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-0819-2019 | Class II | Aguja para Biopsia Tipo Medula Osea Ergonomica 11ga x 10cm | Argon Medical Devices, Inc | DWO | |
| Z-0818-2019 | Class II | Aguja de Aspiracion con Profundidad Ajustable Tipo I 16ga x 5 cm- Product Usage... | Argon Medical Devices, Inc | DWO | |
| Z-0817-2019 | Class II | Double Diamond J Type Bone Marrow Needle & Marrow Extraction Cannula 11ga x 10cm... | Argon Medical Devices, Inc | DWO | |
| Z-0816-2019 | Class II | J Type Bone Marrow Needle 13ga x 6cm - Product Usage: Manual surgical instruments for... | Argon Medical Devices, Inc | DWO | |
| Z-0815-2019 | Class II | J Type Bone Marrow Needle 13ga x 10 cm- Product Usage: Manual surgical instruments for... | Argon Medical Devices, Inc | DWO | |
| Z-0814-2019 | Class II | "J" Type Bone Marrow Needle 11ga x 10 cm - Product Usage: Manual surgical instruments... | Argon Medical Devices, Inc | DWO | |
| Z-0775-2019 | Class II | COOK MEDICAL Captura SERRATED LARGE FORCEP-NO SPIKE, 2.4 mm, 230 cm, DBF-2.4SL- 230-20-S | Wilson-Cook Medical Inc. | FFF | |
| Z-0774-2019 | Class II | COOK MEDICAL Captura SERRATED BIOPSY FORCEPS WITH SPIKE,2.4 mm, 230 cm, with Spike... | Wilson-Cook Medical Inc. | FFF | |
| Z-0747-2019 | Class II | PERMA-HAND Silk Suture Size 5, Black 30" (75cm) Double Armed LR Needles, Product Code... | Ethicon, Inc | GAP | |
| Z-1010-2019 | Class II | Olympus TJF-Q180V Duodenoscope - Product Usage: These endoscopes are intended for use in... | OLYMPUS Corporation of the Americas | NWB | |
| Z-1009-2019 | Class II | Olympus PCF-Q180AC Video Colonoscope - Product Usage: These endoscopes are intended for... | OLYMPUS Corporation of the Americas | NWB | |
| Z-1008-2019 | Class II | Olympus GIF-H180J Gastrointestinal Videoscope - Product Usage: These endoscopes are... | OLYMPUS Corporation of the Americas | NWB | |
| Z-1007-2019 | Class II | Olympus GF-UCT180 Ultrasound Gastrovideoscope - Product Usage: These endoscopes are... | OLYMPUS Corporation of the Americas | IYN | |
| Z-0766-2019 | Class II | BW Lasso 2515 ANV eco Variable Diagnostic EP Catheter, REF D134301 Diagnostic... | Stryker Sustainability Solutions | NLH | |
| Z-1147-2019 | Class II | Tina-quant IgM Gen.2, Catalog Nos. 03507190190, 05220726190, 03507041190... | Roche Diagnostics GmbH | DAQ | |
| Z-1146-2019 | Class II | Lactate Gen.2, Catalog Nos. 03183700190, 05171881190, 11822837190, ***added as of... | Roche Diagnostics GmbH | KHP | |
| Z-1145-2019 | Class II | Bilirubin Total Gen.3, Cat. Nos. 05795397190, 05795419190, 05795320160, 05795338160... | Roche Diagnostics GmbH | CIG | |
| Z-0784-2019 | Class II | Anti-HAV IgM test System, Material No. 11820591160 Product Usage: The Roche Elecsys... | Roche Diagnostics GmbH | LOL | |
| Z-0746-2019 | Class II | DeRoyal(R) Enteral Safe Feed Tube, REF 54-2465 A Nasogastric/Oralgastric enteral... | DeRoyal Industries, Inc. | FPD | |
| Z-0732-2019 | Class II | PREMIER Cryptococcal Antigen, Catalog Number 602096 Product Usage: The PREMIER... | Meridian Bioscience Inc | MDU | |
| Z-0963-2019 | Class II | Hermes NC PTA Balloon Dilatation Catheter The balloon dilatation catheter is intended to... | BrosMed Medical Co.,Ltd. | LIT | |
| Z-0969-2019 | Class II | Draco Enzymatic Deep-Cleaning Pads, Product Number HY0305Z Product Usage: Multi-tiered... | Madison Polymeric Engineering | MNL | |
| Z-0745-2019 | Class II | MAVIG Portegra or Portegra2 Overhead Counterpoise System (OCS) used in conjunction with... | Medrad, Inc. | DXT | |
| Z-1125-2019 | Class II | cobas c 111 with ISE analyzers analyzer used in the following assays: a)Creatinine plus... | Roche Diagnostics GmbH | JJE | |
| Z-1124-2019 | Class II | COBAS INTEGRA 400 plus analyzer used in the following assays: a)Tina-quant Apolipoprotein... | Roche Diagnostics GmbH | JJE | |
| Z-1366-2019 | Class II | Arrow PICC powered by Arrow VPS Precision Stylet Product Code:CDC-44052-VPS2 Product... | Arrow International LLC (subsidiary of Teleflex Incorporated) | LJS | |
| Z-1365-2019 | Class II | Arrow PICC powered by Arrow VPS Precision Stylet Product Code:CDC-45052-VPS2 Product... | Arrow International LLC (subsidiary of Teleflex Incorporated) | LJS | |
| Z-0847-2019 | Class II | VITEK 2 AST-N351 Test Kit | bioMerieux, Inc. | LON | |
| Z-0803-2019 | Class II | SureStep(TM) FOLEY TRAY SYSTEM, Preconnected Closed System Foley Tray, Product Codes... | C.R. Bard Inc | MJC | |
| Z-0821-2019 | Class II | MOSAIQ Oncology Information System and Sequencer MOSAIQ is an oncology information... | Elekta Limited | IYE | |
| Z-0510-2020 | Class II | GelPOINT Path Transanal Procedural Pack with Epix Electrosurgical L-Hook with Smoke... | Applied Medical Resources Corp | FER | |
| Z-0509-2020 | Class II | Epix Electrosurgical Probes with Smoke Evacuation, Angled L-Hook Tip, 5mm x 42 cm REF... | Applied Medical Resources Corp | GEI | |
| Z-1015-2019 | Class II | Dimension Vista 1500, Analyzer, chemistry Model no. 10444801 | Siemens Healthcare Diagnostics Inc. | JJE | |
| Z-1014-2019 | Class II | Dimension Vista 500, Analyzer, chemistry Model no. 10284473 | Siemens Healthcare Diagnostics Inc. | JJE | |
| Z-0698-2019 | Class II | Proteus 235 Product Usage: The Proton Therapy System - Proteus 235 (brand names: Proteus... | Ion Beam Applications S.A. | LHN | |
| Z-0848-2019 | Class II | VITROS Chemistry Products VALP Reagent Pack. For in vitro diagnostic use only. CATALOG... | Ortho-Clinical Diagnostics, Inc. | LEG | |
| Z-0751-2019 | Class II | U by Kotex Sleek, Regular Tampons, 3 Count | Kimberly-Clark Corporation | HEB | |
| Z-0750-2019 | Class II | U by Kotex Sleek, Regular/Super Tampons, 34 Count Multipack | Kimberly-Clark Corporation | HEB | |
| Z-0749-2019 | Class II | U by Kotex Sleek, Regular Tampons, 34 Count | Kimberly-Clark Corporation | HEB | |
| Z-0748-2019 | Class II | U by Kotex Sleek, Regular Tampons, 18 Count | Kimberly-Clark Corporation | HEB | |
| Z-0850-2019 | Class II | Kaguya Automated Peritoneal Dialysis System Product Usage: It is intended for automatic... | Baxter Healthcare Corporation | FKX | |
| Z-0849-2019 | Class II | AMIA Automated Peritoneal Dialysis System Product Usage: It is intended for automatic... | Baxter Healthcare Corporation | FKX | |
| Z-0054-2021 | Class II | VERIGENE Processor SP Model No. 10-0000-07. An in vitro diagnostic device intended for... | Luminex Corporation | OCC | |
| Z-0046-2020 | Class II | Aperio CS2 CE IVD scanner instrument, scanner part #23CS100CE. | Leica Biosystems Imaging, Inc. | NOT | |
| Z-1177-2019 | Class II | ProSun V3 42 Xlc(160w)(10 minutes) tanning bed, Model 500. Labeled as the following... | J&T Health and Wellness LLC | LEJ | |
| Z-1176-2019 | Class II | ProSun Onyx 32 Sli Intensive (12 minutes) tanning bed, Model 32/1. Labeled as the... | J&T Health and Wellness LLC | LEJ | |
| Z-0834-2019 | Class II | Genius Knee Cemented CR Femoral Component Product Usage: Knee replacement component | Signature Orthopaedics Pty Limited | JWH | |
| Z-0833-2019 | Class II | Genius Knee Cemented Tibial Component Product Usage: Knee replacement component | Signature Orthopaedics Pty Limited | JWH | |
| Z-1045-2019 | Class II | JOURNEY II XR TIBIAL POSTERIOR KEEL PUNCH SZ 7-8 , REF 74013988 The JOURNEY II XR Tibial... | Smith & Nephew, Inc. | JWH | |
| Z-1044-2019 | Class II | JOURNEY II XR TIBIAL POSTERIOR KEEL PUNCH SZ 5-6 , REF 74013988 The JOURNEY II XR Tibial... | Smith & Nephew, Inc. | JWH |