510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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

59,528 records, page 522 of 1191
FDA device recalls, page 522 of 1191
Recall numberClassProductRecalling firmProduct codeInitiated
Z-2600-2017Class II4.5 Broad Scp Plt 26-H SterZimmer GmbHKTT
Z-2599-2017Class IIZ Nail Pf 14Mm X 46Cm Univ Z Nail Gt 14Mm X 46Cm R Z Nail Gt 14Mm X 46Cm L Z Nail Tibia...Zimmer GmbHHSB
Z-2598-2017Class IIFem Im Nail 14Mmdx30cm Left, Fem Im Nail 14Mmdx30cm Right Fem Im Nail 13Mmdx32cm Left Fem...Zimmer GmbHHSB
Z-2597-2017Class IITibial I/m Nail 15Mmdx26cm, Tibial I/m Nail 15Mmdx28cm Tibial I/m Nail 15Mmdx30cm Tibial...Zimmer GmbHHSB
Z-2596-2017Class IIFem Im Nail 15Mmdx30cm, Fem Im Nail 16Mmdx30cm Fem Im Nail 14Mmdx32cm Fem Im Nail...Zimmer GmbHHSB
Z-2595-2017Class IIR-F Im Nail 10Mmdx48cm Lg, 11Mmdx42cm, 11Mmdx44cm, 11Mmdx46cm Lg, 11Mmdx48cm Lg...Zimmer GmbHHSB
Z-2594-2017Class IIVersa-Fx II Std Tube 130Dx16h, 130Dx18h, 130Dx20h, 135Dx16h, 135Dx18h, 135Dx20h...Zimmer GmbHKTT
Z-2593-2017Class IIVersa-Fxii Sc Tube Plt 90Dx16h, 95Dx16h, 95Dx18h, 95Dx20h, 95Dx22hZimmer GmbHKTT
Z-2115-2017Class IINexGen Offset Stem Extension, sizes 14mm and 17mm For use in total arthroplasty.Zimmer GmbHJWH
Z-2170-2017Class IIArrow(R) VPS(R) Access Kit for use with 4 and 5 Fr. Peripherally Inserted Central Venous...Arrow International LLC (subsidiary of Teleflex Incorporated)OBJ
Z-2171-2017Class II1000 ml Canister (with Gel) for InfoV.A.C. and V.A.C.ULTA Therapy Systems (Part Number...KCI USA, Inc.OMP
Z-1581-2018Class IAirLife Resuscitation, Infant, with mask, oxygen reservoir bag, pressure-relief valve...Jaeger Medical GmbHOEV
Z-1580-2018Class IAirLife Resuscitation, Infant, with mask, 40inch oxygen reservoir tubing, pressure-relief...Jaeger Medical GmbHOEV
Z-1579-2018Class IAirLife Resuscitation, Replacement kit for outer shell, Broselow Product Usage: The...Jaeger Medical GmbHOEV
Z-1578-2018Class IAirLife Resuscitation, Broselow Hinkle Kit Product Usage: The AirLife Resuscitation...Jaeger Medical GmbHOEV
Z-1577-2018Class IAirLife Resuscitation, Broselow Hinkle Kit Product Usage: The AirLife Resuscitation...Jaeger Medical GmbHOEV
Z-1576-2018Class IAirLife Resuscitation, Pediatric, with mask, 40inch oxygen reservoir tubing...Jaeger Medical GmbHOEV
Z-1575-2018Class IAirLife Resuscitation, Pediatric, with mask, oxygen reservoir bag, manometer...Jaeger Medical GmbHOEV
Z-1574-2018Class IAirLife Resuscitation, Pediatric, with mask, oxygen reservoir bag, pressure-relief valve...Jaeger Medical GmbHOEV
Z-1573-2018Class IAirLife Resuscitation, Infant, with mask, 40inch oxygen reservoir tubing, pressure-relief...Jaeger Medical GmbHOEV
Z-1572-2018Class IAirLife Resuscitation, Pediatric, with mask, 40inch oxygen reservoir tubing...Jaeger Medical GmbHOEV
Z-1571-2018Class IAirLife Resuscitation, Adult, with mask, 40inch oxygen reservoir tubing, PEEP...Jaeger Medical GmbHOEV
Z-1570-2018Class IAirLife Resuscitation, Adult, with mask, oxygen reservoir bag, manometer, PEEP...Jaeger Medical GmbHOEV
Z-1569-2018Class IAirLife Resuscitation, Adult, with mask, oxygen reservoir bag, CO2 detector, PEEP...Jaeger Medical GmbHOEV
Z-1568-2018Class IAirLife Resuscitation, Adult, with mask, oxygen reservoir bag, PEEP valve Product...Jaeger Medical GmbHOEV
Z-1567-2018Class IAirLife Resuscitation, Adult, with mask, 28inch large bore tubing, pressure-relief...Jaeger Medical GmbHOEV
Z-1566-2018Class IAirLife Resuscitation, Infant, with mask, oxygen reservoir bag, pressure-relief...Jaeger Medical GmbHOEV
Z-1565-2018Class IAirLife Resuscitation, Pediatric, with mask, oxygen reservoir bag, pressure-relief...Jaeger Medical GmbHOEV
Z-1564-2018Class IAirLife Resuscitation, Infant, with mask, 28inch large bore tubing, pressure-relief...Jaeger Medical GmbHOEV
Z-1563-2018Class IAirLife Resuscitation, Pediatric, with mask, 28inch large bore tubing, pressure-relief...Jaeger Medical GmbHOEV
Z-1562-2018Class IAirLife Resuscitation, Adult, with mask, 28inch large bore tubing Product Usage: The...Jaeger Medical GmbHOEV
Z-1561-2018Class IAirLife Resuscitation, Infant, with mask, 40 inch oxygen reservoir tubing...Jaeger Medical GmbHOEV
Z-1560-2018Class IAirLife Resuscitation, Infant, with mask, 40inch oxygen reservoir tubing, pressure-relief...Jaeger Medical GmbHOEV
Z-1559-2018Class IAirLife Resuscitation, Infant, with mask, 40inch oxygen reservoir tubing, pressure-relief...Jaeger Medical GmbHOEV
Z-1558-2018Class IAirLife Resuscitation, Pediatric, with mask, 40inch oxygen reservoir tubing...Jaeger Medical GmbHOEV
Z-1557-2018Class IAirLife Resuscitation, Pediatric, with mask, 40inch oxygen reservoir tubing...Jaeger Medical GmbHOEV
Z-1556-2018Class IAirLife Resuscitation, Infant, with mask, 40inch oxygen reservoir tubing, pressure-relief...Jaeger Medical GmbHOEV
Z-1555-2018Class IAirLife Resuscitation, Pediatric, with mask, 40inch oxygen reservoir tubing...Jaeger Medical GmbHOEV
Z-1554-2018Class IAirLife Resuscitation, Pediatric, with mask, 40inch oxygen reservoir tubing...Jaeger Medical GmbHOEV
Z-1553-2018Class IAirLife Resuscitation, Adult, with mask, 40inch oxygen reservoir tubing, filter Product...Jaeger Medical GmbHOEV
Z-1552-2018Class IAirLife Resuscitation, Adult, with mask, 40" oxygen reservoir tubing 6/cs Product...Jaeger Medical GmbHOEV
Z-1551-2018Class IAirLife Resuscitation, Adult, with mask, oxygen reservoir bag, manometer Product...Jaeger Medical GmbHOEV
Z-1550-2018Class IAirLife Resuscitation, Adult, with mask, oxygen reservoir bag, filter Product Usage: The...Jaeger Medical GmbHOEV
Z-1549-2018Class IAirLife Resuscitation, Adult, with mask, oxygen reservoir bag, CO2 detector...Jaeger Medical GmbHOEV
Z-1548-2018Class IAirLife Resuscitation, Adult, with mask, oxygen reservoir bag, CO2 detector Product...Jaeger Medical GmbHOEV
Z-1547-2018Class IAirLife Resuscitation, Adult, with mask, oxygen reservoir bag Product Usage: The AirLife...Jaeger Medical GmbHOEV
Z-2178-2017Class IIAbbVie PEG, PEG Kit 15FR, FOR ENTERAL USE ONLY, STERILE, Rx Only.AbbVie IncKNT
Z-2177-2017Class IIAbbVie PEG, PEG Kit 15FR, FOR ENTERAL USE ONLY, STERILE, Rx Only.AbbVie IncKNT
Z-2167-2017Class IIILiquid Urine Control Level 3 For Professional Use in the quality control monitoring of...Randox Laboratories, LimitedJJY
Z-2176-2017Class IIAbbVie PEG, PEG Kit 20FR, FOR ENTERAL USE ONLY, STERILE, Rx Only.AbbVie IncKNT