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

59,544 records, page 632 of 1191
FDA device recalls, page 632 of 1191
Recall numberClassProductRecalling firmProduct codeInitiated
Z-2706-2015Class IILAPAROTOMY PACK CS/6 Used by medical staff to perform surgical procedures and...Customed, IncLRO
Z-2705-2015Class IIFEMORAL ANGIOGRAPHY PACK 4/CS Used by medical staff to perform surgical procedures and...Customed, IncOEQ
Z-2704-2015Class IIGENERAL MINOR PK 5/CS Used by medical staff to perform surgical procedures and patient...Customed, IncLRO
Z-2703-2015Class IISKIN STAPLE REMOVER KIT 80/CS Used by medical staff to perform surgical procedures and...Customed, IncGDT
Z-2702-2015Class IIINCISION AND DRAINAGE TRAY 50/CS Used by medical staff to perform surgical procedures...Customed, IncLRO
Z-2701-2015Class IICARPAL TUNEL LARGE SURGICAL PACK, 6/CS Used by medical staff to perform surgical...Customed, IncOJH
Z-2700-2015Class IIORTHO-IMPLANT SURGICAL PACK, Used by medical staff to perform surgical procedures...Customed, IncOJH
Z-2699-2015Class IIARTHROSCOPY SURGICAL PACK 4/C Used by medical staff to perform surgical procedures...Customed, IncOJH
Z-2698-2015Class IICESAREAN PACK 5/CS Used by medical staff to perform surgical procedures and patient care...Customed, IncOHM
Z-2697-2015Class IIO.B. PACK HOSPITAL 3/CS Used by medical staff to perform surgical procedures and patient...Customed, IncOKV
Z-2696-2015Class IIPERI GYN PACK 5/CS Used by medical staff to perform surgical procedures and patient...Customed, IncOKV
Z-2695-2015Class IIFANFOLD DRAPE 44"X58 60/CS Used by medical staff to perform surgical procedures and...Customed, IncKKX
Z-2694-2015Class IIO.R. TOWELS 25/CS Used by medical staff to perform surgical procedures and patient...Customed, IncKKX
Z-2693-2015Class IIARTHROSCOPY PK 5/CS Used by medical staff to perform surgical procedures and patient...Customed, IncHRX
Z-2692-2015Class IILAPAROSCOPY-GYN SURGICAL PACK Used by medical staff to perform surgical procedures and...Customed, IncFDE
Z-2691-2015Class IIANGIOGRAPHY PACK 5/CS Used by medical staff to perform surgical procedures and patient...Customed, IncOEQ
Z-2690-2015Class IILAPAROSCOPY GYN PK CS/4 Used by medical staff to perform surgical procedures and...Customed, IncFDE
Z-2689-2015Class IIUTILITY DRAPE END PRODUCT 50PK/CS Used by medical staff to perform surgical procedures...Customed, IncKKX
Z-2688-2015Class IILAP-CHOLECYSTECTOMY SURGICAL PACK Used by medical staff to perform surgical procedures...Customed, IncFDE
Z-2687-2015Class IIPERY-GYN SURGICAL PACK 6/CS Used by medical staff to perform surgical procedures and...Customed, IncOKV
Z-2686-2015Class IILAPAROTOMY BASIC PACK 10/CS Used by medical staff to perform surgical procedures and...Customed, IncLRO
Z-2685-2015Class IIGAUZE SPONGE 4"X4" 16 PLY XRD 1280/CS (STERILE) Used by medical staff to perform...Customed, IncEFQ
Z-2684-2015Class IISURG GOWN POLYREINF LGE CUSTOM 28/CS Used by medical staff to perform surgical...Customed, IncFYA
Z-2683-2015Class IIGOWN POLYREINF XLGE TOWEL/W 24/CS Used by medical staff to perform surgical...Customed, IncFYA
Z-2682-2015Class IILAPAROSCOPY PACK 6/CS Used by medical staff to perform surgical procedures and patient...Customed, IncFDE
Z-2681-2015Class IILAPAROSCOPY OB 6/CS Used by medical staff to perform surgical procedures and patient...Customed, IncFDE
Z-2680-2015Class IILAPAROSCOPY PK 4/CS Used by medical staff to perform surgical procedures and patient...Customed, IncFDE
Z-2679-2015Class IIMINOR LAPAROTOMY PK 5/CS Used by medical staff to perform surgical procedures and...Customed, IncLRO
Z-2678-2015Class IICYSTO TUR PACK 5/CS Used by medical staff to perform surgical procedures and patient...Customed, IncFAJ
Z-2677-2015Class IILABOR & DELIVERY 4/CS Used by medical staff to perform surgical procedures and patient...Customed, IncOKV
Z-2676-2015Class IIGAUZE SPONGE 4"X4" 16 PLY SOFT 1280/CS Used by medical staff to perform surgical...Customed, IncEFQ
Z-2675-2015Class IILAPAROSCOPY CHOLE 4/CS Used by medical staff to perform surgical procedures and patient...Customed, IncFDE
Z-2674-2015Class IICESAREAN PACK 2/CS Used by medical staff to perform surgical procedures and patient...Customed, IncOHM
Z-2673-2015Class IIMAJOR LAP PACK 4/CS Used by medical staff to perform surgical procedures and patient...Customed, IncLRO
Z-2672-2015Class IICESAREAN PACK 3/CS Used by medical staff to perform surgical procedures and patient...Customed, IncOHM
Z-2671-2015Class IIANGIODRAPE PACK DAMAS 6/CS Used by medical staff to perform surgical procedures and...Customed, IncLRO
Z-2670-2015Class IIBASIC PACK W/OUT GOWN 11/CS Used by medical staff to perform surgical procedures and...Customed, IncKKX
Z-2669-2015Class IIBREAST PACK-TPSC 3/CS Used by medical staff to perform surgical procedures and...Customed, IncLRO
Z-2668-2015Class IIGOWN IMPERVIOUS EXTRA LONG 24/CS Used by medical staff to perform surgical procedures...Customed, IncLRO
Z-2667-2015Class IILAPAROSCOPY PACK 2/CS Used by medical staff to perform surgical procedures and...Customed, IncFDE
Z-2666-2015Class IIFACE PACK FJG 8/CS Used by medical staff to perform surgical procedures and patient...Customed, IncLRO
Z-2665-2015Class IITUMMY TUCK PACK-FJG 6/CS Used by medical staff to perform surgical procedures and...Customed, IncLRO
Z-2664-2015Class IIFACE LIFT 4/CS Used by medical staff to perform surgical procedures and patient...Customed, IncLRO
Z-2663-2015Class IIBREAST PACK-BOD 6/CS Used by medical staff to perform surgical procedures and...Customed, IncLRO
Z-2662-2015Class IIHAIR RESTORATION PACK-THR 12/CS Used by medical staff to perform surgical procedures...Customed, IncLRO
Z-2661-2015Class IIOBSTETRICAL SURGICAL PACK 4/CS Used by medical staff to perform surgical procedures...Customed, IncOKV
Z-2660-2015Class IICYSTO TUR PACK BASIC 8/CS Used by medical staff to perform surgical procedures...Customed, IncLRO
Z-2659-2015Class IIORTHOPEDIC PACK BASIC 5/CS Used by medical staff to perform surgical procedures...Customed, IncOJH
Z-2658-2015Class IIBASIC PACK 8/CS Used by medical staff to perform surgical procedures and patient...Customed, IncLRO
Z-2657-2015Class IILAPAROTOMY SURGICAL PACK 3/CS Used by medical staff to perform surgical procedures and...Customed, IncLRO