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

34901–34925 of 40449

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)…
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
SevereFDA (Devices)·Z-2335-2014·2014-09-10
Customed Recalls Laparoscopy Gyn Packs Due to Packaging Integrity Concerns
Customed, Inc. is recalling 1,136 units of Laparoscopy Gyn Packs across 34 lots because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
LAPAROSCOPY GYN PACK - - (1) BLADE SURGICAL #11 STAINLESS STEEL (4) DRAPE UTILITY WITH TAPE LIF (2) ABSORBENT TOWEL 15" X 20" LIF (1) GOWN IMPERVIOUS REINFORCED LARGE SMS (1) TOWEL CLOTH HUCK BLUE (1) BLADE SURGICAL #15 CARBON STEEL (2) UTILITY BOWL 16oz (1) UTILITY…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2336-2014·2014-09-10
Customed Recalls Angiography Packs Due to Potential Packaging Integrity Issues
Customed, Inc. is recalling 1,305 units of angiography packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
ANGIOGRAPHY PACK - ( 1) FEMORAL ANGlO. DRAPE WITH POUCH (2) SYRINGE 10cc W/0 NEEDLE LUER LOCK LIF (2) NEEDLE HYPODERMIC 21G X 1% ( 1) TABLE COVER REINFORCED 44" X 78" LIF (30) GAUZE SPONGES 4" X 4" 12PLY ( 1) GOWN IMPERVIOUS REINFORCED LARGE SMS ( 1) GOWN LARGE NON…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2353-2014·2014-09-10
Customed Recalls Laparotomy Packs Due to Potential Packaging Integrity Issues
Customed, Inc. is recalling 2,300 laparotomy packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
LAPAROTOMY PACK - CONTENTS: ( 1) GOWN XL SMS IMPERVIOUS REINFORCED LIF ( 1) MAYO STAND COVER REINFORCED LIF (1) BAG SUTURE FLORAL LIF (4) DRAPE UTILITY WITH TAPE LIF (2) DRAPE SHEET 41 II X 58" SMS L/F ( 1) TABLE COVER 50" X 90" LIF ( 1) SOLUTION SURGICAL DURAPREP 26ML…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2384-2014·2014-09-10
Customed Recalls Premium Laparotomy Packs Due to Packaging Integrity Concerns
Customed, Inc. is recalling Premium Laparotomy Packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
PREMIUM LAPAROTOMY PACK - CUSTOMED- (1) DRAPE T LAPAROT 102" X 78" X 121" (1) GOWN XL SMS IMPERVIOUS REINFORCED (1) COVER TABLE REINFORCED 50" X 90" LIF (1) COVER MAYO STAND REINFORCED LIF (4) DRAPE UTILITY WITH TAPE LIF (4) TOWELS ABSORBENT 15" X 20" LIF (5) SPONGE LAP…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2461-2014·2014-09-10
Customed Recalls Basic Pack 1 Surgical Packs Due to Packaging Integrity Concerns
Customed, Inc. is recalling Basic Pack 1 surgical packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
BASIC PACK 1 (Ill) CUSTOMED CONTENTS: (1) TABLE COVER REINFORCED 44" X 78" (4) DRAPE UTILITY WffAPE (2) TOWELS ABSORBENT 15" X 20" (1) SUTURE BAG FLORAL (1) DRAPE SHEET 42" X 57" SMS (1) SHEET :X 57" X 63" REINFORCED SMS (1) MAYO STAND COVER REINFORCED Product Usage…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2477-2014·2014-09-10
Customed Recalls EO Sterilized Surgical Gown Packs Due to Packaging Integrity Concerns
Customed, Inc. is recalling 20 lots of EO sterilized surgical gown packs because packaging integrity may be compromised, potentially leading to loss of sterility.
Product
Gown Cool Impervious XLGE Breathable Customed, 900-2592: (1) GOWN XL SURGICAL MICROCOOL (1) WRAPPER 24" X 24" (1) TOWELS ABSORBENT 15" X 20" LIF 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-2502-2014·2014-09-10
Customed Recalls Surgical Packs Due to Potential Packaging Integrity Issues
Customed, Inc. is recalling 208 units of surgical packs for knee and hip replacements because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
REEMPLAZO DE RODILLA Y CADERA CONTENTS: (6) TOWELS ABSORBENT 15" X 20" (I) PK. STRIP STERICLOSURE Y," X 4" (I) COVER MAYO STAND RErNFORCED (I) SKIN MARKERINK W/8 LABEIJfiME OUT/RULER (I) BAG SUTURE FLORAL (2) SCALPEL WEIGHTED SAFETY # I0 (I) STOCKrNETTE…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2470-2014·2014-09-10
Customed Recalls Laparotomy Packs Due to Potential Packaging Integrity Issues
Customed, Inc. is recalling 2,233 units of EO sterilized surgical laparotomy packs because packaging integrity may be compromised, risking product contamination or loss of sterility.
Product
LAPAROTOMY PACK Ill (4) CUSTOMED CONTENT: (4) TOWEL ABSORBENT 15" X 20" (2) GOWN XLARGE SMS IMPERVIOUS REINFORCED (1) COVER MAYO STAND REINFORCED (2) DRAPE SHEET 41" X 58" SMS (4) DRAPE UTILITY WITH TAPE (1) BAG SUTURE FLORAL (1) DRAPE T LAPAROTOMY 102" X 78" X…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2380-2014·2014-09-10
Customed Recalls OB Packs Due to Potential Packaging Integrity Compromise
Customed, Inc. is recalling OB Packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
OB PACK - (2) EXAM GLOVES MED. (1 0) GAUZE SPONGES 4" X 4" 12PL Y (2) LEGGINS W/ 7" CUFF (2) DRAPE SHEET SMS (1) ABDOMINAL DRAPE W/TAPE (1) PLASTIC BOWL W/Lid 70 oz. (1) EAR/ULCER SYRINGE 2oz. L/Free (1) UMBILICAL CORD CLAMP (1) BABY BEANNIES (1) PVP SCRUB 8" STICK…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2430-2014·2014-09-10
Customed Recalls Cesarean Packs Due to Potential Packaging Integrity Issues
Customed, Inc. is recalling 420 units of EO-sterilized Cesarean Packs because packaging integrity may be compromised, posing a risk of product contamination or loss of sterility.
Product
CESAREAN PACK - (1) BABY BLANKET IMP. POLY ABS. (4) ABSORBENT TOWELS 15" x 20" LIF (2) NEEDLE & BLADE COUNTER 10C MAG/CLEAR LIF (2) LITE GLOVES LIF (1) BOWL PLASTIC WITH LID 80 oz. (1) C-SECTION DRAPE W/ POUCH 102" X 121 " X 78" (1) UTILITY BOWL 32 oz. (10) LAP…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2338-2014·2014-09-10
Customed Recalls Arthroscopy Packs Due to Potential Packaging Integrity Issues
Customed, Inc. is recalling 2,620 units 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 (1 0) GAUZE SPONGES 4" X 4" 16PL Y (1) TUBE SUCTION CONNECTING X" X 12' LIF (1) IMP. STOCKINETTE (1) SURGICAL BLADE #11 STAINLESS STEEL (1) ANESTHESIA SPINAL NEEDLE 18G X 3 ~ (1) SYRINGE Sec WITH NEEDLE 21G X 1 ~…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2377-2014·2014-09-10
Customed Recalls Laparoscopy Packs Due to Potential Packaging Integrity Issues
Customed, Inc. is recalling 21 lots of Laparoscopy Packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
LAP AROSCOPY PACK - (10) GAUZE SPONGE 4" X 4" 16 PLY XRD LIF (1) MAYO STAND COVER REINFORCED L/F (4) ADHESIVE BANDAGE%" X 3" ST. LIF (1) TABLE COVER REINFORCED 50" X 90" LIF (2) GOWN IMPERVIOUS REINFORCED LARGE SMS (2) TOWEL ABSORBENT 15" X 20" LIF (1) DRAPE LASER CAMERA…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2419-2014·2014-09-10
Customed Recalls AV Fistula Surgical Packs Due to Packaging Integrity Concerns
Customed, Inc. is recalling AV Fistula surgical packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
AV FISTULA PACK- (1) DRAPE T LAPAROT 102" X 78" X121 " STD SMS (3) GOWN SURG. REINFORCED X-LARGE EXTRA LONG LEVEL IV (1) DRAPE SHEET 42" X 57" SMS (4) DRAPE UTILITY WITH TAPE LIF (1 0) GAUZE SPONGE 4" X 4" 16PL Y XRD LIF (1) PENCIL CAUTERY HAND SWITCHING LIF (1) TUBE…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2386-2014·2014-09-10
Customed Recalls Premium Arthroscopy Packs Due to Packaging Integrity Concerns
Customed, Inc. is recalling Premium Arthroscopy Packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
PREMIUM ARTHROSCOPY PACK - CUSTOMED- (1) ARTHROSCOPY SHEET T WITH POUCH LIF (1) IMPERVIOUS STOCKINETTE (3) STRIPS TAPE 24" X 4" (1) DRAPE U WITH TAPE SPLIT (2) TOWELS ABSORBENT 15" X 20" LIF (1) GOWN IMPERVIOUS REINFORCED X-LARGE SMS (1) GOW SURG. REINFORCED LARGE…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2530-2014·2014-09-10
Customed Recalls Breast Surgical Packs Due to Potential Sterility Loss
Customed is recalling breast surgical packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
Breast pack TPSC, code 900-3431, contains: (1) GOWN LARGE STANDARD SMS AAMIIII (1) GOWN SOFT SMS STD. X-LARGE AAMIIII (4) TOWELS ABSORBENT 15" X 20" LIF (1) PENCIL CAUTERY PUSH BOTTOM LIF (1) SYRINGE 60ML LUER LOCK WITHOUT NEEDLE L/F (1) TUBE SUCTION CONNECT X" X 12' LIF…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2389-2014·2014-09-10
Customed Recalls Open Heart Surgical Trays Due to Packaging Integrity Concerns
Customed, Inc. is recalling Open Heart Surgical Trays because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
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 COVER REINFORCED LIF (7) DRAPE UTILITY WITH TAPE L/F (8) HUCK CLOTH TOWELS WHITE L/F (20) HUCK CLOTH TOWELS BLUE LIF (1) MAYO TRAY LARGE…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2409-2014·2014-09-10
Customed Recalls Minor Laparotomy Packs Due to Packaging Integrity Concerns
Customed, Inc. is recalling Minor Laparotomy Packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
MINOR LAPAROTOMY PACK - (1) TABLE COVER 50" X 90" REINFORCED LIF (1) GOWN SURG. X-LARGE REINFORCED TOWEL/WRAP (1) GOWN X-LARGE SMS IMPERVIOUS REINFORCED LIF (3) TOWELS ABSORBENT 15" X 20" LIF (1) YANKAUER SUCTION TUBE WITHOUT VENT LIF (2) COUNTER NEEDLE & BLADE 10C…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2349-2014·2014-09-10
Customed Recalls Carpal Tunnel Surgical Packs Due to Packaging Integrity Concerns
Customed, Inc. is recalling carpal tunnel surgical packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
CARPAL TUNNEL SURGICAL LARGE PACK (1) COVER TABLE 44" X 90" LIF (1) NEEDLE HYPODERMIC 18G X 1 % LIF (1) SYRINGE 10cc WITHOUT NEEDLE LUER LOCK LIF (1) BOWL UTILITY QUART 32oz. (2) SHEET DRAPE 41" X 58" SMS LIF (2) TOWELS ABSORBENT 15" X 20" LIF (1) BANDAGE GAUZE STRETCH…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2472-2014·2014-09-10
Customed Recalls Orthopedic Surgical Packs Due to Packaging Integrity Concerns
Customed, Inc. is recalling Orthopedic Pack I surgical packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
ORTHOPEDIC PACK I (2) CUSTOMED, 900-2503, contains: (2) TOWELS ABSORBENT 15" X 20" LIF (1) COVER MAYO STAND REINFORCED L/F ( 1) U- DRAPE 60" X 70" W/TAPE SPLIT 6 X 21LIF (1) DRAPE % ECONOMY 53" X 77" LIF (4) DRAPE UTILITY WIT APE LIF (1) BAG SUTURE FLORAL LIF (1) SHEET…
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…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2518-2014·2014-09-10
Customed Recalls Tummy Tuck Surgical Packs Due to Packaging Integrity Concerns
Customed, Inc. is recalling Tummy Tuck Pack-BOD surgical packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
Tummy Tuck Pack-BOD , code 900-3026, contains: (2) GOWN X-LARGE SMS IMPERVIOUS REINFORCED AAMIIII (2) TOWELS ABSORBENT 15 X 20 (1) PENCIL CAUTERY PUSH BOTTOM (1) COUNTER NEEDLE/BLADE 20C FOAM/MAG (1) BOWL UTILITY QUART 32oz TURQ (1) COVER MAYO STAND REINFORCED (2) SKIN…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2433-2014·2014-09-10
Customed Recalls Open Heart Surgical Tray Packs Due to Packaging Integrity Concerns
Customed, Inc. is recalling Open Heart Tray Packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
OPEN HEART TRAY PACK A CONTENTS: (1) TABLE COVER BTC 77" X 110" HD FULL COVERAGE LIF (1) MAYO STAND COVER REINFORCED L/F (3) TOWEL ABSORBENT 15" X 20" LIF (1) TABLE COVER REINFORCED 50" X 90" LIF (1) SPLIT SHEET BILATERAL 84" X 80" (12) % SHEET 60" X 77" DRAPE…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2357-2014·2014-09-10
Customed Recalls Curation Kits Due to Potential Packaging Integrity Issues
Customed, Inc. is recalling 16 lots of Curation Kits because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
CURATION KIT - CUSTOMED- (10) GAUZE SPONGE 4" X 4" 16PL Y (4) ABSORBENT TIP APPLICATOR (4) PVP PREP SOLUTION 1 oz (1) CONTAINER SPECIMEN 4oz WITH LID & LABEL (2) EXAM GLOVES MEDIUM (1) WRAPPER 24" X 24" UF (1) PACKING TRAY EO sterilized surgical convenient packs…
Category
Medical Device
Distribution
Distributed nationwide

How to read this listing

Filters

34901–34925 of 40449