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 deaths or serious injuries are reported, 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

4526–4550 of 5111

CriticalFDA (Devices)·Z-2500-2014·2014-09-10
Customed Recalls Shoulder Arthroscopy Packs Due to Packaging Integrity Concerns
Customed, Inc. is recalling 74 units of Shoulder Arthroscopy Packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
Shoulder Arthroscopy Pack, code 900-2719, contains: (1 0) GAUZE SPONGES 4 X 4 12PL Y (1) COBAN WRAP TAN 4 X 5yds (3) PAD ABDOMINAL 8 X 7.5 (1) DRESSING 1 X 8 XEROFORM PETROLAT (1 0) GAUZE SPONGES 4 X 4 16PL Y XRD (1) NEEDLE HYPODERMIC 18G X 1 (1) NEEDLE SPINAL ANESTH 18G
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2360-2014·2014-09-10
Customed Recalls C-Section Surgical Packs Due to Packaging Integrity Concerns
Customed, Inc. is recalling C-Section surgical packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
C-SECTION SURGICAL PACK- (1) COVER TABLE REINFORCED 50" X 90" (2) TOWELS ABSORBENT 15" X 20" (1) MAYO STAND COVER REINFORCED (1) BABY BLANKET PRINTED (1 0) LAP SPONGES PREWASH 18" X 18" XRD (1) BOWL PLASTIC WITH LID 80oz. (1) BAG GLASSINE (2) NEEDLE & BLADE COUNTER 1 OC
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
CriticalFDA (Devices)·Z-2533-2014·2014-09-10
Customed Recalls Laparoscopy Colorectal Surgical Packs Due to Packaging Integrity Concerns
Customed, Inc. is recalling 280 units of Laparoscopy Colorectal Surgical Packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
LAPAROSCOPY COLORECTAL SURGICAL PACK code 900-2259A, contains: (1) SOLUTION SURGICAL DURAPREP 26ml LIF (4) DRAPE UTILITY WITH TAPE LIF (3) TOWELS ABSORBENT 15" X 20" LIF (2) LEGGINS W/7'' CUFF 30" X 42" LIF (1) BLADE SURGICAL# 15 STAINLESS STEEL (1) BLADE SURGICAL# 11 STA
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2302-2014·2014-09-10
Customed Angiodrape Pack Recalled for Potential Packaging Integrity Issues
Customed, Inc. is recalling 1,536 units of Angiodrape Packs due to potential packaging integrity issues that could compromise sterility and risk patient injury.
Product
Customed Angiodrape Pack convenience pack include multiple components: syringe 10cc and 30cc, gauze, denture cup, specimen container, band bag, glove, gown, needle hypodermic, absorbent towels, table cover, scalpel,cloth huck towel,iodine povidone,applicator sponge,towel clamp,
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2471-2014·2014-09-10
Customed Recalls EENT Surgical Packs Due to Packaging Integrity Concerns
Customed, Inc. is recalling EENT surgical packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
EENT PACK I CUSTOMED CONTENT: (2) TOWEL ABSORBENT 15" X 20" (1) MAYO STAND COVER REINFORCED (1) BAG SUTURE FLORAL (1) SHEET ENT SPLIT 110" X 77" SMS (1) TABLE COVER REINFORCED 50" X 90" (1) DRAPE HEAD W!TAPE 44" X 26" (1) GOWN SURG. REINFORCED XLGE TOWEL/WRAP
Category
Medical Device
Distribution
Distributed nationwide
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) SK
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2498-2014·2014-09-10
Customed Recalls Endovascular Packs Due to Potential Packaging Integrity Issues
Customed, Inc. is recalling Endovascular Packs (code 900-2715) because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
Endovascular Pack, code 900-2715, contains: ( I) DRAPE FEMORAL ANG. 125 X 75 X 56 WITH POUCH LIF (2) TOWELS ABSORBENT 15 X 20 LIF ( I) CONTAINER SPECIMEN 4oz W/LID & LABEL Llf (2) BAG BAND FLUOROSCOPE 36 X 30 LIF ( I) NEEDLE HYPODERMIC 21G X I Y, LIF (2) GOWN LARGE SMS IMPE
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2484-2014·2014-09-10
Customed Recalls Surgical Packs Due to Potential Packaging Integrity Issues
Customed is recalling specific lots of HIP PACK I surgical packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
HIP PACK I (2), CUSTOMED, code 900-2504 (1) GOWN SURG. REINFORCED XLGE TOWEL/WRAP (1) MAYO STAND COVER REINFORCED (1) U-DRAPE 60" X 70" WITH TAPE SPLIT (1) STOCKINETTE IMPERVIOUS 12" X 48" (4) DRAPE UTILITY WITH TAPE (1) BAG SUTURE FLORAL (1) DRAPE HIP 89" X 128" REINFORCE
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2309-2014·2014-09-10
Customed Recalls Labor and Delivery Packs Due to Packaging Integrity Concerns
Customed, Inc. is recalling 3,448 units of Labor and Delivery Packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
Customed LABOR & DELIVERY PACK - Includes: (1) TABLE COVER 44" x 90" (2) LEGGINS WITH/7" CUFF 30" x 42" (5) ABSORBENT TOWELS 15" x 20" LIF (1) BABY BLANKET PRINTED LIF (2) PAD OBSTETRICAL XLGE LIF (1) EAR ULCER SYRINGE 2oz. LIF (1) BABY BLANKET POLY ABS. IMP. LIF (1) Pr
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2346-2014·2014-09-10
Customed Recalls Surgical Packs Due to Potential Packaging Integrity Issues
Customed, Inc. is recalling 1,041 units of EO sterilized surgical convenient packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
IMPLANTE DE ORTHOPEDIA- 1) GOWN IMPERV. XTRA REINF. XL SMS T/WRAP LEVEL IV (1) CAUTERY TIP POLISHER LIF (1) DURAPREP SURGICAL SOLUTION 26ml LIF (1) BAG SUTURE FLORAL LIF (1) TUBE SUCTION CONNECT. Y.!" X 12' L/F (1) CAUTERY PENCIL ROCKER SWITCH LIF (2) *Pr. SURGEON NEUTR
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2414-2014·2014-09-10
Customed Recalls Arthroscopy Packs Due to Potential Packaging Integrity Issues
Customed, Inc. is recalling 39 lots of arthroscopy packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
ARTHROSCOPY PACK- (1) TABLE COVER REINFORCED 50" X 90" (1) PRE PAD WITH CUFF (2) GOWN XL SMS IMPERVIOUS REINFORCED AAMI Ill (1) GOWN IMPERV. EXTRA REINFORCED LGE TNVRAP (1) MAYO STAND COVER REINFORCED (1) TUBE SUCTION CONNECT. X" X 12' (1) STOCKINETTE IMPERVIOUS 14" X 4
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 CONN
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-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-2574-2014·2014-09-10
Elekta FOCAL Sim Workstation Software Recall for Plan Mismatch
Elekta is recalling FOCAL Sim Workstation software versions 4.70.00 and 4.80.00 because exported arc plans may not match approved treatment plans.
Product
FOCAL Sim Workstation, Radiation Treatment Planning System. Used for patient contouring and viewing of treatment plan outputs. Also able to perform CT simulations and forward their information to the RTP System for dose calculation.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2474-2014·2014-09-10
Customed Recalls Urology Packs Due to Potential Packaging Integrity Issues
Customed, Inc. is recalling 612 units of Urology Pack 900-2510 because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
Urology Pack, 900-2510, package contains: (2) TOWELS ABSORBENT 15X 20 UF (1) DRAPE LITHO 11 0" X 63" W/LEGG/POUCH FEN UF (10)GAUZE SPONGE 4" X 4" 12PL Y (1) GOWN XL SMS IMPERVIOUS REINFORCED UF (1) TUR Y SET 81 " 2.1M REGULAR CLAM (1) GOWN SURG REINFORCED LGE TOWEL & WRA
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2330-2014·2014-09-10
Customed Recalls EO Sterilized Laparotomy Packs Due to Packaging Integrity Concerns
Customed, Inc. is recalling 550 units of EO sterilized laparotomy basic packs because packaging integrity may be compromised, potentially leading to loss of sterility and patient injury.
Product
LAPAROTOMY BASIC PACK- CUSTOMED- (1) TABLE COVER REINFORCED 44" X 78" LIF (1) COVER MAYO STAND REINFORCED UF (2) TOWEL ABSORBENT 15" X 20" UF (1 0) GAUZE SPONGES XRD 4" X 4"-12PL Y (2) DRAPE SHEET 41 " X 58" SMS UF (4) DRAPE UTILITY WITH TAPE L/F EO sterilized surgical
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2434-2014·2014-09-10
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 CONTENTS: (1) SUTURE BAG FLORAL LIF (1) NEEDLE & BLADE COUNTER SOC FOAM STR//MAG STR (2) COVER TABLE BTC 77" x 110" HD FULL COVERAGE LIF (4) DRAPE UTILITY WITH TAPE LIF (1) SHEET 'I" 60" X 77" DRAPE REINF. LIF (2) SPECIMEN CONTAINER 4oz W/LID &
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 S
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 7"
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2316-2014·2014-09-10
Customed Recalls Laparotomy Packs Due to Potential Packaging Integrity Issues
Customed, Inc. is recalling specific lots of laparotomy packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
LAPAROTOMY PACK - (I) UTILITY BOWL 16oz ( I) ELECTRODE DUAL DEPRES./GROUNDPAD (I) UTILITY BOWL 32oz ( I) GOWN IMP. REINFORCED XL SMS AAMI Ill (2) NEEDLE & BLADE COUNTER I OC MAG/CLEAR ( I) DRAPE LAPAROT ABDOM WITH POUCH (2) TOWELS ABSORBENT 15" x 20" ( I) TIME OUT BEACO
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 CLOT
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2401-2014·2014-09-10
Customed Recalls Dressing Change Packs Due to Packaging Integrity Concerns
Customed, Inc. is recalling 2,950 units of Dressing Change packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
DRESSING CHANGE - CUSTOMED- (2) GLOVE MED. FREETOUCH VYNIL POWDER FREE ( I) DRESSING TEGADERM 3 Y2 X 4 Y2 ( I) MASK PROCEDURAL YELLOW 80MM HG L/F (4) GAUZE 4" X 4" 4PLY ( I) ALCOHOL PREP PAD MED ( I) CI-ILORASCRUB SWABSTICK 1.6 ( I) LABELCAUTION ( I) DRAPE NON FENE
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

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4526–4550 of 5111