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-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 | ||
| Z-1128-03 | EasyWeb | Philips North America LLC | LLZ | ||
| Z-1223-03 | Easy Access PACS System with software Release 5, 6.2, or 7.2 | Philips North America LLC | LLZ | ||
| Z-0662-03 | Product is labeled as ''Oto-''Flex Bur'', Medtronic-Xomed brand, packed into a sterile... | Medtronic Xomed, Inc. | EQJ | ||
| Z-0462-03 | Novoste, Beta-Cath 3.5F System, New B-Rail 3.5F Delivery Catheter, with Indicator of... | Best Vascular, Inc. | JAJ | ||
| Z-0057-04 | Clinitron At Home Air Fluidized Therapy Unit | Hill-Rom Manufacturing, Inc. | INX | ||
| Z-0779-03 | N/a | 3M Company | FRC | ||
| Z-1181-03 | Zilver Expandable Metal Biliary Stent | Wilson-Cook Medical Inc. | FGE | ||
| Z-1180-03 | Za-Stent Expandable Metal Biliary Stent | Wilson-Cook Medical Inc. | FGE | ||
| Z-1179-03 | Spiral Z Expandable Metal Biliary Stent | Wilson-Cook Medical Inc. | FGE | ||
| Z-0435-05 | B12 Reagent (6C09-20 and 6C09-25) for use with the ARCHITECT i2000 and i2000SR Analyzers... | Abbott Medical | LID | ||
| Z-1133-03 | ARCHITECT Processing Module, List number 8C89-01, manufactured by Abbott Laboratories... | Abbott Medical | JJE | ||
| Z-1031-03 | Rheumatoid Factor ELISA Test Kit. Labeled under the following names: Sigma Diagnostics... | Zeus Scientific LLC | DHR | ||
| Z-0393-05 | Weck, Endo5, Hem-o-lok ML, Ref 544965, Hem-o-lok ML Endoscopic Clip Applier, Non-Sterile... | Teleflex Medical | GDO | ||
| Z-0018-04 | Product is labeled as Cordis Pre-shaped Prowler Plus MP Infusion Catheter (3 F proximal... | Cordis Neurovascular, Inc. | |||
| Z-0843-03 | Aeroset Analyzer, item 9D05-01 | Abbott Medical | JJE | ||
| Z-0739-04 | Asahi APS Series Dialyzers, Model Nos. APS-400S, APS-550S, APS-650S, APS-750S, APS-900S... | Asahi Kasei Medical MT Corp. Oita Works | KDI | ||
| Z-1147-03 | Anti-Cardiolipin IgA ELISA test kit. Product is manufactured by Zeus Scientific... | Zeus Scientific LLC | MID | ||
| Z-0951-03 | ESPRIT VENTILATOR, Model V1000 | Respironics, Inc. | CPK | ||
| Z-0903-04 | Espirit Ventilator, Model V1000 Continuous Ventilator with Respiratory Mechanics | Respironics, Inc. | CBK | ||
| Z-1003-03 | ProLong Continuous Nerve Block Set model nubers PL-50 and PL-100 | Life-Tech International, Inc | CAZ | ||
| Z-0961-03 | Measles (Rubeola) IgG ELISA Test System. It is an enzyme-linked immunosorbent assay... | Zeus Scientific LLC | LJB | ||
| Z-1237-03 | Infant reusable blood pressure cuffs, one tube, male slip luer connector, P/N 2930... | GE Medical Systems Information Technologies, Inc. | |||
| Z-0340-05 | Weck, Bipolar Forceps Cord, REF 394236, 1 (One) Cord, Length 12 Feet (3.7m), Sterile... | Teleflex Medical | FFZ | ||
| Z-1252-06 | SoftPath ASCII Software, used in pathology labs to track and report specimens and... | SCC Soft Computer | JQP |