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

59,528 records, page 700 of 1191
FDA device recalls, page 700 of 1191
Recall numberClassProductRecalling firmProduct codeInitiated
Z-2518-2014Class ITummy Tuck Pack-BOD , code 900-3026, contains: (2) GOWN X-LARGE SMS IMPERVIOUS REINFORCED...Customed, IncLRO
Z-2517-2014Class IChole Cystectomy All Endo System , code 900-3025, contains: (1) TABLE COVER 44X 90 UF...Customed, IncLRO
Z-2516-2014Class IBasic Pack FPSC Florham Pack , code 900-2969, contains: (1) COVER TABLE REINFORCED 50" X...Customed, IncLRO
Z-2515-2014Class IHair Restoration Pack- , code 900-2966, contains: (1) MAYO STAND COVER 23X54 (2) TOWEL...Customed, IncLRO
Z-2514-2014Class IDrape Sheet, Product Code 2942, contains (1) DRAPE % ECONOMY 53 X 77L/F (1) WRAPPER 24 X...Customed, IncKKX
Z-2513-2014Class IObstetrical Surgical pack, code 900-2940, contains: (1) BLANKET RECEIVING 100 COTTON (3)...Customed, IncOKV
Z-2512-2014Class ITLIF PACK SURGICAL CENTER, CODE 900-2918. CONTENTS: (2) SOLUTION SURGICAL DURAPREP...Customed, IncOJH
Z-2511-2014Class IACDFPACK SURGICAL CENTER, CODE 900-2917. CONTENTS: (1) SOLUTION SURGICAL DURAPREP 6ML...Customed, IncOJG
Z-2510-2014Class IBASIC COSMETIC SURG. PACK CUSTOMED (USA), CODE 900-2915. CONTENTS: (2) TOWELS ABSORBENT...Customed, IncLRO
Z-2509-2014Class IORTHOPEDIC IMPLANT PACK CUSTOMED USA, CODE 900-2903 CONTENTS: (1) CAUTERY TIP...Customed, IncOJH
Z-2508-2014Class ICYSTO TUR PACK BASIC CODE 900-2899. CONTENTS: (2) LEGGINGS W/7'' CUFF 30" X 42" (1)...Customed, IncLRO
Z-2507-2014Class IORTHOPEDIC PACK BASIC CODE 900-2830. CONTENTS: (3) TOWELS ABSORBENT 15" X 20" (1)...Customed, IncOJH
Z-2506-2014Class ILAPAROTOMY PACK BASIC CODE 900-2829 CONTENTS: (2) TOWELS ABSORBENT 15" X 20" (1) COVER...Customed, IncLRO
Z-2505-2014Class ISHOULDER PACK CODE 900-2766 CONTENTS: (1) STAPLE SKIN 35 WIDE LIF (1) *GOBAN SELF-ADH...Customed, IncOJH
Z-2504-2014Class INEURO SPINE PACK , CODE 900-2765 CONTENTS: (l ) DRAPE INCISION 23" X 1 7" (I)...Customed, IncOJG
Z-2503-2014Class IMINOR PACK CONTENTS: (1) TOWELS ABSORBENT 15" X 20" (1) WRAPPER 24" X 24" (16)...Customed, IncOJK
Z-2502-2014Class IREEMPLAZO DE RODILLA Y CADERA CONTENTS: (6) TOWELS ABSORBENT 15" X 20" (I) PK...Customed, IncLRO
Z-2501-2014Class IGown Surgical Soft SMS Non Reinforced, code 900-2725, contains: (1) GOWN SOFT SMS STD...Customed, IncLRO
Z-2500-2014Class IShoulder Arthroscopy Pack, code 900-2719, contains: (1 0) GAUZE SPONGES 4 X 4 12PL Y (1)...Customed, IncOJH
Z-2499-2014Class IKnee Arthroscopy Pack, code 900-2718, contains: (1 0) GAUZE SPONGES 4 X 4 12PL Y (2)...Customed, IncOJH
Z-2498-2014Class IEndovascular Pack, code 900-2715, contains: ( I) DRAPE FEMORAL ANG. 125 X 75 X 56 WITH...Customed, IncOFA
Z-2497-2014Class IBandeja para Debridacion, code 900-2702, contains: (1) FORCEP ADSON TISS (20) GAUZE...Customed, IncLRO
Z-2496-2014Class ITummy Tuck Pack, code 900-2684, contains: (3) GOWN SOFT SMS STD XLGE SET IN SLEEVE ( 1)...Customed, IncLRO
Z-2495-2014Class IBreast Augmentation Pack, Imagenes Cosmetic, code 900-2682: (3) GOWN SOFT SMS STD XLGE...Customed, IncLRO
Z-2494-2014Class ILiposuction Pack, code 900-2681, contains: (3) GOWN SOFT SMS STD XLGE SET IN SLEEVE (1)...Customed, IncLRO
Z-2493-2014Class ITummy Tuck and Liposuction Pack, code 900-2661, contains: ( 1) DRAPE % ECONOMY 53 X...Customed, IncLRO
Z-2492-2014Class IBreast Implant Pack, Code 900-2660, contains: (1) DRAPE ECONOMY 53 X 77 (3) GOWN SOFT...Customed, IncLRO
Z-2491-2014Class IBreast Pack MRT, code 900-2658, contains: ( 1) BULB SYRINGE 60cc (2) GOWN SOFT SMS STD...Customed, IncLRO
Z-2490-2014Class ITummy Pack MRT, code 900-2657, contains: (2) GOWN SOFT SMS STD XLGE SET IN SLEEVE ( 1)...Customed, IncLRO
Z-2489-2014Class ILiposuction Pack MRT, code 900-2656, contains: (1) NEEDLE HYPODERMIC 27 X 1 LIF (1)...Customed, IncLRO
Z-2488-2014Class IFace Pack MRT, product code 900-2654, contains: (2) GOWN SOFT SMS STD X-LARGE SET IN...Customed, IncLRO
Z-2487-2014Class IPlastic Pack Customed, code 900-2582 (1) GOWN LGE SMS IMP REINF L/F (1) GOWN SURG. REINF...Customed, IncLRO
Z-2486-2014Class IShoulder pack (I) (2), code 900-2515 (1) GOWN IMP. XTRA REINF. XL TOWEL WRAP LEVEL...Customed, IncOJH
Z-2485-2014Class IUniversal Pack II (2) Customed 900-2509 (1) MAYO STAND COVER REINFORCED (2) DRAPE SIDE...Customed, IncLRO
Z-2484-2014Class IHIP PACK I (2), CUSTOMED, code 900-2504 (1) GOWN SURG. REINFORCED XLGE TOWEL/WRAP (1)...Customed, IncOJH
Z-2483-2014Class ILAP Abdom w/pouch Customed code 900-2619, contains: (1) DRAPE LAP. ABDOM W/POUCH 102" X...Customed, IncFDE
Z-2482-2014Class IOpen Heart Pack, code 900-2618, contains: (9) DRAPE 60" X 76" REINFORCED LIF ( 1) MAYO...Customed, IncOFA
Z-2481-2014Class IShoulder Pack, Code 900-2616, contains: (2) TUBE SUCTION CONNECT Y."X12' UF (1) SYRINGE...Customed, IncOJH
Z-2480-2014Class IExtremity Pack, code 900-2615, contains: (5) LAP SPONGE PREWASH 18" X 18" XRD (1) ELASTIC...Customed, IncLRO
Z-2479-2014Class IHip & Knee replacement pack, 900-2614, contains (1) CAUTERY TIP POLISHER UF (1) BAG...Customed, IncOJH
Z-2478-2014Class IArthroscopy Pack,900-2609, contains: (5) LAP SPONGE PREWASH 18" X 18" XRD (1) SHEET...Customed, IncFWZ
Z-2477-2014Class IGown Cool Impervious XLGE Breathable Customed, 900-2592: (1) GOWN XL SURGICAL...Customed, IncLRO
Z-2476-2014Class ILaparotomy Pack, 900-2516, pack contains: ( I) TABLE COVER44" X 90" ( I) CAUTERY PENCIL...Customed, IncLRO
Z-2475-2014Class IMinor Pack 900-2511, pack contains: (1) GOWN XLGE SMS IMPERVIOUS REINFORCED AAMIIII (10)...Customed, IncLRO
Z-2474-2014Class IUrology Pack, 900-2510, package contains: (2) TOWELS ABSORBENT 15X 20 UF (1) DRAPE LITHO...Customed, IncLRO
Z-2473-2014Class IORTHOPEDIC PACK Ill (1) CUSTOMED CONTENTS: (1) GOWN XL SMS IMPERVIOUS REINFORCED (4)...Customed, IncOJH
Z-2472-2014Class IORTHOPEDIC PACK I (2) CUSTOMED, 900-2503, contains: (2) TOWELS ABSORBENT 15" X 20"...Customed, IncOJH
Z-2471-2014Class IEENT PACK I CUSTOMED CONTENT: (2) TOWEL ABSORBENT 15" X 20" (1) MAYO STAND COVER...Customed, IncOGR
Z-2470-2014Class ILAPAROTOMY PACK Ill (4) CUSTOMED CONTENT: (4) TOWEL ABSORBENT 15" X 20" (2) GOWN...Customed, IncLRO
Z-2469-2014Class ITRANSVERSE LAPAROTOMY PACK (8) CUSTOMED CONTENT: (1) TOWEL ABSORBENT 15" X 20" (1)...Customed, IncFDE