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

22826–22850 of 27663

HighFDA (Devices)·Z-2515-2015·2015-09-09
Halyard KimVent Closed Suction System Recalled Due to Valve Malfunction
Halyard Health is recalling KimVent Closed Suction Systems because the thumb valve may remain partially open after suctioning, compromising the closed system.
Product
KimVent* Turbo-Cleaning Closed Suction System for Adults, 14 F, DSE, MDI (Product Code 2271418) A tracheobronchial suction catheter is a device that is attached to a port of the airway circuit for use as needed to aspirate liquids or semisolids from a patient's upper airway.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2712-2015·2015-09-09
Customed C-Section Surgical Packs Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 874 C-Section Surgical Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
C-SECTION SURGICAL PACK 2/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-2567-2015·2015-09-09
Customed Foley Catheter Kits Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 280 Foley Catheter Kits II in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
FOLEY CATHETER KIT II 18 FR 20/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-2711-2015·2015-09-09
Customed Plastic Surgery Packs Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 105 Plastic Surgery Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
PLASTIC SURGERY PACK 5/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-2636-2015·2015-09-09
Customed EENT Pack I Recalled Due to Sterilization Validation Issues
Customed, Inc. is recalling EENT Pack I sterile medical packs in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
EENT PACK I (1) 10/CS CUSTOMED Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-2631-2015·2015-09-09
Customed Central Line Full Body Drapes Recalled for Sterilization Issues
Customed, Inc. is recalling 56 units of Central Line Full Body Drapes due to inadequate validation of sterilization processes and package integrity.
Product
CENTRAL LINE FULL BODY DRAPE CUSTOMED 28/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-2557-2015·2015-09-09
Customed Wound Closure Trays Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 1,350 Wound Closure Tray II units in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
WOUND CLOSURE TRAY II CUSTOMED 50/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-2623-2015·2015-09-09
Customed Knee Arthroscopy Kits Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 188 Knee Arthroscopy Kits distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
KNEE ARTHROSCOPY PK 4/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-2530-2015·2015-09-09
Mahurkar Elite Acute Dual Lumen Catheter Tray Recalled for Sterility Concerns
Covidien LLC is recalling 53 kits of Mahurkar Elite Acute Dual Lumen Catheter Trays because sterility may be compromised.
Product
Mahurkar" Elite Acute Dual Lumen Catheter Tray, Straight Extensions with IC* Safety Components, 12 Fr x 20 cm Item Code:8888221420 Product Usage: Sterile Delivery are indicated for use in flushing compatible intravenous administration sets and indwelling intravascular…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2689-2015·2015-09-09
Customed Utility Drapes Recalled for Sterilization Validation Issues
Customed, Inc. is recalling Utility Drapes due to inadequate validation of sterilization processes and package integrity.
Product
UTILITY DRAPE END PRODUCT 50PK/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-2677-2015·2015-09-09
Customed Labor and Delivery Kits Recalled for Sterilization Defects
Customed, Inc. is recalling 300 Labor and Delivery kits distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
LABOR & DELIVERY 4/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-2595-2015·2015-09-09
Customed Recalls Surgical Gowns Due to Sterilization Validation Issues
Customed, Inc. is recalling 180 surgical gowns distributed in Puerto Rico because of inadequate validation of sterilization processes and package integrity.
Product
Gown, surgical 30/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-2673-2015·2015-09-09
Customed Major Lap Pack Recalled for Sterilization Validation Issues
Customed, Inc. is recalling Major Lap Packs due to inadequate validation of sterilization processes and package integrity.
Product
MAJOR LAP PACK 4/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-2495-2015·2015-09-09
Halyard Health Recalls KimVent Closed Suction Systems Due to Valve Defect
Halyard Health is recalling specific KimVent Closed Suction Systems because the thumb valve may remain partially open after suctioning, compromising the device's intended function.
Product
KimVent* Wet Pak* Closed Suction System for Adults, 14 F, T-Piece (Product Code 22056); KimVent* Wet Pak* Closed Suction System for Adults, 16 F, T-Piece (Product Code 22556); KimVent* Wet Pak* Closed Suction System for Adults, 14 F, T-Piece (Product Code 22012356) A…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2610-2015·2015-09-09
Customed Laparotomy Packs Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 2,142 units of Laparotomy Packs due to inadequate validation of sterilization processes and package integrity.
Product
LAPAROTOMY PACK CUSTOMED 7/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-2619-2015·2015-09-09
Customed Gauze Sponges Recalled for Sterilization Validation Deficiencies
Customed, Inc. is recalling 18,000 units of 2"x2" 4-ply sterile gauze sponges distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
GAUZE SPONGES 2"x2" 4 PLY ST 2/PK 1500PK/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-2620-2015·2015-09-09
Customed Gauze Sponges Recalled for Sterilization Validation Deficiencies
Customed, Inc. is recalling 3,000 units of gauze sponges due to inadequate validation of sterilization processes and package integrity.
Product
GAUZE SPONGE 2"X2" 8PLY COTTON 1500PK/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-2594-2015·2015-09-09
Customed Medical Leggings Recalled for Sterilization Validation Defects
Customed, Inc. is recalling 300 units of medical leggings used for surgical and patient care procedures due to inadequate sterilization validation and package integrity issues.
Product
LEGGINGS W/7" CUFF 30" x 42" 30/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-2680-2015·2015-09-09
Customed Laparoscopy Kits Recalled for Sterilization Validation Defects
Customed, Inc. is recalling 244 laparoscopy kits distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
LAPAROSCOPY PK 4/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-2633-2015·2015-09-09
Customed Ear Packs Recalled Due to Sterilization Validation Issues
Customed, Inc. is recalling specific lots of Ear Packs used in surgical procedures due to inadequate validation of sterilization processes and package integrity.
Product
EAR PACK 3/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-2659-2015·2015-09-09
Customed Orthopedic Surgical Packs Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 90 units of Orthopedic Pack Basic surgical packs distributed in Puerto Rico due to inadequate sterilization process validation and package integrity concerns.
Product
ORTHOPEDIC PACK BASIC 5/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-2480-2015·2015-09-09
Beckman Coulter Recalls LH Series Diluent Due to Cuvette Compromise Risk
Beckman Coulter is recalling LH Series Diluent because it may eventually compromise the Hgb cuvette in LH 750 and LH780 Hematology Systems.
Product
COULTER LH Series Diluent, Catalog No. 8547194, Product Labeling A40192-AD. The diluent provides the ability to analyze portions of the diluted blood sample for different blood cell types, such as red blood cells and platelets.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2525-2015·2015-09-09
Monoject Saline Flush Recall Due to Potential Sterility Compromise
Covidien LLC is recalling Monoject 0.9% Saline Flush Prefill Double Pouches because sterility may be compromised.
Product
Monoject 0.9% Saline Flush Prefill Double Pouch Item Code: 8881570129 Product Usage: Sterile Delivery are indicated for use in flushing compatible intravenous administration sets and indwelling intravascular access devices.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2634-2015·2015-09-09
Customed Extremity Arm Packs Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 148 Extremity Arm Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
EXTREMITY ARM PACK 4/CS HOSP. DR. CENTER Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-2596-2015·2015-09-09
Customed Universal Packs Recalled for Sterilization Validation Issues
Customed, Inc. is recalling Universal Packs used for surgical procedures due to inadequate validation of sterilization processes and package integrity.
Product
UNIVERSAL PACK 3/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
Category
Medical Device
Distribution
1 state

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