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

4501–4525 of 5038

SevereFDA (Devices)·Z-2480-2014·2014-09-10
Customed Extremity Pack Recall Due to Potential Packaging Integrity Issues
Customed, Inc. is recalling Extremity Packs (code 900-2615) because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
Extremity Pack, code 900-2615, contains: (5) LAP SPONGE PREWASH 18" X 18" XRD (1) ELASTIC BANDAGE WITH VELCRO 4 X 5 (2) BLADE SURGICAL# 15 STAINLES STEEL (4) DRAPE UTILITY WITH TAPE (1) GOWN XL SMS IMPERVIOUS REINFORCED ( 1) GOWN SURG REINFORCED LARGE TOWEL & WRAP (1) SKIN
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 1
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-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" (1
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
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-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-2345-2014·2014-09-10
Customed Recalls Arthroscopy Packs Due to Potential Packaging Integrity Issues
Customed, Inc. is recalling Arthroscopy Packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
ARTHROSCOPY PACK - (1) COVER MAYO STAND REINFORCED UF (1 0) GAUZE SPONGE 4" X 4" 16PL Y XRD LIF (1) TUBE SUCTION CONNECT ~" X 12' LIF (1) SHEET ARTHROSCOPY T STD SMS WITH POUCH LIF (1) STOCKINETIE IMPERVIOUS 14" X 48" LIF (1) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK L/F (
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2352-2014·2014-09-10
Customed Recalls Femoral Angiography Packs Due to Packaging Integrity Concerns
Customed, Inc. is recalling 580 units of femoral angiography packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
FEMORAL ANGIOGRAPHY PACK - (1) TABLE COVER REINFORCED 50" X 90" UF (1) GOWN LARGE SMS IMPERVIOUS REINFORCED LIF (1) TOWEL ABSORBENT 15" X 20" UF (1) DRAPE ANGlO 75" X 145" (4) TOWELS CLOTH HUCK (BLUE) UF (3) SYRINGE 1 Occ WITHOUT NEEDLE LUER LOCK UF (1) IV ADM SET 15ML 1
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-2536-2014·2014-09-03
Smiths Medical Recalls Pediatric Endotracheal Intubation Kits Due to Tube Fastener Issue
Smiths Medical ASD, Inc. is recalling Pediatric Endotracheal Intubation Kits because the tube fastener may compress the tracheal tube, causing difficulty in locking the holder or passing a suction catheter.
Product
4001PS Neonatal/Paed.Intubation Kit 2.5mm Murphy, LDS 15mm Conn Pediatric Endotracheal Intubation Kit
Category
Medical Device
Distribution
41 states
SevereFDA (Devices)·Z-2541-2014·2014-09-03
Smiths Medical Recalls Pediatric Endotracheal Intubation Kit Tube Holders
Smiths Medical ASD, Inc. is recalling H4052 Endo Tube Holders because the fastener may compress the tracheal tube, causing difficulty locking the holder or passing a suction catheter.
Product
H4052 Endo Tube Holder, Pedi 3.0mm Pediatric Endotracheal Intubation Kit
Category
Medical Device
Distribution
41 states
SevereFDA (Devices)·Z-2256-2014·2014-08-27
Ortho Development Recalls Knee Implants Due to Improper Foil Pouch Sealing
Ortho Development is recalling various knee implant components because foil pouches failed to seal properly, allowing air to enter and potentially degrading the material properties of the implants.
Product
Tibila Insert UC, Balanced Knee System, REF163-3YYY Product Usage: UHMWPE component used in TKA procedures to serve as a tibial bearing surface for articulation with the femoral component
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2261-2014·2014-08-27
AngioDynamics Recalls Uni*Fuse Infusion Systems Due to Potential Guidewire Size Error
AngioDynamics is recalling Uni*Fuse Infusion Systems with Cooper Wire because they may contain a guidewire that is too long.
Product
Uni*Fuse INFUSION SYSTEM WITH COOPER WIRE, 5F x 90 cm x 30 cm Infusion Pattern, Catalog No./REF 12401808, Product No. H787124018085, STERILE -- AngioDynamics, 603 Queensbury Avenue, Queensbury, NY 12804
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2254-2014·2014-08-27
Ortho Development Recalls Knee Implant Components Due to Sealing Defects
Ortho Development is recalling specific knee implant components because defective foil pouches allowed air to enter, potentially degrading the material properties of the implants.
Product
Patella 38mm, REF164-0038 Product Usage: UHMWPE component used in a TKA procedure to resurface the patella and serve as a bearing surface for sliding contact with the femoral component
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2206-2014·2014-08-20
Gambro Recalls PrisMARS Kits Due to Connector Breakage and Leakage
Gambro Renal Products is recalling PrisMARS Kits because connector breakages can cause liquid or blood to leak.
Product
PrisMARS Kit (component of MARS Treatment Kit Type 1115/1 PrisMARS US), 1 MARS Treatment Kit per carton box, Product Number 800480, Batch
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-2230-2014·2014-08-20
Zimmer Recalls 23.5 Degree Rasp Handle Assemblies Due to Assembly Failure
Zimmer, Inc. is recalling 412 units of 23.5 Degree Rasp Handle Assemblies because the handle may fail to remain assembled to the rasp during use.
Product
23.5 Deg Rasp Handle Assy- LEFT Nonsterile
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2202-2014·2014-08-20
Gambro Recalls Prismaflex M100 Dialysis Sets Due to Connector Breakage
Gambro Renal Products is recalling Prismaflex M100 dialysis sets because connector breakages can cause leakage of liquid or blood.
Product
Prismaflex M100. Product number 106697. Each set is packaged in a plastic pouch, 4 pouches per carton box
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-2177-2014·2014-08-20
Carestream Recalls Kodak DirectView DR 7500 X-Ray Systems Due to Loose Parts
Carestream Health is recalling 589 Kodak DirectView DR 7500 diagnostic x-ray systems because the x-ray tube assembly may detach from the overhead crane due to insufficiently tightened hardware.
Product
Kodak DirectView DR 7500 Diagnostic X-Ray System Product Usage: The DR 7500 system is a permanently installed diagnostic x-ray system composed of 4 main components: an operator console, over head tube crane, x-ray tube assembly including a collimator and stationary generator
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2209-2014·2014-08-20
Medical Positioning Rapid Response HUT Table Recalled for Malfunction Risk
Medical Positioning Inc is recalling two Model # 1019 HUT tables due to a component defect that may cause the table to drop into the Trendelenburg position more rapidly than normal.
Product
Medical Positioning Rapid Response HUT table, Powered Medical Examination table, Model # 1019. Product Usage: Used to conduct syncope examinations.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2203-2014·2014-08-20
Gambro Recalls Prismaflex M150 Dialysis Sets Due to Connector Breakage
Gambro Renal Products is recalling Prismaflex M150 dialysis sets because connector breakages can cause liquid or blood to leak.
Product
Prismaflex M150. Product number 109990. Each set is packaged in a plastic pouch, 4 pouches per carton box
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-2231-2014·2014-08-20
Zimmer Recalls 23.5 Degree Rasp Handle Assemblies Due to Assembly Failure
Zimmer, Inc. is recalling 23.5 Degree Rasp Handle Assemblies because the handle may fail to remain attached to the rasp during use.
Product
23.5 Deg Rasp Handle Assy- RIGHT Nonsterile
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2225-2014·2014-08-20
Zimmer Recalls Nonsterile Orthopedic Rasp Handles Due to Assembly Failure
Zimmer, Inc. is recalling 412 nonsterile VER2 D8L Offset Rasp Handles because the handle may fail to remain assembled to the rasp during use.
Product
VER2 D8L OFFSET RASP HANDLE, RT Nonsterile
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2204-2014·2014-08-20
Gambro Recalls Prismaflex HF 1000 Dialysis Sets Due to Connector Breakage
Gambro Renal Products is recalling Prismaflex HF 1000 dialysis sets because connector breakages can cause leakage of liquid or blood.
Product
Prismaflex HF 1000. Product number 107140. Each set is packaged in a plastic pouch, 4 pouches per carton box
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-2199-2014·2014-08-20
Gambro Recalls Prisma M100 PRE Pump Infusion Sets Due to Connector Breakage
Gambro Renal Products is recalling Prisma M100 PRE pump infusion sets because connector breakages can cause liquid or blood to leak.
Product
Prisma M100 PRE pump infusion set. Product number 107791. Each set is packaged in a plastic pouch, 4 pouches per carton box
Category
Medical Device
Distribution
0 states

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