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

11126–11150 of 13748

SevereFDA (Devices)·Z-1654-2022·2022-09-14
Philips BiPAP A30 respiratory device motor assemblies recalled for VOC off-gassing
Philips Respironics recalls Philips BiPAP A30 respiratory devices due to motor assemblies with nonconforming plastic that off-gases volatile organic compounds (VOCs). Patients should contact the manufacturer immediately.
Product
Philips BiPAP A30, Rx Only. To provide noninvasive ventilation support for patients with obstructive sleep apnea syndrome (OSA) and respiratory insufficiency.
Category
Medical Device
Distribution
42 states
SevereFDA (Devices)·Z-1658-2022·2022-09-14
Philips OmniLab Advanced+ Ventilation Devices Recalled for Plastic Off-Gassing
Philips Respironics is recalling certain Philips OmniLab Advanced+ noninvasive ventilation devices due to motor assemblies with nonconforming plastic that can off-gas volatile organic compounds (VOCs). This is an FDA Class I recall.
Product
Philips OmniLab Advanced+ Intl (Flow Gen), Rx Only. To provide noninvasive ventilation support for patients with obstructive sleep apnea syndrome (OSA) and respiratory insufficiency.
Category
Medical Device
Distribution
42 states
HighFDA (Devices)·Z-1696-2022·2022-09-14
Port Insertion Packs Recalled Due to Unvalidated Sterilization
American Contract Systems is recalling Various Port Insertion Packs that were exposed to multiple sterilization cycles without proper validation. The devices may not meet sterility standards.
Product
Various Port Insertion Packs
Category
Medical Device
Distribution
13 states
HighFDA (Devices)·Z-1690-2022·2022-09-14
Angiography and Catheterization Packs Recalled Due to Inadequate Sterilization Validation
American Contract Systems is recalling 61 angiography and catheterization packs that were exposed to multiple sterilization cycles without proper validation. The affected packs were distributed to healthcare facilities in 13 U.S. states.
Product
Various Angiography/Cath Lab packs/trays
Category
Medical Device
Distribution
13 states
HighFDA (Devices)·Z-1694-2022·2022-09-14
Laparoscopy surgical instrument packs recalled for sterilization validation failure
American Contract Systems is recalling 39 laparoscopy instrument packs that were exposed to multiple sterilization cycles without validation. The sterilization process was not tested for repeated exposures.
Product
Various Laparoscopy Packs
Category
Medical Device
Distribution
13 states
HighFDA (Devices)·Z-1688-2022·2022-09-14
VYGON Dressing Change Kit Recalled for Potential Seal Integrity Issues
Stradis Healthcare is recalling VYGON DRESSING CHANGE W/MAXISWAB kits due to potential incomplete seals that could compromise product sterility. Affected consumers should stop using recalled kits.
Product
VYGON DRESSING CHANGE W/MAXISWAB kit, REF AMS-8465CS
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1691-2022·2022-09-14
Pacemaker and Cardiothoracic Surgical Packs Recalled for Improper Sterilization Validation
American Contract Systems is recalling 24 units of pacemaker and cardiothoracic surgical packs distributed to health systems in multiple US states. Products were exposed to multiple sterilization cycles without proper validation.
Product
Various Pacemaker Packs, Cardio Thoracic Packs
Category
Medical Device
Distribution
13 states
HighFDA (Devices)·Z-1698-2022·2022-09-14
Medical device convenience packs exposed to unvalidated sterilization cycles
American Contract Systems, Inc. is recalling 116 convenience packs distributed to U.S. health systems and distributors in 13 states because they were exposed to multiple sterilization cycles without validation, potentially compromising device sterility assurance.
Product
Various convenience packs
Category
Medical Device
Distribution
13 states
HighFDA (Devices)·Z-1678-2022·2022-09-14
External Fixation Wire May Fracture During Surgery, Leaving Fragments in Patient
OrthoPediatrics Corp is recalling an external fixation wire due to manufacturing variance that may cause the tip to fracture. Fractured fragments could remain in patients.
Product
Orthex External Fixation Wire Sharp Bayonet 1.8 x 400 mm Model: K400-18BN
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1684-2022·2022-09-14
Early Bird Bleed Monitoring System Introducer fails to power on
Saranas, Inc. is recalling 953 units of the Early Bird Bleed Monitoring System Introducer Sheath Set due to a design error that prevents the device from powering on and completing self-tests. The product was distributed nationwide.
Product
Early Bird Bleed Monitoring System Introducer Sheath Set, REF: FG001-01 (6F), FG001-02 (8F)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1701-2022·2022-09-14
Obstetric and gynecology surgical packs recalled for unvalidated sterilization exposure
American Contract Systems is recalling 15 obstetric and gynecology surgical packs that underwent multiple sterilization cycles without validation. This could compromise product sterility and increase infection risk during procedures.
Product
Various ob/gyn packs
Category
Medical Device
Distribution
13 states
HighFDA (Devices)·Z-1699-2022·2022-09-14
Surgical instrument convenience packs recalled for inadequate sterilization validation
American Contract Systems is recalling 118 convenience packs of surgical instruments because they were exposed to multiple sterilization cycles without validation of the product's ability to withstand repeated sterilizations.
Product
Various convenience packs
Category
Medical Device
Distribution
13 states
HighFDA (Devices)·Z-1661-2022·2022-09-14
Handheld ultraviolet-C germicidal wand recalled for excessive radiation
MERCHSOURCE LLC is recalling a handheld ultraviolet-C germicidal wand (model 1013622) due to excessive ultraviolet-C radiation emission. Consumers should stop using the product immediately.
Product
The product is a handheld ultraviolet-C germicidal wand and contains two, narrow-diameter, tubular lamps with a peak emission wavelength in the 254 nm range.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1685-2022·2022-09-14
MEGA Intra-Aortic Balloon Catheter Recalled for Undersized Dilator
Datascope Corporation is recalling 10,427 units of the MEGA 8Fr 50cc Intra-Aortic Balloon Catheter due to an undersized dilator in certain lots. The device has been distributed internationally and is awaiting domestic distribution.
Product
MEGA 8Fr 50cc Intra-Aortic Balloon Catheter
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1677-2022·2022-09-14
CARTO VIZIGO Guiding Sheath Recalled Due to Water-Damaged Sterile Packaging
Biosense Webster is recalling 98 units of CARTO VIZIGO 8.5F guiding sheaths due to water damage to packaging that may have compromised the sterile barrier, creating a potential infection risk.
Product
CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath, REF: D138501. Used to introduce various cardiovascular catheters into the heart.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1702-2022·2022-09-14
Hysterectomy and Vaginal Packs Recalled for Improper Sterilization Validation
American Contract Systems recalled 29 hysterectomy and vaginal packs distributed to health systems in 13 states due to exposure to multiple sterilization cycles without validation.
Product
Various hysterectomy, vaginal packs
Category
Medical Device
Distribution
13 states
HighFDA (Devices)·Z-1676-2022·2022-09-14
Laboratory diagnostic system may report inaccurate results during shutdown
The VITROS XT 7600 laboratory analyzer may report inaccurate test results when the system performs a shutdown. The issue affects approximately 1,148 units distributed worldwide.
Product
VITROS XT 7600 Integrated System with Version 3.7.2 and below Product Code: 6844461
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1681-2022·2022-09-14
ChemoLock Infusion Ports Recalled for Unintended Disconnection Risk
ICU Medical recalls ChemoLock chemotherapy infusion ports for potential unintended disconnection due to spring variation, which may delay therapy and expose patients to caustic substances.
Product
Product Description/Item: ChemoLock Bag Spike, 10 units/CL-10-10; ChemoLock BAG SPIKE w/ ADDITIVE PORT, DRY SPIKE/CL-12; APPX 1.5ml,ChemoLock BAG SPIKE WITH ADDITIVE PORT/CL-13; ChemoLock Port/CL2100; ChemoLock Port, 5 Units/CL2100-5; ChemoLock Port/CL2100T; Clave Bag Spike
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1687-2022·2022-09-14
Undersized Dilator in Balloon Catheter Insertion Kit Recalled
Datascope Corporation is recalling certain lots of an Insertion Kit for intra-aortic balloon catheters due to undersized dilators. The defect affects 10,427 units distributed in the U.S. and internationally.
Product
Insertion Kit for use with SENSATION PLUS 8F. 50cc Intra-Aortic Balloon Catheter
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1697-2022·2022-09-14
Breast Abdominoplasty Pack Recalled for Inadequate Sterilization Cycle Validation
American Contract Systems, Inc. is recalling Breast Abdominoplasty Packs that were exposed to multiple sterilization cycles without validation that the process could safely maintain instrument sterility through repeated exposures.
Product
Breast Abdominoplasty Pack
Category
Medical Device
Distribution
13 states
HighFDA (Devices)·Z-1693-2022·2022-09-14
ENT Surgical Packs Recalled Due to Sterilization Validation Failure
American Contract Systems recalls various ENT surgical packs that may not have been properly sterilized due to multiple sterilization cycles without adequate validation. The packs were distributed to healthcare facilities in 13 states.
Product
Various ENT Packs
Category
Medical Device
Distribution
13 states
HighFDA (Devices)·Z-1679-2022·2022-09-14
Abbott Alinity m SARS-CoV-2 Control Kit Recalled for Failed Internal Control
Abbott is recalling 579 kits of its Alinity m SARS-CoV-2 CTRL control kit after reports of failed internal control errors preventing verification of test accuracy.
Product
Abbott Alinity m SARS-CoV-2 CTRL Kit, REF 09N78-085, each kit contains 12 x 1.3mL CTRL - and 12 x 1.3 mL CTRL +, For In Vitro Diagnostic Use.
Category
Medical Device
Distribution
24 states
HighFDA (Devices)·Z-1705-2022·2022-09-14
Eye Surgery Packs Recalled Due to Improper Sterilization Validation
American Contract Systems is recalling various eye and cataract surgery packs distributed to US health systems because the products were exposed to multiple sterilization cycles without validation. Unvalidated sterilization may compromise device sterility.
Product
Various eye packs, cataract packs
Category
Medical Device
Distribution
13 states
HighFDA (Devices)·Z-1704-2022·2022-09-14
D&C Pack Recall Due to Sterilization Validation Failure
American Contract Systems is recalling D&C packs that were exposed to multiple sterilization cycles without proper validation. The sterilization failure may compromise device sterility.
Product
D&C pack
Category
Medical Device
Distribution
13 states
HighFDA (Devices)·Z-1682-2022·2022-09-14
ChemoLock Chemotherapy Port Connectors Recalled for Disconnection Risk
ICU Medical recalls ChemoLock and ChemosafeLock port connectors used in chemotherapy delivery systems due to spring defects that may prevent proper connection or cause unintended disconnection, potentially delaying treatment or exposing patients to caustic substances.
Product
Product Description/Item: ChemoLock Vial Spike, 20mm/011-CL-80S; ChemoLock Bag Spike/CL-10; ChemoLock w/Mini Bag Spike/CL-17; 8 IN (20cm) APPX 1.0ml, EXT SET, MicroClave Clear, ChemoLock PORT, YCONN/CL3950; 31" (79 cm) Appx 3.4 ml, Admin Set w/20 Drop Integrated ChemoLock Dri
Category
Medical Device
Distribution
Distributed nationwide

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11126–11150 of 13748