Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means deaths or serious injuries are reported, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

Agency

All agencies FDA (Food)FDA (Drugs)FDA (Devices)USDA FSIS CPSC NHTSA EPA

4451–4475 of 5038

CriticalFDA (Devices)·Z-2471-2014·2014-09-10
Customed Recalls EENT Surgical Packs Due to Packaging Integrity Concerns
Customed, Inc. is recalling EENT surgical packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
EENT PACK I CUSTOMED CONTENT: (2) TOWEL ABSORBENT 15" X 20" (1) MAYO STAND COVER REINFORCED (1) BAG SUTURE FLORAL (1) SHEET ENT SPLIT 110" X 77" SMS (1) TABLE COVER REINFORCED 50" X 90" (1) DRAPE HEAD W!TAPE 44" X 26" (1) GOWN SURG. REINFORCED XLGE TOWEL/WRAP
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2414-2014·2014-09-10
Customed Recalls Arthroscopy Packs Due to Potential Packaging Integrity Issues
Customed, Inc. is recalling 39 lots of arthroscopy packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
ARTHROSCOPY PACK- (1) TABLE COVER REINFORCED 50" X 90" (1) PRE PAD WITH CUFF (2) GOWN XL SMS IMPERVIOUS REINFORCED AAMI Ill (1) GOWN IMPERV. EXTRA REINFORCED LGE TNVRAP (1) MAYO STAND COVER REINFORCED (1) TUBE SUCTION CONNECT. X" X 12' (1) STOCKINETTE IMPERVIOUS 14" X 4
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2456-2014·2014-09-10
Customed Recalls Extremity Arm Packs Due to Packaging Integrity Concerns
Customed, Inc. is recalling 112 units of Extremity Arm Packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
EXTREMITY ARM PACK CONTENTS: (1) STOCKINETTE IMPERVIOUS 14" X 48" (1) GOBAN SELF-ADHERENT WRAP 6" X 5yds (3) BANDAGE ELASTIC 4" X 5yds (1) BANDAGE ESMARK 6" X 9 (1) UTILITY BOWL QUART 32oz (10) GAUZE SPONGE 4" X 4" 16PLY (1) TUBE SUCTION CONNECTX 12' (1) SK
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2498-2014·2014-09-10
Customed Recalls Endovascular Packs Due to Potential Packaging Integrity Issues
Customed, Inc. is recalling Endovascular Packs (code 900-2715) because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
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) CONTAINER SPECIMEN 4oz W/LID & LABEL Llf (2) BAG BAND FLUOROSCOPE 36 X 30 LIF ( I) NEEDLE HYPODERMIC 21G X I Y, LIF (2) GOWN LARGE SMS IMPE
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2484-2014·2014-09-10
Customed Recalls Surgical Packs Due to Potential Packaging Integrity Issues
Customed is recalling specific lots of HIP PACK I surgical packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
HIP PACK I (2), CUSTOMED, code 900-2504 (1) GOWN SURG. REINFORCED XLGE TOWEL/WRAP (1) MAYO STAND COVER REINFORCED (1) U-DRAPE 60" X 70" WITH TAPE SPLIT (1) STOCKINETTE IMPERVIOUS 12" X 48" (4) DRAPE UTILITY WITH TAPE (1) BAG SUTURE FLORAL (1) DRAPE HIP 89" X 128" REINFORCE
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2304-2014·2014-09-10
Customed Laparoscopy Convenience Packs Recalled for Packaging Integrity Concerns
Customed, Inc. is recalling 30 lots of EO sterilized laparoscopy convenience packs because packaging integrity may be compromised, potentially leading to loss of sterility and patient injury.
Product
Customed Laparoscopy convenience pack include multiple components: gowns, table covers, needle and blade counter, bag suture, suture, sponges/gauzes, containers, syringes 20cc & 30cc w/o needle, needle, drape, tubing, towel, dressing island, and blade surgical SS. EO steriliz
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2321-2014·2014-09-10
Customed Recalls Major Lap Packs Due to Potential Packaging Integrity Issues
Customed, Inc. is recalling Major Lap Packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
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) UTILITY BOWL 32oz (1) TUBE CONNECT. SUCTION W X 12' (1) CAUTERY TIP POLISHER (1) YANKAUER SUCTION TUBE W/0 VENT (4) DRAPE UTILITY WITH TAPE (2) L
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2533-2014·2014-09-10
Customed Recalls Laparoscopy Colorectal Surgical Packs Due to Packaging Integrity Concerns
Customed, Inc. is recalling 280 units of Laparoscopy Colorectal Surgical Packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
LAPAROSCOPY COLORECTAL SURGICAL PACK code 900-2259A, contains: (1) SOLUTION SURGICAL DURAPREP 26ml LIF (4) DRAPE UTILITY WITH TAPE LIF (3) TOWELS ABSORBENT 15" X 20" LIF (2) LEGGINS W/7'' CUFF 30" X 42" LIF (1) BLADE SURGICAL# 15 STAINLESS STEEL (1) BLADE SURGICAL# 11 STA
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2309-2014·2014-09-10
Customed Recalls Labor and Delivery Packs Due to Packaging Integrity Concerns
Customed, Inc. is recalling 3,448 units of Labor and Delivery Packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
Customed LABOR & DELIVERY PACK - Includes: (1) TABLE COVER 44" x 90" (2) LEGGINS WITH/7" CUFF 30" x 42" (5) ABSORBENT TOWELS 15" x 20" LIF (1) BABY BLANKET PRINTED LIF (2) PAD OBSTETRICAL XLGE LIF (1) EAR ULCER SYRINGE 2oz. LIF (1) BABY BLANKET POLY ABS. IMP. LIF (1) Pr
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2356-2014·2014-09-10
Customed Recalls Arthroscopy Packs Due to Potential Packaging Integrity Issues
Customed, Inc. is recalling 273 units of arthroscopy packs across 11 lots because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
ARTHROSCOPY PACK- (2) ABSORBENT TOWELS 15" x 20" LIF (1) TUBE SUCTION CONNECT Y.." X 12' LIF (1) ELASTIC BANDAGE 6" X 5yrd. UF (1) IMPERVIOUS STOCKINETTE 14" X 48" (1) HUCK CLOTH TOWEL WHITE (1) MAYO STAND COVER REINFORCED LIF (1) U DRAPE 60" X70" WITH TAPE SPLIT (4) STR
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2422-2014·2014-09-10
Customed Recalls Endoveneous Custom Packs Due to Packaging Integrity Concerns
Customed, Inc. is recalling 12 lots of Endoveneous Custom Packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
ENDOVENOUS CUSTOM PACK - CUSTOMED (1) SYRINGE 5cc WITHOUT NEEDLE LUER LOCK L/F (1) Pr. GLOVE SYNTEGRA CR # 7.5 P/F LIF (2) Pr. GLOVE SYNTEGRA CR # 6.5 P/F LIF (20) GAUZE SPONGE 4" X 4" 12PL Y LIF (3) GOWN SMS X-LARGE STD NON REINFORCED ( 1) TABLE COVER 44" X 90" (4) DRAP
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2340-2014·2014-09-10
Customed Fanfold Drapes Recalled for Potential Packaging Integrity Compromise
Customed, Inc. is recalling Fanfold Drapes due to potential packaging integrity issues that could compromise sterility and risk patient injury.
Product
FANFOLD DRAPE - CUSTOMED (1) DRAPE SHEET 42" X 57" SMS (1) WRAPPER 24" X 24" EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2427-2014·2014-09-10
Customed Recalls O.B. Packs Due to Potential Packaging Integrity Issues
Customed, Inc. is recalling O.B. Packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
O.B. PACK - ( I) PVP SCRUB 8" STICK SPONGES ( I) UNDERBUTTOCK DRAPE WITH POUCH (2) LEGGINS WITH 7" CUFF 30" x 42" ( I) DRAPE ABDOMINAL WITH TAPE LIF ( I) VAGINAL PACKING SPONGEXRD ( I) BOWL WITH LID PLASTIC 80oz ( I) RECEIVING BLANKET 100% COTTON (I) BABY BLANKET POLY AB
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2453-2014·2014-09-10
Customed Recalls Vaginal Procedure Packs Due to Packaging Integrity Concerns
Customed, Inc. is recalling vaginal procedure packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
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 IMPERV. REINFORCED LIF (1) COVER MAYO STAND REINFORCED LIF (1) BAG SUTURE FLORAL (1) COVER TABLE REINF 50" X 90" LIF (1) TUBE SUC
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2346-2014·2014-09-10
Customed Recalls Surgical Packs Due to Potential Packaging Integrity Issues
Customed, Inc. is recalling 1,041 units of EO sterilized surgical convenient packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
IMPLANTE DE ORTHOPEDIA- 1) GOWN IMPERV. XTRA REINF. XL SMS T/WRAP LEVEL IV (1) CAUTERY TIP POLISHER LIF (1) DURAPREP SURGICAL SOLUTION 26ml LIF (1) BAG SUTURE FLORAL LIF (1) TUBE SUCTION CONNECT. Y.!" X 12' L/F (1) CAUTERY PENCIL ROCKER SWITCH LIF (2) *Pr. SURGEON NEUTR
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2446-2014·2014-09-10
Customed Recalls Central Line Full Body Drapes Due to Packaging Integrity Concerns
Customed, Inc. is recalling Central Line Full Body Drapes because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
CENTRAL LINE FULL BODY DRAPE CUSTOMED CONTENTS: (1) WRAPPER 30" X 30" (2) MASK SURGICAL W/ VISOR ANTI-FOG 160mm Hg (2) CAP NURSE 21" GREEN BOUFFANT (2) TOWELS ABSORBENT 15" X 20" (2) GOWN LARGE STANDARD SMS VELCRO/NECK (1) DRAPE SHEET 41" X 58" SMS (1) DRAPE BRACHIAL AN
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2486-2014·2014-09-10
Customed Recalls Surgical Packs Due to Potential Packaging Integrity Issues
Customed, Inc. is recalling specific lots of EO-sterilized surgical packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
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 IMPERVIOUS REINFORCED (1) MAYO STAND COVER REINFORCED (2) STRIPS TAPE 24" X 4" (1) SUTURE BAG FLORAL (1) SHEET SPLIT W/ADHESIVE 1 08" X 77"
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2504-2014·2014-09-10
Customed Recalls Neuro Spine Packs Due to Potential Packaging Integrity Issues
Customed, Inc. is recalling Neuro Spine Packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
NEURO SPINE PACK , CODE 900-2765 CONTENTS: (l ) DRAPE INCISION 23" X 1 7" (I) SCALPEL W/HANDLE # 15 S/STEEL (I) INSTRUMENT POUCH 7 X 1 1 2 COMPART (I) Pk. STRIP SURGICAL W' X 6" (I) CAUTERY PENCIL HAND SWITCHING LIF (4) UTILITY DRAPE W/TAPE L/F (I)
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2381-2014·2014-09-10
Customed Recalls Premium Ophthalmic Packs Due to Packaging Integrity Concerns
Customed, Inc. is recalling 720 units of Premium Ophthalmic Packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
PREMIUM OPHTHALMIC PACK- CUSTOMED- (1) GOWN SMS X-LARGE STD RAGLAN (1) CUP MEDICINE 2oz (1) DRAPE OPHTHAL. WITH POUCH LIF (1 0) SPONGE EYE SPEAR MICRO (1) SHIELD EYE UNIVERSAL (6) COTTON TIP APPLICATION 6" WOOD LIF (1 0) GAUZE SPONGES 4"X 4" 12PL Y (2) TOWELS ABSORBENT
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2391-2014·2014-09-10
Customed Recalls Plastic Surgery Packs Due to Packaging Integrity Concerns
Customed, Inc. is recalling plastic surgery packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
PLASTIC SURGERY PACK - LABEL SAMPLE CONTENTS: (2) GOWN LGE SMS NON REINF T/WRAP L/F (1) MAYO STAND COVER REINF. LIF (10) GAUZE SPONGE 4" X 4" 16 PLY LIF (1) TABLE COVER 44" X 90" (1) DRAPE SHEET 70" X 100" LIF (2) SURGICAL BLADE #15 S/STEEL (1) DRAPE HEAD WIT APE 44" X 26"
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2481-2014·2014-09-10
Customed Recalls Shoulder Packs Due to Potential Packaging Integrity Issues
Customed, Inc. is recalling 114 units of Shoulder Packs (Code 900-2616) because packaging integrity may be compromised, posing a risk of product contamination or loss of sterility.
Product
Shoulder Pack, Code 900-2616, contains: (2) TUBE SUCTION CONNECT Y."X12' UF (1) SYRINGE 20CC W/0 NDL UL UF (2) DRAPE VIDEO CAMERA UF (1) COVER MAYO STAND REINF. UF (5) SPONGE LAP. PRE-WASH XRD UF (1) DRAPE U 60" X 70" WIT APE UF (1 0) GAUZE SPONGE 4" X 4" 16PL Y XRD UF
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2320-2014·2014-09-10
Customed Recalls Cesarean Packs Due to Potential Packaging Integrity Issues
Customed, Inc. is recalling 30 lots of EO sterilized Cesarean Packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
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 UTILITY QUART 32oz. (1) TUBE FEEDING 8Fr. 15" LONG (2) COUNTER NEEDLE/BLADE 10C MAG/CLEAR (1) BEANNIES BABY (2) PAD OBSTRETICAL XLGE ST.
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2529-2014·2014-09-10
Customed Recalls EO Sterilized Surgical Gowns Due to Packaging Integrity Concerns
Customed, Inc. is recalling EO sterilized surgical gowns because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
Gown Impervious , Code 900-3190, contains: GOWN IMPERVIOUS EXTRA LONG X-LARGE WITH TOWEL & WRAP Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2360-2014·2014-09-10
Customed Recalls C-Section Surgical Packs Due to Packaging Integrity Concerns
Customed, Inc. is recalling C-Section surgical packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
C-SECTION SURGICAL PACK- (1) COVER TABLE REINFORCED 50" X 90" (2) TOWELS ABSORBENT 15" X 20" (1) MAYO STAND COVER REINFORCED (1) BABY BLANKET PRINTED (1 0) LAP SPONGES PREWASH 18" X 18" XRD (1) BOWL PLASTIC WITH LID 80oz. (1) BAG GLASSINE (2) NEEDLE & BLADE COUNTER 1 OC
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2524-2014·2014-09-10
Customed Recalls Tummy Tuck Surgical Packs Due to Packaging Integrity Concerns
Customed, Inc. is recalling Tummy Tuck surgical packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
Tummy Tuck Pack- FJG, code 900-3114, contains: (2) GOWN LARGE SMS IMPERVIOUS REINFORCED AAMI Ill (2) TOWEL ABSORBENT 15" X 20" (1) PENCIL CAUTERY PUSH BOTIOM ST. HOLSTER (1) NEEDLE HYPODERMIC 22G X 1 Y2 (2) SYRINGE 20CC WITHOUT NEEDLE LUER LOCK (1) COUNTER NEEDLE & BLADE 20
Category
Medical Device
Distribution
Distributed nationwide

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4451–4475 of 5038