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

35001–35025 of 40449

SevereFDA (Devices)·Z-2333-2014·2014-09-10
Customed Recalls Laparoscopy Cholecystectomy Packs Due to Packaging Integrity Concerns
Customed, Inc. is recalling 26 lots of Laparoscopy Cholecystectomy Packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
LAPAROSCOPY CHOLECYSTECTOMY PACK - (1) SHEET LAPAROS/ABDOMINAL UF (1) MAYO STAND COVER REINFORCED UF (1) BLADE SURGICAL #11 STAINLESS STEEL (1) DRAPE SHEET 41 " X 58" SMS UF (10) GAUZE SPONGE 4" X 4" 16PL Y XRD UF (1) TUBE SUCTION CONNEC. 3/16" x 12' UF (3) TOWEL…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2342-2014·2014-09-10
Customed Recalls EO Sterilized Surgical Packs Due to Packaging Integrity Concerns
Customed, Inc. is recalling 5,574 units of EO sterilized surgical packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
0.B. PACK - - (1) TABLE COVER 44" x 90" (1) UNDERBUTTOCK DRAPE WITH POUCH (2) LEGGINS WITH 7" CUFF 30" x 42" (1) GOWN IMPERVIOUS REINFORCED LARGE SMS (3) TOWELS ABSORBENT 15" x 20" (1) PAD OBSTETRICAL X-LARGE (1) VAGINAL SPONGE XRD (10) GAUZE SPONGES 4" X 4" 12PLY XRD…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2499-2014·2014-09-10
Customed Recalls Knee Arthroscopy Packs Due to Packaging Integrity Concerns
Customed, Inc. is recalling specific lots of Knee Arthroscopy Packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
Knee Arthroscopy Pack, code 900-2718, contains: (1 0) GAUZE SPONGES 4 X 4 12PL Y (2) PADDING CAST SOFT ROLL 6 X 4yds. (1) GOBAN SELF-ADHERENT WRAP 6 X 5yds (3) PAD ABDOMINAL 8 X 7.5 (1) DRESSING 1 X 8 XEROFORM PETROLAT (10) GAUZE SPONGES 4 X 4 16PLY XRD (3) NEEDLE…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2385-2014·2014-09-10
Customed Recalls Premium O.B. Packs Due to Packaging Integrity Concerns
Customed is recalling Premium O.B. Packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
PREMIUM O.B. PACK - CUSTOMED- (1) TABLE COVER REINFORCED 50" X 90" LIF (10) GAUZE SPONGES 4" X 4" 12PLY LIF (2) LEGGINS WITH 7" CUFF 30" x 42" LIF (2) PAD OBSTETRICAL X-LARGE ST. (2) SHEET DRAPE 42" X 55" LIF (1) UNDERBUTTOCK DRAPE WITH POUCH LIF (1) DRAPE ABDOMINAL 40" X…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2467-2014·2014-09-10
Customed Recalls Laparoscopy Packs Due to Potential Packaging Integrity Issues
Customed, Inc. is recalling specific lots of Laparoscopy Pack I surgical packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
LAPAROSCOPY PACK I (4) CUSTOMED CONTENTS: (1) TOWEL ABSORBENT 15" X 20" LIF (2) LEGGINGS W/7'' CUFF 30" X 42" LIF (1) DRAPE UTILITY WITAPE L/F (1) SUTURE BAG FLORAL LIF (1) SHEET T LAPAROSCOPY SOFT 97" X 96" X 36 LIF" (1) TABLE COVER REINFORCED 44" X 78" L/F…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2508-2014·2014-09-10
Customed Recalls Cysto TUR Packs Due to Potential Sterility Loss
Customed, Inc. is recalling Cysto TUR Pack Basic surgical kits because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
CYSTO TUR PACK BASIC CODE 900-2899. CONTENTS: (2) LEGGINGS W/7'' CUFF 30" X 42" (1) COVER TABLE REINFORCED 44" X 78" (2) TOWELS ABSORBENT 15" X 20" (1) GOWN XLGE SMS IMPERV. REINFORCED AAMI LEVEL Ill (1) TUR CYSTO IRRIGATION SET 79" SINGLE (1) TIME OUT BEACON NON WOVEN…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2429-2014·2014-09-10
Customed Recalls Laparoscopy Chole Packs Due to Packaging Integrity Concerns
Customed, Inc. is recalling 681 units of Laparoscopy Chole Packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
LAPAROSCOPY CHOLE PACK - (6) TOWELS ABSORBENT 15" X 20" LIF (1) MAYO STAND COVER REINFORCED L/F (1) SYRINGE 3cc WITHOUT NEEDLE LUER LOCK LIF (1) SURGICAL BLADE #11 CARBON STEEL (1) TUR Y SET, 2LEAD L/F (4) DRAPE UTILITY WITH TAPE LIF (1) TROCAR ENDO. XCEL DILATING TIP…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2482-2014·2014-09-10
Customed Recalls Open Heart Packs Due to Potential Sterility Loss
Customed, Inc. is recalling Open Heart Packs (code 900-2618) because packaging integrity may be compromised, potentially leading to loss of sterility and patient injury.
Product
Open Heart Pack, code 900-2618, contains: (9) DRAPE 60" X 76" REINFORCED LIF ( 1) MAYO STAND COVER REINFORCED LIF (6) TOWELS ABSORBENT 15" X 20" L/F ( 1) TABLE COVER BTC 77" X 110" HD FULL COVERAGE LIF ( 1) MAYO TRAY LARGE (8) DRAPE UTILITY WfTAPE LIF (1 ) TABLE COVER…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2347-2014·2014-09-10
Customed Recalls Ortho Implant Surgical Packs Due to Packaging Integrity Concerns
Customed, Inc. is recalling Ortho Implant Surgical Packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
ORTHO IMPLANT SURGICAL PACK - (1) CAUTERY TIP POLISHER (1) U-DRAPE 60" X 70" WITH TAPE SPLIT 6" X 21" (1) BAG SUTURE FLORAL (2) ABDOMINAL PAD 8" X 7 Y:z" (1) TUBE SUCTION CONNECT. }4" X 12' (1) DURAPREP SURGICAL SOLUTION 26ml (1) BAG GLASSINE (1) YANKAUER SUCTION TUBE…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2408-2014·2014-09-10
Customed Recalls Cesarean Packs Due to Potential Packaging Integrity Issues
Customed, Inc. is recalling 23 lots of EO-sterilized Cesarean Packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
CESAREAN PACK - (1) MAYO STAND COVER REINFORCED LIF (5) TOWELS ABSORBENT LIF (1) GOWN X-LARGE SMS IMPERVIOUS REINFORCED L/F (3) DRAPE SHEET 41" X 58" SMS LIF (1) BABY BLANKET PRINTED LIF (1) BOWL PLASTIC 80oz WITH LID (1) TUBE SUCTION CONNECT.%" X 12' LIF (15) LAP…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2460-2014·2014-09-10
Customed Recalls Surgical Packs Due to Potential Packaging Integrity Issues
Customed, Inc. is recalling Basic Pack IV surgical packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
BASIC PACK IV (6) CUSTOMED CONTENTS: (3) TOWELS ABSORBENT 15" X 20" (1) MAYO STAN COVER REINFORCED (1) DRAPE % ECONOMY 53" X 77" (1) DRAPE SHEET 41" X 58" SMS (4) UTILITY DRAPE W/TAPE (1) SUTURE BAG FLORAL (1) TABLE COVER REINFORCED 44" X 78" (2) GOWN SOFT SMS…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2382-2014·2014-09-10
Customed Recalls Premium Cesarean Packs Due to Packaging Integrity Concerns
Customed, Inc. is recalling 730 units of Premium Cesarean Packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
PREMIUM CESAREAN PACK- CUSTOMED- (1)BABY BLANKET IMP. 30" X 30" POLY ABSORBENT (3) TOWELS ABSORBENT 15" X 20" LIF (1) BOWL PLASTIC 80oz WITH LID (10) LAP SPONGE PREWASH XRD LIF (2) PAD OBSTETRICAL X-LARGE ST. (1) MAYO STAND COVER REINFORCED LIF (1) DRAPE SHEET 41 " X…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2572-2014·2014-09-10
St Jude Medical Recalls Ellipse ICDs Due to High Voltage Capacitor Defect
St Jude Medical is recalling Ellipse ICDs because internal capacitor damage may delay or prevent high voltage therapy delivery.
Product
Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411 Ellipse ST Implantable Cardioverter Defibrillators (ICDs), Model No. CD1273, CD1309, CD1409, CD2273, CD2309, CD2409.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2359-2014·2014-09-10
Customed Recalls Cesarean Packs Due to Potential Packaging Integrity Issues
Customed, Inc. is recalling 1,784 units of EO sterilized Cesarean Packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
CESAREAN PACK- (1) COVER TABLE REINFORCED 50" X 90" (2) TOWELS ABSORBENT 15" X 20" (1) BABY BLANKET PRINTED (1) BOWL PLASTIC WITH LID 80oz. (2) NEEDLE & BLADE COUNTER 10C MAG/CLEAR (1) CORD UMBILICAL CLAMP (1) MUCUSTRAP 20cc, 10FR. (1) BOWL UTILITY 32oz (1) C-SECTION…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2516-2014·2014-09-10
Customed Recalls Basic Pack FPSC Florham Pack Due to Packaging Integrity Concerns
Customed, Inc. is recalling Basic Pack FPSC Florham Pack surgical packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
Basic Pack FPSC Florham Pack , code 900-2969, contains: (1) COVER TABLE REINFORCED 50" X 90" (10) GAUZE SPONGE 4" X 4" 16 PLY XRD (1) COVER MAYO STAND REINFORCED (2) GOWN SOFT SMS STD. X-LARGE AAMI Ill (1) COUNTER NEEDLE & BLADE 20C FOAM/MAG (2) TOWELS ABSORBENT 15" X 20"…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2494-2014·2014-09-10
Customed Recalls Liposuction Packs Due to Potential Packaging Integrity Issues
Customed, Inc. is recalling Liposuction Packs (code 900-2681) because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
Liposuction Pack, code 900-2681, contains: (3) GOWN SOFT SMS STD XLGE SET IN SLEEVE (1) TUBE SUCTION CONNECT (1) MAYO STAND COVER REINFORCED (1) SKIN MARKER INK W LABEL (2) TABLE COVER REINFORCED 50 X 90 (1) RULER 6 CLEAR (12) TOWELS CLOTH HUCK (BLUE) (1 0) LAP SPONGE…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2421-2014·2014-09-10
Customed Recalls Universal Surgical Packs Due to Packaging Integrity Concerns
Customed, Inc. is recalling Universal Packs containing surgical instruments and supplies because packaging integrity may be compromised, potentially leading to loss of sterility.
Product
UNIVERSAL PACK - (1) UTILITY BOWL 16oz. (1) NEEDLE SPINAL ANEST. 22G X 31!2 (1) SYRINGE 5cc WITHOUT NEEDLE LUER LOCK LIF (2) SYRINGE 10ccWITHOUT NEEDLE LUER LOCK LIF (1) SYRINGE 30cc WITHOUT NEEDLE LUER LOCK LIF (1) NEEDLE HYPODERMIC 20G X 1 1!2 (2) GOWN X-LARGE SMS…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2463-2014·2014-09-10
Customed Recalls C-Birth Pack II Due to Potential Packaging Integrity Issues
Customed is recalling C-Birth Pack II surgical packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
C - BIRTH PACK II {2) CUSTOMED CONTENT: (1) GOWN SURGEON REINFORCED XLGE TOWEL/WRAP LIF (4) TOWEL ABSORBENT 15" X 20" LIF (2) GOWN XLGE SMS IMPERVIOUS REINFORCED LIF (1) COVER MAYO STAND REINFORCED LIF (1) BLANKET BABY 30" X 30" POLYABS IMPERVIOUS LIF (1) SYRINGE…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2515-2014·2014-09-10
Customed Recalls Hair Restoration Packs Due to Packaging Integrity Concerns
Customed, Inc. is recalling Hair Restoration Packs (code 900-2966) because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
Hair Restoration Pack- , code 900-2966, contains: (1) MAYO STAND COVER 23X54 (2) TOWEL CLOTH HUCK BLUE (2) TABLE COVER BACK ZONE REINFORCED 44 X 90 (2) GOWN SOFT SMS STD. X-LARGE AAMI Ill (2) TOWEL ABSORBENT 15 X 20 (1) MINDE KNIFE 1.0MM, WIDE, 40 DEGREE ANGLE, 6.0MM IN…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2507-2014·2014-09-10
Customed Recalls Orthopedic Surgical Packs Due to Packaging Integrity Concerns
Customed is recalling 402 units of Orthopedic Pack Basic (Code 900-2830) because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
ORTHOPEDIC PACK BASIC CODE 900-2830. CONTENTS: (3) TOWELS ABSORBENT 15" X 20" (1) COVER MAYO STAND REINFORCED (1) U-DRAPE 60" X 70" WITH TAPE SPLIT 6 X 21 SPLIT (1) DRAPE% ECONOMY 53" X 77" (4) DRAPE UTILITY WITH TAPE (1) BAG SUTURE FLORAL (1) SHEET SPLITW/ADHES…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2322-2014·2014-09-10
Customed Recalls Cesarean Packs Due to Potential Packaging Integrity Issues
Customed, Inc. is recalling 2,564 units of EO sterilized Cesarean Packs because packaging integrity may be compromised, potentially leading to loss of sterility.
Product
CESAREAN PACK - - (1) MAYO STAND COVER REINFORCED LIF (20) LAP SPONGES PRE-WASH XRD LIF (1) UMBILICAL CORD CLAMP LIF (1) COVER TABLE REINFORCED 50" X 90" LIF (1) SURGICAL DURAPREP SOLUTION 26ML LIF (1) BEANNIES BABY (1) POLISHER TIP CAUTERY LIF (1) LITE GLOVE L/F (1)…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2365-2014·2014-09-10
Customed Recalls PERl GYN PACK Surgical Kits Due to Packaging Integrity Concerns
Customed, Inc. is recalling PERl GYN PACK surgical kits because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
PERl GYN PACK (1) TABLE COVER 44" x 90" (2) LEGGINS W/7" CUFF 30" x 42" (1) ABDOMINAL DRAPE WITH TAPE LIF (2) TOWELS ABSORBENT 15" X 20" (10) GAUZE SPONGE 4" X 4" 16PLY (2) DRESSING NON ADH TELFA 4" X 3" (1) ROBINSON RED CATHETER 14FR. (1) UNDERBUTTOCK DRAPE WITH…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2495-2014·2014-09-10
Customed Recalls Breast Augmentation Packs Due to Packaging Integrity Concerns
Customed, Inc. is recalling breast augmentation packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
Breast Augmentation Pack, Imagenes Cosmetic, code 900-2682: (3) GOWN SOFT SMS STD XLGE SET IN SLEEVE ( 1) CAUTERY PENCIL PUSH BOTTOM ( 1) TUBE SUCTION CONNECT ( 1) MAYO STAND COVER REINFORCED ( 1) SKIN MARKER INK W LABEL (2) TABLE COVER REINFORCED 50 X 90 ( 1) RULER 6…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2489-2014·2014-09-10
Customed Recalls Liposuction Packs Due to Potential Packaging Integrity Issues
Customed, Inc. is recalling specific lots of Liposuction Pack MRT due to potential packaging integrity issues that could compromise sterility.
Product
Liposuction Pack MRT, code 900-2656, contains: (1) NEEDLE HYPODERMIC 27 X 1 LIF (1) UTILITY BOWL QUART 32oz LIF (1) MAYO STAND COVER REINFORCED LIF (2) GOWN SOFT SMS STD X-LARGE SET IN SLEEVE LIF ( 1) PVP SCRUB SOLUTION 4oz BOTTLE (20) GAUZE SPONGES 4 X 4 (12) TOWEL…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2475-2014·2014-09-10
Customed Recalls Minor Surgical Packs Due to Potential Packaging Integrity Issues
Customed, Inc. is recalling Minor Pack 900-2511 surgical packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
Minor Pack 900-2511, pack contains: (1) GOWN XLGE SMS IMPERVIOUS REINFORCED AAMIIII (10) GAUZE SPONGE 4" X 4" 16PLY XRD (5) LAP SPONGE PREWASH 18" X 18" XRD (1) DRAPE LAPAROTOMY W/POUCH 100" x 72" x 124" (4) DRAPE UTILITY WITH TAPE (2) DRAPE SHEET 41" X 69" MEDIUM ( 1)…
Category
Medical Device
Distribution
Distributed nationwide

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35001–35025 of 40449