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-2194-2020 | Class II | Gambro Cartridge Blood Transport System for Hemodialysis Blood Set - Product Usage: is... | Baxter Healthcare Corporation | FJK | |
| Z-2156-2020 | Class II | Knee Products: TMJPM-1510 Microfixation Custom Made Device, Left PM-TMJ... | Zimmer GmbH | N/A | |
| Z-2155-2020 | Class II | Knee Products: US154709 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Right... | Zimmer GmbH | HRY | |
| Z-2154-2020 | Class II | Knee Products: 184762 Knees Vanguard Knee System, Series-A Standard Patella, 28... | Zimmer GmbH | JWH | |
| Z-2153-2020 | Class II | Knee Products: 183742 Vanguard Knee System, PS+ Tibial Bearing, 12 MM, 71/75... | Zimmer GmbH | JWH | |
| Z-2152-2020 | Class II | Knee Products: 189420 Vanguard Knee System, PS Mono Lock Tibial Bearing, 10 MM X 63... | Zimmer GmbH | JWH | |
| Z-2151-2020 | Class II | Knee Products: 189260 Vanguard Knee System, CR-L Mono Lock Tibial Bearing, 10 MM X 71... | Zimmer GmbH | JWH | |
| Z-2150-2020 | Class II | Knee Products: 183622 Vanguard Knee System PS Tibial Bearing, 12 MM X 63/67... | Zimmer GmbH | JWH | |
| Z-2149-2020 | Class II | Knee Products: 155308 Knees AGC Knee System PS Molded Tibial Component, 10 MM X 65... | Zimmer GmbH | JWH | |
| Z-2148-2020 | Class II | Knee Products: 154335 Oxford Partial Knee System, Fixed Lateral Tibial Construct, Left... | Zimmer GmbH | HRY | |
| Z-2147-2020 | Class II | Knee Products: 150414 Orthopedic Salvage System (OSS) Tibial Bearing, 20 MM Standard... | Zimmer GmbH | JDI | |
| Z-2146-2020 | Class II | Knee Products: 141356 Regenerex Series-A Patella 3 Peg, 31 MM 141358 Regenerex Series-A... | Zimmer GmbH | MBH | |
| Z-2145-2020 | Class II | Hip Products Item Number: 1) 110010462 RingLoc Hip System, Acetabular Bi-Polar Cup, 28... | Zimmer GmbH | LZO | |
| Z-2144-2020 | Class II | Extremities Item Number: 1)113954 Hybrid Glenoid Glenoid Base, 4 MM 2)... | Zimmer GmbH | PHX | |
| Z-2193-2020 | Class II | Gambro Cartridge Blood Set Prime Line - Product Usage: is intended for single use in a... | Baxter Healthcare Corporation | FJK | |
| Z-2099-2020 | Class II | Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 68 right, Sterile... | Howmedica Osteonics Corp | LPH | |
| Z-2098-2020 | Class II | Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 68 left, Sterile... | Howmedica Osteonics Corp | LPH | |
| Z-2097-2020 | Class II | Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 66 right, Sterile... | Howmedica Osteonics Corp | LPH | |
| Z-2096-2020 | Class II | Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 64 right, Sterile... | Howmedica Osteonics Corp | LPH | |
| Z-2095-2020 | Class II | Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 66 left, Sterile... | Howmedica Osteonics Corp | LPH | |
| Z-2094-2020 | Class II | Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 64 left, Sterile... | Howmedica Osteonics Corp | LPH | |
| Z-2093-2020 | Class II | Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 62 right, Sterile... | Howmedica Osteonics Corp | LPH | |
| Z-2092-2020 | Class II | Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 62 left, Sterile... | Howmedica Osteonics Corp | LPH | |
| Z-2091-2020 | Class II | Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 60 right, Sterile... | Howmedica Osteonics Corp | LPH | |
| Z-2090-2020 | Class II | Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 60 Left, Sterile... | Howmedica Osteonics Corp | LPH | |
| Z-2089-2020 | Class II | Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 58 Right, Sterile... | Howmedica Osteonics Corp | LPH | |
| Z-2088-2020 | Class II | Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 56 Right, Sterile... | Howmedica Osteonics Corp | LPH | |
| Z-2087-2020 | Class II | Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 58 Left, Sterile... | Howmedica Osteonics Corp | LPH | |
| Z-2086-2020 | Class II | Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 56 Left, Sterile... | Howmedica Osteonics Corp | LPH | |
| Z-2085-2020 | Class II | Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 54 Right, Sterile... | Howmedica Osteonics Corp | LPH | |
| Z-2084-2020 | Class II | Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 54 Left, Sterile... | Howmedica Osteonics Corp | LPH | |
| Z-1825-2020 | Class II | Elekta MONACO RTP Sytem, radiation treatment planning software system - Product Usage... | Elekta Limited | MUJ | |
| Z-2065-2020 | Class II | BD Posiflush SF Saline Flush Syringe (US Distributed Catalog 306553), UDI 50382903065535 | Becton Dickinson & Co | NGT | |
| Z-1970-2020 | Class II | SureStep Foley Tray System - Product Usage: Intended for use in the drainage and/or... | C.R. Bard Inc | MJC | |
| Z-1940-2020 | Class II | Formula 418 Renal Balloon-Expandable Stent, RPN FOR418-18-80-6-12, Order Number (GPN)... | Cook Incorporated | NIN | |
| Z-2048-2020 | Class II | BD BBLTM Gram Stain Kit with Stabilized Iodine-- IVD For the differential staining of... | Becton Dickinson & Co | JTS | |
| Z-2047-2020 | Class II | BD BBLTM Gram Crystal Violet 3.8L-- IVD Primary stain for Staining Microorganisms... | Becton Dickinson & Co | JTS | |
| Z-2046-2020 | Class II | BD BBLTM Gram Crystal Violet 250mL-- IVD Primary stain for Staining Microorganisms... | Becton Dickinson & Co | JTS | |
| Z-2245-2020 | Class II | Magnetic Resonance Imaging Diagnostic Device accessory - Product Usage: The chest... | Philips North America LLC | MWI | |
| Z-2244-2020 | Class II | Cardiovascular Monitoring Device accessory - Product Usage: The chest pneumograph (also... | Philips North America LLC | MWI | |
| Z-2179-2020 | Class II | Sterile Custom Packs to be used in surgical procedures. | American Contract Systems, Inc. | PKE | |
| Z-2178-2020 | Class II | Sterile Custom Packs to be used in surgical procedures. | American Contract Systems, Inc. | OJU | |
| Z-2177-2020 | Class II | Sterile Custom Packs to be used in surgical procedures. | American Contract Systems, Inc. | OJH | |
| Z-2176-2020 | Class II | Sterile Custom Packs to be used in surgical procedures. | American Contract Systems, Inc. | OJG | |
| Z-2175-2020 | Class II | Sterile Custom Packs to be used in surgical procedures. | American Contract Systems, Inc. | OHP | |
| Z-2174-2020 | Class II | Sterile Custom Packs to be used in surgical procedures. | American Contract Systems, Inc. | OHM | |
| Z-2173-2020 | Class II | Sterile Custom Packs to be used in surgical procedures. | American Contract Systems, Inc. | OGR | |
| Z-2172-2020 | Class II | Sterile Custom Packs to be used in surgical procedures. | American Contract Systems, Inc. | OES | |
| Z-2171-2020 | Class II | Sterile Custom Packs to be used in surgical procedures. | American Contract Systems, Inc. | OEQ | |
| Z-2170-2020 | Class II | Sterile Custom Packs to be used in surgical procedures. | American Contract Systems, Inc. | LRO |