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Customed, Inc Recalls

452 recalls on record. Search official CPSC, FDA, and USDA datasets for every recall issued for Customed, Inc.

452Total Recalls
281Critical
976,432Units Affected
Jan 7, 2016Most Recent
All Recalls

Every Customed, Inc Recall

Sorted by most recent. Click any recall for full details.

452 recalls
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
CriticalFDA
Customed, Inc
TOTAL HYCTERECTOMY (I) CANNULA 5MM XCEL SLEEVES LIF ( I ) TROCAR XCEL BLADELESS II MM (I) TROCAR 5MM BLADELESS W/STAB SLEEVE LI...
Surgical Devices·1 affected·May 20, 2014
CriticalFDA
Customed, Inc
PREMIUM O.B. PACK - CUSTOMED- (1) TABLE COVER REINFORCED 50" X 90" LIF (10) GAUZE SPONGES 4" X 4" 12PLY LIF (2) LEGGINS WITH 7" CUFF 3...
Surgical Devices·44 affected·May 20, 2014
CriticalFDA
Customed, Inc
Open Heart Pack, code 900-2618, contains: (9) DRAPE 60" X 76" REINFORCED LIF ( 1) MAYO STAND COVER REINFORCED LIF (6) TOWELS ABSORBENT...
Cardiac Devices·7 affected·May 20, 2014
CriticalFDA
Customed, Inc
HIP PACK CONTENTS: (2) TOWELS ABSORBENT 15" X 20" (2) GOWN XL SMS IMPERV. REINFORCED (1) MAYO STAND COVER REINFORCED (1) SUTU...
Surgical Devices·4 affected·May 20, 2014
CriticalFDA
Customed, Inc
Minor Pack 900-2511, pack contains: (1) GOWN XLGE SMS IMPERVIOUS REINFORCED AAMIIII (10) GAUZE SPONGE 4" X 4" 16PLY XRD (5) LAP SPONG...
Surgical Devices·10 affected·May 20, 2014
CriticalFDA
Customed, Inc
BASIC PACK W/OUT GOWN- (1) TABLE COVER REINFORCED 50" X 90" UF (4) DRAPE UTILITY WITH TAPE UF (1) TOWEL ABSORBENT 15" x 20" L/F (1) S...
Surgical Devices·38 affected·May 20, 2014
CriticalFDA
Customed, Inc
Customed Laparoscopy convenience pack include multiple components: gowns, table covers, needle and blade counter, bag suture, suture, sp...
Surgical Devices·30 affected·May 20, 2014
CriticalFDA
Customed, Inc
IMPLANTE DE ORTHOPEDIA - ( I) CAUTERY T IP POLI SHER LIF ( I) BAG SUTURE FLORAL LIF ( I) TUBE SUCTION CONNECT \14'' X 12' LIF ( I)...
Medical Implants·12 affected·May 20, 2014
CriticalFDA
Customed, Inc
EAR PACK CONTENTS: (I) CAUTERY PENC IL ROCKER SW I TI-I CH ( I ) EMESIS BASIN l Oin 700cc (2) LABEL FOR SKIN MARKERS ( I) ...
Surgical Devices·3 affected·May 20, 2014
CriticalFDA
Customed, Inc
CESAREAN PACK- (1) COVER TABLE REINFORCED 50" X 90" (2) TOWELS ABSORBENT 15" X 20" (1) BABY BLANKET PRINTED (1) BOWL PLASTIC WITH LI...
Surgical Devices·16 affected·May 20, 2014
CriticalFDA
Customed, Inc
LAPAROSCOPY PACK I (4) CUSTOMED CONTENTS: (1) TOWEL ABSORBENT 15" X 20" LIF (2) LEGGINGS W/7'' CUFF 30" X 42" LIF (1) DRAPE UTILITY W...
Surgical Devices·2 affected·May 20, 2014
CriticalFDA
Customed, Inc
PERY GYN PACK - (1) TABLE COVER REINFORCED 44" X 78" (1) DRAPE UTILITY (2) TOWELS ABSORBENT 15" X 20" (1) GOWN XL SMS IMPERV. REI...
Surgical Devices·2 affected·May 20, 2014
CriticalFDA
Customed, Inc
CENTRAL LINE DRAPE PACK 1) MASK PROCEDUAL EAR LOOP 120MM HG V/B L/Free (1) DRAPE SHEET 41" X 58" SMS L/Free (1) CAP NURSE 21" GRE...
Surgical Devices·6 affected·May 20, 2014
CriticalFDA
Customed, Inc
CESAREAN PACK- - (3) ABSORBENT TOWELS 15" x 20" LIF (1) PLASTIC BOWL WITH LID 80oz. (1 0) LAP SPONGES PRE-WASH 18" x 18" XRD (2) PA...
Surgical Devices·47 affected·May 20, 2014
CriticalFDA
Customed, Inc
CESAREAN PACK - (1) BABY BLANKET IMP. 30" X 30" POLY ABS. (1) NEEDLE & BLADE COUNTER 60c FOAM/STRIP MAG/STRIP LIF (1) DRESSING ISLAND...
Surgical Devices·20 affected·May 20, 2014
CriticalFDA
Customed, Inc
Extremity Pack, code 900-2615, contains: (5) LAP SPONGE PREWASH 18" X 18" XRD (1) ELASTIC BANDAGE WITH VELCRO 4 X 5 (2) BLADE SURGICAL...
Surgical Devices·6 affected·May 20, 2014
CriticalFDA
Customed, Inc
LAPAROTOMY PACK- (1) MAYO STAND COVER REINFORCED LIF (10) GAUZE SPONGE 4" X 4" 16PLY XRD LIF (5) LAP SPONGES PRE-WASH 18" X 18" XRD...
Surgical Devices·34 affected·May 20, 2014
CriticalFDA
Customed, Inc
LAPAROSCOPY GYN PACK - (1) TABLE COVER REINFORCED 44" X 78" (1) LAPAROSCOPY SHEET "T" SMS (3) TOWELS ABSORBENT 15" X 20" (1) SURGIC...
Surgical Devices·24 affected·May 20, 2014
CriticalFDA
Customed, Inc
CESAREAN PACK- (1) BEANNIES BABY LIF (1) TABLE COVER REINFORCED 50" X 90" LIF (1) COVER MAYO STAND REINFORCED LIF (3) SHEET DRAPE 41...
Surgical Devices·19 affected·May 20, 2014
CriticalFDA
Customed, Inc
LAPAROSCOPY CHOLE PACK - - ( 1) STRIP STERI CLOSURE W' X 4" LIF ( 1) TABLE COVER REINFORCED 50" X 90" LIF ( 1) DRAPE LAP ABDOMINAL W/...
Surgical Devices·26 affected·May 20, 2014
CriticalFDA
Customed, Inc
LAPAROSCOPY OB GYN PACK - (1) DURAPREP SURGICAL SOLUTION 26ML LIF (1) SHEET T LAPAROSCOPY SMS LIF (2) DRAPE UTILITY WITH TAPE LIF (1...
Surgical Devices·10 affected·May 20, 2014
CriticalFDA
Customed, Inc
Tummy Tuck Pack, code 900-2684, contains: (3) GOWN SOFT SMS STD XLGE SET IN SLEEVE ( 1) CAUTERY PENCIL PUSH BOTTOM ( 1) TUBE SUCTION C...
Surgical Devices·2 affected·May 20, 2014
CriticalFDA
Customed, Inc
CARPALTUNNELLARGE - (1) TABLE COVER 50" X 90" REINFORCED LIF (1) SYRINGE 10ccWITHOUT NEEDLE LUER LOCK LIF (1) UTILITY BOWL 32oz LIF ...
Surgical Devices·38 affected·May 20, 2014
CriticalFDA
Customed, Inc
REEMPLAZO DE RODILLA Y CADERA CONTENTS: (6) TOWELS ABSORBENT 15" X 20" (I) PK. STRIP STERICLOSURE Y," X 4" (I) COVER MAYO STAN...
Surgical Devices·7 affected·May 20, 2014
CriticalFDA
Customed, Inc
Breast Implant Pack, Code 900-2660, contains: (1) DRAPE ECONOMY 53 X 77 (3) GOWN SOFT SMS STANDARD XLGE SET IN SLEEVE (3) TOWELS ABSO...
Medical Implants·2 affected·May 20, 2014
CriticalFDA
Customed, Inc
LAPAROSCOPY CHOLE PACK - (1) DRAPE LASER CAMERA WITH ELASTIC 6" X 96" LIF (2) SHEET DRAPE 42" X 57" SMS (1) TUBE SUCTION CONNECT. %" ...
Surgical Devices·16 affected·May 20, 2014
CriticalFDA
Customed, Inc
Universal Pack- - (1) TABLE COVER REINFORCED 50" X 90" LIF (3) TOWEL ABSORBENT 15" X 20" LIF (1) MAYO STAND COVER REINFORCED LIF (1...
Surgical Devices·8 affected·May 20, 2014
CriticalFDA
Customed, Inc
Face Pack- BOD, code 900-3027, contains: (2) GOWN XL SMS IMPERVIOUS REINFORCED AAMI Ill (2) TOWELS ABSORBENT 15" X 20" (1 ) DRAPE INST...
Surgical Devices·1 affected·May 20, 2014
CriticalFDA
Customed, Inc
LAPAROSCOPY CHOLECYSTECTOMY PACK- (1 0) GAUZE SPONGE 4" X 4" 16 PLY XRD UF (2) ABSORBENT TOWELS 15" X 20" UF (1) MAYO STAND COVER REI...
Surgical Devices·2 affected·May 20, 2014
CriticalFDA
Customed, Inc
LAPAROSCOPY CHOLECYSTECTOMY SURGICAL PACK - - (1) DRAPE LAPAROS/ABDOMINAL UF (1) GOWN IMPER. EXTRA REINFORCED LGE TIVVRAP (1) BL...
Surgical Devices·2 affected·May 20, 2014
CriticalFDA
Customed, Inc
Hip & Knee replacement pack, 900-2614, contains (1) CAUTERY TIP POLISHER UF (1) BAG SUTURE FLORAL (1) TUBE SUCTION CONNECT Y." X 12' U...
Surgical Devices·1 affected·May 20, 2014
CriticalFDA
Customed, Inc
UROLOGY PACK- (2) SYRINGE 30ML SLIP TIP 1 ML LIF (2) GOWN SURG. REINFORCED LARGE TOWEL & WRAP (1 0) GAUZE SPONGE 4" X 4" 12 PLY (1) ...
Surgical Devices·36 affected·May 20, 2014
CriticalFDA
Customed, Inc
MINOR LAPAROTOMY PACK - (1) DRAPE T LAPAROTOMY (1) BAG SUTURE FLORAL LIF (4) DRAPE UTILITY WITH TAPE LIF (1) TABLE COVER REINFORCED 5...
Surgical Devices·60 affected·May 20, 2014
CriticalFDA
Customed, Inc
VEIN PACK - (1) GOWN STANDARD LARGE SMS VELCRO/NECK (3) LAP. SPONGES PREWASH XRD LIF (1) EXTREMITY SHEET ABS LIF (1) WRAPPER 36" X 3...
Surgical Devices·3 affected·May 20, 2014
CriticalFDA
Customed, Inc
D & C LAPAROSCOPY PACK - (1) TUBING INSUFFLATION OPEN TIP WITHOUT VENT (1) MAYO STAND COVER REINFORCED UF (4) DRAPE UTILITY UF (1) T...
Surgical Devices·22 affected·May 20, 2014