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-0303-05 | NAMIC Custom Angiographic Kit, Left Heart Kit. - . Model #: H7496019054110. Catalog... | Boston Scientific Corporation | FMI | ||
| Z-0302-05 | NAMIC Custom Angiographic Kit, Left Heart Kit - . Model #H749651947220. Catalog #... | Boston Scientific Corporation | FMI | ||
| Z-0269-05 | Patient tables of CT systems with brand name: CT/e; CT/e Dual; CT/e Plus, CT/e Dual Plus... | GE Healthcare | IXR | ||
| Z-0176-05 | Alto implantable cardioverter defibrillator | Ela Medical, Inc. | LWS | ||
| Z-0633-05 | ETI-MP IgM Enzyme-Linked Immunosorbent Assay (ELISA) for the qualitative detection of... | Diasorin Inc. | LAZ | ||
| Z-0323-05 | BD, Febrile Antigen Negative Control | Lee Laboratories, Inc. | GSM | ||
| Z-0322-05 | BD, Brucella Postive Control Antiserum (AMS) | Lee Laboratories, Inc. | GSM | ||
| Z-0321-05 | BD, Proteus Polyvalent Antiserum (OXK, OX2, OX19) | Lee Laboratories, Inc. | GSY | ||
| Z-0320-05 | BD, Francisella tularensis Antigen | Lee Laboratories, Inc. | GSK | ||
| Z-0319-05 | BD, Proteus OX19 Antigen | Lee Laboratories, Inc. | GSY | ||
| Z-0318-05 | BD, Salmonella Flagellar Polyvalent Antiserum (a,b,d) | Lee Laboratories, Inc. | GSN | ||
| Z-0317-05 | BD, Salmonella O Group B Antigen (1-4-5-12) | Lee Laboratories, Inc. | GNC | ||
| Z-0316-05 | BD, Salmonella O Group A Antigen (1-2-12) | Lee Laboratories, Inc. | GNC | ||
| Z-0315-05 | BD, Salmonella Flagellar d Antigen (Typhoid H) | Lee Laboratories, Inc. | GNC | ||
| Z-0314-05 | BD, Brucella abortus Antigen | Lee Laboratories, Inc. | GSO | ||
| Z-0313-05 | BD, Salmonella Somatic Polyvalent Antiserum (A,B,D) | Lee Laboratories, Inc. | GSN | ||
| Z-0312-05 | BD, Salmonella O Group D Antigen (9-12) (Typhoid O) | Lee Laboratories, Inc. | GNC | ||
| Z-0311-05 | BD, Brucella melitensis Antigen | Lee Laboratories, Inc. | GSO | ||
| Z-0207-05 | Medtronic CapSureFix Novus Lead Model 5076. | Medtronic, Inc. | DTA | ||
| Z-0198-05 | MX20170: Pediatric 40 In Sampling Kit w/10cc syringe, MX20443: LogiCal Single Pressure... | Abbott Medical | DQO | ||
| Z-0665-05 | Nellcor brand Pulse Oximeter, model N-395, Made in Ireland; Distributed by Tyco... | Medtronic, Inc. | DQA | ||
| Z-0664-05 | Nellcor brand OxiMax Pulse Oximeter, model number N-595 Made in Ireland; Distributed by... | Medtronic, Inc. | DQA | ||
| Z-0663-05 | Nellcor Puritan Bennett brand Pulse Oximeter, Model NPB295, Made in Ireland... | Medtronic, Inc. | DQA | ||
| Z-0662-05 | Nellcor brand Pulse Oximeter, Model NPB290, MALLINCKRODT, Made in Ireland... | Medtronic, Inc. | DQA | ||
| Z-0566-05 | Deltec Cozmo 3 ml Insulin Cartridge with 0.7mm(22G) x 12.5mm (1/2 in.) needle and cap... | Abbott Medical | LZG | ||
| Z-0191-05 | Custom Convenience Kit | Merit Medical Systems, Inc. | DQO | ||
| Z-0190-05 | Safety Paracentesis Procedure Tray | Merit Medical Systems, Inc. | DQY | ||
| Z-0058-05 | SafeSheath KR under the Pressure Products label. Tearaway KR Kit. Catalog number... | Merit Medical Systems, Inc. | DYB | ||
| Z-0057-05 | SafeSheath KR under the Pressure Products label. Tearaway KR Kit. Catalog number... | Merit Medical Systems, Inc. | DYB | ||
| Z-0056-05 | SafeSheath KR under the Pressure Products label. Tearaway KR Kit. Catalog number... | Merit Medical Systems, Inc. | DYB | ||
| Z-0421-05 | Bosworth Superbite Zinc Oxide Eugenol Bite Registration Paste Kit; the kit consists of... | Harry J. Bosworth Co. | ELW | ||
| Z-0420-05 | Bosworth Tray Aways #3 Disposable Impression Trays; styrene plastic perforated medium... | Harry J. Bosworth Co. | EHY | ||
| Z-0164-05 | Counterfeit contact lenses labeled as: 'CooperVision Proclear compatibles (omafilcon A)'... | 1-800 Contacts Inc. | MVN | ||
| Z-0063-05 | Pagewriter Touch Cardiograph Software Versions A.01.01 or A.01.02 | Philips North America LLC | DPS | ||
| Z-1105-2007 | Smith & Nephew TRIVEX System Pneumatic Footswitch, Part #7209791; distributed by Smith &... | Smith & Nephew, Inc. | DWQ | ||
| Z-0333-2007 | Terumo Advanced Perfusion System 1 Flow Module; Catalog number 802018. | Terumo Cardiovascular Systems Corporation | DTQ | ||
| Z-0337-2007 | Terumo Advanced Perfusion System 1 Central Control Monitor; Catalog number 802100. | Terumo Cardiovascular Systems Corporation | DTQ | ||
| Z-0336-2007 | Terumo Advanced Perfusion System 1 Electronic Oxygen Blender/analyzer; Catalog number... | Terumo Cardiovascular Systems Corporation | DTQ | ||
| Z-0335-2007 | Terumo Advanced Perfusion System 1 Control Unit; Catalog number 801046. | Terumo Cardiovascular Systems Corporation | DTQ | ||
| Z-0334-2007 | Terumo Advanced Perfusion System 1 Data Interface RS 485; Catalog number 803518. | Terumo Cardiovascular Systems Corporation | DTQ | ||
| Z-0332-2007 | Terumo Advanced Perfusion System 1 Temperature Monitoring System; Catalog number 802114. | Terumo Cardiovascular Systems Corporation | DTQ | ||
| Z-0331-2007 | Terumo Advanced Perfusion System 1 Pressure Monitoring; Catalog number 802112. | Terumo Cardiovascular Systems Corporation | DTQ | ||
| Z-0330-2007 | Terumo Advanced Perfusion System 1 Level Detection; Catalog number 802111. | Terumo Cardiovascular Systems Corporation | DTQ | ||
| Z-0329-2007 | Terumo Advanced Perfusion System 1 Venous Occluder; Catalog number 803480. | Terumo Cardiovascular Systems Corporation | DTQ | ||
| Z-0328-2007 | Terumo Advanced Perfusion System 1 Data Interface CDI 500; Catalog number 803479. | Terumo Cardiovascular Systems Corporation | DTQ | ||
| Z-0327-2007 | Terumo Advanced Perfusion System 1 Data Interface CDI 100; Catalog number 802558. | Terumo Cardiovascular Systems Corporation | DTQ | ||
| Z-0326-2007 | Terumo Advanced Perfusion System 1 Air Bubble Detection Module; Catalog number 802110. | Terumo Cardiovascular Systems Corporation | DTQ | ||
| Z-0325-2007 | Terumo Advanced Perfusion System 1, 6 inch diameter Roller Pump; Model 801041. | Terumo Cardiovascular Systems Corporation | DTQ | ||
| Z-324-2007 | Terumo Advanced Perfusion System 1, 4 inch diameter Roller Pump; Model 801040. | Terumo Cardiovascular Systems Corporation | DTQ | ||
| Z-0323-2007 | Terumo Advanced Perfusion System 1; 220V -240V, 7A (circuit breaker), 50/60 Hz (10A power... | Terumo Cardiovascular Systems Corporation | DTQ |