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

4251–4275 of 5038

SevereFDA (Devices)·Z-0562-2015·2014-12-17
PFM Medical Recalls ASEPT Drainage Kits for Bacterial Endotoxin Concerns
PFM Medical is recalling ASEPT 600 ml Drainage Kits because they may exceed USP limits for bacterial endotoxin. The recall affects 1,470 units distributed in the US and abroad.
Product
ASEPT 600 ml Drainage Kit, Ref No. 622287, M7052 Product Usage: The ASEPT Drainage Kit is an accessory to be used to connect to the ASEPT Pleural or Peritoneal Drainage Catheter to drain fluid from the chest or abdomen.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0524-2015·2014-12-17
Medtronic MiniMed Infusion Sets Recalled Due to Tubing Detachment Risk
Medtronic MiniMed is recalling Silhouette and Sure-T infusion sets because tubing may detach, interrupting insulin delivery without an alarm.
Product
Medtronic MiniMed Silhouette and/or MiniMed Sure-T Infusion Sets; Paradigm Silhouette infusion sets: MMT-368, MMT-368600, MMT-371, MMT-373, MMT-377, MMT-377600, MMT378, MMT-378600, MMT-38 1, MMT-381 600, MMT-382, MMT-382600, MMT-383, MMT-383600, MMT384, & MMT384600. Sure-T infusi
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0507-2015·2014-12-17
TomoTherapy Treatment System Recalled for Jaw Position Monitoring Failure
TomoTherapy Incorporated is recalling 210 TomoTherapy Treatment Systems worldwide due to a software defect that may fail to monitor jaw position after an error, potentially leading to incorrect treatment delivery.
Product
TomoTherapy Treatment System with software versions 2.0.1 / 2.0.2 / 2.0.3/ (Hi:Art 5.0.1 / 5.0.2 / 5.0.3)
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-0311-2015·2014-12-10
Customed Minor Laparotomy Packs Recalled Due to Compromised Sterility
Customed, Inc. is recalling 625 Minor Laparotomy Packs because compromised sterility and manufacturing deficiencies may result in patient infection.
Product
Minor Laparotomy Pack, Catalog number 900-1735. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Medical Device
Distribution
3 states
CriticalFDA (Devices)·Z-0458-2015·2014-12-10
ConMed Adult Radiotransparent Electrode Recall Due to Connection Failure Risk
ConMed is recalling Adult Radiotransparent Electrodes because design changes to Philips AEDs may prevent connection, delaying therapy and risking patient death or serious injury.
Product
ADULT Radiotransparent Electrode, REF/Catalog Number 2516H-PC, Rx ONLY --- COMPARABLE TO PHILIPS MEDICAL HEARTSTART ELECTRODES PLUG STYLE CONNECTOR
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-0460-2015·2014-12-10
ConMed Pediatric Electrodes Recalled Due to Connection Design Changes
ConMed is recalling 174,610 pediatric electrodes because design changes to Philips AEDs may prevent connection, delaying therapy and risking death or serious injury.
Product
MINI PEDIATRIC Radiotransparent Electrode, REF/Catalog Number 2602H, Rx ONLY --- COMPARABLE TO PHILIPS MEDICAL HEARTSTART ELECTRODES PLUG STYLE CONNECTOR--Intended for use during defibrillation, cardioversion, pacing, and ECG monitoring applications. This product is a single-use,
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-0455-2015·2014-12-10
ConMed Adult Radiotransparent Electrode Recall Due to Connection Design Changes
ConMed is recalling Adult Radiotransparent Electrodes because design changes to Philips AED connections may cause connection failures, potentially delaying therapy and resulting in patient death or serious injury.
Product
ADULT Radiotransparent Electrode, REF/Catalog Number 2001H-C, Rx ONLY --- COMPARABLE TO PHILIPS MEDICAL HEARTSTART ELECTRODES PLUG STYLE CONNECTOR
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-0296-2015·2014-12-10
Customed Laparotomy Packs Recalled Due to Compromised Sterility and Contamination Risk
Customed, Inc. is recalling 892 Laparotomy Packs (Catalog 900-149) because compromised sterility and inadequate storage conditions may result in patient infection.
Product
Laparotomy Pack, Catalog number 900-149. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Medical Device
Distribution
3 states
CriticalFDA (Devices)·Z-0457-2015·2014-12-10
ConMed Adult Radiotransparent Electrode Recall Due to Connection Design Changes
ConMed is recalling 174,610 Adult Radiotransparent Electrodes because design changes to Philips AED connections may cause therapy delays, risking patient death or serious injury.
Product
ADULT Radiotransparent Electrode, REF/Catalog Number 2516H, Rx ONLY --- COMPARABLE TO PHILIPS MEDICAL HEARTSTART ELECTRODES PLUG STYLE CONNECTOR
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-0383-2015·2014-12-10
Customed Minor Laparotomy Packs Recalled for Sterility Compromise
Customed, Inc. is recalling 250 Minor Laparotomy Packs due to compromised sterility and manufacturing deficiencies that may cause patient infection.
Product
Minor Laparotomy Pack, Catalog number 900-450. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Medical Device
Distribution
3 states
CriticalFDA (Devices)·Z-0459-2015·2014-12-10
ConMed Pediatric Radiotransparent Electrode Recall Due to Connection Design Changes
ConMed is recalling 174,610 pediatric radiotransparent electrodes because design changes to Philips AED connections may cause therapy delays, risking patient death or serious injury.
Product
PEDIATRIC Radiotransparent Electrode, REF/Catalog Number 2603H, Rx ONLY --- COMPARABLE TO PHILIPS MEDICAL HEARTSTART ELECTRODES PLUG STYLE CONNECTOR
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-0461-2015·2014-12-10
ConMed Pediatric Multifunction Electrodes Recalled for Connection Design Flaws
ConMed is recalling Pediatric R2 Multifunction Electrodes because design changes to the connection with Philips Heartstart devices may cause connection failures, potentially delaying therapy and leading to patient death or serious injury.
Product
CONMED PEDIATRIC R2 Multifunction Electrodes, REF/Catalog Number 3115-1750, Direct Connect to Philips Heartstart, Rx ONLY --- ASSEMBLED IN MEXICO -Intended for use during defibrillation, cardioversion, pacing, and ECG monitoring applications. This product is a single-use, disposa
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-0454-2015·2014-12-10
ConMed Adult Radiotransparent Electrodes Recalled for Connection Design Failure
ConMed is recalling Adult Radiotransparent Electrodes because a design change in Philips AEDs may prevent connection, delaying therapy and risking patient death or serious injury.
Product
ADULT Radiotransparent Electrode, REF/Catalog Number 2001H, Rx ONLY --- COMPARABLE TO PHILIPS MEDICAL HEARTSTART ELECTRODES PLUG STYLE CONNECTOR Intended for use during defibrillation, cardioversion, pacing, and ECG monitoring applications. This product is a single-use, disposab
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-0462-2015·2014-12-10
ConMed Multifunction Electrodes Recalled for Connection Design Failure
ConMed is recalling multifunction electrodes due to a design change that may prevent connection to Philips AEDs, potentially delaying therapy.
Product
CONMED ADULT R2 Multifunction Electrodes, REF/Catalog Number 3115-1751, Direct Connect to Philips Heartstart, Rx ONLY --- ASSEMBLED IN MEXICO -Intended for use during defibrillation, cardioversion, pacing, and ECG monitoring applications. This product is a single-use, disposable
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-0456-2015·2014-12-10
ConMed Adult Radiotransparent Electrodes Recalled for Connection Design Changes
ConMed is recalling 174,610 Adult Radiotransparent Electrodes because design changes to Philips AED connections may cause therapy delays, risking patient death or serious injury.
Product
ADULT Radiotransparent Electrode, REF/Catalog Number 2001H-PC, Rx ONLY --- COMPARABLE TO PHILIPS MEDICAL HEARTSTART ELECTRODES PLUG STYLE CONNECTOR
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0414-2015·2014-12-10
Customed Peri Gyn Pack Recalled Due to Sterility Compromise
Customed, Inc. is recalling 230 units of Peri Gyn Packs due to compromised sterility and manufacturing deficiencies that may cause patient infection.
Product
Peri Gyn Pack, Catalog # 900-997 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Medical Device
Distribution
3 states
SevereFDA (Devices)·Z-0387-2015·2014-12-10
Customed Laparotomy Basic Packs Recalled for Sterility Compromise
Customed, Inc. is recalling 70 Laparotomy Basic Packs due to compromised sterility and manufacturing deficiencies that may increase the risk of patient infection.
Product
Laparotomy Basic Pack, Catalog number 900-547 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Medical Device
Distribution
3 states
SevereFDA (Devices)·Z-0351-2015·2014-12-10
Customed Gown Cool Impervious XLGE Breathable Recalled for Sterility Compromise
Customed, Inc. is recalling 144 units of Gown Cool Impervious XLGE Breathable gowns due to compromised sterility and manufacturing deficiencies that may lead to patient infection.
Product
Gown Cool Impervious XLGE Breathable, catalog #900-2592 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Medical Device
Distribution
3 states
SevereFDA (Devices)·Z-0329-2015·2014-12-10
Customed Femoral Pack Recalled Due to Sterility Compromise and Contamination Risk
Customed, Inc. is recalling 92 units of Femoral Packs (catalog #900-2164) due to compromised sterility and manufacturing deficiencies that may cause patient infection.
Product
Femoral Pack, catalog #900-2164 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Medical Device
Distribution
3 states
SevereFDA (Devices)·Z-0385-2015·2014-12-10
Customed Laparoscopy Packs Recalled for Sterility and Contamination Risks
Customed, Inc. is recalling 48 Laparoscopy Packs due to compromised sterility and manufacturing deficiencies that may lead to patient infection.
Product
Laparoscopy Pack, Catalog number 900-484 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Medical Device
Distribution
3 states
SevereFDA (Devices)·Z-0275-2015·2014-12-10
Customed Recalls Peri Gyn Packs Due to Compromised Sterility
Customed, Inc. is recalling 740 Peri Gyn Packs because compromised sterility and inadequate storage conditions may result in patient infection.
Product
Peri Gyn Pack, Catalog number 900-1091. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Medical Device
Distribution
3 states
SevereFDA (Devices)·Z-0395-2015·2014-12-10
Customed Recalls Pery Gyn Packs Due to Sterility Compromise
Customed, Inc. is recalling 475 Pery Gyn Packs because significant sterility compromises and manufacturing deficiencies may result in patient infection.
Product
Pery Gyn Pack, Catalog number 900-635. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Medical Device
Distribution
3 states
SevereFDA (Devices)·Z-0315-2015·2014-12-10
Customed Ophthalmic Packs Recalled for Compromised Sterility and Contamination Risk
Customed, Inc. is recalling 582 Ophthalmic Packs due to compromised sterility and inadequate storage conditions that may result in patient infection.
Product
Ophtalmic Pack, Catalog number 900-1780. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Medical Device
Distribution
3 states
SevereFDA (Devices)·Z-0280-2015·2014-12-10
Customed Laparoscopy OB GYN Packs Recalled for Compromised Sterility
Customed, Inc. is recalling 105 Laparoscopy OB GYN Packs due to compromised sterility and manufacturing deficiencies that may result in patient infection.
Product
Laparoscopy OB GYN Pack, Catalog number 900-1192. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Medical Device
Distribution
3 states
SevereFDA (Devices)·Z-0262-2015·2014-12-10
Customed Gown Fabric Reinforced XXL Recalled for Compromised Sterility
Customed, Inc. is recalling 1,120 units of Gown Fabric Reinforced XXL due to compromised sterility and manufacturing deficiencies that may result in patient infection.
Product
Gown Fabric Reinforced XXL, Catalog number 900-2567. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Medical Device
Distribution
3 states

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4251–4275 of 5038