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FDA Recalls

The U.S. Food and Drug Administration regulates drugs, medical devices, food, cosmetics, and tobacco products. Recall data here includes pharmaceutical adverse events and drug recalls.

68,659Total Recalls
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68,659 recalls
CriticalFDA
Customed, Inc
PERl GYN PACK - (1) TOWEL NON ABS. W/TAPE L/Free (1) DRAPE UNDERBUTTOCK W/POUCH (2) TOWELS ABSORBENT L/Free (2) LEGGINGS W/7" CUFF (...
Surgical Devices·1 affected·May 20, 2014
CriticalFDA
Customed, Inc
DRESSING CHANGE - CUSTOMED- (2) GLOVE MED. FREETOUCH VYNIL POWDER FREE ( I) DRESSING TEGADERM 3 Y2 X 4 Y2 ( I) MASK PROCEDURAL YEL...
Surgical Devices·12 affected·May 20, 2014
CriticalFDA
Customed, Inc
CIRUGIA CARDIOVASCULAR - CASE CART - (1) CIRUGIA CARDIOVASCULAR (PREPARACION) (1) CIRUGIA CARDIOVASCULAR (ENFERMERA CIRCULANTE) (1) CI...
Cardiac Devices·7 affected·May 20, 2014
CriticalFDA
Customed, Inc
LAPAROSCOPY CHOLE PACK - (6) TOWELS ABSORBENT 15" X 20" LIF (1) MAYO STAND COVER REINFORCED L/F (1) SYRINGE 3cc WITHOUT NEEDLE LUER L...
Surgical Devices·11 affected·May 20, 2014
CriticalFDA
Customed, Inc
LAPAROSCOPY CHOLECYSTECTOMY PACK - (1) SHEET LAPAROS/ABDOMINAL UF (1) MAYO STAND COVER REINFORCED UF (1) BLADE SURGICAL #11 STAINLE...
Surgical Devices·26 affected·May 20, 2014
CriticalFDA
Customed, Inc
O.B. PACK - ( I) PVP SCRUB 8" STICK SPONGES ( I) UNDERBUTTOCK DRAPE WITH POUCH (2) LEGGINS WITH 7" CUFF 30" x 42" ( I) DRAPE ABDOMIN...
Surgical Devices·23 affected·May 20, 2014
CriticalFDA
Customed, Inc
Shoulder pack (I) (2), code 900-2515 (1) GOWN IMP. XTRA REINF. XL TOWEL WRAP LEVEL Ill (1) TOWEL ABSORBENT 15" X 20" (1) GOWN XXL SMS ...
Surgical Devices·2 affected·May 20, 2014
CriticalFDA
Customed, Inc
LUMBAR PACK ADVANCED AMBULATORY SURGICAL CENTER CONTENTS: (1) COVER TABLE REINFORCED 50" X 90" UF (4) SYRINGE 3CC WITHOUT NEEDLE...
Surgical Devices·5 affected·May 20, 2014
CriticalFDA
Customed, Inc
ARTHROSCOPY PACK - (1) SURGICAL DURAPREP SOLUTION 26ML LIF (1) ESMARK BANDAGE (1 ) ELASTIC BANDAGE 6" X 5yds LIF (1) NEEDLE & BLADE ...
Surgical Devices·12 affected·May 20, 2014
CriticalFDA
Customed, Inc
UNIVERSAL PACK - (1) TRAY ORGANIZER FULL DEEP (1) ANESTHESIA SPINAL NEEDLE 22G X 3 ~ UF (1) SYRINGE 5cc WITHOUT NEEDLE LUER LOCK UF ...
Surgical Devices·36 affected·May 20, 2014
CriticalFDA
Customed, Inc
PERY GYN PACK - (1) TABLE COVER REINFORCED 44" X 78" UF (2) TOWEL ABSORBENT 15" X 20" LIF (2) GOWN LARGE SMS IMPERVIOUS REINFORCED ...
Surgical Devices·60 affected·May 20, 2014
CriticalFDA
Customed, Inc
LAPAROTOMY BASIC PACK- CUSTOMED- (1) TABLE COVER REINFORCED 44" X 78" LIF (1) COVER MAYO STAND REINFORCED UF (2) TOWEL ABSORBENT 15" ...
Surgical Devices·19 affected·May 20, 2014
CriticalFDA
Customed, Inc
Endovascular Pack, code 900-2715, contains: ( I) DRAPE FEMORAL ANG. 125 X 75 X 56 WITH POUCH LIF (2) TOWELS ABSORBENT 15 X 20 LIF ( I)...
Surgical Devices·1 affected·May 20, 2014
CriticalFDA
Customed, Inc
Breast Pack BOD, code 900-3029, contains: (2) GOWN X-LARGE SMS IMPERVIOUS REINFORCED AAMI Ill (2) TOWEL ABSORBENT 15" X 20" (1) PENCIL...
Surgical Devices·3 affected·May 20, 2014
CriticalFDA
Customed, Inc
Chole Cystectomy All Endo System , code 900-3025, contains: (1) TABLE COVER 44X 90 UF (1) SYRINGE 20ccW/O NDL LUER LOCK LIF (2) MAYO ...
Surgical Devices·1 affected·May 20, 2014
CriticalFDA
Customed, Inc
NEURO PACK- (1)TABLE COVER 44" x 90" (1) GOWN SURGEON REINFORCED X-LARGE TIWRAP (1) GOWN IMPERVIOUS REINFORCED X-LARGE SMS (1) BAG S...
Surgical Devices·37 affected·May 20, 2014
CriticalFDA
Customed, Inc
LAPAROSCOPY PACK - - (1) MAYO STAND COVER REINFORCED LIF (2) DRAPE % ECONOMY 53" X 77" LIF (1) TUBE SUCTION CONNECT. v.i" X 12' LIF ...
Surgical Devices·39 affected·May 20, 2014
CriticalFDA
Customed, Inc
Face Lift , Code 900-3083, contains: (I) SHEET ENT SPLIT 110" X 77" LIF (I) COVER TABLE REINFORCED 50" X 90" LIF (I) DRAPE HEAD WITH T...
Surgical Devices·5 affected·May 20, 2014
CriticalFDA
Customed, Inc
Shoulder Arthroscopy Pack, code 900-2719, contains: (1 0) GAUZE SPONGES 4 X 4 12PL Y (1) COBAN WRAP TAN 4 X 5yds (3) PAD ABDOMINAL 8 X...
Surgical Devices·3 affected·May 20, 2014
CriticalFDA
Customed, Inc
LAPAROTOMY PACK - CONTENTS: ( 1) GOWN XL SMS IMPERVIOUS REINFORCED LIF ( 1) MAYO STAND COVER REINFORCED LIF (1) BAG SUTURE FLORAL L...
Surgical Devices·23 affected·May 20, 2014
CriticalFDA
Customed, Inc
ARTHROSCOPY PACK- (1) TABLE COVER REINFORCED 50" X 90" (1) PRE PAD WITH CUFF (2) GOWN XL SMS IMPERVIOUS REINFORCED AAMI Ill (1) GO...
Surgical Devices·39 affected·May 20, 2014
CriticalFDA
Customed, Inc
LAPAROSCOPY CHOLE SYSTEM PACK MIAMI METRO CON TENTS: (12) TOWELS CLOTH HUCK BLUE LIF (1) MAYO STAND COVER REINFORCED LIF (1) ...
Surgical Devices·1 affected·May 20, 2014
CriticalFDA
Customed, Inc
FANFOLD DRAPE - CUSTOMED (1) DRAPE SHEET 42" X 57" SMS (1) WRAPPER 24" X 24" EO sterilized surgical convenient packs packaged into p...
Surgical Devices·56 affected·May 20, 2014
CriticalFDA
Customed, Inc
Customed Angiodrape Pack convenience pack include multiple components: syringe 10cc and 30cc, gauze, denture cup, specimen container, b...
Surgical Devices·26 affected·May 20, 2014
CriticalFDA
Customed, Inc
TRANSVERSE LAPAROTOMY PACK (8) CUSTOMED CONTENT: (1) TOWEL ABSORBENT 15" X 20" (1) MAYO STAND COVER REINFORCED (4) DRAPE U...
Surgical Devices·4 affected·May 20, 2014
CriticalFDA
Customed, Inc
PREMIUM CESAREAN PACK- CUSTOMED- (1)BABY BLANKET IMP. 30" X 30" POLY ABSORBENT (3) TOWELS ABSORBENT 15" X 20" LIF (1) BOWL PLASTIC 8...
Surgical Devices·18 affected·May 20, 2014
CriticalFDA
Customed, Inc
C-SECTION SURGICAL PACK- (1) COVER TABLE REINFORCED 50" X 90" (2) TOWELS ABSORBENT 15" X 20" (1) MAYO STAND COVER REINFORCED (1) BAB...
Surgical Devices·4 affected·May 20, 2014
CriticalFDA
Customed, Inc
LAPAROSCOPY ABO PACK (1) (2) CUSTOMED CONTENTS: (1) GOWN SURG. REINFORCED X-LARGE TOWEL I WRAP (2) TOWELS ABSORBENT 15" X 20" (2)...
Surgical Devices·5 affected·May 20, 2014
CriticalFDA
Customed, Inc
Breast pack TPSC, code 900-3431, contains: (1) GOWN LARGE STANDARD SMS AAMIIII (1) GOWN SOFT SMS STD. X-LARGE AAMIIII (4) TOWELS ABSOR...
Surgical Devices·1 affected·May 20, 2014
CriticalFDA
Customed, Inc
ARTHROSCOPY PACK - (1) MAYO STAND COVER REINFORCED LIF (1 0) GAUZE SPONGES 4" X 4" 16PL Y (1) TUBE SUCTION CONNECTING X" X 12' LIF ...
Surgical Devices·28 affected·May 20, 2014
CriticalFDA
Customed, Inc
CURATION KIT - CUSTOMED- (10) GAUZE SPONGE 4" X 4" 16PL Y (4) ABSORBENT TIP APPLICATOR (4) PVP PREP SOLUTION 1 oz (1) CONTAINER SPEC...
Surgical Devices·16 affected·May 20, 2014
CriticalFDA
Customed, Inc
GENERAL PACK - CONTENTS: (4) ABSORBENT TOWEL 15" x 20" LIF (1) MAYO STAND COVER REINFORCED LIF ( 1) NEEDLE & BLADE COUNTER 20c FOAM/M...
Surgical Devices·29 affected·May 20, 2014
CriticalFDA
Customed, Inc
Customed Laparotomy Pack , convenience pack include multiple components: drape laparot., gown, absorbent towel, scrub, stck sponges/ gauz...
Surgical Devices·32 affected·May 20, 2014
CriticalFDA
Customed, Inc
BASIC COSMETIC SURG. PACK CUSTOMED (USA), CODE 900-2915. CONTENTS: (2) TOWELS ABSORBENT 15" X 20" LIF (1) DRAPE BREAST/CHEST SMS L...
Surgical Devices·4 affected·May 20, 2014
CriticalFDA
Customed, Inc
PERl GYN PACK (1) TABLE COVER 44" x 90" (2) LEGGINS W/7" CUFF 30" x 42" (1) ABDOMINAL DRAPE WITH TAPE LIF (2) TOWELS ABSORBENT 15...
Surgical Devices·54 affected·May 20, 2014
CriticalFDA
Customed, Inc
NEURO SPINE PACK CONTENTS: (1) SUTURE BAG FLORAL LIF (1) NEEDLE & BLADE COUNTER SOC FOAM STR//MAG STR (2) COVER TABLE BTC 77" x...
Surgical Devices·1 affected·May 20, 2014
CriticalFDA
Customed, Inc
NEURO SPINE PACK , CODE 900-2765 CONTENTS: (l ) DRAPE INCISION 23" X 1 7" (I) SCALPEL W/HANDLE # 15 S/STEEL (I) INSTRUMEN...
Surgical Devices·6 affected·May 20, 2014
CriticalFDA
Customed, Inc
General Cosmetic Pack FCSC, Code 900-3113, contains: (1) COVER MAYO STAND REINFORCED LIF (10) LAP SPONGE PREWASH 18" X 18" XRD LIF (2)...
Surgical Devices·2 affected·May 20, 2014
CriticalFDA
Customed, Inc
ORTHOPEDIC PACK BASIC CODE 900-2830. CONTENTS: (3) TOWELS ABSORBENT 15" X 20" (1) COVER MAYO STAND REINFORCED (1) U-DRAPE 60" X ...
Surgical Devices·3 affected·May 20, 2014
CriticalFDA
Customed, Inc
EAR PACK CONTENTS: ( I ) B LADE SU RG ICA L # 15 CARBON STEEL ( I ) EMESI S BASIN lO in 700cc ( I ) GOWN XL SMS IM P. REINFO...
Surgical Devices·8 affected·May 20, 2014
CriticalFDA
Customed, Inc
LAPAROSCOPY PACK CONTENTS: ( I ) BULB SYRINGE 60cc LIF ( I 0) GAUZE SPONGE 4" X 4" 1 6PLY XRD LIF ( I ) MAYO STAND COYER REINFO...
Surgical Devices·5 affected·May 20, 2014
CriticalFDA
Customed, Inc
ORTHOPEDIC IMPLANT PACK CUSTOMED USA, CODE 900-2903 CONTENTS: (1) CAUTERY TIP POLISHER UF (1) SKIN MARKER W/RULER (1) BAG...
Medical Implants·4 affected·May 20, 2014
CriticalFDA
Customed, Inc
LAMINECTOMY PACK - ( I) RING BASIN LIF (2) TABLE COVER REINFORCED 50" X 90" LIF ( I) SKIN MARKER INK W/8 LABEL ( I) CAUTERY TIP POL...
Surgical Devices·12 affected·May 20, 2014
CriticalFDA
Customed, Inc
Breast Pack- FJG, code 900-3118, contains: (2) GOWN LARGE STANDARD SMS AAMIIII (2) TOWEL ABSORBENT 15" X 20" (1) PENCIL CAUTERY PUSH B...
Surgical Devices·2 affected·May 20, 2014
CriticalFDA
Customed, Inc
OPEN HEART TRAY - - PACK A ( 1) CV SPLIT DRAPE W/ CLEAR AN EST SCREEN STD SMS LIF (5) DRAPE % ECONOMY 53" X 77" LIF ( 1) MAYO STAND ...
Cardiac Devices·6 affected·May 20, 2014
CriticalFDA
Customed, Inc
CESAREAN PACK - (1) BABY BLANKET IMP. POLY ABS. (4) ABSORBENT TOWELS 15" x 20" LIF (2) NEEDLE & BLADE COUNTER 10C MAG/CLEAR LIF (2...
Surgical Devices·14 affected·May 20, 2014
CriticalFDA
Customed, Inc
LABOR & DELIVERY PAC - 1) NEEDLE HYPODERMIC 18G X 1% ST. (2) DRAPE UNDERBUTTOCK WITH POUCH (4) TOWELS ABSORBENT 15" X 20" ( 1) FEE...
Surgical Devices·16 affected·May 20, 2014
CriticalFDA
Customed, Inc
SHOULDER PACK CODE 900-2766 CONTENTS: (1) STAPLE SKIN 35 WIDE LIF (1) *GOBAN SELF-ADH 4" X 5YD WRAP TAN LATEX (2) U-DRAPE 60"...
Surgical Devices·6 affected·May 20, 2014