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-0518-03 | Baxter Interlink System Microbore T-Connector Extension Set with 0.22 Micron High... | Baxter Healthcare Corporation | FPA | ||
| Z-0517-03 | Baxter Interlink System Microbore T-Connector Extension Set with 0.22 Micron High... | Baxter Healthcare Corporation | FPA | ||
| Z-0516-03 | Baxter Minivolume Extension Set with 0.22 Micron High Pressure Pediatric Filter, catalog... | Baxter Healthcare Corporation | FPA | ||
| Z-0515-03 | Baxter Minivolume T-Connector Extension Set with 0.22 Micron High Pressure Pediatric... | Baxter Healthcare Corporation | FPA | ||
| Z-0514-03 | Baxter AutoSyringe Extension Set with 0.22 Micron Filter, catalog 1M8529; Baxter... | Baxter Healthcare Corporation | FPA | ||
| Z-0513-03 | Baxter Auto Syringe Micro-Volume Extension Set with 0.22 Micron Filter, catalog 1M8527... | Baxter Healthcare Corporation | FPA | ||
| Z-0512-03 | Baxter Auto Syringe Micro-Volume Extension Set with 0.22 Micron Filter, catalog 1M8522... | Baxter Healthcare Corporation | FPA | ||
| Z-0511-03 | Baxter Auto Syringe Micro-Volume Extension Set with 0.22 Micron Filter, catalog 1M8516... | Baxter Healthcare Corporation | FPA | ||
| Z-0510-03 | Baxter Interlink System Buretrol Solution Set, 10 drops/mL; catalog 1C8633; Baxter... | Baxter Healthcare Corporation | FPA | ||
| Z-0523-03 | Baxter Interlink System Buretrol Solution Set, 60 drops/mL; catalog 1C8600; Baxter... | Baxter Healthcare Corporation | FPA | ||
| Z-0509-03 | Baxter Interlink System Minivolume Extension Set with 0.22 Micron Filter, catalog 1C8577... | Baxter Healthcare Corporation | FPA | ||
| Z-0508-03 | Baxter Interlink System Vented Buretrol Solution Set, 10 drops/mL; catalog 1C8560; Baxter... | Baxter Healthcare Corporation | FPA | ||
| Z-0507-03 | Baxter Interlink System Extension Set with 0.22 Micron Filter, catalog 1C8546, Baxter... | Baxter Healthcare Corporation | FPA | ||
| Z-0506-03 | Baxter Y-Type Minivolume Extension Set; catalog 1C8499; Baxter Healthcare Corporation... | Baxter Healthcare Corporation | FPA | ||
| Z-0522-03 | Baxter Interlink System Minivolume Extension Set; catalog 1C8483; Baxter Healthcare... | Baxter Healthcare Corporation | FPA | ||
| Z-0505-03 | Baxter Interlink System Minivolume Extension Set; catalog 1C8412; Baxter Healthcare... | Baxter Healthcare Corporation | FPA | ||
| Z-0504-03 | Baxter Vented Buretrol Volumetric Pump Solution Set, 10 drops/mL; catalog 1C8384; 10... | Baxter Healthcare Corporation | FPA | ||
| Z-0447-03 | Microtainer Brand Tube with EDTA (K2), Catalog Number 365974. | Becton Dickinson & Co | JKA | ||
| Z-0648-03 | Abbott brand DILUENT/SHEATH, CELL-DYN 4000 System CELL-DYN REAGENT Model/List Number... | Abbott Medical | GKZ | ||
| Z-0842-03 | Somatom Sensation 16, Computed Tomography System, Diagnostic Imaging. | Siemens Medical Solutions USA, Inc. | KPS | ||
| Z-0841-03 | Leonardo MM-WS systems. System, Image Processing. | Siemens Medical Solutions USA, Inc. | LLZ | ||
| Z-0399-03 | Genuine One Touch Glucose 50 Test Strips, For the quantitative measure of glucose in... | River City Drug | JJQ | ||
| Z-0398-03 | SureStep 50 Test Strips, For the measurement of glucose in whole blood, Two bottles of 25... | River City Drug | JJQ | ||
| Z-0560-03 | ChemMate (brand) Keratin Primary Antibody, Clones AE1, AE3, CAM 5.2 and 35betaH11... | Ventana Medical Systems Inc | |||
| Z-1030-03 | Roche/Hitachi Tina-quant RF II; catalog # 3004902 | Roche Diagnostics GmbH | |||
| Z-0526-03 | Philips BV300 Mobile X-Ray System | Philips North America LLC | IZL | ||
| Z-650/51-03 | Easy Moving Motor Driven Mobile X-Ray Unit, Models SM-20HF and SM-30HF; Manufactured by... | Sedecal USA, Inc | IZL-- | ||
| Z-0649-03 | Sedecal X-Ray High Voltage Generators and Controls; Manufactured by SEDECAL, C/Pelya 9... | Sedecal USA, Inc | IZO-- | ||
| Z-0652-03 | Optima URS X-Ray System; Manufactured by SEDECAL, C/Pelya 9 Pol. Ind. Rio De Janeiro... | Sedecal USA, Inc | KPR-- | ||
| Z-0611-03 | Datex-Ohmeda Cardiocap/5 Anesthesia Monitor with N-XOSAT SpO2 measurement option | GE Healthcare | DPZ | ||
| Z-0610-03 | Datex-Ohmeda S/5 Oxygen Saturation Module (M-OSAT) | GE Healthcare | DQA | ||
| Z-0170-04 | TC-PLUS Solution Femoral Component Size 12L, part 21041-C, lot 0006.13.2635. | Plus Orthopedics | JWH | ||
| Z-0444-03 | UltraSafe Dental Needle Guard, P/N: 401801 Lot:T20201501 | Safety Syringes, Inc. | MEG | ||
| Z-0562-03 | Boston Scientific Microvasive Radial Jaw 3 Single-Use Maximum Capacity Biopsy Forceps... | Boston Scientific Corporation | |||
| Z-1049-04 | Model 509M Pulse Oximetry Interface Module Software versions 2.0 or 2.5 | Respironics Novametrix, LLC. | DQA | ||
| Z-1144-03 | Bardex Foley Catheter, 22 Fr 40cc- 20cc Ribbed Balloons, Coleman Model Red Latex, 3 Way... | C.R. Bard Inc | MJC | ||
| Z-0068-04 | Howell D.A.S.H. Extraction Balloon, DASH-8.5-12-15, with Multiple Sizing, Catheter: 6... | Wilson-Cook Medical Inc. | GCA | ||
| Z-0591-03 | Scimed PT Graphix Intermediate PCTA Guide Wire with ICE Hydrophilic Coating, 300 cm... | Boston Scientific Corporation | DQX | ||
| Z-0590-03 | Scimed ChoICE PT Extra Support PTCA Guide Wire with ICE Hydrophilic Coating, 300 cm length | Boston Scientific Corporation | DQX | ||
| Z-0089-04 | ZILBS-8-6, ZILVER EXPANDABLE METAL BILIARY STENT SYSTEM, Stent Diameter: 8 MM. Stent... | Wilson-Cook Medical Inc. | FGE | ||
| Z-0677-03 | One heart and pericardium from donor 12144. | DCI Donor Services Tissue Services Division | MIE | ||
| Z-0312-04 | Eclipse Infusion Pump, 250 ml X 250 ml per hour) Part 5001247 | Halyard Health | MEB | ||
| Z-0844-03 | AEROSET Analyzer | Abbott Medical | JJE | ||
| Z-0624-03 | NEEDLEZAP, a battery operated needle destruction device. The product is labeled and... | E Med Future | MTV | ||
| Z-0051-04 | propper brand cal-mark(R), Micro-Hematocrit Calibrated Capillary Tubes... | Propper Mfg Co Inc | G-IO | ||
| Z-0347-03 | Axiom Artis System, X-ray, Angiographic | Siemens Medical Solutions USA, Inc. | IZI | ||
| Z-0165-04 | AEROSET Immunoglobulin M, list number 1E01-01, manufactured by Abbott Laboratories, South... | Abbott Medical | DFT | ||
| Z-0635-03 | Latex examination gloves, Uniseal brand. | American Healthcare Products Inc | LYY | ||
| Z-1373-04 | ProSpecT Shiga Toxin E. coli (STEC) Micorplate Assay. Catalog #: 2474048 (48 well plate)... | Remel Inc | GMZ | ||
| Z-0589-03 | Scimed ChoICE PT ''J'' Tip 182 cm Guide Wire, a single use, sterile (EO), device packaged... | Boston Scientific Corporation | DQX |