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

4076–4100 of 5038

SevereFDA (Devices)·Z-2533-2015·2015-09-09
Mahurkar Elite Acute Triple Lumen Catheter Tray Recalled for Sterility Concerns
Covidien LLC is recalling 165 Mahurkar Elite Acute Triple Lumen Catheter Trays because sterility may be compromised. The affected units were distributed nationwide.
Product
Mahurkar Elite Acute Triple Lumen Catheter Tray, Curved Extensions with IC* Safety Components, 12.5 Fr x 13 cm Item Code: 8888233413 Product Usage: Sterile Delivery are indicated for use in flushing compatible intravenous administration sets and indwelling intravascular acce
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2684-2015·2015-09-09
Customed Surgical Gowns Recalled for Sterilization Validation Deficiencies
Customed, Inc. is recalling surgical gowns due to inadequate validation of sterilization processes and package integrity. The products were distributed only in Puerto Rico.
Product
SURG GOWN POLYREINF LGE CUSTOM 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
SevereFDA (Devices)·Z-2615-2015·2015-09-09
Customed Endoveneous Custom Packs Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 20 units of Endoveneous Custom Packs in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
ENDOVENOUS CUSTOM PACK 5/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
SevereFDA (Devices)·Z-2527-2015·2015-09-09
Recall of Mahurkar Acute Dual Lumen Catheter Trays Due to Sterility Concerns
Covidien LLC is recalling 8 kits of Mahurkar Acute Dual Lumen Catheter Trays because sterility may be compromised.
Product
Mahurkar Acute Dual Lumen Catheter Tray, High Flow¿ Pre-Curved with IC* Safety Components, 13.5 FR x 13.5 cm Item Code: 8888135139 Product Usage: Sterile Delivery are indicated for use in flushing compatible intravenous administration sets and indwelling intravascular access
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2710-2015·2015-09-09
Customed Curations Kits Recalled Due to Sterilization Validation Issues
Customed, Inc. is recalling Curations Kits in Puerto Rico because the sterilization process and package integrity were not adequately validated.
Product
CURATION KIT 10/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
SevereFDA (Devices)·Z-2676-2015·2015-09-09
Customed Gauze Sponges Recalled for Sterilization Process Validation Issues
Customed, Inc. is recalling 19,328 units of 4"x4" 16-ply gauze sponges distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
GAUZE SPONGE 4"X4" 16 PLY SOFT 1280/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
SevereFDA (Devices)·Z-2545-2015·2015-09-09
MediTrace Cadence Defibrillation Electrodes Recalled for Wire Insulation Damage
Covidien LLC is recalling MediTrace Cadence Adult Multi-Function Defibrillation Electrodes due to potential wire insulation damage that may cause burns or reduced therapy.
Product
MediTrace Cadence Adult Multi-Function Defibrillation Electrodes Item Code:22550PC
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2546-2015·2015-09-09
MediTrace Cadence Defibrillation Electrodes Recalled for Wire Insulation Damage
Covidien LLC is recalling MediTrace Cadence Adult Zoll defibrillation electrodes due to potential wire insulation damage that could cause burns or reduced therapy.
Product
MediTrace Cadence Adult Zoll, Preconnect Defibrillation Electrode, Nonsterile Item Code:22770PC
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2558-2015·2015-09-09
Customed Cysto TUR Pack Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 290 packs of Cysto TUR Pack due to inadequate validation of sterilization processes and package integrity.
Product
CYSTO TUR PACK CUSTOMED 10/CS REV. C 10/13 NON STERILE 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
SevereFDA (Devices)·Z-2707-2015·2015-09-09
Customed Cesarean PK 4/CS Recalled for Sterilization Validation Defects
Customed, Inc. is recalling 48 units of CESAREAN PK 4/CS surgical kits due to inadequate validation of sterilization processes and package integrity.
Product
CESAREAN 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
SevereFDA (Devices)·Z-2688-2015·2015-09-09
Customed Recalls Lap-Cholecystectomy Surgical Packs Due to Sterilization Issues
Customed, Inc. is recalling 320 lap-cholecystectomy surgical packs distributed in Puerto Rico because of inadequate validation of sterilization processes and package integrity.
Product
LAP-CHOLECYSTECTOMY SURGICAL PACK 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
SevereFDA (Devices)·Z-2494-2015·2015-09-09
Halyard KimVent Closed Suction System Thumb Valve Recall
Halyard Health is recalling KimVent Closed Suction Systems because the thumb valve may remain partially open after suctioning, despite appearing locked.
Product
KimVent* Wet Pak* Closed Suction System for Adults, 14 F, DT, T-Piece (Product Code 220569) 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
SevereFDA (Devices)·Z-2560-2015·2015-09-09
Customed Arthroscopy Packs Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 45 Arthroscopy Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
ARTHROSCOPY 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
SevereFDA (Devices)·Z-2655-2015·2015-09-09
Customed Suction Catheter Kits Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 8,300 suction catheter kits distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
SUCTION CATHETER KIT 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
SevereFDA (Devices)·Z-2536-2015·2015-09-09
MAHURKAR Acute Dialysis Catheters Recalled for Potential Sterility Compromise
FDA is recalling MAHURKAR 12Fr Acute Dialysis Catheters due to a potential compromise in sterility.
Product
MAHURKAR"* 12Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20cm, Curved Extensions, PASS Tray Item Code: 8888103003HP Product Usage: Sterile Delivery are indicated for use in flushing compatible intravenous administration sets and indwelling intravascular access
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2517-2015·2015-09-09
Halyard Health Recalls KimVent Multi-Access Port Replacement Catheters
Halyard Health is recalling KimVent Multi-Access Port Replacement Catheters because the thumb valve may remain partially open after suctioning, potentially compromising the closed suction system.
Product
KimVent* Multi-Access Port Replacement Catheter for Adults,Tracheostomy, 14 F (Product Code 2401453-5) 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 airw
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2697-2015·2015-09-09
Customed O.B. Pack Hospital 3/CS Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 147 units of O.B. Pack Hospital 3/CS in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
O.B. PACK HOSPITAL 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
SevereFDA (Devices)·Z-2547-2015·2015-09-09
Physio-Control QuikCombo Pacing and Defibrillation Electrodes Recalled for Wire Insulation Damage
Covidien is recalling 56,000 sets of Physio-Control QuikCombo electrodes due to potential wire insulation damage that could cause burns or reduced therapy.
Product
Physio-Control QuikCombo Pacing/Defibrillation/ECG Electrodes RediPak¿ Preconnect System Item Code:PM20022
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2488-2015·2015-09-09
Synthes Recalls VEPTR Inferior Cradles Due to Mechanical Failure Risk
Synthes (USA) Products LLC is recalling VEPTR Inferior Cradles because a partially formed hole may cause mechanical failure, potentially requiring surgery.
Product
VEPTR Vertical Expandable Prosthetic Titanium Rib, inferior cradles also known as caudal rib supports. The VEPTR/VEPTR II devices mechanically stabilize and/or correct thoracic deformities to allow the chest and lungs to grow.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2538-2015·2015-09-09
Panoramic X-ray Model PC-1000 Recalled for Jackscrew Nut Failure
Panoramic Rental Corp. is recalling 7,885 Panoramic X-ray Model PC-1000 units due to a jackscrew nut part failure that could cause device malfunction and injury.
Product
Panoramic X-ray Model PC-1000 The PC-1000 will enable the user to take panoramic x-ray images. The PC-1000/Laser 1000 will enable the user to take panoramic x-ray images as well as cephalometric x-ray images.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2589-2015·2015-09-09
Customed D & C Laparoscopy Packs Recalled for Sterilization Defects
Customed, Inc. is recalling 192 D & C Laparoscopy Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
D & C 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
SevereFDA (Devices)·Z-2535-2015·2015-09-09
MAHURKAR Acute Dialysis Catheter Recalled for Potential Sterility Compromise
Covidien LLC is recalling 569 MAHURKAR 12Fr Acute Dialysis Catheters because sterility may be compromised. The products were distributed nationwide in the US.
Product
MAHURKAR 12Fr High Pressure Triple Lumen Acute Dialysis Catheter, 16cm, Curved Extensions, PASS Tray Item Code: 8888103002HP Product Usage: Sterile Delivery are indicated for use in flushing compatible intravenous administration sets and indwelling intravascular access devic
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2534-2015·2015-09-09
Mahurkar Elite Acute Triple Lumen Catheter Tray Recalled for Sterility Concerns
Covidien LLC is recalling 171 kits of Mahurkar Elite Acute Triple Lumen Catheter Trays because sterility may be compromised.
Product
Mahurkar Elite Acute Triple Lumen Catheter Tray, Curved Extensions with IC* Safety Components, 12.5 Fr x 20 cm Item Code: 8888233420 Product Usage: Sterile Delivery are indicated for use in flushing compatible intravenous administration sets and indwelling intravascular ac
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2526-2015·2015-09-09
Mahurkar Acute Dual Lumen Catheter Tray Recalled for Sterility Concerns
Covidien LLC is recalling 96 kits of Mahurkar Acute Dual Lumen Catheter Trays because sterility may be compromised.
Product
Mahurkar Acute Dual Lumen Catheter Tray, High Flow Straight Extensions with IC* Safety Components, 13.5 FR x 13.5 cm Item Code: 8888135137 Product Usage: Sterile Delivery are indicated for use in flushing compatible intravenous administration sets and indwelling intravascul
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2462-2015·2015-09-02
Arrow International Recalls PICC Kits with Potential Peel-Away Sheath Defect
Arrow International is recalling 52,109 PICC kits because the peel-away sheath hub tabs may prematurely detach. One injury has been reported.
Product
PICC Kits with Peel-Away Sheath Component; catheter, intravascular, therapeutic, ultrasound Product Usage: catheter, intravascular, therapeutic, ultrasound
Category
Medical Device
Distribution
Distributed nationwide

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4076–4100 of 5038