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-2293-2018 | Class II | LFIT Anatomic CoCr Femoral Heads, Catalog No. 6260-9-040 | Howmedica Osteonics Corp | JDI | |
| Z-2292-2018 | Class II | LFIT Anatomic CoCr Femoral Heads, 6260-9-036 | Howmedica Osteonics Corp | JDI | |
| Z-2496-2018 | Class II | Ingenuity Digital PET/CT System, Model 882446 with the following UDI's... | Philips North America LLC | KPS | |
| Z-1618-2023 | Class I | EXCOR Pediatric Ventricular Assist Device Blood Pumps, Models: P10P-001 (10 ml blood... | Berlin Heart GmbH | DSQ | |
| Z-2789-2018 | Class II | TCube One Step Multi-Drug Oral Fluid Test Cube (AMPSO, BARGO, SUPS, BZ030, COC20,MDMAlOO... | Guangzhou Wondfo Biotech Co., Ltd. | DIS | |
| Z-2788-2018 | Class II | TCube One Step Multi-Drug Oral Fluid Test Cube (AMPSO, BARGO, BZ030,COC20,MDMA100,METSO... | Guangzhou Wondfo Biotech Co., Ltd. | DIS | |
| Z-2787-2018 | Class II | TCube One Step Multi-Drug Oral Fluid Test Cube (AMPSO,COC20,METSO... | Guangzhou Wondfo Biotech Co., Ltd. | DIS | |
| Z-2540-2018 | Class II | OMNI Hip System, ApeX-LNK Acetabular Inserts 0 degree, 4+mm offset, Product Codes... | Omni Life Science, Inc. | LPH | |
| Z-2577-2018 | Class I | AmniSure ROM Test under the following labels: 1) Catalog Number FMRT-1-25 and 2) Catalog... | Qiagen | NQM | |
| Z-2376-2018 | Class II | REPLANT 5.0mmD ABUTMENT, Part number 6050-52-60 | Implant Direct Sybron Manufacturing LLC | DZE | |
| Z-2737-2018 | Class II | Natus Neurology ErgoJust Carts labeled as the following: ICU Cart Export For PTZ Video... | Natus Medical Incorporated | ODI | |
| Z-2177-2018 | Class II | Biomet Modular Primary Tibial Tray Implants; Modular Interlok Primary Tray (size 75 mm)... | Zimmer GmbH | JWH | |
| Z-2835-2018 | Class II | The da Vinci Xi Surgical System (IS4000) Model Name: IS4000, Endoscope Controller. Model... | Intuitive Surgical, Inc. | NAY | |
| Z-2385-2018 | Class II | Peripherally Inserted Midline Catheter Kit with Placement Wire, REF MK-02031-TW Product... | Arrow International LLC (subsidiary of Teleflex Incorporated) | LJS | |
| Z-2384-2018 | Class II | VPS TipTracker Stylet Accessory, REF RHY-177-TTSAP Product Usage: To provide real time... | Arrow International LLC (subsidiary of Teleflex Incorporated) | LJS | |
| Z-2383-2018 | Class II | VPS Rhythm ECG Accessory Pack, REF RHY-100-ECGO Product Usage: To provide real time tip... | Arrow International LLC (subsidiary of Teleflex Incorporated) | LJS | |
| Z-2382-2018 | Class II | VPS Rhythm ECG Accessory Pack with Johans Adapter, REF RHY-100-ECGJ Product Usage: To... | Arrow International LLC (subsidiary of Teleflex Incorporated) | LJS | |
| Z-1995-2019 | Class II | Transferrin is an in vitro diagnostic assay for the quantitative determination... | Abbott Medical | DDG | |
| Z-1994-2019 | Class II | Apolipoprotein B is an in vitro diagnostic assay for the quantitative determination... | Abbott Medical | DFC | |
| Z-1993-2019 | Class II | The,K -ASSAY HP assay is intended for the quantitative determination of human... | Abbott Medical | DAD | |
| Z-1992-2019 | Class II | C4 is an in vitro diagnostic assay for the quantitative determination of C4 in... | Abbott Medical | DBI | |
| Z-1991-2019 | Class II | Apolipoprotein A1 is an in vitro diagnostic assay for the quantitative determination... | Abbott Medical | DER | |
| Z-1990-2019 | Class II | Immunoglobulin M is an in vitro diagnostic assay for the quantitative determination... | Abbott Medical | DFT | |
| Z-1989-2019 | Class II | Immunoglobulin G is an in vitro diagnostic assay for the quantitative determination... | Abbott Medical | DEW | |
| Z-1988-2019 | Class II | Immunoglobulin A is an in vitro diagnostic assay for the quantitative determination... | Abbott Medical | CZP | |
| Z-1987-2019 | Class II | C3 is an in vitro diagnostic assay for the quantitative determination of C3 in... | Abbott Medical | CZW | |
| Z-2945-2018 | Class II | Ceterix Disposable Knot Pusher / Suture Cutter; NovoCut Suture Manager. Model# CTX-C001... | Ceterix Orthopedics, Inc. | NBH | |
| Z-3201-2018 | Class II | Contour Plus Link 2.4, Product Catalog Number: MMT-1151SK. wireless blood glucose... | Medtronic, Inc. | QBJ | |
| Z-2535-2018 | Class II | HexaPOD evo RT Couch Top (also known as HexaPOD evo Module), a component of the HexaPOD... | Elekta Limited | JAI | |
| Z-2598-2018 | Class III | BD FACS Universal Loader (Optional) to the BD FACSLyric Clinical System, Model 662879... | Becton, Dickinson and Company, BD Biosciences | OYE | |
| Z-2424-2018 | Class II | Proteus 235, Version PTS-11.0.1.2 and PTS-11.0.2 Product Usage: A device designed to... | Ion Beam Applications S.A. | LHN | |
| Z-2242-2018 | Class II | 3.2MM X 560MM COCR THD TIP; 14-441053 Intended to be used as a guide pin for insertion... | Zimmer GmbH | HTY | |
| Z-2241-2018 | Class II | RECON DRILL 6MM X 439MM; 14-443023 Intended to be used as a guide pin for insertion of... | Zimmer GmbH | HTY | |
| Z-2240-2018 | Class II | 3.2MM X 510MM COCR THD TIP; 14-443053 Intended to be used as a guide pin for insertion... | Zimmer GmbH | HTY | |
| Z-2239-2018 | Class II | BEAD TIP GD WIRE 3.0MM X 60CM; 29402 Intended to be used as a guide pin for insertion... | Zimmer GmbH | HTY | |
| Z-2238-2018 | Class II | G-PIN 2.8BL 3.2PL 98CM 2PK; 467260 NL DRIVING GUIDE 4.4MM X 80CM; 467220 Intended to be... | Zimmer GmbH | HTY | |
| Z-2237-2018 | Class II | G-PIN 2.8BL 3.2PL 98CM 2PK; 467260 Intended to be used as a guide pin for insertion of... | Zimmer GmbH | HTY | |
| Z-2236-2018 | Class II | G-PIN 2.8BL 3.2PL 60CM 2PK; 467265 Intended to be used as a guide pin for insertion of... | Zimmer GmbH | HTY | |
| Z-2235-2018 | Class II | BALL TIP GUIDE WIRE 2.0MMX60CM; 469020 Intended to be used as a guide pin for insertion... | Zimmer GmbH | HTY | |
| Z-2234-2018 | Class II | GUIDE WIRE w/ BALL TIP 2.0MMX98CM; 469040 Intended to be used as a guide pin for... | Zimmer GmbH | HTY | |
| Z-2233-2018 | Class II | BALL TIP GUIDE WIRE 3.2MMX55CM; 469055 Intended to be used as a guide pin for insertion... | Zimmer GmbH | HTY | |
| Z-2232-2018 | Class II | BALL TIP GUIDE WIRE 3.2MMX98CM; 469060 Intended to be used as a guide pin for insertion... | Zimmer GmbH | HTY | |
| Z-2231-2018 | Class II | DRILL PT GUIDE WIRE 2MM X 60CM; 469320 Intended to be used as a guide pin for insertion... | Zimmer GmbH | HTY | |
| Z-2230-2018 | Class II | DRILL PT GUIDE WIRE 3.2MMX98CM, 469360 Intended to be used as a guide pin for insertion... | Zimmer GmbH | HTY | |
| Z-2887-2018 | Class II | CAREstream ProNox Nitrous Oxide Delivery System labeled as the following: a. CMI-0100... | Carestream Medical | BZR | |
| Z-2792-2018 | Class II | MegaPower Electrosurgical Generator, Product code 1000, GTIN 10614559103715 | Megadyne Medical Products, Inc | GEI | |
| Z-2570-2018 | Class II | XLTEK EMU40EX EEG Headbox | Natus Medical Incorporated | GWQ | |
| Z-2047-2018 | Class I | Draeger Jaundice Meter JM-105 The device is intended for use in hospitals, clinics or... | Draeger Medical Systems, Inc. | MQM | |
| Z-2046-2018 | Class I | Draeger Jaundice Meter JM-103 The device is intended for use in hospitals, clinics or... | Draeger Medical Systems, Inc. | MQM | |
| Z-0489-2019 | Class II | Minicon Clinical Sample Concentrators for In Vitro Diagnostic Use 9031 (Model: Minicon... | Merck Millipore Ltd. | JJH |