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 701 of 1191
FDA device recalls, page 701 of 1191
Recall numberClassProductRecalling firmProduct codeInitiated
Z-2468-2014Class ILAPAROTOMY PACK 1 (2&3) CUSTOMED CONTENT: (2) TOWEL ABSORBENT 15" X 20" (1) MAYO...Customed, IncFDE
Z-2467-2014Class ILAPAROSCOPY PACK I (4) CUSTOMED CONTENTS: (1) TOWEL ABSORBENT 15" X 20" LIF...Customed, IncFDE
Z-2466-2014Class ILAPAROSCOPY ABO PACK (1) (2) CUSTOMED CONTENTS: (1) GOWN SURG. REINFORCED X-LARGE TOWEL...Customed, IncFDE
Z-2465-2014Class ICYSTOSCOPY PACK Ill (1) (2) CUSTOMED CONTENTS: (1) TABLE COVER REINFORCED 44" X 78" (2)...Customed, IncKKK
Z-2464-2014Class IMINOR EXTREMITY PACK {2) CUSTOMED CONTENT: (1) GOWN LGE STD SMS VELC/NE T/WRAP (1)...Customed, IncOJH
Z-2463-2014Class IC - BIRTH PACK II {2) CUSTOMED CONTENT: (1) GOWN SURGEON REINFORCED XLGE TOWEL/WRAP LIF...Customed, IncOKV
Z-2462-2014Class IARTHROSCOPY PACK I (1) CUSTOMED CONTENTS: (1) TOWELS ABSORBENT 15" X 20" (1) GOWN...Customed, IncLRO
Z-2461-2014Class IBASIC PACK 1 (Ill) CUSTOMED CONTENTS: (1) TABLE COVER REINFORCED 44" X 78" (4) DRAPE...Customed, IncLRO
Z-2460-2014Class IBASIC PACK IV (6) CUSTOMED CONTENTS: (3) TOWELS ABSORBENT 15" X 20" (1) MAYO STAN...Customed, IncLRO
Z-2459-2014Class I08 PAD PACK II (2,3) CUSTOMED CONTENTS: (3) TOWEL ABSORBENT 15" X 20" (1) BOWL W/LID...Customed, IncOKV
Z-2458-2014Class IKNEE ARTHROSCOPY PACK 4 CUSTOMED CONTENTS: (1) COVER TABLE REINFORCED 50" X 90" (1)...Customed, IncOJH
Z-2457-2014Class ICENTRAL LINE DRAPE PACK 1) MASK PROCEDUAL EAR LOOP 120MM HG V/B L/Free (1) DRAPE...Customed, IncLRO
Z-2456-2014Class IEXTREMITY ARM PACK CONTENTS: (1) STOCKINETTE IMPERVIOUS 14" X 48" (1) GOBAN...Customed, IncLRO
Z-2455-2014Class IEAR PACK CONTENTS: (I) CAUTERY PENC IL ROCKER SW I TI-I CH ( I ) EMESIS BASIN l...Customed, IncOGR
Z-2454-2014Class ITOTAL HYCTERECTOMY (I) CANNULA 5MM XCEL SLEEVES LIF ( I ) TROCAR XCEL BLADELESS II...Customed, IncOJF
Z-2453-2014Class IVAGINAL PROCEDURE PACK CUSTOM ED CONTENTS: (1) DRAPE LITHOTOMY 110" X 63" W/LEGGINGS...Customed, IncLRO
Z-2452-2014Class IORTHO PACK EXTREMITY CUSTOMED CONTENTS: (1) TABLE COVER REINFORCED 50" X 90" (1)...Customed, IncOJH
Z-2451-2014Class IFACE PACK AESTHETIC SURGERY AESTHETIC SURGERY CONTENTS: (15) APPLICATOR COTION 6"...Customed, IncLRO
Z-2450-2014Class ILIPOSUCTION PACK AESTHETIC SURG.CENTER CONTENTS: (1) BLADE SURG. #11 CARBON STEEL (3) *...Customed, IncLRO
Z-2449-2014Class ICERVICAL PACK ADVANCED AMBULATORY SURGICAL CENTER CONTENTS: (1) COVER TABLE REINFORCED...Customed, IncLRO
Z-2448-2014Class ILUMBAR PACK ADVANCED AMBULATORY SURGICAL CENTER CONTENTS: (1) COVER TABLE REINFORCED...Customed, IncOJH
Z-2447-2014Class ILAPAROSCOPY CHOLE SYSTEM PACK MIAMI METRO CON TENTS: (12) TOWELS CLOTH HUCK BLUE...Customed, IncFDE
Z-2446-2014Class ICENTRAL LINE FULL BODY DRAPE CUSTOMED CONTENTS: (1) WRAPPER 30" X 30" (2) MASK SURGICAL...Customed, IncLRO
Z-2445-2014Class ILAPAROSCOPY COLORECTAL SURGICAL PACK CONTENTS: (1) SOLUTION SURGICAL DURAPREP 26ml...Customed, IncFDE
Z-2444-2014Class ILAPAROSCOPIA COLORECTAL PACK CONTENTS: (1) SOLUTION SURGICAL DURAPREP 26ml (4) DRAPE...Customed, IncFDE
Z-2443-2014Class INEURO PACK CONTENTS: (4) TOWEL ABSOSRBENT 15" X 20" LIF ( I ) BAG BI OH AZARD 30" X...Customed, IncOJG
Z-2442-2014Class IEAR PACK CONTENTS: ( I ) B LADE SU RG ICA L # 15 CARBON STEEL ( I ) EMESI S BASIN...Customed, IncOGR
Z-2441-2014Class ISURGICAL PACK CONTENTS: (1) SUTURE BAG FLORAL (1) WRAPPER 30" X 30" (2) UTILITY...Customed, IncLRO
Z-2440-2014Class ILAPAROSCOPY PACK CONTENTS: ( I ) BULB SYRINGE 60cc LIF ( I 0) GAUZE SPONGE 4" X 4" 1...Customed, IncFDE
Z-2439-2014Class ISHOULDER ARTHROSCOPY PACK CONTENTS: (1) SUTURE BAG FLORAL (1) UTILITY BOWL 32oz. (2)...Customed, IncOJH
Z-2438-2014Class IHIP PACK CONTENTS: (2) TOWELS ABSORBENT 15" X 20" (2) GOWN XL SMS IMPERV...Customed, IncLRO
Z-2437-2014Class ILITHOTOMY PACK CONTENTS: (2) TOWELS ABSORBENT 15" X 20" (2) LEGGINGS W/7'' CUFF 30" X...Customed, IncLRO
Z-2436-2014Class IFEMORAL PACK CONTENTS: (2) TOWELS ABSORBENT 15" X 20" LIF (2) DRAPE SHEET 42" X 57"...Customed, IncOJH
Z-2435-2014Class IKNEE ARTHROSCOPY PACK CONTENTS: (1) TOWEL ABSORBENT 15" X 20" L/F (10) GAUZE SPONGE...Customed, IncFWZ
Z-2434-2014Class INEURO SPINE PACK CONTENTS: (1) SUTURE BAG FLORAL LIF (1) NEEDLE & BLADE COUNTER SOC...Customed, IncOJG
Z-2433-2014Class IOPEN HEART TRAY PACK A CONTENTS: (1) TABLE COVER BTC 77" X 110" HD FULL COVERAGE LIF...Customed, IncOFA
Z-2432-2014Class IORTHOPEDIC SURGICAL PACK HOSPITAL SAN CRISTOBAL CONTENTS: (I) CAUTERY TIP POLISH ER...Customed, IncOJH
Z-2431-2014Class IANGIOGRAPHY PACK CONTENTS: (4) CLOTH HUCK TOWEL BLUE (1) TABLE COVER REINFORCED 50" x...Customed, IncOEQ
Z-2430-2014Class ICESAREAN PACK - (1) BABY BLANKET IMP. POLY ABS. (4) ABSORBENT TOWELS 15" x 20" LIF (2)...Customed, IncOHM
Z-2429-2014Class ILAPAROSCOPY CHOLE PACK - (6) TOWELS ABSORBENT 15" X 20" LIF (1) MAYO STAND COVER...Customed, IncFDE
Z-2428-2014Class IGENERAL PACK - CONTENTS: (4) ABSORBENT TOWEL 15" x 20" LIF (1) MAYO STAND COVER...Customed, IncLRO
Z-2427-2014Class IO.B. PACK - ( I) PVP SCRUB 8" STICK SPONGES ( I) UNDERBUTTOCK DRAPE WITH POUCH (2)...Customed, IncOKV
Z-2426-2014Class ISHOULDER PACK- CUSTOMED- (1) TABLE COVER REINFORCED 50" x 90" LIF (2) MAYO STAND COVER...Customed, IncOJH
Z-2425-2014Class ITRAATEK NEURO PACK (4)TOWEL ABSORBENT 15" X 20" LIF ( 1) MAYO STAND COVER REINFORCED...Customed, IncLRO
Z-2424-2014Class ILAPAROSCOPY PACK - ( 1) APPLIER MULTI CLIP WITH SHAF GUN L/F ( 1) NEEDLE ULTRA VERES...Customed, IncFDE
Z-2423-2014Class IHIGADO & PANCREA PACK - (1) BAG SUTURE FLORAL (2) YANKAUER SUCTION TUBE WITHOUT...Customed, IncLRO
Z-2422-2014Class IENDOVENOUS CUSTOM PACK - CUSTOMED (1) SYRINGE 5cc WITHOUT NEEDLE LUER LOCK L/F (1) Pr...Customed, IncLRO
Z-2421-2014Class IUNIVERSAL PACK - (1) UTILITY BOWL 16oz. (1) NEEDLE SPINAL ANEST. 22G X 31!2 (1) SYRINGE...Customed, IncLRO
Z-2420-2014Class IOPHTALMIC PACK- (1) TABLE COVER REINF. 44" X 78" UF (1) GOWN SMS XLGE STD UF (2) TOWEL...Customed, IncOJK
Z-2419-2014Class IAV FISTULA PACK- (1) DRAPE T LAPAROT 102" X 78" X121 " STD SMS (3) GOWN SURG. REINFORCED...Customed, IncLRO