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

34951–34975 of 40325

SevereFDA (Devices)·Z-2388-2014·2014-09-10
Customed Recalls Pediatric Lap Packs Due to Potential Packaging Integrity Issues
Customed, Inc. is recalling 984 units of Pediatric Lap Packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
PEDIATRIC LAP PACK - ( I) SHEET MINOR LAP 102" X 121" X 78" ( I) MAYO STAND COVER REINFORCED LIF ( I) TABLE COVER REINFORCED 50" X 90" LIF (2) DRAPE SHEET 41 " X 58" SMS (2) TOWELS ABSORBENT 15" x 20" LIF (I ) BAG SUTURE FLORAL LIF (4) DRAPE UTILITY WITH TAPE L/F EO…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2399-2014·2014-09-10
Customed Recalls Laparoscopy Cholecystectomy Packs Due to Packaging Integrity Concerns
Customed, Inc. is recalling 148 units of laparoscopy cholecystectomy packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
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 REINFORCED UF (4) BANDAGE ADHESIVE W' x 3" L I F (4) DRAPE UTILITY WIT APE UF (1) TUBE SUCTION CONNECT. Y..'' X 12' UF (1) INSUFLAT TUBING…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2390-2014·2014-09-10
Customed Recalls VEIN PACK Surgical Kits Due to Packaging Integrity Concerns
Customed, Inc. is recalling specific lots of VEIN PACK surgical kits because packaging integrity may be compromised, potentially leading to loss of sterility.
Product
VEIN PACK - (1) GOWN STANDARD LARGE SMS VELCRO/NECK (3) LAP. SPONGES PREWASH XRD LIF (1) EXTREMITY SHEET ABS LIF (1) WRAPPER 36" X 36" (1) IMP. STOCKINETTE 14" X 48" LIF EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2575-2014·2014-09-10
Zimmer Persona Knee Trial Articular Surface Provisional Breakage Recall
Zimmer, Inc. is recalling Persona Knee Trial Articular Surface Provisionals due to reports of breakage and updated surgical techniques.
Product
PERSONA The Personalized Knee System Constrained Tibial Articular Surface Provisional BOTTOM with the following: L CD +0MM; L CD +6MM; L EF +0MM;L EF +6MM; L GH +0MM; L GH +6MM; L J +0MM; L J +6MM; R CD +0MM; R CD +6MM; R EF +0MM; R EF +6MM; R GH +0MM; R GH +6MM; R J +0MM; R…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2350-2014·2014-09-10
Customed Recalls Neuro Surgical Packs Due to Packaging Integrity Concerns
Customed, Inc. is recalling 37 lots of NEURO PACK surgical kits because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
NEURO PACK- (1)TABLE COVER 44" x 90" (1) GOWN SURGEON REINFORCED X-LARGE TIWRAP (1) GOWN IMPERVIOUS REINFORCED X-LARGE SMS (1) BAG SUTURE FLORAL (1) MAYO STAND COVER REINFORCED LIF (2) TOWELS ABSORBENT 15" X 20" LIF (4) DRAPE UTILITY WITH TAPE LIF (1) U-DRAPE 60" X 70"…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2344-2014·2014-09-10
Customed Recalls Arthroscopy Packs Due to Potential Packaging Integrity Issues
Customed, Inc. is recalling 20 lots of arthroscopy packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
ARTHROSCOPY PACK - - (1) MAYO STAND COVER REINFORCED LIF (3) TOWELS ABSORBENT 15" X 20" LIF (1) STOCKINETTE IMPERVIOUS 14" X 48" LIF (1) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK LIF (1) BLADE SURGICAL # 11 STAINLESS STEEL (1) NEEDLE HYPODERMIC 21G X 1 ~ LIF (1) TUR Y SET…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2372-2014·2014-09-10
Customed Recalls Pery Gyn Surgical Packs Due to Packaging Integrity Concerns
Customed, Inc. is recalling Pery Gyn surgical packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
PERY GYN PACK- CUSTOMED- (1) DRAPE ABDOMINAL WITH TAPE UF (1) TOWEL ABSORBENT 15" X 20" UF (2) LEGGINGS W/7" CUFF 30" X 42" (1) TABLE COVER REINFORCED 44" X 78" UF (1) DRAPE UNDERBUTTOCK WITH POUCH EO sterilized surgical convenient packs packaged into…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2448-2014·2014-09-10
Customed Recalls Lumbar Surgical Packs Due to Packaging Integrity Concerns
Customed, Inc. is recalling 280 units of Lumbar Packs for Advanced Ambulatory Surgical Centers because packaging integrity may be compromised, risking loss of sterility.
Product
LUMBAR PACK ADVANCED AMBULATORY SURGICAL CENTER CONTENTS: (1) COVER TABLE REINFORCED 50" X 90" UF (4) SYRINGE 3CC WITHOUT NEEDLE LUER LOCK UF (8) TOWELS CLOTH HUCK BLUE UF (1) SYRINGE 10CC WITHOUT NEEDLE LUER LOCK UF (10) GAUZE SPONGE 4" X 4" 16PLY XRD UF (1) STRIP…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2483-2014·2014-09-10
Customed recalls surgical drapes due to potential packaging integrity issues
Customed, Inc. is recalling EO sterilized surgical drapes because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
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 Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2435-2014·2014-09-10
Customed Recalls Knee Arthroscopy Packs Due to Packaging Integrity Concerns
Customed, Inc. is recalling 22 lots of Knee Arthroscopy Packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
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 1Y. ST. LIF (1) NEEDLE HYPODERMIC 18G X 1Y:z (1) U-DRAPE 60" X 70" WITH TAPE SPLIT (1) SKIN MARKER INK W/8 LABEL (2) TUBE SUCTION…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2431-2014·2014-09-10
Customed Recalls Angiography Packs Due to Potential Packaging Integrity Issues
Customed, Inc. is recalling 1,196 units of Angiography Packs across 21 lots because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
ANGIOGRAPHY PACK CONTENTS: (4) CLOTH HUCK TOWEL BLUE (1) TABLE COVER REINFORCED 50" x 90" LIF (2) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK L/F (2) CUP MEDICINE 2oz LIF (2) UTILITY BOWL 32oz LIF (1) EMESIS BASIN 101N 700cc (4) TOWEL CLAMP (3) TOWELS ABSORBENT 15" x 20" LIF…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2328-2014·2014-09-10
Customed Recalls EO Sterilized Surgical Packs Due to Packaging Integrity Concerns
Customed, Inc. is recalling 552 units of EO sterilized surgical packs because packaging integrity may be compromised, posing a risk of product contamination or loss of sterility.
Product
LAPAROSCOPY~OBPACK - (4) ABSORBENT TOWELS 15" x 20" LIF (2) LEGGINS WITH 7" CUFF (1) LAPAROSCOPY T SHEET SMS (1) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK LIF (1) NEEDLE HYPODERMIC 18G X 1% (1) *ROBIN REDRUBBER CATHETER 14FR LATEX (1) DRAPE LASER CAMERA W/EL LIF (1) PAD…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2473-2014·2014-09-10
Customed Recalls Orthopedic Surgical Packs Due to Potential Sterility Loss
Customed, Inc. is recalling specific lots of Orthopedic Pack III surgical packs because packaging integrity may be compromised, risking patient injury from contamination or loss of sterility.
Product
ORTHOPEDIC PACK Ill (1) CUSTOMED CONTENTS: (1) GOWN XL SMS IMPERVIOUS REINFORCED (4) DRAPE UTILITY WffAPE (1) MAYO STAND COVER REINFORCED (1) SUTURE BAG FLORAL (1) DRAPE TOP W/ADHESIVE 108" X 50" STD SMS (1) DRAPE ORTHOPEDIC SPLIT (1) U- DRAPE 60" X 70" WffAPE SPLIT…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2532-2014·2014-09-10
Customed Recalls Cardiovascular Case Carts Due to Packaging Integrity Concerns
Customed, Inc. is recalling 48 units of Cirugia Cardiovascular Case Carts because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
Cirugia Cardiovascular Case Cart, c ode 900-1415A, contains: (1) CIRUGIA CARDIOVASCULAR .(INDUCCION) (1) CIRUGIA CARDIOVASCULAR (CIRUGIA ) (1) CIRUGIA CARDIOVASCULAR (PREP ENFERMERA CIRCULANTE) (1) CIRUGIA CARDIOVASCULAR (PERFUSION SUPPLIES) (1) CIRUGIA CARDIOVASCULAR…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2449-2014·2014-09-10
Customed Recalls Cervical Surgical Packs Due to Potential Packaging Integrity Issues
Customed, Inc. is recalling cervical surgical packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
CERVICAL PACK ADVANCED AMBULATORY SURGICAL CENTER CONTENTS: (1) COVER TABLE REINFORCED 50" X 90" (1) COVER FLUORO 30" X 30" WITH RUBBER BAND (8) TOWELS CLOTH HUCK BLUE (1) SHEET :Y. 60" X 77" DRAPE REINFORCED (10) GAUZE SPONGE 4" X 4" 16PLY XRD (1) SKIN MARKER W/RULER…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2478-2014·2014-09-10
Customed Recalls Arthroscopy Packs Due to Potential Packaging Integrity Issues
Customed, Inc. is recalling 63 arthroscopy packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
Arthroscopy Pack,900-2609, contains: (5) LAP SPONGE PREWASH 18" X 18" XRD (1) SHEET ARTHROSCOPY T STD SMS WITH POUCH (3) STRIPS TAPE 24" X 4" (1) U-DRAPE 60" X 70" WITH TAPE SPLIT (4) TOWELS ABSORBENT 15" X 20" (1) MAYO STAND COVER REINFORCED (1) TUBE SUCTION CONNECT Y4"…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2480-2014·2014-09-10
Customed Extremity Pack Recall Due to Potential Packaging Integrity Issues
Customed, Inc. is recalling Extremity Packs (code 900-2615) because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
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# 15 STAINLES STEEL (4) DRAPE UTILITY WITH TAPE (1) GOWN XL SMS IMPERVIOUS REINFORCED ( 1) GOWN SURG REINFORCED LARGE TOWEL & WRAP (1)…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2428-2014·2014-09-10
Customed Recalls Surgical Packs Due to Potential Packaging Integrity Issues
Customed, Inc. is recalling General Packs containing surgical supplies because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
GENERAL PACK - CONTENTS: (4) ABSORBENT TOWEL 15" x 20" LIF (1) MAYO STAND COVER REINFORCED LIF ( 1) NEEDLE & BLADE COUNTER 20c FOAM/MAG LIF (2) UTILITY BOWL 16 oz. LIF (1) GLASINE BAG PLAIN ( 1) SUTURE BAG FLORAL (4) DRAPE UTILITY WITH TAPE LIF ( 1) TABLE COVER…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2415-2014·2014-09-10
Customed Recalls Hip Orthopedic Packs Due to Potential Sterility Loss
Customed, Inc. is recalling 36 units of Hip Orthopedic Packs because packaging integrity may be compromised, risking patient injury from contamination or loss of sterility.
Product
HIP ORTHOPEDIA PACK - (1) BLADE SURGICAL #15 STAINLES /STEEL (1) GOWN XL SMS IMPERVIOUS REINFORCED MMI Ill LIF (1) TABLE COVER REINFORCED 50" X 90" LIF (1) MAYO STAND COVER REINFORCED LIF (4) DRAPE UTILITY WIT APE LIF (4) TOWEL ABSORBENT 15" X 20" LIF (1) YANKAUER…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2493-2014·2014-09-10
Customed Recalls Tummy Tuck and Liposuction Packs Due to Packaging Integrity Concerns
Customed, Inc. is recalling Tummy Tuck and Liposuction Packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
Tummy Tuck and Liposuction Pack, code 900-2661, contains: ( 1) DRAPE % ECONOMY 53 X 77 (3) GOWN SOFT SMS STANDARD X-LARGE SET IN SLEEVE (3) TOWELS ABSORBENT 15 X 20 (1) MAYO STAND COVER REINFORCED (1) TABLE COVER REINFORCED 50 X 90 ( 1) SUTURE BAG FLORAL (6) TOWEL CLOTH…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2527-2014·2014-09-10
Customed Recalls Breast Packs Due to Potential Packaging Integrity Issues
Customed, Inc. is recalling specific lots of Breast Packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
Breast Pack- FJG, code 900-3118, contains: (2) GOWN LARGE STANDARD SMS AAMIIII (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 UTIL TIY QUART 32oz (1)…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2308-2014·2014-09-10
Customed Recalls Femoral Packs Due to Potential Packaging Integrity Issues
Customed, Inc. is recalling 855 units of Customed Femoral Packs because packaging integrity may be compromised, potentially leading to loss of sterility or patient injury.
Product
Customed Femoral Pack , convenience pack include multiple components: Syringe 3cc, 5cc, 10cc, 20cc; swabstick chlorascrub, needles, gauze/sponges, table cover, absrobent towels, halsted Mosquito CVD, gown, bowls, wrapper, scalpel safety, Mosquito forcep, cloth huck, clamp towel…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2457-2014·2014-09-10
Customed Recalls Central Line Drape Packs Due to Packaging Integrity Concerns
Customed, Inc. is recalling Central Line Drape Packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
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" GREEN BOUFFANT (1) DRAPE BRACHIAL ANGlO 44" X 31" REINFORCED CIRC/ FENE (1) WRAPPER 24" X 24" GOWN LGE STANDARD SMS VELCRO NECK…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2341-2014·2014-09-10
Customed Recalls Pery Gyn Packs Due to Potential Packaging Integrity Issues
Customed, Inc. is recalling Pery Gyn Packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
PERY GYN PACK- (1) DRAPE UTILITY WITH TAPE UF (1) UNDERBUTTOCK DRAPE WITH POUCH (2) ABSORBENT TOWELS 15" x 20" UF (2) LEGGINS W/7'' CUFF 30" X 42" (1) TABLE COVER REINFORCED 50" X 90" UF (1) ABDOMINAL DRAPE WITH TAPE UF (1) UTILITY BOWL 16oz. (1 0) GAUZE SPONGE 4"…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2374-2014·2014-09-10
Customed Recalls Foley Catheter Kits Due to Packaging Integrity Concerns
Customed, Inc. is recalling 13 lots of Foley Catheter Kits because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
FOLEY CATHETER KIT 1118FR.- CUSTOM ED CONTENTS: (1) WRAPPER 24" X 24" (1) LABEL ID PATIENT (1) TRAY ORGANIZER (1) PVP TRIPLE SWABSTICK IODOPHOR (2) GLOVE MED FREETOUCH VYNIL P/F (1) JELLY LUBRICATING 5 GRAM (1) TOWEL 3PL Y POLY 17" X 18" (2) SWABSTICK DRY COTTON…
Category
Medical Device
Distribution
Distributed nationwide

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34951–34975 of 40325