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-0625-03 | Medtronic AVE Everest PTCA Inflation Catheter 20 cc Item #AC2200 | Medtronic, Inc. | LOX | ||
| Z-1410-04 | Esophageal Z-Stent Fully Coated or Uncoated Flanges, Endoprosthesis Systems with the Z... | Wilson-Cook Medical Inc. | ESW | ||
| Z-0883-04 | Minstrel Patient Lift; a non-AC-powered patient lift; Arjo, Inc., 50 N. Gary Ave... | Arjo, Inc. | FSA | ||
| Z-0693-03 | Access 2 immunoassay side of LXi 725 | Siemens Healthcare Diagnostics Inc. | |||
| Z-0692-03 | Access 2 Immunoassay System | Siemens Healthcare Diagnostics Inc. | |||
| Z-0676-03 | CryoValve Allograft heart valve | Artivion, Inc. | MIE | ||
| Z-1157-04 | Immage Antidioxyribonuclease B (DNB) reagent part no. 447480 | Siemens Healthcare Diagnostics Inc. | EXEMP | ||
| Z-0922-03 | ThinPrep Microscope Slides for Non-Gynecologic Use Size 1'' x 3'' Reorder Number... | Hologic, Inc. | KEW | ||
| Z-0553-03 | Boston Scientific/Microvasive Rapid Exchange Retrieval Balloon15.5 mm balloon Catalog #... | Boston Scientific Corporation | |||
| Z-0552-03 | Boston Scientific/Microvasive Rapid Exchange Retrieval Balloon/11.5 mm balloon Catalog #... | Boston Scientific Corporation | |||
| Z-0551-03 | Boston Scientific/Microvasive Rapid Exchange Retrieval Balloon/8.5 mm balloon Catalog #... | Boston Scientific Corporation | |||
| Z-0665-03 | LTX Endosseous Implant 6.0 mm X 11.5 mm and also LTX Endosseous Implant 5.0 mm X 15 mm... | ZimVie US Corp LLC | DZE | ||
| Z-0796-03 | AEROSET System External Waste Pump | Abbott Medical | JJE | ||
| Z-0795-03 | ARCHITECT i System External Waste Pump | Abbott Medical | JJE | ||
| Z-0609-03 | Compat DualFlo Enteral Delivery Pump Set with 1000-mL Twist Cap Formula Vinyl Bag and... | Novartis Nutrition Corp. | LZH | ||
| Z-0608-03 | Compat 500 mL Baggle Top Fill Enteral Feeding Container with Preattached Enteral Delivery... | Novartis Nutrition Corp. | LZH | ||
| Z-0619-03 | Access and Access 2 Immunoassay Systems 862.2160 Discrete photometric chemistry analyzer... | Siemens Healthcare Diagnostics Inc. | JJE | ||
| Z-0575-03 | Nobel Biocare Replace Select Radiographic Template, part number 30159. | Nobel Biocare USA LLC | |||
| Z-0607-03 | Compat Enteral Delivery Pump Set with Piercing Spike, Item number 19930700 | Novartis Nutrition Corp. | LZH | ||
| Z-0542-03 | LIFEPAK 12 defibrillator/monitor is a portable, battery operated, complete acute cardiac... | Physio Control, Inc. | MKJ | ||
| Z-0717-03 | Product is packed in a pouch which is labeled as MicroChoice FOOTSWITCH Linvatec LINVATEC... | Linvatec Corporation | HWE | ||
| Z-0634-03 | BD K-3000 Microkeratome Blade REF 378607 | Becton Dickinson & Co | HMY | ||
| Z-0710-03 | Finger Joint Implants, Silicone Models TRL-10 and TRL-20 | Avanta Orthopaedics, Inc. | KYI | ||
| Z-0858-03 | Interax Knee Midi 1 Tibial Inserts. IX HC Tib Ins Midi 1 14mm R. | Howmedica Osteonics Corp | JWH | ||
| Z-0857-03 | Interax Knee Midi 1 Tibial Inserts. IX HC Tib Ins Midi 1 14mm L. | Howmedica Osteonics Corp | JWH | ||
| Z-0856-03 | Interax Knee Midi 1 Tibial Inserts. IX HC Tib Ins Midi 1 10mm L. | Howmedica Osteonics Corp | JWH | ||
| Z-0855-03 | Interax Knee Midi 1 Tibial Inserts. Interax Tib Ins Midi 1 10 Rgt. | Howmedica Osteonics Corp | JWH | ||
| Z-0854-03 | Interax Knee Midi 1 Tibial Inserts. IX HC Tib Bear Ins M1 14mm R. | Howmedica Osteonics Corp | JWH | ||
| Z-0853-03 | Interax Knee Midi 1 Tibial Inserts. Interax Tib Ins Midi 1 10mm Lft. | Howmedica Osteonics Corp | JWH | ||
| Z-0852-03 | Interax Knee Midi 1 Tibial Inserts. Interax Tib Ins Midi 1 8mm Lft. | Howmedica Osteonics Corp | JWH | ||
| Z-0851-03 | Interax Knee Midi 1 Tibial Inserts. Interax Tib Ins Midi 1 6mm Lft. | Howmedica Osteonics Corp | JWH | ||
| Z-0675-03 | CryoValve Allograft heart valve | Artivion, Inc. | MIE | ||
| Z-0563-03 | Prism 3000S and 3000XP Gamma Camera Systems, Models N210060 and N210335. | Philips North America LLC | KPS | ||
| Z-0576-03 | Convertors Three Quarter Sheet (Drape Sheet), catalog #29350; Allegiance Healthcare... | Medtronic, Inc. | KKX-- | ||
| Z-0555-03 | Pursuit ureteral dilation balloon catheters, 6 mm x 8 cm. Order # PAB-050080-6-8.0 | Cook Incorporated | EZN | ||
| Z-0561-03 | Boston Medical Products Otocell Ear Wick 15 mm, sterile Ref: EW-0915 | Boston Medical Products, Inc. | |||
| Z-0299-03 | Biosound Caris Plus Ultrasound System with phased array probes, model 7230. Biosound... | Esaote North America, Inc | |||
| Z-0554-03 | Pursuit ureteral dilation balloon catheters, 6 mm x 4 cm. Order # PAB-050080-6-4.0 | Cook Incorporated | EZN | ||
| Z-0906-03 | ATF 40 Fast Start Kit - contains one each AT1 Autotransfusion Set, ATS Suction Line, and... | Fresenius Hemocare GmbH | CAC | ||
| Z-0585-03 | T2 4.2mmx130mm Tri Flat Bit | Howmedica Osteonics Corp | HTW | ||
| Z-0584-03 | T2 4.2mmx130mm AO Drill Bit | Howmedica Osteonics Corp | HTW | ||
| Z-0583-03 | T2 3.5x130mm Tri Flat Drill Bit | Howmedica Osteonics Corp | HTW | ||
| Z-0582-03 | T2 3.5x130mm AO Drill Bit | Howmedica Osteonics Corp | HTW | ||
| Z-0581-03 | Gamma Drill Dia. 4.2x300mm | Howmedica Osteonics Corp | HTW | ||
| Z-0580-03 | Gamma AO Drill 5.5x300mm | Howmedica Osteonics Corp | HTW | ||
| Z-0579-03 | Gamma Drill 5.5x300mm | Howmedica Osteonics Corp | HTW | ||
| Z-0570-03 | AcT 5 diff Cap Pierce Hematology Analyzer 864.5220 Automated differential cell counter | Siemens Healthcare Diagnostics Inc. | |||
| Z-0718-04 | Apex Pilot Shaft 17.5mm | VQ Orthocare | HTO | ||
| Z-0717-04 | Apex Pilot Shaft 16mm | VQ Orthocare | HTO | ||
| Z-0716-04 | Apex Pilot Shaft 14.4mm | VQ Orthocare | HTO |