Category
Surgical Devices Recalls
3,817 surgical devices recalls on record from CPSC, FDA, and USDA.
3,817 recalls
CriticalFDA
Customed, Inc
Liposuction Pack MRT, code 900-2656, contains: (1) NEEDLE HYPODERMIC 27 X 1 LIF (1) UTILITY BOWL QUART 32oz LIF (1) MAYO STAND COVER ...
Surgical Devices1 affectedMay 20, 2014
CriticalFDA
Customed, Inc
ANGIOGRAPHY PACK CONTENTS: (4) CLOTH HUCK TOWEL BLUE (1) TABLE COVER REINFORCED 50" x 90" LIF (2) SYRINGE 20cc WITHOUT NEEDLE LUER ...
Surgical Devices21 affectedMay 20, 2014
CriticalFDA
Customed, Inc
RETINA PACK - (1) TABLE COVER REINFORCED 44" X 78" LIF (50) COTTON TIP APPLICATOR 6" WOOD LIF (2) GOWN IMPERVIOUS EXTRA REINFORCED LA...
Surgical Devices10 affectedMay 20, 2014
CriticalFDA
Customed, Inc
CESAREAN PACK - - (7) TOWELS ABSORBENT 15" X 20" (2) SCALPEL WEIGHTED SAFETY #1 0 (1) BLANKET BABY 30" X 30" POLY ABS IMP (1) BOWL...
Surgical Devices30 affectedMay 20, 2014
CriticalFDA
Customed, Inc
Customed O.B. Pack convenience pack include multiple components: set up cover, absorbent towel, ear ulcer syringe, pad, umbilical cord ...
Surgical Devices24 affectedMay 20, 2014
CriticalFDA
Customed, Inc
Customed Femoral Pack , convenience pack include multiple components: Syringe 3cc, 5cc, 10cc, 20cc; swabstick chlorascrub, needles, gauze...
Surgical Devices14 affectedMay 20, 2014
CriticalFDA
Customed, Inc
Urology Pack, 900-2510, package contains: (2) TOWELS ABSORBENT 15X 20 UF (1) DRAPE LITHO 11 0" X 63" W/LEGG/POUCH FEN UF (10)GAUZE SP...
Surgical Devices10 affectedMay 20, 2014
CriticalFDA
Customed, Inc
ORTHOPEDIC SURGICAL PACK HOSPITAL SAN CRISTOBAL CONTENTS: (I) CAUTERY TIP POLISH ER LIF (1) BAG SUTURE FLORAL (1) TUBE SUCTIO...
Surgical Devices7 affectedMay 20, 2014
CriticalFDA
Customed, Inc
O.B. PACK - (I) TABLE COVER REINFORCED 50" X 90" LIF (I) DRAPE UNDERBUTTOCK WITH POUCH 44" X 35" (2) LEGGINS W/7'' CUFF 30" X 42" (1...
Surgical Devices49 affectedMay 20, 2014
CriticalFDA
Customed, Inc
ARTHROSCOPY PACK - - (1) MAYO STAND COVER REINFORCED LIF (3) TOWELS ABSORBENT 15" X 20" LIF (1) STOCKINETTE IMPERVIOUS 14" X 48" LIF...
Surgical Devices20 affectedMay 20, 2014
CriticalFDA
Customed, Inc
LAPAROSCOPY PACK - (1) TUBING INSUFFLAT SET W/0 RING ADAPTOR LIF (1) DRAPE ENDOSCOPY 1 00" X 123W' X 77" WITH TROUGHS (1) MAYO STA...
Surgical Devices18 affectedMay 20, 2014
CriticalFDA
Customed, Inc
VAGINAL PROCEDURE PACK CUSTOM ED CONTENTS: (1) DRAPE LITHOTOMY 110" X 63" W/LEGGINGS I POUCH FEN 3 X 6 SMS LIF (1) GOWN XL SMS...
Surgical Devices7 affectedMay 20, 2014
CriticalFDA
Customed, Inc
Laparoscopy pack, , Code 900-3178, contains: (1) BULB SYRINGE 60cc LIF (10) GAUZE SPONGE 4" X 4" 16PLY XRD LIF (1) MAYO STAND COVER RE...
Surgical Devices4 affectedMay 20, 2014
CriticalFDA
Customed, Inc
LAPAROSCOPY CHOLE PACK - (4) DRAPE UTILITY WITH TAPE LIF (2) ABSORBENT TOWELS 15" X 20" LIF (2) GOWN IMPERVIOUS EXTRA REINFORCED X-LA...
Surgical Devices16 affectedMay 20, 2014
CriticalFDA
Customed, Inc
FOLEY CATHETER KIT 1118FR.- CUSTOM ED CONTENTS: (1) WRAPPER 24" X 24" (1) LABEL ID PATIENT (1) TRAY ORGANIZER (1) PVP TRIPLE SWABS...
Surgical Devices13 affectedMay 20, 2014
CriticalFDA
Customed, Inc
LAPAROTOMY PACK - (I) UTILITY BOWL 16oz ( I) ELECTRODE DUAL DEPRES./GROUNDPAD (I) UTILITY BOWL 32oz ( I) GOWN IMP. REINFORCED XL SMS...
Surgical Devices3 affectedMay 20, 2014
CriticalFDA
Customed, Inc
Liposuction Pack BOD, code 900-3028, contains: (2) GOWN XL SMS IMPERVIOUS REINFORCED AAMI Ill (2) LITE GLOVES LIF (2) TOWEL ABSORBENT ...
Surgical Devices2 affectedMay 20, 2014
CriticalFDA
Customed, Inc
MINOR LAPAROTOMY PACK - (1) TABLE COVER 50" X 90" REINFORCED LIF (1) GOWN SURG. X-LARGE REINFORCED TOWEL/WRAP (1) GOWN X-LARGE SMS I...
Surgical Devices50 affectedMay 20, 2014
CriticalFDA
Customed, Inc
NEURO PACK CONTENTS: (4) TOWEL ABSOSRBENT 15" X 20" LIF ( I ) BAG BI OH AZARD 30" X 37" (2) MAYO STAND COYER REINFORCED UF (2...
Surgical Devices12 affectedMay 20, 2014
CriticalFDA
Customed, Inc
CERVICAL PACK ADVANCED AMBULATORY SURGICAL CENTER CONTENTS: (1) COVER TABLE REINFORCED 50" X 90" (1) COVER FLUORO 30" X 30" WITH R...
Surgical Devices2 affectedMay 20, 2014
CriticalFDA
Customed, Inc
PREMIUM UROLOGY PACK - CUSTOMED- (1) LITHOTOMY DRAPE W/POUCH ANESTH. (2) ABSORBENT TOWELS UF (1) MAYO STAND COVER REINFORCED UF (1...
Surgical Devices2 affectedMay 20, 2014
CriticalFDA
Customed, Inc
Face Pack MRT, product code 900-2654, contains: (2) GOWN SOFT SMS STD X-LARGE SET IN SLEEVE LIF (2) TOWELS ABSORBENT 15 X 20 LIF (1) D...
Surgical Devices2 affectedMay 20, 2014
CriticalFDA
Customed, Inc
OPHTALMIC PACK - (1) GOWN LGE SMS NON REINF TIWRAP (1) IODINE POVIDONE 1oz. (2) TOWEL ABSORBENT 15" x 20" UF (1) SYRINGE 3cc W/...
Surgical Devices25 affectedMay 20, 2014
CriticalFDA
Customed, Inc
LAPAROSCOPIA COLORECTAL PACK CONTENTS: (1) SOLUTION SURGICAL DURAPREP 26ml (4) DRAPE UTILITY WITH TAPE (1) TOWELS ABSORBENT 15...
Surgical Devices17 affectedMay 20, 2014
CriticalFDA
Customed, Inc
BASIC PACK - (1) TABLE COVER REINF. LIF (1) MAYO STAND COVER REINF. LIF (2) TOWELS ABSORBENT LIF (10) GAUZE SPONGES XRD 4" X 4" 12...
Surgical Devices1 affectedMay 20, 2014
CriticalFDA
Customed, Inc
TLIF PACK SURGICAL CENTER, CODE 900-2918. CONTENTS: (2) SOLUTION SURGICAL DURAPREP 26ML UF (6) Pr. GLOVE SURG. DERMA PRENE # 8...
Surgical Devices8 affectedMay 20, 2014
CriticalFDA
Customed, Inc
08 PAD PACK II (2,3) CUSTOMED CONTENTS: (3) TOWEL ABSORBENT 15" X 20" (1) BOWL W/LID PLASTIC 80oz (1) GOWN XL SMS IMPERVIOUS REINFOR...
Surgical Devices3 affectedMay 20, 2014
CriticalFDA
Customed, Inc
ORTHO PACK EXTREMITY CUSTOMED CONTENTS: (1) TABLE COVER REINFORCED 50" X 90" (1) MAYO STAND COVER REINFORCED (1) SUTURE BAG FLOR...
Surgical Devices3 affectedMay 20, 2014
CriticalFDA
Customed, Inc
LAP Abdom w/pouch Customed code 900-2619, contains: (1) DRAPE LAP. ABDOM W/POUCH 102" X 122" X 78" (1) WRAPPER 30" X 30" Product Usa...
Surgical Devices2 affectedMay 20, 2014
CriticalFDA
Customed, Inc
OB PACK - (2) EXAM GLOVES MED. (1 0) GAUZE SPONGES 4" X 4" 12PL Y (2) LEGGINS W/ 7" CUFF (2) DRAPE SHEET SMS (1) ABDOMINAL DRAPE W/...
Surgical Devices1 affectedMay 20, 2014
CriticalFDA
Customed, Inc
Gown Impervious , Code 900-3190, contains: GOWN IMPERVIOUS EXTRA LONG X-LARGE WITH TOWEL & WRAP Product Usage: EO sterilized surgical...
Surgical Devices5 affectedMay 20, 2014
CriticalFDA
Customed, Inc
Liposuction Pack, code 900-2681, contains: (3) GOWN SOFT SMS STD XLGE SET IN SLEEVE (1) TUBE SUCTION CONNECT (1) MAYO STAND COVER REIN...
Surgical Devices1 affectedMay 20, 2014
CriticalFDA
Customed, Inc
Drape Sheet, Product Code 2942, contains (1) DRAPE % ECONOMY 53 X 77L/F (1) WRAPPER 24 X 24 L/F Product Usage: EO sterilized surgical...
Surgical Devices3 affectedMay 20, 2014
CriticalFDA
Customed, Inc
OPHTALMIC PACK- (1) TABLE COVER REINF. 44" X 78" UF (1) GOWN SMS XLGE STD UF (2) TOWEL ABSORBENT 15" X 20" LIF (1) SYRINGE 3cc W/0...
Surgical Devices20 affectedMay 20, 2014
CriticalFDA
Customed, Inc
BASIC PACK 1 (Ill) CUSTOMED CONTENTS: (1) TABLE COVER REINFORCED 44" X 78" (4) DRAPE UTILITY WffAPE (2) TOWELS ABSORBENT 15" X 20" (1...
Surgical Devices5 affectedMay 20, 2014
CriticalFDA
Customed, Inc
STRABISMUS & PLASTIC PACK - (1) TABLE COVER REINFORCED 44" X 78" UF (2) GOWN STANDARD LARGE SMS (3) TOWELS ABSORBENT 15" X 20" UF (1) ...
Surgical Devices46 affectedMay 20, 2014
CriticalFDA
Customed, Inc
SHOULDER PACK- CUSTOMED- (1) TABLE COVER REINFORCED 50" x 90" LIF (2) MAYO STAND COVER REINFORCED L/F (1) U-DRAPE 60" X 70" WITH TAP...
Surgical Devices16 affectedMay 20, 2014
CriticalFDA
Customed, Inc
KNEE ARTHROSCOPY PACK CONTENTS: (1) TOWEL ABSORBENT 15" X 20" L/F (10) GAUZE SPONGE 4" X 4" 16PLY (1) SAFETY IV INTROCAN 18 X...
Surgical Devices22 affectedMay 20, 2014
CriticalFDA
Customed, Inc
Hair Restoration Pack- , code 900-2966, contains: (1) MAYO STAND COVER 23X54 (2) TOWEL CLOTH HUCK BLUE (2) TABLE COVER BACK ZONE REINF...
Surgical Devices2 affectedMay 20, 2014
CriticalFDA
Customed, Inc
PREMIUM LAPAROTOMY PACK - CUSTOMED- (1) DRAPE T LAPAROT 102" X 78" X 121" (1) GOWN XL SMS IMPERVIOUS REINFORCED (1) COVER TABLE REINFO...
Surgical Devices51 affectedMay 20, 2014
CriticalFDA
Customed, Inc
E..N.T. PACK - (5) SPONGE TONSIL 7/8 XRD (1) TABLE COVER REINFORCED 50" X 90" LIF (1) MAYO STAND COVER REINFORCED L/F (1) TUBE SUCTI...
Surgical Devices39 affectedMay 20, 2014
CriticalFDA
Customed, Inc
Tummy Pack MRT, code 900-2657, contains: (2) GOWN SOFT SMS STD XLGE SET IN SLEEVE ( 1) CAUTERY PENCIL PUSH BOTTOM ( 1) NEEDLE ULTRACLE...
Surgical Devices3 affectedMay 20, 2014
CriticalFDA
Customed, Inc
OB PACK - (1) BABY BLANKET PRINTED (1) BABY BEANIES (1) TABLE COVER REINFORCED 50" X 90" LIF (2) LEGGINS W/7'' CUFF 30" X 42" LIF (1...
Surgical Devices18 affectedMay 20, 2014
CriticalFDA
Customed, Inc
MAJOR LAP PACK - (1) TABLE COVER REINF. 50" X 90" 10) GUZE SPONGE 4" X 4" 16PLY XRD (1) DRAPE T LAPAROT 102" X 78" X 121" SMS (1) UTILI...
Surgical Devices35 affectedMay 20, 2014
CriticalFDA
Customed, Inc
ANGIODRAPE PACK - - (1) GUIDEWIRE 0.035" X 150cm (2) SYRINGE 10ccWITHOUT NEEDLE LUER LOCK UF (2) Pr. SURGICAL GLOVES #8 (2) GOWN STA...
Surgical Devices5 affectedMay 20, 2014
CriticalFDA
Customed, Inc
UROLOGY PACK - (3) TOWELS ABSORBENT 15" X 20" UF (1) WASH BASIN ROUND 6QT. (1) SYRINGE 30cc W/O NEEDLE LUER LOCK UFN (1) BAG UR...
Surgical Devices14 affectedMay 20, 2014
CriticalFDA
Customed, Inc
UNIVERSAL PACK - (1) UTILITY BOWL 16oz. (1) NEEDLE SPINAL ANEST. 22G X 31!2 (1) SYRINGE 5cc WITHOUT NEEDLE LUER LOCK LIF (2) SYRINGE...
Surgical Devices22 affectedMay 20, 2014
CriticalFDA
Customed, Inc
HIP ORTHOPEDIA PACK - (1) BLADE SURGICAL #15 STAINLES /STEEL (1) GOWN XL SMS IMPERVIOUS REINFORCED MMI Ill LIF (1) TABLE COVER REINFO...
Surgical Devices3 affectedMay 20, 2014