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-0160-06 | Ohmeda Giraffe SPOT PT Lite Phototherapy System | GE Healthcare | LBI | ||
| Z-0300-06 | Titanium Greenfield Vena Cava Filter with 12 Fr./4,0 mm Introducer System. Catalog no... | Boston Scientific Corporation | DTK | ||
| Z-0299-06 | Stainless Steel Greenfield Vena Cava Filter with 12 Fr. / 4,0 mm FlexCarrier Capsule... | Boston Scientific Corporation | DTK | ||
| Z-1390-05 | Stryker brand Consolidated Operating Room Equipment (CORE) SystemPowered Instrument... | Stryker Corp. | DZJ | ||
| Z-1389-05 | Stryker brand Consolidated Operating Room Equipment (CORE) System Powered Instrument... | Stryker Corp. | DZJ | ||
| Z-1497-06 | Skytron General Purpose Surgical Table, battery model; Model 6600B, Dist. by Skytron... | Skytron, LLC | FQO | ||
| Z-1496-06 | Skytron General Purpose Surgical Table; Model 6600, Dist. by Skytron, Grand Rapids, MI. | Skytron, LLC | FQO | ||
| Z-0019-06 | TC-PLUS Tibial Insert UC 10; 11mm, Model 25457 | Plus Orthopedics | JWH | ||
| Z-0018-06 | TC-PLUS Tibial Insert UC 6; 13mm, Model 25438 | Plus Orthopedics | JWH | ||
| Z-0017-06 | TC-PLUS Tibial Insert UC 6; 9 mm, Model 25436 | Plus Orthopedics | JWH | ||
| Z-0016-06 | TC-PLUS Tibial Insert UC 4; 13mm, Model 25428 | Plus Orthopedics | JWH | ||
| Z-0015-06 | TC-PLUS Tibial Insert UC 4; 11mm, Model 25427 | Plus Orthopedics | JWH | ||
| Z-0014-06 | TC-PLUS Tibial Insert 2; 15mm, Model 25309 | Plus Orthopedics | JWH | ||
| Z-1439-05 | Baxter Interlink System Huber Needle Extension Set, product code 2N3716; An Rx sterile... | Baxter Healthcare Corporation | FPA | ||
| Z-1438-05 | Baxter Interlink System Huber Needle Extension Set, product code 2N3714; An Rx sterile... | Baxter Healthcare Corporation | FPA | ||
| Z-1437-05 | Baxter Interlink System Huber Needle Extension Set, product code 2N3712; An Rx sterile... | Baxter Healthcare Corporation | FPA | ||
| Z-1436-05 | Baxter Interlink System Huber Needle Extension Set, product code 2N3710; An Rx sterile... | Baxter Healthcare Corporation | FPA | ||
| Z-1435-05 | Baxter Interlink System Huber Needle Extension Set, product code 2N3709; An Rx sterile... | Baxter Healthcare Corporation | FPA | ||
| Z-1434-05 | Baxter Interlink System Huber Needle Extension Set, product code 2N3707; An Rx sterile... | Baxter Healthcare Corporation | FPA | ||
| Z-1433-05 | Baxter Interlink System Huber Needle Extension Set, product code 2N3706; An Rx sterile... | Baxter Healthcare Corporation | FPA | ||
| Z-0013-06 | TC-PLUS Tibial Insert Ultra-Congruent Size 10 ; 9 mm, Model 25456 | Plus Orthopedics | JWH | ||
| Z-1432-05 | Baxter Interlink System Huber Needle Extension Set, product code 2N3703; An Rx sterile... | Baxter Healthcare Corporation | FPA | ||
| Z-1431-05 | Baxter Extension Set, product code 2C9219; An Rx sterile, nonpyrogenic fluid pathway... | Baxter Healthcare Corporation | FPA | ||
| Z-1430-05 | Baxter Tamper Resistant Anti-Siphon Combination Set, 101'', product code 2L3507; An Rx... | Baxter Healthcare Corporation | FPA | ||
| Z-1429-05 | Baxter Tamper Resistant Anti-Siphon PCA Extension Set, 96'', product code 2C9206; An Rx... | Baxter Healthcare Corporation | FPA | ||
| Z-1428-05 | Baxter Tamper Resistant Anti-Siphon PCA Extension Set, 60'', product code 2C9205; An Rx... | Baxter Healthcare Corporation | FPA | ||
| Z-1427-05 | Baxter Mini-Infuser Microbore Extension Set, product code 2C9201; An Rx sterile... | Baxter Healthcare Corporation | FPA | ||
| Z-1426-05 | Baxter Minivolume Extension Set, 36'', product code 2C5685; An Rx sterile, nonpyrogenic... | Baxter Healthcare Corporation | FPA | ||
| Z-1425-05 | Baxter Minivolume Extension Set, 72'', product code 2C5687; An Rx sterile, nonpyrogenic... | Baxter Healthcare Corporation | FPA | ||
| Z-1424-05 | Baxter Interlink System Non-DEHP Y-Type Catheter Extension Set, product code 2N3371; An... | Baxter Healthcare Corporation | FPA | ||
| Z-0932-2007 | Terumo Advanced Perfusion System 1, 4 inch diameter Roller Pump; Model 801040. | Terumo Cardiovascular Systems Corporation | DTQ | ||
| Z-0931-2007 | Terumo Advanced Perfusion System 1, 6 inch diameter Roller Pump; Model 801041. | Terumo Cardiovascular Systems Corporation | DTQ | ||
| Z-0603-2007 | Terumo Advanced Perfusion System 1; 220V -240V, 7A (circuit breaker), 50/60 Hz (10A power... | Terumo Cardiovascular Systems Corporation | DTQ | ||
| Z-0602-2007 | Terumo Advanced Perfusion System 1; 100V -120V, 15 A (circuit breaker), 50/60 Hz (20A... | Terumo Cardiovascular Systems Corporation | DTQ | ||
| Z-0442-06 | Primus Biliary Stent and Delivery System. Balloon Expandable Stent and Delivery System... | Medtronic, Inc. | FGE | ||
| Z-0123-06 | Powermobil Mobile X-Ray System | Siemens Medical Solutions USA, Inc. | IZL | ||
| Z-0122-06 | Siremobil Iso-C Mobile X-Ray System | Siemens Medical Solutions USA, Inc. | IZL | ||
| Z-0121-06 | Siremobil Compact L Mobile X-Ray System | Siemens Medical Solutions USA, Inc. | IZL | ||
| Z-0120-06 | Siremobil Compact Mobile X-Ray System | Siemens Medical Solutions USA, Inc. | IZL | ||
| Z-0119-06 | Arcadis Orbic Mobile X-Ray System | Siemens Medical Solutions USA, Inc. | IZL | ||
| Z-0118-06 | Arcadis Varic Mobile X-Ray System | Siemens Medical Solutions USA, Inc. | IZL | ||
| Z-1531-05 | Linvatec LS 7500, 300 Watt Xenon Light Source Catalog Numbers: LS7500, LS7500L (loaner)... | Conmed Linvatec Endoscopy Division | GCT | ||
| Z-1584-05 | Cook brand Fascial Dilator; 10FR/37cm, sterile, Rx Only, Cook Ireland Ltd., Limerick... | Cook Incorporated | KOE | ||
| Z-1147-06 | LADARVision Excimer Laser System. | Alcon Laboratories | LZS | ||
| Z-0157-06 | Boehringer Suction Regulator Model number 3714 | Boehringer Laboratories, LLC | KDP | ||
| Z-0156-06 | Boehringer Suction Regulator Model number 3704D3 | Boehringer Laboratories, LLC | KDP | ||
| Z-0155-06 | Boehringer Suction Regulator Model number 3704 | Boehringer Laboratories, LLC | KDP | ||
| Z-1368-05 | Portable Oxygen Generator | Inogen, Inc | CAW | ||
| Z-1542-05 | Boston Scientific brand LeVeen Needle Electrode, 5.0/13/25; Model number M001262170,Ref... | Boston Scientific Corporation | GEI | ||
| Z-1541-05 | Boston Scientific brand LeVeen Needle Electrode, 5.0/13/15; Model number M001262160, Ref... | Boston Scientific Corporation | GEI |