II | Exactech Connexion GXL acetabular polyethylene liners used in the following systems... | Exactech, Inc. | LPH | |
| Z-2118-2021 | Class II | Exactech Connexion GXL acetabular polyethylene liners used in the following systems... | Exactech, Inc. | LPH | |
| Z-2117-2021 | Class II | Exactech Connexion GXL acetabular polyethylene liners used in the following systems... | Exactech, Inc. | LPH | |
| Z-2116-2021 | Class II | Exactech Connexion GXL acetabular polyethylene liners used in the following systems... | Exactech, Inc. | LPH | |
| Z-2115-2021 | Class II | Exactech Connexion GXL acetabular polyethylene liners used in the following systems... | Exactech, Inc. | LPH | |
| Z-2114-2021 | Class II | Exactech Connexion GXL acetabular polyethylene liners used in the following systems... | Exactech, Inc. | LPH | |
| Z-2113-2021 | Class II | Exactech Connexion GXL acetabular polyethylene liners used in the following systems... | Exactech, Inc. | LPH | |
| Z-2112-2021 | Class II | Exactech Connexion GXL acetabular polyethylene liners used in the following systems... | Exactech, Inc. | LPH | |
| Z-2384-2021 | Class II | MY01 Continuous Compartmental Pressure Monitor, Reference Number MY01-0001 | MY01, Inc. | LXC | |
| Z-2331-2021 | Class II | AltiVate Anatomic Shoulder System for the following Part Numbers: 1. Part # 520-08-00... | Encore Medical, LP | KWS | |
| Z-2336-2021 | Class II | KeyPrint Soft- bottle, 32.5 oz (1kg). Resin for the fabrication of orthodontic and dental... | Straumann USA, LLC | MQC | |
| Z-2310-2021 | Class II | OPTI SARS-CoV-2 RT-PCR Test, REF Numbers: a) 99-57003 b) 99-57004 | Opti Medical Systems Inc | QJR | |
| Z-2246-2021 | Class II | Cutting Electrode Bipo 24.5Fr, Ref 4653.1323 | Richard Wolf GmbH | FJL | |
| Z-2137-2021 | Class II | Infusomat Space Volumetric Pump Administration Set, Product Code 490100 | B Braun Medical Inc | FPA | |
| Z-2291-2021 | Class II | The Aequalis Pyrocarbon Humeral Heads. Shoulder implant component. Sold OUS only: a)... | Tornier S.A.S. | QHE | |
| Z-0069-2022 | Class II | CardioQuip, Modular Cooler-Heater 1000(i), Refrigeration Module, Model: MCH-10RMS, UDI... | CardioQuip | DWC | |
| Z-2590-2021 | Class II | AMX Navigate Mobile X-Ray System | GE Healthcare | IZL | |
| Z-2444-2021 | Class II | cobas infinity central lab running software version 3.01.03 through 3.02.08, Catalog#... | Roche Diagnostics GmbH | JQP | |
| Z-2226-2021 | Class II | ETEST IMIPENEM RELEBACTAM. in vitro diagnostic | bioMerieux, Inc. | JWY | |
| Z-2249-2021 | Class II | TIN3018 Illinois Bone Marrow Aspiration/Intraosseous Infusion Needle 18G x 79mm TIN3015... | Bard Peripheral Vascular Inc | KNW | |
| Z-2248-2021 | Class II | EJM4011 Jamshidi Evolve" Bone Marrow Biopsy/Aspiration Needle with Specimen Cradle. 11G x... | Bard Peripheral Vascular Inc | KNW | |
| Z-2247-2021 | Class II | TJM6008 Jamshidi" Crown Bone Marrow Biopsy/Aspiration Needle with Marrow Acquisition... | Bard Peripheral Vascular Inc | KNW | |
| Z-2240-2021 | Class II | Covidien Sonicision Reusable Generator-converts electrical power from the battery pack to... | Medtronic, Inc. | LFL | |
| Z-2241-2021 | Class II | Kaluza C Flow Cytometry Software Versions: 1.0*, 1.1.1 and 1.1.2 Kits: C10574 - Kaluza C... | Siemens Healthcare Diagnostics Inc. | JQP | |
| Z-2225-2021 | Class II | MYLA software. Used to manage microbiology test workflow from the reception of requests... | bioMerieux, Inc. | N/A | |
| Z-0956-2025 | Class II | muRata Vios Monitoring System Model 2050; bedside cardiac monitor, including... | Murata Vios, Inc. | DRT | |
| Z-2453-2021 | Class II | Configura Advance Chair, Model Number: CHAIR-0-SC1-030; Advance Chair, 100mm Castors, Std... | Accora Ltd | INM | |
| Z-2305-2021 | Class II | WOLF-PAK Self Safe Safety IV Catheter: a) REF PIVD2010W b) REF PIV2210W c) REF PIV2475W | Delta Med SpA | FOZ | |
| Z-2304-2021 | Class II | NEO DELTA SELFSAFE PUR T, I.V. Catheter: | Delta Med SpA | FOZ | |
| Z-2303-2021 | Class II | NEO DELTA SELFSAFE PUR T, I.V. Catheter: a) REF 3738522 b) REF 3738822 | Delta Med SpA | FOZ | |
| Z-2302-2021 | Class II | NEO DELTA SELFSAFE PUR 1, I.V. Catheter, REF 3718122 | Delta Med SpA | FOZ | |
| Z-2301-2021 | Class II | NEO DELTA Self Safe T, I.V. catheter of PUR a) REF 3779422 b) REF 3769522 c) REF 3708522 | Delta Med SpA | FOZ | |
| Z-2300-2021 | Class II | NEO DELTA Self Safe 1, I.V. Catheter with PUR REF 3708122, Lot 00A1160627 5000 units | Delta Med SpA | FOZ | |
| Z-2299-2021 | Class II | NEO DELTA Self Safe, I.V. Catheter REF 3738222 | Delta Med SpA | FOZ | |
| Z-2298-2021 | Class II | DELTAVEN Y, Safety I.V. Catheter in Pur with closed system a) REF 3832072 b) REF... | Delta Med SpA | FOZ | |
| Z-2297-2021 | Class II | DELTAVEN FASTFLASH, Safety I.V. Catheter in Pur with closed system: a) REF 3814773 b) REF... | Delta Med SpA | FOZ |