Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR

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

59,486 records, page 859 of 1190
FDA device recalls, page 859 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-0100-2013Class IIPulset Arterial Blood Gas (ABG) sampling kit. Modified Kit, Pulset, 3 cc, w/Crickett 22g...Westmed IncCBT
Z-0099-2013Class IIPulset Arterial Blood Gas (ABG) sampling kit. Full Kit, Pulset, 1 cc, with Eclipse, 25 g...Westmed IncCBT
Z-0098-2013Class IIPulset Arterial Blood Gas (ABG) sampling kit. Full Kit, Pulset, 1 cc, 25 g x 5/8" A...Westmed IncCBT
Z-0097-2013Class IIPulset Arterial Blood Gas (ABG) sampling kit. Modified Kit, Pulset, 1 cc, with Eclipse...Westmed IncCBT
Z-0096-2013Class IIPulset Arterial Blood Gas (ABG) sampling kit. Modified Kit, Pulset, 1 cc, w/Crickett 25g...Westmed IncCBT
Z-0905-2011BuckyDiagnost general purpose x-ray system with Optimus Generator. General Purpose...Philips North America LLCIZO
Z-2238-2026Class IAutomated Impella Controller (AIC) with the below product descriptions and corresponding...Abiomed, Inc.OZD
Z-1721-2011KING SYSTEMS, A Consort Medical Company, KLTSD415, Quantity: 5 PER CASE, KING KLTSD, KIT...King Systems Corporation.CAE
Z-1720-2011KING SYSTEMS, A Consort Medical Company, KLTSD414, Quantity: 5 PER CASE, KING LTSD, KIT...King Systems Corporation.CAE
Z-1719-2011KING SYSTEMS, A Consort Medical Company, KLTSD413, Quantity: 5 PER CASE, KING LTSD, KIT...King Systems Corporation.CAE
Z-1718-2011KING SYSTEMS, A Consort Medical Company, KLTD215, Quantity: 5 PER CASE, KING LT-D, KIT...King Systems Corporation.CAE
Z-1717-2011KING SYSTEMS, A Consort Medical Company, KLTD214, Quantity: 5 PER CASE, KING LT-D, KIT...King Systems Corporation.CAE
Z-1716-2011KING SYSTEMS, A Consort Medical Company, KLTD213, Quantity: 5 PER CASE, KING LT-D, KIT...King Systems Corporation.CAE
Z-1715-2011KING SYSTEMS, A Consort Medical Company, KLTD2125, Quantity: 5 PER CASE, KING LT-D, KIT...King Systems Corporation.CAE
Z-1714-2011KING SYSTEMS, A Consort Medical Company, KLTD212, Quantity: 5 PER CASE, KING LT-D, KIT...King Systems Corporation.CAE
Z-1713-2011CRQ425, Cardiac ResQ Kit, Quantity 3 units, KING SYSTEMS, A Consort Medical Company...King Systems Corporation.CAE
Z-1712-2011CRQ424, Cardiac ResQ Kit, Quantity 3 units, KING SYSTEMS, A Consort Medical Company...King Systems Corporation.CAE
Z-1711-2011CRQ423, Cardiac ResQ Kit, Quantity 3 units, KING SYSTEMS, A Consort Medical Company...King Systems Corporation.CAE
Z-1710-2011KING LTS-D, SIZE 5, QUANTITY 5 EACH, Distributed by North American Rescue, Greer, South...King Systems Corporation.CAE
Z-1709-2011KING LTS-D, SIZE 4, QUANTITY 5 EACH, Distributed by North American Rescue, Greer, South...King Systems Corporation.CAE
Z-1708-2011KING LTS-D, SIZE 3, QUANTITY 5 EACH, Distributed by North American Rescue, Greer, South...King Systems Corporation.CAE
Z-1707-2011KING LTD, SIZE 5, QUANTITY 1 EACH, Distributed by North American Rescue, Greer, South...King Systems Corporation.CAE
Z-1706-2011KING LTD, SIZE 4, QUANTITY 1 EACH, Distributed by North American Rescue, Greer, South...King Systems Corporation.CAE
Z-1705-2011KING LT-D, SIZE 3, QUANTITY 1 EACH, Distributed by North American Rescue, Greer, South...King Systems Corporation.CAE
Z-1421-2011AXIOM SIRESKOP SD, SIRESKOP SX, AXIOM LUMINOS System, X-Ray, Fluoroscopic...Siemens Medical Solutions USA, Inc.MQB
Z-1471-2011Dressing Change Tray, DT5880A, Sterile, Centurion Medical Products Corp., Williamston...Centurion Medical Products, LPMCY
Z-1470-2011Dressing Change Kit, DT15215, Sterile, Centurion Medical Products Corp., Williamston...Centurion Medical Products, LPMCY
Z-1469-2011IN-PATIENT Port Access Dressing Tray, DT14880, Sterile, Centurion Medical Products...Centurion Medical Products, LPMCY
Z-1468-2011OUT-PATIENT Port Access Dressing Tray, DT14875, Sterile, Centurion Medical Products...Centurion Medical Products, LPMCY
Z-1467-2011PICC/Central Line Dressing Change Tray, DT14675, Sterile, Centurion Medical Products...Centurion Medical Products, LPMCY
Z-1466-2011Central Line Dressing Change Tray, DT13850, Sterile, Centurion Medical Products Corp...Centurion Medical Products, LPMCY
Z-1465-2011Dressing Change Tray , DT13650, Sterile, Centurion Medical Products Corp., Williamston...Centurion Medical Products, LPMCY
Z-1464-2011Dressing Change Tray, DT12770, Sterile, Centurion Medical Products Corp., Williamston...Centurion Medical Products, LPMCY
Z-1463-2011Dressing Change Tray for Hickman & Dialysis Catheters, DT12110, Sterile, Centurion...Centurion Medical Products, LPMCY
Z-1462-2011Dressing Change Tray for CVC & PICC Lines, DT12105, Sterile, Centurion Medical Products...Centurion Medical Products, LPMCY
Z-1461-2011Central Line Dressing Change Tray, DT10020, Sterile, Centurion Medical Products Corp...Centurion Medical Products, LPMCY
Z-1460-2011Universal Insertion Tray Bundle, CV13530, Sterile, Centurion Medical Products Corp...Centurion Medical Products, LPLRS
Z-1724-2011W Vital Health Pulsating Clean Rechargeable Toothbrush; Distributed by: Walgreen Co., 200...Brushpoint Innovations, Inc.JEQ
Z-1062-2011Medtronic SynchroMed EL (Model No: 8626 and 8627) implantable drug pump The SynchroMed...Medtronic NeuromodulationLKK
Z-1061-2011Medtronic SynchroMed implantable drug pump Refill Kits (Model No: 8551, 8555, 8561...Medtronic NeuromodulationLKK
Z-1060-2011Medtronic SynchroMed II (Model No: 8637) implantable drug pump The SynchroMed II...Medtronic NeuromodulationLKK
Z-2598-2011Monaco Radiation Treatment Planning Workstation, Monaco Release 2.03.00 and above To...Elekta LimitedMUJ
Z-2561-2011Monaco Radiation Treatment Planning Workstation. Monaco Release 2.03.00 and above. The...Elekta LimitedMUJ
Z-1033-2011Smiths Medical, CADD-Solis Ambulatory Infusion Pump, Model Number: 2100 and 2110, Reorder...Abbott MedicalMEA
Z-2405-2011Drainage Bag, Model 600D, 600 mL, Single use, Ethylene Oxide sterilized, Remington...Remington MedicalEXF
Z-2112-2011ABL90 FLEX Portable Blood Gas Analyzer System, Part Number: 393-090, 510 (k) #K092686...Radiometer America, IncCEM
Z-1643-2011AFFIXUS Lag Screw Drill, REF 2112-01-303, Non-Sterile, DePuy Orthopaedics, Inc...Depuy Orthopaedics Inc.LXH
Z-1400-2011Integra Radionics HRAIM Intubation Head Ring Assembly Ref: HRAIM Head Rings serve as the...Integra LifeSciences CorporationHAW
Z-1728-2011Hc2 System Software Suite 4.0 version 3.0, available as component in Qiagen user guide...QiagenJJQ
Z-1395-2011SP Brand Strep A Cassette; Part Number: B1077-26; Lot #: STA0010037 The SP Brand Strep A...Alere San Diego, Inc.GTY