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

9376–9400 of 27393

HighFDA (Devices)·Z-1715-2022·2022-09-21
Vascular catheter wire guide recalled for sterility testing failure
Cook Incorporated is recalling Roadrunner UniGlide Hydrophilic Wire Guides due to packaging testing failures that may compromise device sterility. The recall affects 865 units distributed nationwide and internationally.
Product
Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWAS-35-150 ORDER NUMBER (GPN): G56176. For vascular catheter positioning and exchange in diagnostic and interventional procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1722-2022·2022-09-21
ICU Medical Recalls Intravascular Connectors for Manufacturing Defect
ICU Medical is recalling approximately 5.8 million MicroClave Clear Connectors used in IV administration due to a manufacturing defect that creates a visible gap between the connector housing.
Product
MicroClave Clear Neutral Connector; MicroClave Clear Connector; MicroClave Clear Neutral Connector, Approx Priming Volume: 0.04 mL. Accessory for Intravascular Administration Set
Category
Medical Device
Distribution
53 states
HighFDA (Devices)·Z-1709-2022·2022-09-21
Roadrunner PC Wire Guide Recalled for Sterility Testing Failure
Cook Incorporated is recalling 1,997 units of the Roadrunner PC Hydrophilic Wire Guide due to packaging failure in sterility testing. The device's sterility may be compromised.
Product
Roadrunner PC Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): RPC-35-180 ORDER NUMBER (GPN):G07518. For vascular catheter positioning and exchange in diagnostic and interventional procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1744-2022·2022-09-21
Pinnacle3 Radiation Therapy Planning System dose-calculation software error
Philips Pinnacle3 radiation therapy planning systems may export incorrect dose information when multiple beams are used with certain Edit Prescription settings. 169 systems are affected.
Product
Pinnacle3 Radiation Therapy Planning System, Model numbers 870231 and 870237.
Category
Medical Device
Distribution
21 states
HighFDA (Devices)·Z-1745-2022·2022-09-21
INOmax DSIR Delivery System incompatible with upgraded Leoni Plus ventilator
The INOmax DSIR nitric oxide delivery system is incompatible with the 2021-upgraded Leoni Plus ventilator. Without proper connection including a required one-way valve, patients may receive excessive nitric oxide.
Product
INOmax DSIR -(delivery system) delivers INOMAX (nitric oxide for inhalation) therapy gas into the inspiratory limb of the patient breathing circuit in a way that provides a constant concentration of nitric oxide (NO), as set by the user, Model Number: 10007
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1716-2022·2022-09-21
Roadrunner UniGlide wire guide recalled for potential sterility compromise
Cook Incorporated is recalling 189 Roadrunner UniGlide hydrophilic wire guides because they failed packaging testing requirements and their sterility may be compromised.
Product
Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWAS-35-80 ORDER NUMBER (GPN): G56175. For vascular catheter positioning and exchange in diagnostic and interventional procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1726-2022·2022-09-21
GXL Acetabular Liners Recalled Due to Improper Packaging and Accelerated Wear
Exactech is recalling 136 GXL acetabular liners used in hip implants due to non-conforming packaging that may cause accelerated wear. The devices were distributed worldwide to multiple countries.
Product
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. ACUMATCH 15 DEGREE LINER 22MM SZ C, REF 132-22-03 b. ACUMATCH 15 DEGREE LINER 28MM SZ D, REF 13-28-04
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1728-2022·2022-09-21
GXL Acetabular Liners Recalled Due to Non-Conforming Packaging Bags
Exactech recalls GXL acetabular hip implant liners packaged in non-conforming bags that may cause premature wear. No injuries have been reported.
Product
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. ACUMATCH GXL 0 DEGREE LINER 28MM SZ E, REF 130-28-25 b. ACUMATCH GXL 0 DEGREE LINER 28MM SZ F, REF 130-28-26 c. ACUMATCH GXL 0 DEGREE LINER 28MM SZ G, REF 130-28-27 d. ACUMATCH GXL 0 DEGREE
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1720-2022·2022-09-21
ICU Medical Infusion Extension Set Recall Due to Connector Housing Gap
ICU Medical recalls 5.8 million infusion extension sets due to a manufacturing defect that creates a visible gap in the connector housing, potentially compromising device integrity.
Product
8.5" (22 cm) Appx 0.85 ml, Bifuse Pressure Infusion (400 psig) Ext Set w/2 Remv MicroClave Clear, 2 Purple Clamps, Rotating Luer;
Category
Medical Device
Distribution
53 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-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-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-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-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
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
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-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-1680-2022·2022-09-14
Medical embolization coil system recalled for untested alternate supplier material
BALT USA recalls the Optima Coil System because devices were distributed with material from an alternate supplier before required testing was approved. No illnesses or injuries have been reported.
Product
Optima Coil System Model OPTI0520CSF10. For endovascular embolization.
Category
Medical Device
Distribution
2 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-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-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-1683-2022·2022-09-14
Medline Chest Tube Kit Recalled for Non-Sterile Tape Component
Medline Industries is recalling Chest Tube Convenience Kits due to non-sterile tape included in the sterile portion of the kit, creating a contamination and infection risk.
Product
Medline CHEST TUBE REORDER NO: DYNJ36762A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1675-2022·2022-09-14
VITROS XT 3400 Chemistry System May Produce Inaccurate Test Results
The VITROS XT 3400 Chemistry System may produce inaccurate test results during shutdown due to electrical current shifts. The FDA has classified this Class II recall, affecting 506 units distributed worldwide.
Product
VITROS XT 3400 Chemistry System with Version 3.7.2 and below Product Code: 6844458
Category
Medical Device
Distribution
Distributed nationwide
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-1686-2022·2022-09-14
FDA Recalls Sensation Plus Catheter for Undersized Dilator Manufacturing Defect
Datascope Corporation recalls certain lots of Sensation Plus 8Fr 50cc Intra-Aortic Balloon Catheters due to undersized dilators. The manufacturing defect affects approximately 10,427 units distributed internationally and awaiting U.S. distribution.
Product
Sensation Plus 8Fr 50cc Intra-Aortic Balloon Catheter
Category
Medical Device
Distribution
0 states

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9376–9400 of 27393