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-1134-2022 | Class II | SUR-FIT Natura S4S Durahesive Wafer 70MM (1X10PK) US. Each market unit contains 10... | ConvaTec Limited | EXE | |
| Z-1297-2022 | Class II | Atrium Firm PVC Thoracic Catheter 28French-Intended to facilitate the evacuation of air... | Atrium Medical Corporation | GBZ | |
| Z-1239-2022 | Class II | Oakworks Bed (Emergency Field Bed); Model No. OBMPBR361980A6TTGRCS | Oakworks Inc | FNJ | |
| Z-1238-2022 | Class II | PX200 Emergency Relief Bed; Model No. PXEXEB362280A6TTZZH4C19 | Oakworks Inc | FNL | |
| Z-1292-2022 | Class II | ProudP Everyday Uroflow Tracker Software Version 1.x.x Software Version 1.2.0 or earlier | Soundable Health Korea, Inc. (Subsidiary of Soundable Health, Inc.) | EXY | |
| Z-1221-2022 | Class II | MEDLINE Polyurethane Foam Bedside Cleaning Kit, REF DYK100FS | MEDLINE INDUSTRIES, LP - Northfield | MNL | |
| Z-1220-2022 | Class II | MEDLINE Polyurethane Foam Bedside Cleaning Kit, REF DYK215FS | MEDLINE INDUSTRIES, LP - Northfield | MNL | |
| Z-1219-2022 | Class II | MEDLINE Polyurethane Bedside Cleaning Kit, REF DYK500FSAW | MEDLINE INDUSTRIES, LP - Northfield | MNL | |
| Z-1218-2022 | Class II | MEDLINE Polyurethane Foam Bedside Cleaning Kit, REF DYK500FS | MEDLINE INDUSTRIES, LP - Northfield | MNL | |
| Z-1217-2022 | Class II | MEDLINE Polyurethane Foam Enzymatic Cleaning Sponge, REF DYK1000TSE | MEDLINE INDUSTRIES, LP - Northfield | MNL | |
| Z-1146-2022 | Class II | APD Drain Manifold | Baxter Healthcare Corporation | KDJ | |
| Z-1145-2022 | Class II | 3,65 m Extension Set with Luer-lock Connector | Baxter Healthcare Corporation | KDJ | |
| Z-1144-2022 | Class II | Effluent Sample Bag | Baxter Healthcare Corporation | FKX | |
| Z-1143-2022 | Class II | 5 Prong Manifold Set (with Luer Connectors) | Baxter Healthcare Corporation | KDJ | |
| Z-1142-2022 | Class II | Locking Cap for PD Catheter Adapter | Baxter Healthcare Corporation | KDJ | |
| Z-1141-2022 | Class II | 15 Liters Drain Bag | Baxter Healthcare Corporation | KDJ | |
| Z-1205-2022 | Class II | Proteus235- Proton Therapy System: to produce and deliver a proton beam for the... | Ion Beam Applications S.A. | LHN | |
| Z-1264-2022 | Class II | Olympus URETERO-RENO FIBERSCOPE Model: URF-P6R | OLYMPUS Corporation of the Americas | FGB | |
| Z-1263-2022 | Class II | Olympus URETERO-RENO FIBERSCOPE Model: URF-P6 | OLYMPUS Corporation of the Americas | FGB | |
| Z-1262-2022 | Class II | Olympus CYSTONEPHROFIBERSCOPE Model: CYF-5 | OLYMPUS Corporation of the Americas | FAJ | |
| Z-1206-2022 | Class II | The C304-HIS device features a guide wire to access the vein, a valve to reduce blood... | Medtronic, Inc. | DQY | |
| Z-1131-2022 | Class II | Cardioblate" Gemini"-s Irrigated RF Surgical Ablation System; The device is placed in a... | Medtronic Perfusion Systems | OCL | |
| Z-1298-2022 | Class II | Product Name: TEG5000 Analyzer (07-022, 07-033) with TEG Analytical Software (07-030... | Haemonetics Corporation | JPA | |
| Z-1099-2022 | Class II | LEGION NARROW PS OXIN SZ 6N RT and JRNY II BCS FEMORAL OXIN LT SZ 5 | Smith & Nephew, Inc. | JWH | |
| Z-1227-2022 | Class I | Replacement back up batteries distributed on or after April 1, 2019, for CARESCAPE R860... | GE Healthcare | CBK | |
| Z-1226-2022 | Class I | Back up batteries in Ventilators labeled as the following: a. CARESCAPE R860 Ventilators... | GE Healthcare | CBK | |
| Z-1137-2022 | Class II | progenamatrix Human Keratin Matrix, sterile, Rx, with the following model numbers: (1)... | ProgenaCare | KGN | |
| Z-1272-2022 | Class I | Medfusion Syringe Pump Models: 3500, 3500-0600-00, 3500-0600-01, 3500-0600-249... | Abbott Medical | FRN | |
| Z-1271-2022 | Class I | Medfusion Syringe Pump Model: Model 4000-0100-50, Model 4000-0101-249, Model... | Abbott Medical | FRN | |
| Z-1058-2022 | Class II | ProterixBio SARS-CoV-2 (RBD) IgG Antibody Test, and associated ProterixBio Dried Blood... | Proterixbio | QKO | |
| Z-1501-2022 | Class II | Turbett Surgical Container, TS1500 | TURBETT SURGICAL, Inc | FRG | |
| Z-1096-2022 | Class II | BioPlex 2200 REF 12000670 ToRC IgM Reagent Pack | Bio-Rad Laboratories Inc. | LIP | |
| Z-1056-2022 | Class III | putty i-FACTOR Peptide Enhanced Bone Graft 1.0cc Syringe REF 700-010, PUTTY | Cerapedics, Inc. | NOX | |
| Z-1207-2022 | Class I | HeartWare HVAD Pump Implant Kit, a) Model Number 1104JP, b) Model Number MCS1705PU | Medtronic, Inc. | DSQ | |
| Z-1243-2022 | Class II | Sensis, Programmable Diagnostic Computer, Model Nos. 6623974... | Siemens Medical Solutions USA, Inc. | DQK | |
| Z-1253-2022 | Class II | Atellica IM 1600 Analyzer - automated, immunoassay analyzer designed to perform in vitro... | Siemens Healthcare Diagnostics Inc. | JLW | |
| Z-1252-2022 | Class II | Atellica IM 1300 Analyzer - automated, immunoassay analyzer designed to perform in vitro... | Siemens Healthcare Diagnostics Inc. | JLW | |
| Z-1249-2022 | Class II | Getinge CM320 WUWD Series Washer Disinfector-For use as a multi-chamber... | Maquet Cardiovascular Us Sales, LLC | MEC | |
| Z-1248-2022 | Class II | Getinge CM320-2 CHAMBER WU Series Washer Disinfector- For Use as a multi-chamber... | Maquet Cardiovascular Us Sales, LLC | MEC | |
| Z-1235-2022 | Class II | AUTOLITH Touch 1.9F 375cm Biliary Electrohydraulic Lithotripter Probe | Northgate Technologies Inc. | FFK | |
| Z-1247-2022 | Class II | GMK Efficiency - GMK Sphere CR Insert Instrument Set Size 1 | Medacta USA, Inc. | LXH | |
| Z-1094-2022 | Class II | Voalte Nurse Call System provides a comprehensive communication and information system... | Baxter Healthcare Corporation | ILQ | |
| Z-1093-2022 | Class II | NaviCare Nurse Call System provides a comprehensive communication and information system... | Baxter Healthcare Corporation | ILQ | |
| Z-1268-2022 | Class II | Crome Models loaded with CareLink SmartSync Device Manager application software D00U005... | Medtronic, Inc. | LWS | |
| Z-1267-2022 | Class II | Cobalt Models loaded with CareLink SmartSync Device Manager application... | Medtronic, Inc. | NIK | |
| Z-1246-2022 | Class II | Artis icono floor-angiography systems developed for single and biplane diagnostic imaging... | Siemens Medical Solutions USA, Inc. | OWB | |
| Z-1245-2022 | Class II | Artis icono biplane -angiography systems developed for single and biplane diagnostic... | Siemens Medical Solutions USA, Inc. | OWB | |
| Z-1136-2022 | Class II | AC-powered adjustable medical beds with built-in electric DC actuators and controls. | Umano Medical Inc. | FNL | |
| Z-1135-2022 | Class II | AC-powered adjustable medical beds with built-in electric DC actuators and controls. | Umano Medical Inc. | FNL | |
| Z-1127-2022 | Class II | (1) Teleflex Flex tube, Product #20011, sterile; (2) Teleflex Smooth-Flo Flex with Double... | Teleflex Medical | BZO |