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-2568-2014 | Class III | LINEAR 7.5 FR. 40cc IAB Catheter Maquet Getinge Group | Datascope Corp. | DSP | |
| Z-0006-2015 | Class III | ENVOY 500 AST Reagent Kit, reference Model/Catalog 55255, for Envoy 500. Intended Use... | VitalScientific | CIT | |
| Z-2596-2014 | Class II | Prime Care Transcend Mattress, Prime Care Transcend Perimeter Mattress, Prime Care... | Primus Medical LLC | FMW | |
| Z-1534-2015 | Class II | MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Containing Lower... | Siemens Healthcare Diagnostics Inc. | JWY | |
| Z-1533-2015 | Class II | MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Containing Lower... | Siemens Healthcare Diagnostics Inc. | JWY | |
| Z-1532-2015 | Class II | MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Containing Lower... | Siemens Healthcare Diagnostics Inc. | JWY | |
| Z-1531-2015 | Class II | MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Containing Lower... | Siemens Healthcare Diagnostics Inc. | JWY | |
| Z-1530-2015 | Class II | MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Containing Lower... | Siemens Healthcare Diagnostics Inc. | JWY | |
| Z-1529-2015 | Class II | MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Containing Lower... | Siemens Healthcare Diagnostics Inc. | JWY | |
| Z-1528-2015 | Class II | MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Containing Lower... | Siemens Healthcare Diagnostics Inc. | JWY | |
| Z-1275-2015 | Class II | BD Posiflush Saline Flush Syringe 10 ml inlcuded in the following device kits: Groshong... | Bard Access Systems, Inc. | DQY | |
| Z-1274-2015 | Class II | BD Posiflush Saline Flush Syringe 10 ml inlcuded in the following device kits: PowerGlide... | Bard Access Systems, Inc. | FOZ | |
| Z-1273-2015 | Class II | BD Posiflush Saline Flush Syringe 10 ml inlcuded in the following device kits: SafeStep... | Bard Access Systems, Inc. | FPA | |
| Z-1272-2015 | Class II | BD Posiflush Saline Flush Syringe 10 ml inlcuded in the following device kits: PowerLoc... | Bard Access Systems, Inc. | LJT | |
| Z-1271-2015 | Class II | BD Posiflush Saline Flush Syringe 10 ml inlcuded in the following device kits: Bard Poly... | Bard Access Systems, Inc. | LJS | |
| Z-0959-2015 | Class II | IC PROFILER-MR - Model 1123. A radiologic quality assurance instrument is a device... | Sun Nuclear Corporation | IYE | |
| Z-0022-2015 | Class II | Philips Healthcare Integris Allura 15 -12 Fluoroscopy x ray system | Philips North America LLC | OWB | |
| Z-2734-2014 | Class II | The Rejuvenator Chamber manufactured by Baro-Therapies, Inc. Product Usage: Indicated... | Baro-Therapies, Inc | CBF | |
| Z-2593-2014 | Class I | CareFusion EnVe and ReVel Ventilators. The EnVe/ ReVel Ventilator is designed for use on... | Pulmonetic Systems, Inc. | CBK | |
| Z-2617-2014 | Class II | CARESCAPE Respiratory Modules E-sCO, E-sCOV, E-sCAiO, E-sCAiOV, E-sCAiOE, E-sCAiOVE; the... | GE Healthcare | CCL | |
| Z-2580-2014 | Class II | PERSONA" The Personalized Knee System UC Tibial Articular Surface Provisional Left Size... | Zimmer GmbH | JWH | |
| Z-2579-2014 | Class II | PERSONA The Personalized Knee System PS Tibial Articular Surface Provisional Left with... | Zimmer GmbH | JWH | |
| Z-2578-2014 | Class II | PERSONA The Personalized Knee System Tibial Articular Surface Provisional Left with the... | Zimmer GmbH | JWH | |
| Z-2577-2014 | Class II | PERSONA The Personalized Knee System CR Tibial Articular Surface Provisional with the... | Zimmer GmbH | JWH | |
| Z-2576-2014 | Class II | PERSONA The Personalized Knee System Constrained Posterior Stabilized Tibial Articular... | Zimmer GmbH | JWH | |
| Z-2535-2014 | Class II | Philips IntelliSpace ECG Management System, with software option C61 needed to import... | Philips North America LLC | DQK | |
| Z-2575-2014 | Class II | PERSONA The Personalized Knee System Constrained Tibial Articular Surface Provisional... | Zimmer GmbH | JWH | |
| Z-1040-2015 | Class II | MobileDiagnost wDR motorized portable diagnostic X-ray systems. | Sedecal S.A. | IZL | |
| Z-0145-2015 | Class II | Parker Eclipse Probe Cover, Latex Free, REF 38-01, 10 Eclipse Probe Covers, Size... | Parker Laboratories, Inc. | IYO | |
| Z-2655-2014 | Class II | B.Braun Accuflo 100ML/H 100ML Elastomeric Infusion Device. AccuFlo devices are intended... | B Braun Medical Inc | MEB | |
| Z-2590-2014 | Class II | iTRACK250A Canaloplasty Microcatheter Kit; Catalogue number: iT-250A; Rx only... | Nova Eye Inc. | HMX | |
| Z-0066-2015 | Class II | Arrow Select Kits (ASK) and Maximal Barrier Precautions Kits (CDC) with BD Medical... | Arrow International LLC (subsidiary of Teleflex Incorporated) | DQY | |
| Z-2262-2014 | Class II | Uni*Fuse INFUSION SYSTEM WITH COOPER WIRE, 5F x 90 cm x 40 cm Infusion Pattern, Catalog... | Boston Scientific Corporation | KRA | |
| Z-2261-2014 | Class II | Uni*Fuse INFUSION SYSTEM WITH COOPER WIRE, 5F x 90 cm x 30 cm Infusion Pattern, Catalog... | Boston Scientific Corporation | KRA | |
| Z-2260-2014 | Class II | Uni*Fuse INFUSION SYSTEM WITH COOPER WIRE, 5F x 90 cm x 10 cm Infusion Pattern, Catalog... | Boston Scientific Corporation | KRA | |
| Z-2671-2014 | Class II | VITROS Immunodiagnostic Products Anti-HCV Reagent Pack for in vitro qualitative detection... | Ortho-Clinical Diagnostics, Inc. | MZO | |
| Z-2643-2014 | Class II | ADVIA Chemistry A1c_3 CAL (Calibrator) for use on the ADVIA Chemistry Systems... | Siemens Healthcare Diagnostics Inc. | JIX | |
| Z-2595-2014 | Class II | DualCap IV Pole Strips Disinfectant Caps for Luer Access Valves, REF 500-LB... | Catheter Connections, Inc. | LKB | |
| Z-2295-2014 | Class II | Port Access Kit with MicroClave Clear Connector, Item No. B79104 BD prefilled syringes... | Abbott Medical | GAX | |
| Z-2294-2014 | Class II | Cap Change Kit with MicroClave Clear Connector, Item No. B79103 BD prefilled syringes... | Abbott Medical | GAX | |
| Z-2293-2014 | Class II | CAP Change Kit w/MicroClave Clear, Item No. B78109 BD prefilled syringes are co-packaged... | Abbott Medical | GAX | |
| Z-2554-2014 | Class II | CURBELL MEDICAL CareSense Wireless Advanced LCD Bed and Chair Monitor, MODEL #... | Curbell Medical Products, Inc. | KMI | |
| Z-2592-2014 | Class II | Split Cath III Trays, 16F x 28CM Product Usage: The Split Cath III is indicated for use... | Medical Components, Inc. | MSD | |
| Z-2642-2014 | Class II | Vac-Assist Suction Units (SUA01 Suction Aspirator Unit w/800 cc Canister). The suction... | EMG Technology Co., Ltd. | JCX | |
| Z-0682-2017 | Class II | STCKERT HeaterCooler System 3T; Item Number 160281, HeaterCooler 3T, 240V/60Hz; Item... | LivaNova USA, Inc. | DWC | |
| Z-2558-2014 | Class II | CollectEVAC, Sterile device with tubing and adaptor for use with ACMI and STORZ/Wolf... | CIVCO Medical Instruments Co., Inc. | KQT | |
| Z-2200-2015 | Class II | Pinnacle3 Software Version 9.0, 9.2, 9.4 and 9.6, Model Numbers 453560446041... | Philips North America LLC | LNH | |
| Z-0236-2015 | Class II | Philips Brilliance iCT Computed Tomography X-Ray System Product Usage: The Brilliance... | Philips North America LLC | JAK | |
| Z-0107-2015 | Class II | Mindray V21, Size: 515 mm X 335 mm X 685 mm, N.W.: 8 kg, G.W.: 11 kg, Qty:1 The V-Series... | Datascope Corp. | MHX | |
| Z-2689-2014 | Class II | CareFusion AirLife Heated Infant Breathing Circuit Product Usage: Respiratory breathing... | Medtronic, Inc. | BZE |