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 the agency’s own highest classification or reported deaths or serious injuries, 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

34976–35000 of 40325

SevereFDA (Devices)·Z-2352-2014·2014-09-10
Customed Recalls Femoral Angiography Packs Due to Packaging Integrity Concerns
Customed, Inc. is recalling 580 units of femoral angiography packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
FEMORAL ANGIOGRAPHY PACK - (1) TABLE COVER REINFORCED 50" X 90" UF (1) GOWN LARGE SMS IMPERVIOUS REINFORCED LIF (1) TOWEL ABSORBENT 15" X 20" UF (1) DRAPE ANGlO 75" X 145" (4) TOWELS CLOTH HUCK (BLUE) UF (3) SYRINGE 1 Occ WITHOUT NEEDLE LUER LOCK UF (1) IV ADM SET 15ML 1…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2375-2014·2014-09-10
Customed Recalls Neuro Pack Surgical Kits Due to Packaging Integrity Concerns
Customed, Inc. is recalling 936 units of NEURO PACK surgical kits because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
NEURO PACK - (1) CAUTERY TIP POLISHER LIF (4) DRAPE UTILITY WITH TAPE LIF (1) INSTRUMENT POUCH (10) LAP SPONGE PRE-WASH XRD (1) Pk. SURGICAL STRIP W' X 6" (2) UTILITY BOWL 32oz (1) MAYO TRAY LARGE (9) SHEET DRAPE 41 " X 69" MEDIUM LIF (1) NEEDLE HYPODERMIC 18G X 1 LIF…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2387-2014·2014-09-10
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 - (1) BAG SUTURE FLORAL (1) COVER TABLE 44" X 90" (4) ABSORBENT TOWELS 15" X 20" UF (1) LAPAROTOMY T DRAPE 102" X 78" X 121" STD SMS (4) DRAPE UTILITY WITH TAPE LIF (3) GOWN IMP. EXTRA REINFORCED LARGE TIWRAP (1) DURAPREP SURGICAL SOLUTION 26mL UF…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2469-2014·2014-09-10
Customed Transverse Laparotomy Surgical Packs Recalled for Packaging Integrity Concerns
Customed, Inc. is recalling Transverse Laparotomy Packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
TRANSVERSE LAPAROTOMY PACK (8) CUSTOMED CONTENT: (1) TOWEL ABSORBENT 15" X 20" (1) MAYO STAND COVER REINFORCED (4) DRAPE UTILITY WITHffAPE (1) SUTURE BAG FLORAL (1) DRAPE LAP TRANSVERSE (1) TABLE COVER REINFORCED 50" X 90" (1) GOWN SURG. REINFORCED…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2464-2014·2014-09-10
Customed Recalls Minor Extremity Packs Due to Potential Sterility Loss
Customed, Inc. is recalling Minor Extremity Packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
MINOR EXTREMITY PACK {2) CUSTOMED CONTENT: (1) GOWN LGE STD SMS VELC/NE T/WRAP (1) TOWELS ABSORBENT 15" X 20" (1) MAYO STAND COVER REINFORCED (1) SHEET PLASTIC 44" X 65" (1) DRAPE% ECONOMY 53" X 77" (1) DRAPE UTILITY WITH TAPE (1) BAG SUTURE FLORAL (1) SHEET…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2317-2014·2014-09-10
Customed Recalls EO Sterilized Surgical Packs Due to Packaging Integrity Concerns
Customed, Inc. is recalling EO sterilized surgical convenient packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
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) SUTURE BAG FLORAL (1) DRAPE SHEET 42" X 57" SMS g~ SHEET o/. 57" X 63" REINFORCED SMS UF MAYO STAND COVER REINFORCED UF EO sterilized…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2420-2014·2014-09-10
Customed Recalls Ophthalmic Surgical Packs Due to Packaging Integrity Concerns
Customed, Inc. is recalling 1,812 units of ophthalmic surgical packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
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 NDL LILOCK UF (1) MAYO STAND COVER REINF. LIF (1) NEEDLE HYPODERMIC 18G X 1% ST. UF (10) EYE MICRO SPONGE UF (2) LABEL CONTRAST BLUE…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2324-2014·2014-09-10
Customed Recalls Labor and Delivery Packs Due to Packaging Integrity Concerns
Customed, Inc. is recalling 1,852 units of Labor & Delivery Packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
LABOR & DELIVERY PAC - 1) NEEDLE HYPODERMIC 18G X 1% ST. (2) DRAPE UNDERBUTTOCK WITH POUCH (4) TOWELS ABSORBENT 15" X 20" ( 1) FEEDING TUBE 8FR, 15" LONG ( 1) BEANNIES BABY ( 1) SYRINGE 20cc WITHOUT NEEDLE LILOCK ( 1) UMBILICAL CORD CLAMP ST. ( 1) RECEIVING BLANKET…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2345-2014·2014-09-10
Customed Recalls Arthroscopy Packs Due to Potential Packaging Integrity Issues
Customed, Inc. is recalling Arthroscopy Packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
ARTHROSCOPY PACK - (1) COVER MAYO STAND REINFORCED UF (1 0) GAUZE SPONGE 4" X 4" 16PL Y XRD LIF (1) TUBE SUCTION CONNECT ~" X 12' LIF (1) SHEET ARTHROSCOPY T STD SMS WITH POUCH LIF (1) STOCKINETIE IMPERVIOUS 14" X 48" LIF (1) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK L/F…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2510-2014·2014-09-10
Customed Recalls Basic Cosmetic Surgical Packs Due to Packaging Integrity Concerns
Customed, Inc. is recalling 168 units of Basic Cosmetic Surgical Packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
BASIC COSMETIC SURG. PACK CUSTOMED (USA), CODE 900-2915. CONTENTS: (2) TOWELS ABSORBENT 15" X 20" LIF (1) DRAPE BREAST/CHEST SMS L/F (1) SYRINGE 20cc W/0 NEEDLE LUER LOCK LIF (1) TUBE SUCTION CONNECT Yt" X 12' LIF (1) YANKAUER SUCTION TUBE W/0 VENT L/F (1) STERI…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2525-2014·2014-09-10
Customed Liposuction Surgical Packs Recalled for Potential Sterility Loss
Customed, Inc. is recalling Liposuction Pack FJG units because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
Liposuction Pack FJG, code 900-3115, contains: (2) GOWN LARGE SMS IMPERVIOUS REINFORCED AAMIIII LIF (2) TOWEL ABSORBENT 15" X 20" LIF (1) NEEDLE HYPODERMIC 25 X 1 LIF (1) BOWL UTILITY QUART 32oz LIF (1) COVER MAYO STAND REINFORCED L/F (20) GAUZE SPONGE 4" X 4" 16PLY LIF…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2492-2014·2014-09-10
Customed Recalls Breast Implant Packs Due to Potential Packaging Compromise
Customed, Inc. is recalling 54 units of Breast Implant Packs (Code 900-2660) because packaging integrity may be compromised, posing a risk of product contamination or loss of sterility.
Product
Breast Implant Pack, Code 900-2660, contains: (1) DRAPE ECONOMY 53 X 77 (3) GOWN SOFT SMS STANDARD XLGE SET IN SLEEVE (3) TOWELS ABSORBENT 15 X 20 (1) MAYO STAND COVER REINFORCED (2) TABLE COVER REINFORCED 50 X 90 (1) SUTURE BAG FLORAL (1) TUBE SUCTION CONNECT Y (6)…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2438-2014·2014-09-10
Customed Recalls HIP PACK Surgical Kits Due to Packaging Integrity Concerns
Customed, Inc. is recalling HIP PACK surgical kits because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
HIP PACK CONTENTS: (2) TOWELS ABSORBENT 15" X 20" (2) GOWN XL SMS IMPERV. REINFORCED (1) MAYO STAND COVER REINFORCED (1) SUTURE BAG (1) DRAPE UTILITY WITH TAPE (1) STOCKINETTE IMPERV. 14" X 48" (1) U-DRAPE 54 X 72 WITH TAPE SPLIT HIP DRAPE 89" X 128" WITH…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2392-2014·2014-09-10
Customed Recalls Umbilical Vessel Catheter Kits Due to Packaging Integrity Concerns
Customed, Inc. is recalling specific lots of Umbilical Vessel Catheter Kits because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
UMBILICAL VESSEL CATHETER KIT - CUSTOMED- (1) PAPER TAPE MEASURE DISP. 24" (1) FENESTRATED DRAPE 18" x 26" LIF (1) NEEDLE HOLDER BAUMGARTNER 5" (2) HALSTED MOSQUITO CVD 5" SERRAT (1) ADSON FORCEP TISS. Wff (1) SYRINGE 3cc WITHOUT NEEDLE LUER LOCK LIF (6) GAUZE SPONGE 2"…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2447-2014·2014-09-10
Customed Recalls Laparoscopy Chole System Packs Due to Packaging Integrity Concerns
Customed, Inc. is recalling specific lots of Laparoscopy Chole System Packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
LAPAROSCOPY CHOLE SYSTEM PACK MIAMI METRO CON TENTS: (12) TOWELS CLOTH HUCK BLUE LIF (1) MAYO STAND COVER REINFORCED LIF (1) TABLE COVER REINFORCED 50" X 90" LIF (1) SUTURE BAG FLORAL LIF (10) GAUZE SPONGE 4" X 4" 16PLY XRD LIF (1) BULB SYRINGE 60cc LIF (1)…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2406-2014·2014-09-10
Customed Recalls PERY GYN PACK Surgical Drapes Due to Packaging Integrity Concerns
Customed, Inc. is recalling PERY GYN PACK surgical drapes because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
PERY GYN PACK- (1) DRAPE UTILITY WITH TAPE (1) DRAPE UNDERBUTIOCK WITH POUCH (1) TOWELS ABSORBENT 15" x 20" UF (2) LEGGINS W/7'' CUFF 30" X 42" (1 ) TABLE COVER REINFORCED 50" X 90" UF (1) DRAPE ABDOMINAL WITH TAPE UF EO sterilized surgical convenient packs packaged…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2501-2014·2014-09-10
Customed Recalls Surgical Gown Packs Due to Packaging Integrity Concerns
Customed, Inc. is recalling EO sterilized surgical gown packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
Gown Surgical Soft SMS Non Reinforced, code 900-2725, contains: (1) GOWN SOFT SMS STD X-LARGE SET IN SLEEVE (1) TOWEL ABSORBENT 15" X 20" (1) WRAPPER 24" X 24" Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2364-2014·2014-09-10
Customed Recalls Laparotomy Packs Due to Potential Packaging Integrity Issues
Customed, Inc. is recalling 3,603 units of EO sterilized laparotomy packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
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 LIF (1) LITE GLOVE LIF (1) BAG SUTURE FLORAL (1) BLADE SURGICAL #1 0 CARBON STEEL (1) BLADE SURGICAL #15 CARBON STEEL (1) YANKAUER…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2521-2014·2014-09-10
Customed Recalls Breast Surgical Packs Due to Packaging Integrity Concerns
Customed, Inc. is recalling specific lots of Breast Pack BOD surgical packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
Breast Pack BOD, code 900-3029, contains: (2) GOWN X-LARGE SMS IMPERVIOUS REINFORCED AAMI Ill (2) TOWEL ABSORBENT 15" X 20" (1) PENCIL CAUTERY PUSH BOTTOM (1) SYRINGE BULB 60CC (1) TUBE SUCTION CONNECT%" X 12' (1) COUNTER NEEDLE/BLADE 20C FOAM/MAG (1) BOWL UTILITY QUART…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2462-2014·2014-09-10
Customed Recalls Arthroscopy Packs Due to Potential Packaging Integrity Issues
Customed, Inc. is recalling Arthroscopy Pack I units because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
ARTHROSCOPY PACK I (1) CUSTOMED CONTENTS: (1) TOWELS ABSORBENT 15" X 20" (1) GOWN XL SMS IMPERVIOUS REINFORCED (1) MAYO STAND COVER REINFORCED (1) U - DRAPE 60" X 70" WITAPE SPLIT 6 X 21 (1) SHEET SPLIT W/ADHESIVE 108" X 77" STD SMS (1) STOCKINETTE…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2479-2014·2014-09-10
Customed Recalls Hip and Knee Replacement Packs Due to Sterility Concerns
Customed, Inc. is recalling Hip & Knee replacement packs (900-2614) because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
Hip & Knee replacement pack, 900-2614, contains (1) CAUTERY TIP POLISHER UF (1) BAG SUTURE FLORAL (1) TUBE SUCTION CONNECT Y." X 12' UF (1) TABLE COVER REINFORCED 50" X 90" UF (1) MAYO STAND COVER REINFORCED UF (5) TOWELS ABSORBENT 15" X 20" UF (2) DRAPE SHEET 70" X 100"…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2329-2014·2014-09-10
Customed Recalls Laparoscopy Packs Due to Potential Packaging Integrity Issues
Customed, Inc. is recalling 39 lots of EO sterilized laparoscopy packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
LAPAROSCOPY PACK - - (1) MAYO STAND COVER REINFORCED LIF (2) DRAPE % ECONOMY 53" X 77" LIF (1) TUBE SUCTION CONNECT. v.i" X 12' LIF (1) SCALPEL WITH HANDLE #11 (1) DRAPE LAP ABDOMINAL WITH POUCH 1 02" X 122" X 78" LIF (1 0) GAUZE SPONGE 4" X 4" 16 PLY XRD LIF (8) TOWEL…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2490-2014·2014-09-10
Customed Recalls Tummy Pack MRT Surgical Kits Due to Packaging Integrity Concerns
Customed, Inc. is recalling Tummy Pack MRT surgical kits because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
Tummy Pack MRT, code 900-2657, contains: (2) GOWN SOFT SMS STD XLGE SET IN SLEEVE ( 1) CAUTERY PENCIL PUSH BOTTOM ( 1) NEEDLE ULTRACLEAN 1" (2) SYRINGE 10cc WITHOUT NEEDLE LUER LOCK ( 1) NEEDLE & BLADE COUNTER 20c FOAM/MAG ( 1) BOWL UTILITY QUART 32oz (1 ) MAYO STAND…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2315-2014·2014-09-10
Customed Recalls Laparotomy Packs Due to Potential Packaging Integrity Issues
Customed, Inc. is recalling 3,576 units of EO sterilized laparotomy packs because packaging integrity may be compromised, risking loss of sterility and patient injury.
Product
LAPAROTOMY PACK - (I) SURGICAL BLADE #10 S/STEEL ( I) UTILITY BOWL 32oz (I) UTILITY BOWL 16oz (2) NEEDLE & BLADE COUNTER IOC MAG/CLEAR ( I) DRAPE T LAPAROTOMY STD SMS (2) TOWELS ABSORBENT 15" x 20" (2) GOWN IMP. REINFORCED LARGE SMS (4) DRAPE UTILITY WITH TAPE ( I)…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2505-2014·2014-09-10
Customed Recalls Shoulder Packs Due to Potential Packaging Integrity Issues
Customed is recalling 171 units of Shoulder Pack Code 900-2766 because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
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" X 70" WITAPE SPLIT 6" X 21" (1) TABLE COVER 44" X 90" (4) TOWELS ABSORBENT 15" X 20" LIF (2) TUBE SUCTION CONNECT" X 12' LIF (1)…
Category
Medical Device
Distribution
Distributed nationwide

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34976–35000 of 40325