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-1126-2022 | Class II | (1) Gibeck Humid-Vent 2S Flex DC, Product #17731, sterile; (2) Gibeck Humid-Vent 2S Flex... | Teleflex Medical | BYD | |
| Z-1045-2022 | Class I | Joysbio SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold); COVID 19 Test | Woodside Acquisitions Inc. | QKP | |
| Z-1044-2022 | Class I | Oral Rapid SARS-CoV-2 Antigen Rapid Test Kit; COVID 19 Test | Woodside Acquisitions Inc. | QKP | |
| Z-1212-2022 | Class II | XVIVO Organ Chamber REF 19020 | Xvivo Perfusion, Inc. | PHO | |
| Z-1115-2022 | Class II | Radiometer, REF:956-552, PIC050- Arterial Blood Sampler 1 X 2 mL, 80 IU... | Radiometer Medical ApS | JKA | |
| Z-1052-2022 | Class II | HemosIL ReadiPlasTin, Part No. 0020301400 | Instrumentation Laboratory Co. | GJS | |
| Z-1071-2022 | Class II | TMJ Arthroscopy Drape, 85''x 96'' | Microtek Medical LLC | PUI | |
| Z-1442-2022 | Class II | NanoSight NS300 | Malvern Panalytical Ltd | REN | |
| Z-1208-2022 | Class II | Resin UPDATE CD-ROM, REF: 250-3020 inside VARIANTnbs Sickle Cell Program Reorder Pack... | Bio-Rad Laboratories Inc. | GKA | |
| Z-1072-2022 | Class II | Radial Head Replacement System Implant is a one-piece, stemmed radial head replacement... | Synthes (USA) Products LLC | KWI | |
| Z-1244-2022 | Class II | V8 Immunodisplacement Kit REF 1803 | Helena Laboratories, Corp. | CFF | |
| Z-1009-2022 | Class I | Accula SARS-CoV-2 Test, REF: COV4100 | Mesa Biotech, Inc. | QJR | |
| Z-1033-2022 | Class II | TRAY RING COVER, REF OM271000, CONTAINS (1) TRAY RING COVER, STERILE R, Rx Only, | Advanced Medical Optics, Inc. | HQC | |
| Z-1092-2022 | Class II | Verigene Processor SP, Models 10-0000-07/10-0000-07R a component of the Verigene system | Luminex Corporation | OOI | |
| Z-1098-2022 | Class I | Sara Plus Active Floor Lift | ArjoHuntleigh Polska Sp. zo.o. | FSA | |
| Z-1060-2022 | Class II | The following first aid kits and cabinets containing components Medi-First XS... | Certified Safety Mfg Inc | LRR | |
| Z-1050-2022 | Class II | Diagnostic Kit SARS-cCo V Antigen Rapid Test | USA Medical, LLC | QKP | |
| Z-1111-2022 | Class II | Turbett Surgical Container, TS1500 | TURBETT SURGICAL, Inc | FRG | |
| Z-1108-2022 | Class II | VITRIGUARD, CARRIER, CLEAR; Model. No. 43782001 The VitriGuard device is a... | CooperSurgical, Inc. | MQK | |
| Z-1078-2022 | Class II | Getinge 9100-Series Washer Disinfector models: 9120E, 9125E, 9127E, 9128E, 9122EW, 9128EW. | Maquet Cardiovascular Us Sales, LLC | MEC | |
| Z-1070-2022 | Class II | 11278VSA 11278VSAK Flexible Video-Uretero-Renoscope (FLEX-XC) Z23117US-BA... | Karl Storz Endoscopy-America, Inc. | FGB | |
| Z-1069-2022 | Class II | 11278VSA 11278VSAK Flexible Video-Uretero-Renoscope (FLEX-XC) Z23117US-BA... | Karl Storz Endoscopy-America, Inc. | FGB | |
| Z-1068-2022 | Class II | 11278V 11278VK CMOS Video Ureteroscope Z17744US-A (04/2016); 11278VA 11278VAK Flexible... | Karl Storz Endoscopy-America, Inc. | FGB | |
| Z-1067-2022 | Class II | 11278A2 11278AK2 Flexible Ureteroscope Z20615US-BA (08-2018); 11278AC1 N/A Flexible... | Karl Storz Endoscopy-America, Inc. | FGB | |
| Z-1066-2022 | Class II | 11274BCU1 11274BCUK1 Flexible Cystoscope Z18449US-BD (08-2018) | Karl Storz Endoscopy-America, Inc. | FAJ | |
| Z-1065-2022 | Class II | 11272VUE 11272VUEK Flexible Video Cysto-Urethroscope 96136031USCA V1.1... | Karl Storz Endoscopy-America, Inc. | FBO | |
| Z-0953-2022 | Class I | Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02 | Celltrion USA Inc | QKP | |
| Z-1019-2022 | Class II | Flo-Thru Intraluminal Shunt. Used in coronary artery or peripheral vascular procedures... | Baxter Healthcare Corporation | DXC | |
| Z-1055-2022 | Class II | 11005BC1 11005BCK1 Flexible Bronchoscope Z21493US-BA (06/2019) | Karl Storz Endoscopy-America, Inc. | EOQ | |
| Z-1054-2022 | Class II | 11001RD1 11001RDK1 KARL STORZ Slim Nasopharyngolaryngoscope 96216006US V5.0 (10-2018) | Karl Storz Endoscopy-America, Inc. | EOB | |
| Z-1064-2022 | Class II | 11272VN 11272VNK Flexible Video Urethro Cystoscope Z18442US-BD (08/2018); 11272VNU... | Karl Storz Endoscopy-America, Inc. | FBO | |
| Z-1063-2022 | Class II | 11272VH-TL 11272VHK-TL HD-VIEW Flexible HD Cysto-Urethroscope Z23875US-BC (10-2021)... | Karl Storz Endoscopy-America, Inc. | FBO | |
| Z-1062-2022 | Class II | 11272V Cmos Video-Cysto-Urethroscope Rev 11272Va 11272Vak Cmos Video-Cysto-Urethroscope... | Karl Storz Endoscopy-America, Inc. | FBO | |
| Z-1061-2022 | Class II | CYSTO-URETHRO-FIBERSCOPE REF 11272C1 CYSTOSCOPE, 15FR X 370MM, ADULT REF 11272C2 and Kit... | Karl Storz Endoscopy-America, Inc. | FBO | |
| Z-0504-2024 | Class II | CooperSurgical H/S CATHETER SET FR 5 with Integated Stylet Model: 61-4005S For... | CooperSurgical, Inc. | LKF | |
| Z-0503-2024 | Class II | Cooper Surgical H/S ELLIPTOSPHERE CATH 5 FR Set-For administering contrast media during... | CooperSurgical, Inc. | LKF | |
| Z-0502-2024 | Class II | Cooper Surgical H/S ELLIPTOSPHERE CATH 5 Fr -For administering contrast media during... | CooperSurgical, Inc. | LKF | |
| Z-1122-2022 | Class II | Olympus DISPOSABLE GRASPING FORCEPS, FG-51D | OLYMPUS Corporation of the Americas | FBN | |
| Z-1237-2022 | Class II | Triathlon Tritanium Tibial Component (Size 6); Catalog Number 5536-B-600 Triathlon... | Howmedica Osteonics Corp | JWH | |
| Z-1124-2022 | Class II | HydroMARK Breast Biopsy Marker, Model No. 4010-05-08-T4 | Devicor Medical Products Inc | NEU | |
| Z-1107-2022 | Class II | HeartWare Ventricular Assist Device (HVAD) System, individual pamphlets: HVAD System... | HeartWare, Inc. | DSQ | |
| Z-1106-2022 | Class II | HeartWare Ventricular Assist Device (HVAD) System, Model Number 1521DE, MONITOR 1521DE... | HeartWare, Inc. | DSQ | |
| Z-1105-2022 | Class II | HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number... | HeartWare, Inc. | DSQ | |
| Z-1104-2022 | Class II | HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1420 | HeartWare, Inc. | DSQ | |
| Z-1130-2022 | Class II | Invacare TDX SP2, Model Nos. TDXSP2 TDXSP2-MCG TDXSP2V | Invacare GmbH | ITI | |
| Z-1103-2022 | Class II | HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1407DE Kit | HeartWare, Inc. | DSQ | |
| Z-1102-2022 | Class II | HeartWare Ventricular Assist Device (HVAD) System, Pump Implant Kit, Model Number1104 | HeartWare, Inc. | DSQ | |
| Z-1028-2022 | Class II | Evans Wedge Disposable Trials, Large Footprint, 8mm Thickness (Model: 6101-22200818)... | restor3d, Inc. | LXH | |
| Z-1027-2022 | Class II | Evans Wedge Disposable Trials, Medium Footprint, 10mm Thickness (6101-20181018)... | restor3d, Inc. | LXH | |
| Z-1095-2022 | Class I | Dragonfly OpStar Imaging Catheter, REF 1014651/1014652, 0.068 in, 0.014 in, 135 cm... | Abbott Vascular | DQO |