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-1736-2010 | EVA 450 Patient Lift Battery Charger. | Romedic, Inc. | FSA | ||
| Z-1785-2010 | Passport V Monitor: Mindray, North America. Mindray DS USA, Inc. Mahwah, NJ... | Datascope Corp. | MHX | ||
| Z-2548-2018 | Class II | AperFix Femoral Implant Coring Removal Drill, labeled as the following: a. Femoral... | Cayenne Medical Inc. | HTO | |
| Z-1994-2010 | FLEXIMA Biliary Stent System, 11.5Fr-15cm, M00539390, Sterile EO, Boston Scientific... | Boston Scientific Corporation | FGE | ||
| Z-1993-2010 | FLEXIMA Biliary Stent System, 11.5Fr-12cm, M00539380, Sterile EO, Boston Scientific... | Boston Scientific Corporation | FGE | ||
| Z-1992-2010 | FLEXIMA Biliary Stent System, 11.5Fr-10cm, M00539370, Sterile EO, Boston Scientific... | Boston Scientific Corporation | FGE | ||
| Z-1991-2010 | FLEXIMA Biliary Stent System, 11.5Fr-7cm, M00539360, Sterile EO, Boston Scientific... | Boston Scientific Corporation | FGE | ||
| Z-1990-2010 | FLEXIMA Biliary Stent System, 11.5Fr-5cm, M00539350, Sterile EO, Boston Scientific... | Boston Scientific Corporation | FGE | ||
| Z-1989-2010 | FLEXIMA Biliary Stent System, 10Fr-15cm, M00539340, Sterile EO, Boston Scientific... | Boston Scientific Corporation | FGE | ||
| Z-1988-2010 | FLEXIMA Biliary Stent System, 10Fr-12cm, M00539330, Sterile EO, Boston Scientific... | Boston Scientific Corporation | FGE | ||
| Z-1987-2010 | FLEXIMA Biliary Stent System, 10Fr-10cm, M00539320, Sterile EO, Boston Scientific... | Boston Scientific Corporation | FGE | ||
| Z-1986-2010 | FLEXIMA Biliary Stent System, 10Fr-7cm, M00539310, Sterile EO, Boston Scientific... | Boston Scientific Corporation | FGE | ||
| Z-1985-2010 | FLEXIMA Biliary Stent System, 10Fr-5cm, M00539300, Sterile EO, Boston Scientific... | Boston Scientific Corporation | FGE | ||
| Z-1984-2010 | FLEXIMA Biliary Stent System, 8.5Fr-15cm, M00539290, Sterile EO, Boston Scientific... | Boston Scientific Corporation | FGE | ||
| Z-1983-2010 | FLEXIMA Biliary Stent System, 8.5Fr-12cm, M00539280, Sterile EO, Boston Scientific... | Boston Scientific Corporation | FGE | ||
| Z-1982-2010 | FLEXIMA Biliary Stent System, 8.5Fr-10cm, M00539270, Sterile EO, Boston Scientific... | Boston Scientific Corporation | FGE | ||
| Z-1981-2010 | FLEXIMA Biliary Stent System, 8.5Fr-7cm, M00539260, Sterile EO, Boston Scientific... | Boston Scientific Corporation | FGE | ||
| Z-1980-2010 | FLEXIMA Biliary Stent System, 8.5Fr-5cm, M00539250, Sterile EO, Boston Scientific... | Boston Scientific Corporation | FGE | ||
| Z-1979-2010 | FLEXIMA Biliary Stent System, 7Fr-15cm, M00539240, Sterile EO, Boston Scientific... | Boston Scientific Corporation | FGE | ||
| Z-197-2010 | FLEXIMA Biliary Stent System, 7Fr-12cm, M00539230, Sterile EO, Boston Scientific... | Boston Scientific Corporation | FGE | ||
| Z-1977-2010 | FLEXIMA Biliary Stent System, 7Fr-10cm, M00539220, Sterile EO, Boston Scientific... | Boston Scientific Corporation | FGE | ||
| Z-1976-2010 | FLEXIMA Biliary Stent System, 7Fr-7cm, M00539210, Sterile EO, Boston Scientific, Spencer... | Boston Scientific Corporation | FGE | ||
| Z-1975-2010 | FLEXIMA Biliary Stent System, 7Fr-5cm, M00539200, Sterile EO, Boston Scientific, Spencer... | Boston Scientific Corporation | FGE | ||
| Z-1913-2010 | FemSoft Insert, Female Urethral Insert, Sterile (R), Rx Only. Assorted Sizes Multi-Pack... | Rochester Medical Corp. | OCK | ||
| Z-1912-2010 | FemSoft Insert, Female Urethral Insert, Size 3 Long, 4.5 cm Length, Sterile (R), Rx Only... | Rochester Medical Corp. | OCK | ||
| Z-1911-2010 | FemSoft Insert, Female Urethral Insert, Size 2 Long, 4.5 cm Length, Sterile (R), Rx Only... | Rochester Medical Corp. | OCK | ||
| Z-1910-2010 | FemSoft Insert, Female Urethral Insert, Size 1 Long, 4.5 cm Length, Sterile (R), Rx Only... | Rochester Medical Corp. | OCK | ||
| Z-1909-2010 | FemSoft Insert, Female Urethral Insert, Size 3 Standard, 3.5 cm Length, Sterile (R), Rx... | Rochester Medical Corp. | OCK | ||
| Z-1908-2010 | FemSoft Insert, Female Urethral Insert, Size 2 Standard, 3.5 cm Length, Sterile (R), Rx... | Rochester Medical Corp. | OCK | ||
| Z-1907-2010 | FemSoft Insert, Female Urethral Insert, Sterile (R), Rx Only. Assorted Sizes Multi-Pack... | Rochester Medical Corp. | OCK | ||
| Z-1906-2010 | FemSoft Insert, Female Urethral Insert, Size 1 Standard, 3.5 cm Length, REF 71201 or... | Rochester Medical Corp. | OCK | ||
| Z-1706-2010 | AIR OPTIX (lotrafilcon B) for Astigmatism Soft Contact Lenses. CIBA Vision, Corp. Duluth... | Alcon Laboratories | LPM | ||
| Z-2418-2010 | NexGen complete knee solution MIS total knee procedure stemmed tibial component fixed... | Zimmer GmbH | JWH | ||
| Z-2417-2010 | NexGen complete knee solution MIS total knee procedure stemmed tibial component fixed... | Zimmer GmbH | JWH | ||
| Z-2416-2010 | NexGen complete knee solution MIS total knee procedure stemmed tibial component fixed... | Zimmer GmbH | JWH | ||
| Z-2415-2010 | NexGen complete knee solution MIS total knee procedure stemmed tibial component fixed... | Zimmer GmbH | JWH | ||
| Z-2414-2010 | NexGen complete knee solution MIS total knee procedure stemmed tibial component fixed... | Zimmer GmbH | JWH | ||
| Z-2413-2010 | NexGen complete knee solution MIS total knee procedure stemmed tibial component fixed... | Zimmer GmbH | JWH | ||
| Z-2412-2010 | NexGen complete knee solution MIS total knee procedure stemmed tibial component fixed... | Zimmer GmbH | JWH | ||
| Z-2411-2010 | NexGen complete knee solution MIS total knee procedure stemmed tibial component fixed... | Zimmer GmbH | JWH | ||
| Z-2410-2010 | NexGen complete knee solution MIS total knee procedure stemmed tibial component fixed... | Zimmer GmbH | JWH | ||
| Z-2409-2010 | NexGen complete knee solution MIS total knee procedure stemmed tibial component fixed... | Zimmer GmbH | JWH | ||
| Z-2408-2010 | NexGen complete knee solution MIS total knee procedure stemmed tibial component fixed... | Zimmer GmbH | JWH | ||
| Z-2164-2010 | MIKA Speedblock, Size 8-12. The MIKA Speedblock is placed on the distal femur as a guide... | Encore Medical, LP | LXH | ||
| Z-2241-2012 | Class II | GE HC OEC 9900 Elite and GE OEC 9800 Fluoroscopes Snubber Boards are a PCB with a 70 amp... | GE Healthcare | OXO | |
| Z-1286-2012 | Product is labeled in part: "***REF: 01-7036, LOT 999999, "1.5MM" SYSTEM PLATE L-SHAPE... | Biomet Microfixation | JEY | ||
| Z-2288-2010 | ReliaMed Deluxe Portable Adjusting Table. Product is a medical table used on patients for... | MDC Acquisition Co. | FPS | ||
| Z-1599-2010 | Eon Mini Implantable Pulse Generator (IPG). Advanced Neuromodulation Systems, Inc... | Abbott Medical | LGW | ||
| Z-1685-2011 | Estrone Radioimmunoassay (RIA) Kit, DSL-8700. Intended for in vitro diagnostic use. | Siemens Healthcare Diagnostics Inc. | CGF | ||
| Z-0585-2011 | Active INTACT PTH, Part Number: DSL-8000 The DSL-80000 ACTIVE Intact PTH IRMA Kit... | Siemens Healthcare Diagnostics Inc. | CEW |