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-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 | ||
| Z-1372-04 | ProSpecT Campylobacter Microplate Assay. Catalog #2476096. | Remel Inc | LQP | ||
| Z-0880-05 | SC-AcuFix Thinline Low-Profile Anterior Cervical Plate System manufactured by Spinal... | Spinal Concepts, Inc. | KWQ | ||
| Z-0092-04 | Solar 8000M Patient Monitor with software versions 3A, 3B and 3C | GE Medical Systems Information Technologies, Inc. | DSI | ||
| Z-0173-04 | AxSYM Analyzer, Small Heater Block Clamp, manufactured by Abbott Laboratories, Irving... | Abbott Medical | JJE | ||
| Z-0443-03 | Sterilized gowns and towels. MULTI-GOWN PACK: MAJOR - contains 2 operating room towels... | Sterile Surgical Systems LLC | FYA | ||
| Z-0442-03 | Sterilized gowns and towels. MULTI-GOWN PACK: MINOR - contains - 2 operating room... | Sterile Surgical Systems LLC | FYA | ||
| Z-0441-03 | Sterilized gowns and towels. C-Section Pack - contains 8 towels, 1 each large single-ply... | Sterile Surgical Systems LLC | FYA | ||
| Z-0440-03 | Sterilized gowns and towels. LINEN PACK II - contains 12 towels, 1 each large gortex... | Sterile Surgical Systems LLC | FYA | ||
| Z-0439-03 | Sterile gowns and towels in packages. LINEN PACK I - contains 12 towels, 1 each large... | Sterile Surgical Systems LLC | FYA | ||
| Z-0745-04 | RAD SOURCE RS 3000 Blood Irradiator Three Bag Option | Rad-Source Technologies, Inc. | MOT | ||
| Z-0949-03 | Alpha Mirage Top Tightening Spinal System 5.5 mm x 45 mm Length Bone Screws | Alphatec Spine, Inc. | |||
| Z-0973-03 | Resolve Systems Cerebrospinal Fluid Test Kit, 50 tests per kit, Catalog #FR-8050. | Revvity Health Sciences, Inc. | |||
| Z-1376-04 | ProSpecT Cryptosporidium Microplate Assay. Catalog #2454096. | Remel Inc | MHJ | ||
| Z-0172-04 | ARCHITECT Processing Module, manufactured by Abbott Laboratories, Irving, Texas | Abbott Medical | JJE | ||
| Z-1201-03 | Gyroscan 1.5T Intera | Philips North America LLC | LNH | ||
| Z-1200-03 | Gyroscan NT-Intera 1.5T | Philips North America LLC | LNH | ||
| Z-1199-03 | Gyroscan ACS-NT system | Philips North America LLC | LNH | ||
| Z-0738-04 | Carbomedics VT-200 Valve Tester | Carbomedics, Inc. | DTJ | ||
| Z-0079-04 | EUSN-19-QC Quick-Core Ultrasound Biopsy Needle, Specimen Notch: 20 MM.; Diameter: 5.2 FR... | Wilson-Cook Medical Inc. | FCG | ||
| Z-0922-04 | 955-5 BackFix Coldwelder II with straight tip manufactured by Spinal Concepts, Austin... | Spinal Concepts, Inc. | KWP | ||
| Z-0921-04 | 955-4 BacFix Coldwelder II with angled tip, manufactured by Spinal Concepts, Austin, Texas | Spinal Concepts, Inc. | KWP | ||
| Z-0920-04 | 955-3 BacFix Coldwelder, manufactured by Spinal Concepts, Austin, Texas | Spinal Concepts, Inc. | KWP | ||
| Z-1230-04 | Esprit Ventilator | Respironics, Inc. | CBK | ||
| Z-1205-03 | Multidiagnost 97 | Philips North America LLC | IZZ | ||
| Z-1204-03 | Multidiagnost 96 | Philips North America LLC | IZZ | ||
| Z-1203-03 | Diagnost 94 | Philips North America LLC | IZZ |