510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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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

59,460 records, page 162 of 1190
FDA device recalls, page 162 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-1062-2024Class IAirLife Adult Manual Resuscitator, 40" (1.0m) Oxygen Reservoir Tubing, Adult Mask...Jaeger Medical GmbHBTM
Z-1061-2024Class IAirLife Adult Manual Resuscitator, 40" (1.0m) Oxygen Reservoir Tubing, Adult Mask, REF...Jaeger Medical GmbHBTM
Z-1060-2024Class IAirLife Adult Manual Resuscitator, Oxygen Reservoir Bag, Adult Mask, CO2 Detector, REF...Jaeger Medical GmbHBTM
Z-1059-2024Class IAirLife Adult Manual Resuscitator, Oxygen Reservoir Bag, Expiratory Filter, REF 2K8004FJaeger Medical GmbHBTM
Z-1058-2024Class IAirLife Adult Manual Resuscitator, 40" (1.0m) Oxygen Reservoir Tubing, without Mask, REF...Jaeger Medical GmbHBTM
Z-1057-2024Class IAirLife Adult Manual Resuscitator, Oxygen Reservoir Bag, without Mask, REF 2K8000,Jaeger Medical GmbHBTM
Z-1900-2025Class IISignature Laparoscopic Instruments, 20mm Atraumatic Grasper with Rotating Shaft and...Silex Medical, LLCGEI
Z-1899-2025Class IISignature Laparoscopic Instruments, Atraumatic Grasper with Rotating Shaft and Monopolar...Silex Medical, LLCGEI
Z-1898-2025Class IISignature Laparoscopic Instruments, Alligator Grasper with Rotating Shaft and Monopolar...Silex Medical, LLCGEI
Z-1897-2025Class IISignature Laparoscopic Instruments, Bullet Tip Grasper with Rotating Shaft and Monopolar...Silex Medical, LLCGEI
Z-1896-2025Class IISignature Laparoscopic Instruments, Sharp Tooth Grasper with Rotating Shaft and Monopolar...Silex Medical, LLCGEI
Z-1895-2025Class IISignature Laparoscopic Instruments, Debakey Grasper with Rotating Shaft and Monopolar...Silex Medical, LLCGEI
Z-1894-2025Class IISignature Laparoscopic Instruments, Allis Clamp Grasper with Rotating Shaft and Monopolar...Silex Medical, LLCGEI
Z-1893-2025Class IISignature Laparoscopic Instruments, Dolphin Nose Grasper with Rotating Shaft and...Silex Medical, LLCGEI
Z-3300-2024Class IICustodiol HTK Solution, 500ml bottle. 10 per carton.Dr. Franz Kohler Chemie GmbHKDL
Z-1315-2024Class IIAbbott Point of Care Control Control i-STAT Level 3 1.7 mLMckesson Medical-Surgical Inc. Corporate OfficeJJY
Z-1314-2024Class IIAbbott Point of Care Control Control i-STAT Level 1 10 X 1.7 mLMckesson Medical-Surgical Inc. Corporate OfficeJJY
Z-1313-2024Class IISteris Corporation Endo Cleaning Indicator VERIFY" RESITEST"Mckesson Medical-Surgical Inc. Corporate OfficeMNL
Z-1312-2024Class IIAbbott Rapid Dx N America LLC Reproductive Endocrinology Control Set McKesson Consult"...Mckesson Medical-Surgical Inc. Corporate OfficeJJX
Z-1311-2024Class IISekisui Diagnostics Control Kit OSOM BVBLUE Bacterial VaginosisMckesson Medical-Surgical Inc. Corporate OfficeMXB
Z-1732-2024Class IIMedtronic Invos, Reusable Sensor Cable for PM7100, REF: PMAC71RSCMedtronic, Inc.MUD
Z-1731-2024Class IIMedtronic Invos, Reusable Infant Sensor Adapter Cable for PM7100, REF: PMAC71RICMedtronic, Inc.MUD
Z-1247-2024Class IIDISP.HASSON TROCAR 12/110MM, Product Code EK240SU. For use in laparoscopic procedures.Aesculap IncGCJ
Z-1246-2024Class IIDISP.TROCAR W.DILATING PIN 12/110MM, Product Code EK236SU. For use in laparoscopic...Aesculap IncGCJ
Z-1245-2024Class IIDISP.TROCAR W.DILATING PIN 12/110MM, Product Code EK234SU. For use in laparoscopic...Aesculap IncGCJ
Z-1244-2024Class IIDISP.HASSON TROCAR 10/110MM, Product Code EK230SU. For use in laparoscopic procedures.Aesculap IncGCJ
Z-1243-2024Class IIDISP.TROCAR W. DILATING PIN 10/110MM, Product Code EK224SU. For use in laparoscopic...Aesculap IncGCJ
Z-1070-2024Class IVOCSN Patient Breathing Package (Pediatric, Active, Oxygen, Blue) REF PRT-01013-000 with...Ventec Life Systems, Inc.CBK
Z-0978-2024Class IIBO-RF-32-USA RotaFlow Centrifugal Pump with SOFTLINE Coating, Product Code 701047553. For...Maquet Cardiovascular Us Sales, LLCKFM
Z-0977-2024Class IIBEQ-RF-32-USA RotaFlow Centrifugal Pump with BIOLINE Coating, Product Code 701047554. For...Maquet Cardiovascular Us Sales, LLCKFM
Z-1040-2024Class IIBD BBL Sensi Disc Tetracycline 30 ug,used for semi-quantitative in vitro susceptibility...Becton Dickinson & CoJTN
Z-1039-2024Class IIBD BBL Sensi Disc Sulfamethoxazole with Trimethoprim 23.75/1.25 ug, used for...Becton Dickinson & CoJTN
Z-1038-2024Class IIBD BBL Sensi Disc Rifampin- 5 ug, used for semi-quantitative in vitro susceptibility...Becton Dickinson & CoJTN
Z-1037-2024Class IIBD BBL Sensi Disc Piperacillin/Tazobactam- 100/10 ug, used for semi-quantitative in...Becton Dickinson & CoJTN
Z-1036-2024Class IIBD BBL Sensi Disc Ofloxacin- 5 ug, used for semi-quantitative in vitro susceptibility...Becton Dickinson & CoJTN
Z-1035-2024Class IIBD BBL Sensi Disc Moxifloxacin- 5 ug, used for semi-quantitative in vitro susceptibility...Becton Dickinson & CoJTN
Z-1034-2024Class IIBD BBL Sensi Disc Minocycline - 30 ug, used for semi-quantitative in vitro...Becton Dickinson & CoJTN
Z-1033-2024Class IIBD BBL Sensi Disc Meropenem- 10 ug, used for semi-quantitative in vitro susceptibility...Becton Dickinson & CoJTN
Z-1032-2024Class IIBD BBL Sensi Disc Levofloxacin- 5 ug, used for semi-quantitative in vitro susceptibility...Becton Dickinson & CoJTN
Z-1031-2024Class IIBD BBL Sensi Disc Imipenem- 10 ug, used for semi-quantitative in vitro susceptibility...Becton Dickinson & CoJTN
Z-1030-2024Class IIBD BBL Sensi Disc Ertapenem- 10 ug, used for semi-quantitative in vitro susceptibility...Becton Dickinson & CoJTN
Z-1029-2024Class IIBD BBL Sensi Disc Doripenem- 15 ug, used for semi-quantitative in vitro susceptibility...Becton Dickinson & CoJTN
Z-1028-2024Class IIBD BBL Sensi Disc Clarithromycin- 15 ug, used for semi-quantitative in vitro...Becton Dickinson & CoJTN
Z-1027-2024Class IIBD BBL Sensi Disc Ciprofloxacin- 5 ug, used for semi-quantitative in vitro susceptibility...Becton Dickinson & CoJTN
Z-1026-2024Class IIBD BBL Sensi Disc Chloramphenicol- 30 ug, used for semi-quantitative in vitro...Becton Dickinson & CoJTN
Z-1025-2024Class IIBD BBL Sensi Disc Cefuroxime- 30 ug, used for semi-quantitative in vitro susceptibility...Becton Dickinson & CoJTN
Z-1024-2024Class IIBD BBL Sensi Disc Ceftriaxone- 30 ug, used for semi-quantitative in vitro susceptibility...Becton Dickinson & CoJTN
Z-1023-2024Class IIBD BBL Sensi Disc Ceftazidime- 30 ug, used for semi-quantitative in vitro susceptibility...Becton Dickinson & CoJTN
Z-1022-2024Class IIBD BBL Sensi Disc Ceftaroline - 30 ug, used for semi-quantitative in vitro susceptibility...Becton Dickinson & CoJTN
Z-1021-2024Class IIBD BBL Sensi Disc Cefpodoxime - 10 ug, used for semi-quantitative in vitro susceptibility...Becton Dickinson & CoJTN