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
| Recall number | Class | Product | Recalling firm | Product code | Initiated |
|---|---|---|---|---|---|
| Z-2518-2014 | Class I | Tummy Tuck Pack-BOD , code 900-3026, contains: (2) GOWN X-LARGE SMS IMPERVIOUS REINFORCED... | Customed, Inc | LRO | |
| Z-2517-2014 | Class I | Chole Cystectomy All Endo System , code 900-3025, contains: (1) TABLE COVER 44X 90 UF... | Customed, Inc | LRO | |
| Z-2516-2014 | Class I | Basic Pack FPSC Florham Pack , code 900-2969, contains: (1) COVER TABLE REINFORCED 50" X... | Customed, Inc | LRO | |
| Z-2515-2014 | Class I | Hair Restoration Pack- , code 900-2966, contains: (1) MAYO STAND COVER 23X54 (2) TOWEL... | Customed, Inc | LRO | |
| Z-2514-2014 | Class I | Drape Sheet, Product Code 2942, contains (1) DRAPE % ECONOMY 53 X 77L/F (1) WRAPPER 24 X... | Customed, Inc | KKX | |
| Z-2513-2014 | Class I | Obstetrical Surgical pack, code 900-2940, contains: (1) BLANKET RECEIVING 100 COTTON (3)... | Customed, Inc | OKV | |
| Z-2512-2014 | Class I | TLIF PACK SURGICAL CENTER, CODE 900-2918. CONTENTS: (2) SOLUTION SURGICAL DURAPREP... | Customed, Inc | OJH | |
| Z-2511-2014 | Class I | ACDFPACK SURGICAL CENTER, CODE 900-2917. CONTENTS: (1) SOLUTION SURGICAL DURAPREP 6ML... | Customed, Inc | OJG | |
| Z-2510-2014 | Class I | BASIC COSMETIC SURG. PACK CUSTOMED (USA), CODE 900-2915. CONTENTS: (2) TOWELS ABSORBENT... | Customed, Inc | LRO | |
| Z-2509-2014 | Class I | ORTHOPEDIC IMPLANT PACK CUSTOMED USA, CODE 900-2903 CONTENTS: (1) CAUTERY TIP... | Customed, Inc | OJH | |
| Z-2508-2014 | Class I | CYSTO TUR PACK BASIC CODE 900-2899. CONTENTS: (2) LEGGINGS W/7'' CUFF 30" X 42" (1)... | Customed, Inc | LRO | |
| Z-2507-2014 | Class I | ORTHOPEDIC PACK BASIC CODE 900-2830. CONTENTS: (3) TOWELS ABSORBENT 15" X 20" (1)... | Customed, Inc | OJH | |
| Z-2506-2014 | Class I | LAPAROTOMY PACK BASIC CODE 900-2829 CONTENTS: (2) TOWELS ABSORBENT 15" X 20" (1) COVER... | Customed, Inc | LRO | |
| Z-2505-2014 | Class I | SHOULDER PACK CODE 900-2766 CONTENTS: (1) STAPLE SKIN 35 WIDE LIF (1) *GOBAN SELF-ADH... | Customed, Inc | OJH | |
| Z-2504-2014 | Class I | NEURO SPINE PACK , CODE 900-2765 CONTENTS: (l ) DRAPE INCISION 23" X 1 7" (I)... | Customed, Inc | OJG | |
| Z-2503-2014 | Class I | MINOR PACK CONTENTS: (1) TOWELS ABSORBENT 15" X 20" (1) WRAPPER 24" X 24" (16)... | Customed, Inc | OJK | |
| Z-2502-2014 | Class I | REEMPLAZO DE RODILLA Y CADERA CONTENTS: (6) TOWELS ABSORBENT 15" X 20" (I) PK... | Customed, Inc | LRO | |
| Z-2501-2014 | Class I | Gown Surgical Soft SMS Non Reinforced, code 900-2725, contains: (1) GOWN SOFT SMS STD... | Customed, Inc | LRO | |
| Z-2500-2014 | Class I | Shoulder Arthroscopy Pack, code 900-2719, contains: (1 0) GAUZE SPONGES 4 X 4 12PL Y (1)... | Customed, Inc | OJH | |
| Z-2499-2014 | Class I | Knee Arthroscopy Pack, code 900-2718, contains: (1 0) GAUZE SPONGES 4 X 4 12PL Y (2)... | Customed, Inc | OJH | |
| Z-2498-2014 | Class I | Endovascular Pack, code 900-2715, contains: ( I) DRAPE FEMORAL ANG. 125 X 75 X 56 WITH... | Customed, Inc | OFA | |
| Z-2497-2014 | Class I | Bandeja para Debridacion, code 900-2702, contains: (1) FORCEP ADSON TISS (20) GAUZE... | Customed, Inc | LRO | |
| Z-2496-2014 | Class I | Tummy Tuck Pack, code 900-2684, contains: (3) GOWN SOFT SMS STD XLGE SET IN SLEEVE ( 1)... | Customed, Inc | LRO | |
| Z-2495-2014 | Class I | Breast Augmentation Pack, Imagenes Cosmetic, code 900-2682: (3) GOWN SOFT SMS STD XLGE... | Customed, Inc | LRO | |
| Z-2494-2014 | Class I | Liposuction Pack, code 900-2681, contains: (3) GOWN SOFT SMS STD XLGE SET IN SLEEVE (1)... | Customed, Inc | LRO | |
| Z-2493-2014 | Class I | Tummy Tuck and Liposuction Pack, code 900-2661, contains: ( 1) DRAPE % ECONOMY 53 X... | Customed, Inc | LRO | |
| Z-2492-2014 | Class I | Breast Implant Pack, Code 900-2660, contains: (1) DRAPE ECONOMY 53 X 77 (3) GOWN SOFT... | Customed, Inc | LRO | |
| Z-2491-2014 | Class I | Breast Pack MRT, code 900-2658, contains: ( 1) BULB SYRINGE 60cc (2) GOWN SOFT SMS STD... | Customed, Inc | LRO | |
| Z-2490-2014 | Class I | Tummy Pack MRT, code 900-2657, contains: (2) GOWN SOFT SMS STD XLGE SET IN SLEEVE ( 1)... | Customed, Inc | LRO | |
| Z-2489-2014 | Class I | Liposuction Pack MRT, code 900-2656, contains: (1) NEEDLE HYPODERMIC 27 X 1 LIF (1)... | Customed, Inc | LRO | |
| Z-2488-2014 | Class I | Face Pack MRT, product code 900-2654, contains: (2) GOWN SOFT SMS STD X-LARGE SET IN... | Customed, Inc | LRO | |
| Z-2487-2014 | Class I | Plastic Pack Customed, code 900-2582 (1) GOWN LGE SMS IMP REINF L/F (1) GOWN SURG. REINF... | Customed, Inc | LRO | |
| Z-2486-2014 | Class I | Shoulder pack (I) (2), code 900-2515 (1) GOWN IMP. XTRA REINF. XL TOWEL WRAP LEVEL... | Customed, Inc | OJH | |
| Z-2485-2014 | Class I | Universal Pack II (2) Customed 900-2509 (1) MAYO STAND COVER REINFORCED (2) DRAPE SIDE... | Customed, Inc | LRO | |
| Z-2484-2014 | Class I | HIP PACK I (2), CUSTOMED, code 900-2504 (1) GOWN SURG. REINFORCED XLGE TOWEL/WRAP (1)... | Customed, Inc | OJH | |
| Z-2483-2014 | Class I | LAP Abdom w/pouch Customed code 900-2619, contains: (1) DRAPE LAP. ABDOM W/POUCH 102" X... | Customed, Inc | FDE | |
| Z-2482-2014 | Class I | Open Heart Pack, code 900-2618, contains: (9) DRAPE 60" X 76" REINFORCED LIF ( 1) MAYO... | Customed, Inc | OFA | |
| Z-2481-2014 | Class I | Shoulder Pack, Code 900-2616, contains: (2) TUBE SUCTION CONNECT Y."X12' UF (1) SYRINGE... | Customed, Inc | OJH | |
| Z-2480-2014 | Class I | Extremity Pack, code 900-2615, contains: (5) LAP SPONGE PREWASH 18" X 18" XRD (1) ELASTIC... | Customed, Inc | LRO | |
| Z-2479-2014 | Class I | Hip & Knee replacement pack, 900-2614, contains (1) CAUTERY TIP POLISHER UF (1) BAG... | Customed, Inc | OJH | |
| Z-2478-2014 | Class I | Arthroscopy Pack,900-2609, contains: (5) LAP SPONGE PREWASH 18" X 18" XRD (1) SHEET... | Customed, Inc | FWZ | |
| Z-2477-2014 | Class I | Gown Cool Impervious XLGE Breathable Customed, 900-2592: (1) GOWN XL SURGICAL... | Customed, Inc | LRO | |
| Z-2476-2014 | Class I | Laparotomy Pack, 900-2516, pack contains: ( I) TABLE COVER44" X 90" ( I) CAUTERY PENCIL... | Customed, Inc | LRO | |
| Z-2475-2014 | Class I | Minor Pack 900-2511, pack contains: (1) GOWN XLGE SMS IMPERVIOUS REINFORCED AAMIIII (10)... | Customed, Inc | LRO | |
| Z-2474-2014 | Class I | Urology Pack, 900-2510, package contains: (2) TOWELS ABSORBENT 15X 20 UF (1) DRAPE LITHO... | Customed, Inc | LRO | |
| Z-2473-2014 | Class I | ORTHOPEDIC PACK Ill (1) CUSTOMED CONTENTS: (1) GOWN XL SMS IMPERVIOUS REINFORCED (4)... | Customed, Inc | OJH | |
| Z-2472-2014 | Class I | ORTHOPEDIC PACK I (2) CUSTOMED, 900-2503, contains: (2) TOWELS ABSORBENT 15" X 20"... | Customed, Inc | OJH | |
| Z-2471-2014 | Class I | EENT PACK I CUSTOMED CONTENT: (2) TOWEL ABSORBENT 15" X 20" (1) MAYO STAND COVER... | Customed, Inc | OGR | |
| Z-2470-2014 | Class I | LAPAROTOMY PACK Ill (4) CUSTOMED CONTENT: (4) TOWEL ABSORBENT 15" X 20" (2) GOWN... | Customed, Inc | LRO | |
| Z-2469-2014 | Class I | TRANSVERSE LAPAROTOMY PACK (8) CUSTOMED CONTENT: (1) TOWEL ABSORBENT 15" X 20" (1)... | Customed, Inc | FDE |
