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-1405-04 | Guardian Distal Femur Axial Pin | Wright Medical Technology Inc | JDI | ||
| Z-1303-04 | Roche brand Reflotron GPT (ALT) 30 test strips; catalog # 745138. | Roche Diagnostics GmbH | CIT | ||
| Z-1302-04 | Roche brand Reflotron GOT (AST), 30 test strips; catalog # 745120. | Roche Diagnostics GmbH | CKD | ||
| Z-1131-04 | Thermovent 1200, Heat and Moisture Exchanger Catalog # 580021 | Abbott Medical | BYD | ||
| Z-1130-04 | ThermovenT 600, Heat and Moisture Exchangers Catalog # 580011 | Abbott Medical | BYD | ||
| Z-1129-04 | Portex Thermovent T, Heat and Moisture Exchangers Catalog # 570016; | Abbott Medical | BYD | ||
| Z-0815-05 | InstaTrak 3500 Plus Navigation and Visualization System | GE Healthcare | LLZ | ||
| Z-0814-05 | InstaTrak 3500 Navigation and Visualization System | GE Healthcare | LLZ | ||
| Z-0813-05 | ENTrak Plus Navigation and Visualization System | GE Healthcare | LLZ | ||
| Z-0812-05 | ENTrak Navigation and Visualization System | GE Healthcare | LLZ | ||
| Z-1327-04 | Neuro Adapter 2 used with the Berchtold B-810 Surgical Table or Getinge USA Fortis... | Allen Medical Systems, Inc. | FQO | ||
| Z-1138-04 | Staple Removal Set/Kit; a sterile Rx convenience kit containing a staple remover and a... | Gyn-Disposables, Inc. | KKX | ||
| Z-1137-04 | MediChoice Skin Staple Remover, reorder no. SSR 1001; a sterile Rx convenience kit... | Gyn-Disposables, Inc. | KKX | ||
| Z-1136-04 | Staple Removal Tray/Set/Kit; a sterile Rx convenience kit containing a staple remover... | Gyn-Disposables, Inc. | KKX | ||
| Z-1411-04 | Heat Loop cautery instrument, EO sterile - single use only; Arthrotek Ref. No. 905414 and... | Zimmer GmbH | GEI | ||
| Z-1315-04 | ProLumen Rotational Thrombectomy System. Catalog No. 86311, sold as a single unit... | Datascope Collagen Products Division | MCW | ||
| Z-1127-04 | Disposable Oxygen Mask & Bag, Adult Non-Rebreathing Mask w/Safety Vent and 84'' Tube... | Abbott Medical | KGB | ||
| Z-1126-04 | Disposable Oxygen Mask & Bag, a High Concentration Non-Rebreathing Mask, complete w/Bag... | Abbott Medical | KGB | ||
| Z-1125-04 | Disposable Water Trap with ''Y'' for Ventilator Circuits; product reorder 6091; SIngle... | Abbott Medical | BYH | ||
| Z-1124-04 | Disposable Water Trap with ''T'' for Ventilator Circuits; product reorder 6090; SIngle... | Abbott Medical | BYH | ||
| Z-1123-04 | Ventilator Circuit with ''Y'' & elbow with 2 Water Traps, for use with/compatible with... | Abbott Medical | BZO | ||
| Z-1122-04 | IPI Ventilator Circuit with 2 Water Traps, product reorder no. 6066; SIngle Patient Use... | Abbott Medical | BZO | ||
| Z-0036-05 | AXIOM Sensis Programmable diagnostic computer, Model number 66 48 161 | Siemens Medical Solutions USA, Inc. | DQK | ||
| Z-0035-05 | AXIOM Sensis Programmable diagnostic computer, Model number 66 34 658 | Siemens Medical Solutions USA, Inc. | DQK | ||
| Z-0034-05 | AXIOM Sensis Programmable diagnostic computer, Model number 66 34 641 | Siemens Medical Solutions USA, Inc. | DQK | ||
| Z-0033-05 | AXIOM Sensis Programmable diagnostic computer, Model number 66 34 633. | Siemens Medical Solutions USA, Inc. | DQK | ||
| Z-0032-05 | AXIOM Sensis Programmable diagnostic computer, Model number 66 23 974. | Siemens Medical Solutions USA, Inc. | DQK | ||
| Z-1330-04 | Protege GPS Biliary System (6Fr 10mm x 30mm) - Product number SERB65-10-30-120 (.035)... | Medtronic, Inc. | FGE | ||
| Z-1329-04 | Protege GPS Biliary System (6Fr 10mm x 30mm) - Product number SER6-10-30-135 (.018)... | Medtronic, Inc. | FGE | ||
| Z-0379-05 | MammoTest Breast Biopsy System. | Fischer Imaging Corp. | IZH | ||
| Z-1132-04 | Encision ES4107 Disposable AEM Cord, Sterile. | Encision, Inc. | GEI | ||
| Z-1340-04 | WALLSTENT Endoprostheses with UNISTEP Plus Delivery System. | Boston Scientific Corporation | JCT | ||
| Z-1184-06 | Theratron Elite 100 Cobalt Radiotherapy | Bwxt Medical Ltd. | IWB | ||
| Z-1183-06 | Theratron Elite 80 Cobalt Radiotherapy | Bwxt Medical Ltd. | IWB | ||
| Z-1182-06 | Theratron Phoenix Cobalt Radiotherapy | Bwxt Medical Ltd. | IWB | ||
| Z-1181-06 | Theratron 1000E Cobalt Radiotherapy | Bwxt Medical Ltd. | IWB | ||
| Z-1180-06 | Theratron 1000 Cobalt Radiotherapy | Bwxt Medical Ltd. | IWB | ||
| Z-1179-06 | Theratron 780E Cobalt Radiotherapy | Bwxt Medical Ltd. | IWB | ||
| Z-1178-06 | Theratron 780C Cobalt Radiotherapy | Bwxt Medical Ltd. | IWB | ||
| Z-0001-05 | Aquasorb Border, Hydrogel Wound Dressing with Polyurethane Film Border, 25 individual... | DeRoyal Wound Care | MGQ | ||
| Z-1312-04 | Shiley TracheoSoft XLT Extended Length Tracheostomy tube; Model Numbers: 72110-050... | Medtronic, Inc. | --- | ||
| Z-1359-04 | Sarns brand Retrograde Cardioplegia Cannulae, manual-inflate, 15 Fr, steerable stylet... | Terumo Cardiovascular Systems Corporation | DWF | ||
| Z-1358-04 | Sarns brand Retrograde Cardioplegia Cannulae, manual-inflate, 15 Fr, guidewire stylet... | Terumo Cardiovascular Systems Corporation | DWF | ||
| Z-1357-04 | Sarns brand Retrograde Cardioplegia Cannulae, manual-inflate, 15 Fr, steerable stylet... | Terumo Cardiovascular Systems Corporation | DWF | ||
| Z-1356-04 | Sarns brand Retrograde Cardioplegia Cannulae, manual-inflate, 15 Fr, guidewire stylet... | Terumo Cardiovascular Systems Corporation | DWF | ||
| Z-1355-04 | Sarns brand Retrograde Cardioplegia Cannulae, auto-inflate, 13 Fr, rigid stylet, ribbed... | Terumo Cardiovascular Systems Corporation | DWF | ||
| Z-1354-04 | Sarns brand Retrograde Cardioplegia Cannulae, auto-inflate, 13 Fr, rigid stylet, ribbed... | Terumo Cardiovascular Systems Corporation | DWF | ||
| Z-1353-04 | Sarns brand Retrograde Cardioplegia Cannulae, auto-inflate, 13 Fr, steerable stylet... | Terumo Cardiovascular Systems Corporation | DWF | ||
| Z-1352-04 | Sarns brand Retrograde Cardioplegia Cannulae, auto-inflate, 13 Fr, malleable stylet... | Terumo Cardiovascular Systems Corporation | DWF | ||
| Z-1351-04 | Sarns brand Retrograde Cardioplegia Cannulae, manual-inflate, 13 Fr, guidewire stylet... | Terumo Cardiovascular Systems Corporation | DWF |