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 40449

SevereFDA (Devices)·Z-2361-2014·2014-09-10
Customed Recalls Cataract Surgical Packs Due to Packaging Integrity Concerns
Customed, Inc. is recalling cataract surgical packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
CATARACT PACK- OJOS INC.- (1) TABLE COVER REINF. 44" X 78" L/F (2) MEDICINE CUP 1oz. (2) ABSORBENT TOWEL 15" X 20" LIF (1 0) EYE SPEAR MICRO SPONGE (1) EYE PAD 2 1/8 X 2 5/8 LIF (4) DRAPE UTILITY LIF (1) EYE SHIELD UNIVERSAL (2) GOWN LGE STANDARD SMS VELCRO/NECK…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2450-2014·2014-09-10
Customed Recalls Liposuction Packs Due to Potential Packaging Integrity Issues
Customed, Inc. is recalling liposuction packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
LIPOSUCTION PACK AESTHETIC SURG.CENTER CONTENTS: (1) BLADE SURG. #11 CARBON STEEL (3) * GLOVE PERRY SURG. # 7LATEX (15) SPONGE LAP PREWASH 18" X 18" XRD L/F (4) * GLOVE PERRY SURG. # 7 LATEX (1) TABLE COVER REINF 50" X 90" LIF (2) GOWN SOFT SMS STD XL SET IN SLEEVE L/F (4)…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2397-2014·2014-09-10
Customed Recalls D & C Laparoscopy Packs Due to Packaging Integrity Concerns
Customed, Inc. is recalling D & C Laparoscopy Packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
D & C LAPAROSCOPY PACK - (1) TUBING INSUFFLATION OPEN TIP WITHOUT VENT (1) MAYO STAND COVER REINFORCED UF (4) DRAPE UTILITY UF (1) TRAY MAYO SMALL LIF (1) SPECIMEN CONTAINER 4oz. WITH LID & LABEL (1) SUTURE BAG FLORAL LIF (1) TUBE SUCTION CONNECT X" X 12' LIF (1)…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2517-2014·2014-09-10
Customed Recalls Chole Cystectomy All Endo System Due to Packaging Integrity Concerns
Customed, Inc. is recalling Chole Cystectomy All Endo System kits because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
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 STAND COVER REINFORCED UF (1) NEEDLE HYPODERMIC (6) ABSORBENT TOWEL 15 X 20 UF (1) NEEDLE HYPODERMIC 22G X 1Y. UF (4) UTILITY DRAPE WIT…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2306-2014·2014-09-10
Customed Cysto Tur Pack Recalled for Potential Packaging Integrity Issues
Customed is recalling Cysto Tur Packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
Customed Cysto Tur Pack, convenience pack include multiple components: legging with cuff, drape cystoscopy, towel absorbent & table cover. EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2351-2014·2014-09-10
Customed Recalls General Minor Packs Due to Potential Sterility Loss
Customed, Inc. is recalling General Minor Packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
GENERAL MINOR PACK- (1) MAYO STAND COVER REINFORCED LIF (2) BOWL UTILITY 16oz LIF (1) TIP CAUTERY POLISHER LIF (3) TOWELS ABSORBENT 15" X 20" LIF (1) BOWL UTILITY 32oz (1) BAG SUTURE FLORAL (1) YANKAUER SUCTION TUBE WITHOUT VENT LIF (10) GAUZE SPONGES 4" X 4" 16PLY XRD…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2334-2014·2014-09-10
Customed Recalls Laparoscopy Cholecystectomy Surgical Packs Due to Packaging Integrity Concerns
Customed, Inc. is recalling 40 units of laparoscopy cholecystectomy surgical packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
LAPAROSCOPY CHOLECYSTECTOMY SURGICAL PACK - - (1) DRAPE LAPAROS/ABDOMINAL UF (1) GOWN IMPER. EXTRA REINFORCED LGE TIVVRAP (1) BLADE SURGICAL #11 STAINLESS STEEL (1) TIME OUT BEACON NON WOVEN UF (10) GAUZE SPONGE 4" X 4" 16PLY XRD UF (1) GOWN XLARGE SMS IMPERV.…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2506-2014·2014-09-10
Customed Recalls Laparotomy Packs Due to Potential Packaging Integrity Issues
Customed, Inc. is recalling 360 units of laparotomy packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
LAPAROTOMY PACK BASIC CODE 900-2829 CONTENTS: (2) TOWELS ABSORBENT 15" X 20" (1) COVER MAYO STAND REINFORCED (4) DRAPE UTILITY WITH TAPE (1) BAG SUTURE FLORAL (1) DRAPE T LAPAROT 102" X 78" X 121" STD SMS (1) COVER TABLE REINFORCED 50" X 90" (1) GOWN XL SMS IMPERVIOUS…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2327-2014·2014-09-10
Customed Recalls Laparoscopy Packs Due to Potential Packaging Integrity Issues
Customed, Inc. is recalling 1,168 units of laparoscopy packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
LAPAROSCOPY PACK- - (1) DRAPE LAP ABDOMINAL WITH POUCH (1) CAMARA DRAPE 9" X 96" LIF (5) TOWELS ABSORBENT 15" X 20" (1) MAYO STAND COVER REINFORCED (1) TABLE COVER REINFORCED 50" X 90" (4) DRAPE UTILITY WITH TAPE (3) DRAPE SHEET 41" X 58" SMS (1) TUBING INSUFFLAT SET…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2400-2014·2014-09-10
Customed Recalls Urology Packs Due to Potential Packaging Integrity Issues
Customed, Inc. is recalling 2,700 urology packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
UROLOGY PACK- (10) GAUZE SPONGE 4" X 4" 16PLY (1) TUBE SUCTION CONNECT Y." X12' (1) SYRINGE 30cc WITHOUT NEEDLE ULOCK (1) BASIN RING (1) TUR Y SET, 2 LEAD, ST. (1) BAG SUTURE FLORAL (1) GOWN SURG. REINF. XL EXTRA LONG LEVEL IV (2) TOWEL CLAMP (1) DRAPE LITHOTOMY…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2451-2014·2014-09-10
Customed Recalls Face Pack Aesthetic Surgery Kits Due to Packaging Integrity Concerns
Customed, Inc. is recalling 96 units of Face Pack Aesthetic Surgery kits because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
FACE PACK AESTHETIC SURGERY AESTHETIC SURGERY CONTENTS: (15) APPLICATOR COTION 6" WOOD (60) GAUZE SPONGE 4" X 4" 16 PLY SOFT LIF (2) NEEDLE SPINAL ANEST 22G X 3 Y2 LIF (8) TOWELS CLOTH HUCK BLUE LIF (2) SYRINGE 10CC WITHOUT NEEDLE LUER LOCK LIF (6) BLADE #15…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2337-2014·2014-09-10
Customed Recalls Laparoscopy Gyn Packs Due to Packaging Integrity Concerns
Customed, Inc. is recalling 648 units of Laparoscopy Gyn Packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
LAPAROSCOPY GYN PACK - (1) TABLE COVER REINFORCED 44" X 78" (1) LAPAROSCOPY SHEET "T" SMS (3) TOWELS ABSORBENT 15" X 20" (1) SURGICAL BLADE#11 STAINLESS STEEL (1) MAYO STAND COVER REINFORCED (1) SYRINGE 10cc WITHOUT NEEDLE LUER LOCK (2) LEGGINS WITH 7" CUFF 30" x 42"…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2442-2014·2014-09-10
Customed Recalls Surgical Ear Packs Due to Packaging Integrity Concerns
Customed, Inc. is recalling 123 units of surgical ear packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
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. REINFORCED ( I ) NEEDLE HYPODERM IC 1 8G X I 'h ( I ) WASH BASIN ROUND 6QT ( I ) INSTRUMENT POUCH 7 X II 2COMPARTMENT (I) STERI STR I P…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2318-2014·2014-09-10
Customed Recalls Ophthalmic Surgical Packs Due to Packaging Integrity Concerns
Customed, Inc. is recalling ophthalmic surgical packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
OPHTALMIC PACK- (3) ABSORBENT TOWELS 15" X 20" LIF (1) MAYO STAND COVER REINFORCED LIF (1) OPHTALMIC DRAPE WITH POUCH LIF (2) SYRINGE 3cc WITHOUT NEEDLE LUER LOCK LIF (10) COTTON TIP APPLICATOR 6" WOOD (1) SYRINGE 10cc WITHOUT NEEDLE LUER LOCK LIF (2) NEEDLE HYPODERMIC…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2332-2014·2014-09-10
Customed Recalls Pery Gyn Pack Surgical Kits Due to Packaging Integrity Concerns
Customed, Inc. is recalling Pery Gyn Pack surgical kits because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
PERY GYN PACK - (1) TABLE COVER REINFORCED 44" X 78" (1) DRAPE UTILITY (2) TOWELS ABSORBENT 15" X 20" (1) GOWN XL SMS IMPERV. REINF. AAMI LEVEL Ill (1) DRAPE UNDERBUTIOCK W/POUCH 44" X 35" (1) TIME OUT BEACON NON WOVEN (1) BOWL UTILITY BLUE 16oz (1) BAG SUTURE…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2325-2014·2014-09-10
Customed Recalls Cysto TUR Packs Due to Potential Packaging Integrity Issues
Customed, Inc. is recalling 29 lots of Cysto TUR Packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
CYSTO TUR PACK- - (1) UTILITY BOWL 32oz LIF (1) SPECIMEN CUP WITH CAP 4oz LIF (1 0) GAUZE SPONGE 4" X 4" 12PL Y LIF (4) ABSORBENT TOWELS 15" X 20" LIF (1) CYSTOSCOPY 'T' DRAPE 60" X 87" X 35" SMS STD LIF (2) GOWN IMPERVIOUS EXTRA REINFORCED X-LARGE LIF (2) LEGGINS WITH…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2331-2014·2014-09-10
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) TABLE COVER REINFORCED 44" X 78" UF (2) TOWEL ABSORBENT 15" X 20" LIF (2) GOWN LARGE SMS IMPERVIOUS REINFORCED (1) DRAPE UNDERBUTTOCK WITH POUCH (1) UTILITY BOWL 16oz. (10) GAUZE SPONGE 4" X 4" 16PL Y XRD UF (1) ROBNEL CATHETER 18FR. (1) DRAPE…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2488-2014·2014-09-10
Customed Recalls Face Pack MRT Due to Potential Packaging Integrity Issues
Customed, Inc. is recalling Face Pack MRT surgical kits because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
Face Pack MRT, product code 900-2654, contains: (2) GOWN SOFT SMS STD X-LARGE SET IN SLEEVE LIF (2) TOWELS ABSORBENT 15 X 20 LIF (1) DRAPE INST. MAGNETIC 10 X 16 LIF (1) TRAY HALF DEEP (1) COVER MAYO STAND REINFORCED LIF (1) SHEET ENT SPLIT 110 X 77 SMS LIF (1) COVER…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2393-2014·2014-09-10
Customed Recalls Reyito Urology Packs Due to Potential Sterility Loss
Customed, Inc. is recalling 2,900 units of Reyito Urology Packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
REYITO UROLOGY PACK - (2) GOWN IMP. REINFORCED X-LARGE SMS (2) TOWELS ABSORBENT UF ( I) URINARY DRAIN. BAG 2000ML ANTI-REFLUX UF ( I) SYRINGE 30cc W/0 NDL. LUER LOCK UF ( I) BAG SUTURE (I) TABLE COVER ( I} TUBE SUCTION CONNECT. W' X 12' UF (10) GAUZE SPONGES 4" X 4"…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2368-2014·2014-09-10
Customed Recalls Arthroscopy Packs Due to Potential Packaging Integrity Issues
Customed, Inc. is recalling 432 units of Arthroscopy Packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
ARTHROSCOPY PACK - (1) SURGICAL DURAPREP SOLUTION 26ML LIF (1) ESMARK BANDAGE (1 ) ELASTIC BANDAGE 6" X 5yds LIF (1) NEEDLE & BLADE COUNTER 20C FOAM/MAG (1) TUBE SUCTION CONNECTING W X 12' LIF (1) SHEET EXTREMITY ABS. 125" X 85" SMS (1) DRAPE LASER CAMERA W/EL (3)…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2410-2014·2014-09-10
Customed Recalls Urology Packs Due to Potential Packaging Integrity Issues
Customed, Inc. is recalling 440 units of Urology Packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
UROLOGY PACK - (4) ABSORBENT TOWELS UF (2) GOWN SURGICAL POLY-REINF. BREATHABLE XL LEVEL IV (1) SYRINGE 30cc WITHOUT NDL LUER LOCK L/F (1) TUR Y SET, 81 "2 .1M REGULAR CLAM (1) TABLE COVER 44" x 90" (1) DRAPE LITHO 11 0" X 63" WITH POUCH /LEGGING FEN (1) TUBE SUCTION…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2319-2014·2014-09-10
Customed Recalls Angiodrape Packs Due to Potential Packaging Integrity Issues
Customed, Inc. is recalling 180 units of Angiodrape Packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
ANGIODRAPE PACK - - (1) GUIDEWIRE 0.035" X 150cm (2) SYRINGE 10ccWITHOUT NEEDLE LUER LOCK UF (2) Pr. SURGICAL GLOVES #8 (2) GOWN STANDARD LARGE SMS VELCRO NECK (2) NEEDLE HYPODERMIC 21G X 1 W' UF (1) TABLE COVER 44" X 90" (3) CLOTH HUCK TOWELS BLUE (2) UTILITY BOWL 16oz…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2526-2014·2014-09-10
Customed Recalls Face Pack FJG Due to Potential Packaging Integrity Issues
Customed, Inc. is recalling Face Pack FJG surgical kits because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
Face Pack FJG, code 900-3116, contains: (2) GOWN LARGE STANDARD SMS AAMIIII (2) TOWEL ABSORBENT 15" X 20" (1) COUNTER NEEDLE & BLADE 20C FOAM/MAG (1) COVER MAYO STAND REINFORCED (1) SHEET ENT SPLIT 11 0" X 77" SMS (1) COVER TABLE REINFORCED 44" X 78" (20) GAUZE SPONGE 4"…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2405-2014·2014-09-10
Customed Recalls Cesarean Packs Due to Potential Packaging Integrity Issues
Customed is recalling 1,095 units of EO sterilized Cesarean Packs because packaging integrity may be compromised, potentially leading to loss of sterility and patient injury.
Product
CESAREAN PACK - (1) BABY BLANKET IMP. 30" X 30" POLY ABS. (1) NEEDLE & BLADE COUNTER 60c FOAM/STRIP MAG/STRIP LIF (1) DRESSING ISLAND 4" x 10" (1) CESAREAN DRAPE 71" x 125" LIF (2) GOWN SURG REINFORCED LARGE TOWEL/WRAP (10) LAP SPONGES PREWASH XRD LIF (1) BABY BEANNIES…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2534-2014·2014-09-10
Customed Recalls Lithotomy Pack III Due to Potential Packaging Integrity Issues
Customed, Inc. is recalling Lithotomy Pack III surgical packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
Lithotomy Pack III (3), code 900-2487, contains: (3) TOWEL ABSORBENT 15" X 20" (1) GOWN LARGE STANDARD SMS VELCRO NECK (2) LEGGINS WITH 7" CUFF 30" X 42" (1) DRAPE UNDERBUTTOCK WITH POUCH 44" X 35" (1) DRAPE ABDOMINAL WITH TAPE 40" X 54" (1) DRAPE UTILITY WITH TAPE (1)…
Category
Medical Device
Distribution
Distributed nationwide

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34976–35000 of 40449