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

4476–4500 of 5038

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-2564-2014·2014-09-10
Hitachi Echelon Oval MRI Systems Recalled for Gradient Coil Overheating
Hitachi Medical Systems America Inc is recalling 39 Echelon Oval MRI systems because the gradient coil can overheat and become a burn hazard.
Product
Hitachi Echelon Oval MRI system is a diagnostic imaging device (one unit per package) and is intended to provide the physician with physiological and clinical information, obtained non-invasively and without the use of ionizing radiation.
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-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-2311-2014·2014-09-10
Customed Recalls Open Heart Surgical Trays Due to Packaging Integrity Concerns
Customed, Inc. is recalling Open Heart Tray surgical packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
OPEN HEART TRAY - PACK- (25) SPONGE LAP PREWASH 18" X 18" XRD L/F (1) TRAY PLATO LARGE (3) DRESSING NON ADH TELFA 8 X 3 (2) BAG GLASSINE PLAIN (2) YANKAUER SUCTION TUBE WITHOUT VENT LIF (1) COVER TABLE REINFORCED 50" X 90" LIF (1) NEEDLE HYPODERMIC 27G X 'h" (4) CO
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-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 J
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-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 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-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 CARBO
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 CO
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 1
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 4"
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-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-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-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-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) MA
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2520-2014·2014-09-10
Customed Liposuction Surgical Packs Recalled for Packaging Integrity Concerns
Customed, Inc. is recalling Liposuction Pack BOD units due to potential packaging integrity issues that could compromise sterility and lead to patient injury.
Product
Liposuction Pack BOD, code 900-3028, contains: (2) GOWN XL SMS IMPERVIOUS REINFORCED AAMI Ill (2) LITE GLOVES LIF (2) TOWEL ABSORBENT 15" X 20" L/F (1) NEEDLE HYPODERMIC 27G X 1 %" LIF (1) BOWL UTILITY QUART 32oz TURQ (1) COVER MAYO STAND REINFORCED L/F (1) PVP SCRUB SOLUT
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 58"
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 PRE
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2476-2014·2014-09-10
Customed Recalls Laparotomy Packs Due to Potential Packaging Integrity Issues
Customed, Inc. is recalling 93 units of Laparotomy Packs (900-2516) because packaging integrity may be compromised, risking product contamination or loss of sterility.
Product
Laparotomy Pack, 900-2516, pack contains: ( I) TABLE COVER44" X 90" ( I) CAUTERY PENCIL PUSH BOTTOM (4) TOWELS ABSORBENT 15" X 20" L/F ( I) BULB SYRINGE 60cc LIF (4) DRAPE UTILITY WIT APE LIF (I) SKIN MARKER W/RULER ( I) SUTURE BAG FLORAL LIF ( I) Y ANKAUER SUCTION TU
Category
Medical Device
Distribution
Distributed nationwide

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4476–4500 of 5038