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

11201–11225 of 13816

HighFDA (Devices)·Z-1714-2022·2022-09-21
Vascular Wire Guide Recalled Due to Sterility Concerns From Packaging Failure
Cook Incorporated is recalling Roadrunner UniGlide Hydrophilic Wire Guides (Lot 14156569) because packaging testing failed, indicating the device's sterility may be compromised. The recall affects 75 units distributed in the U.S. and internationally.
Product
Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWA-35-80 ORDER NUMBER (GPN): G56172. For vascular catheter positioning and exchange in diagnostic and interventional procedures.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1736-2022·2022-09-21
Steris SixCess Challenge Pack Recalled for Incorrect Chemical Indicators
Steris Corporation is recalling 619 boxes of Verify SixCess Challenge Pack due to incorrect chemical indicators in the packaging. This sterilization validation device is distributed across 31 U.S. states.
Product
Verify SixCess Challenge Pack. Used to confirm that critical parameters of steam sterilization have been reached within a challenging test pack design.
Category
Medical Device
Distribution
31 states
ModerateFDA (Devices)·Z-1729-2022·2022-09-21
GXL Acetabular Liners Recalled Due to Non-Conforming Packaging
Exactech is recalling certain GXL acetabular liners packaged in non-conforming bags that may cause accelerated wear of the hip implant component. No injuries have been reported.
Product
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION GXL LINER, NEUTRAL, 28MM ID, GROUP 1 CUPS, REF 130-28-51 b. NOVATION GXL LINER, NEUTRAL, 32MM ID, GROUP 2 CUPS, REF 130-32-52 c. NOVATION GXL LINER, NEUTRAL, 36MM ID, GROUP 3 CUPS, RE
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1741-2022·2022-09-21
PTS Panels CHOL+GLU Test Strips Recalled for Incorrect Instructions
PTS Panels CHOL+GLU Test Strips (lot A202) are recalled because incorrect instructions for use were packaged with the product. Distribution includes the US, Japan, and Russia.
Product
PTS Panels CHOL+GLU Test Strips (REF 1765)
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1735-2022·2022-09-21
Stryker USB Converter in Mako Robotic Surgery System May Fail
Mako Surgical Corporation is recalling certain Stryker USB Converter components that may arrive non-functional or fail during use. Affected units are in Illinois and Arizona.
Product
Stryker USB Converter, Polaris Spectra Camera, Catalog #201148, a component of the Mako Robotic-Arm Assisted Surgery System.
Category
Medical Device
Distribution
2 states
ModerateFDA (Devices)·Z-1733-2022·2022-09-21
GXL Hip Implant Liners Recalled for Packaging Defect Risk
Exactech is recalling specific GXL acetabular polyethylene hip implant liners because non-conforming packaging may cause accelerated wear. The company has distributed 4,956 affected devices worldwide.
Product
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 42, REF 106-22-42; b. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 44, REF 106-22-44; c. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 2
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1740-2022·2022-09-21
Helix Elite SARS-CoV-2 Reference Standard Recalled for Unregistered UK Distribution
Microbiologics Inc. has recalled Helix Elite Inactivated SARS-CoV-2 reference standards distributed to the United Kingdom because the product was not registered for use in that region.
Product
Helix Elite Inactivated Standard, labeled as: a. Inactivated SARS-CoV-2 B.1.1.7 Whole Virus, REF HE0071N; b. Inactivated SARS-CoV-2 B.1.351 Whole Virus, REF HE0073N
Category
Medical Device
Distribution
0 states
LowFDA (Devices)·Z-1743-2022·2022-09-21
BIOPHEN UFH Control Plasma Includes Incorrect Product Labeling in Package
BIOPHEN UFH Control Plasma boxes contain incorrect product labeling. Aniara Diagnostica LLC is recalling 13 units (Lot FA2035) distributed in Illinois and Michigan.
Product
BIOPHEN UFH Control Plasma
Category
Medical Device
Distribution
2 states
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-1657-2022·2022-09-14
Philips OmniLab Advanced+ sleep apnea devices recalled for off-gassing
Philips Respironics is recalling 85 units of the OmniLab Advanced+ ventilation device due to motor assemblies containing nonconforming plastic that off-gasses volatile organic compounds.
Product
Philips OmniLab Advanced+, 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-1656-2022·2022-09-14
Philips BiPAP V30 Auto Respirators Recalled for VOC Off-Gassing Risk
Philips Respironics recalls 295 BiPAP V30 Auto respiratory devices due to motor assemblies with nonconforming plastic. These assemblies off-gas volatile organic compounds (VOCs) during device operation.
Product
Philips BiPAP V30 Auto, 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-1659-2022·2022-09-14
Philips OmniLab ventilator recalled for motor assembly plastic off-gassing defect
Philips Respironics is recalling OmniLab Advanced + ventilators due to motor assemblies manufactured with nonconforming plastic that releases volatile organic compounds (VOCs). The 8 affected units were distributed across the US and internationally.
Product
Philips OmniLab Advanced + with Heated Tube Humidifier, 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
SevereFDA (Devices)·Z-1655-2022·2022-09-14
Philips BiPAP A40 Respiratory Devices Recalled for Motor Assembly Off-Gassing
Philips is recalling BiPAP A40 respiratory support devices because motor assemblies were manufactured with nonconforming plastic that off-gases volatile organic compounds (VOCs). Approximately 1,414 units have been distributed domestically and internationally.
Product
Philips BiPAP A40, 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-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-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-1700-2022·2022-09-14
Neurology Surgical Packs Recalled for Sterilization Validation Failure
American Contract Systems recalls 37 units of neurology surgical packs distributed across 13 US states due to exposure to multiple sterilization cycles without proper validation.
Product
Various neurology packs
Category
Medical Device
Distribution
13 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-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
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-1703-2022·2022-09-14
C-Section Surgical Packs recalled for improper sterilization validation
American Contract Systems recalls C-section surgical packs that were exposed to multiple sterilization cycles without validation. The sterilization integrity of the 24 affected units cannot be assured.
Product
Various C-section packs
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-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-1695-2022·2022-09-14
Cysto Packs Recalled Due to Inadequate Sterilization Validation
American Contract Systems is recalling Cysto Packs distributed to health systems and distributors because the devices were exposed to multiple sterilization cycles without validation for multiple exposures.
Product
Various Cysto 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

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11201–11225 of 13816