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

11151–11175 of 13816

HighFDA (Devices)·Z-1767-2022·2022-09-28
Medical Device Recall: CARDIOHELP HLS Set Advanced Sterility Barrier Breach
Maquet Medical Systems is expanding its recall of the CARDIOHELP HLS Set Advanced due to a potential breach in the sterility barrier that could compromise product sterility, affecting 6,871 US units and 18,670 worldwide.
Product
BEQ-HLS 7050 USA; HLS Set Advanced 7.0 Part No. 70106.9078. A preconnected set used for extracorporeal respiratory and/or cardiovascular support, as part of the CARDIOHELP System.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1756-2022·2022-09-28
BD MaxGuard Administration Set Recalled for Incorrect Expiration Date Labels
BD MaxGuard Drop Administration set labels incorrectly list expiration year 2027 instead of 2025. Use of expired product risks compromised integrity, potential leaks, and patient or worker infection.
Product
BD MaxGuard Drop Administration set with 3 Needleless Y-Sites Removable 3-port Manifold and removable 4-way stopcock, REF: MX4436
Category
Medical Device
Distribution
39 states
HighFDA (Devices)·Z-1755-2022·2022-09-28
BD MaxGuard Flow Controller Extension Set recalled for mislabeled expiration dates
CAREFUSION is recalling BD MaxGuard Flow Controller Extension Sets because product labels show expiration year 2027 instead of 2025. Using expired sets risks product integrity failure and potential patient infection.
Product
BD MaxGuard Flow Controller Extension Set with Needleless Y-Site, REF: MFS141
Category
Medical Device
Distribution
39 states
HighFDA (Devices)·Z-1765-2022·2022-09-28
Medical device set recalled for potential sterility barrier compromise
Maquet Medical Systems USA is recalling the BEQ-HLS 5050 (HLS Set Advanced 5.0) due to a potential breach in the sterility barrier that may compromise product sterility.
Product
BEQ-HLS 5050 USA; HLS Set Advanced 5.0 Part No. 70105.2797. A preconnected set used for extracorporeal respiratory and/or cardiovascular support, as part of the CARDIOHELP System.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1764-2022·2022-09-28
FDA expands recall: HLS Set Advanced 7.0 sterility barrier compromise
Maquet Medical Systems USA has expanded a recall for HLS Set Advanced 7.0, a preconnected medical device used for heart and lung support, due to a potential breach in the sterility barrier that could compromise product sterility.
Product
BEQ-HLS 7050 USA; HLS Set Advanced 7.0 Part No. 70105.2794. A preconnected set used for extracorporeal respiratory and/or cardiovascular support, as part of the CARDIOHELP System.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1753-2022·2022-09-28
BD MaxGuard Extension Set Mislabeled With Wrong Expiration Date
BD MaxGuard Extension Set units have labels listing 2027 as the expiration year instead of 2025. Using expired medical devices may compromise product integrity and increase the risk of leaks and infection.
Product
BD MaxGuard Extension Set, REF: ME1069
Category
Medical Device
Distribution
39 states
HighFDA (Devices)·Z-1766-2022·2022-09-28
HLS Set Advanced Sterility Breach Recall for Cardiac Support Equipment
Maquet Medical Systems USA is recalling HLS Set Advanced 5050 units due to a potential breach in the sterility barrier. The defect may result in compromised product sterility for this cardiac and respiratory support equipment.
Product
BEQ-HLS 5050 USA; HLS Set Advanced 5.0 Part No. 70106.9077. A preconnected set used for extracorporeal respiratory and/or cardiovascular support, as part of the CARDIOHELP System.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1772-2022·2022-09-28
Serological Test Positive Control Shows False Negative Results for Hepatitis B
Randox Serology I Positive Control may test negative for Hepatitis B surface antigen (HBsAg) on certain analyzers despite being designed as a positive control, potentially affecting laboratory quality control procedures.
Product
The Randox Serology I Positive Control contains the following analytes in human based plasma: Anti HIV 1/2, Anti HTLV 1/2, Anti HCV, HBsAg, Anti HBc, and Anti Treponema pallidum IgG. The product is delivered as a liquid in a kit of 3 identical ready-to-use vials of 5 mL each.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1758-2022·2022-09-28
BD MaxGuard Extension Set Wrong Expiration Label Poses Infection Risk
CAREFUSION is recalling 600 BD MaxGuard Extension Sets because labels list expiration year 2027 instead of 2025. Using expired products may cause leaks and infection risk.
Product
BD MaxGuard Extension Set with 0.2 Micron Filter and Needleless Y-Site, REF: MX9166
Category
Medical Device
Distribution
39 states
ModerateFDA (Devices)·Z-1774-2022·2022-09-28
Fungitell STAT IVD Assay affected by incorrect printed reconstitution instructions
Associates of Cape Cod is recalling Fungitell STAT IVD Assay kits due to incorrect printed information on clamshells regarding reconstitution and pretreatment volumes. Users should verify procedures against official documentation before use.
Product
Fungitell STAT- IVD Assay for (1 ¿ 3)-~-D-Glucan in Serum Ref: FT007
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1771-2022·2022-09-28
Diversatek M-Catch Retrieval Nets: incorrect inner polybag labeling
Diversatek Healthcare is recalling M-Catch Retrieval Nets (Part Number REF 1175-01, Lot Number 001919) due to incorrect inner polybag labeling. 245 devices were distributed nationwide between September and October 2021.
Product
Diversatek Health, M-Catch Retrieval Nets, Part Number REF 1175-01, Quantity 5 EA/u. Used to endoscopically retrieve severed polyps, tissue samples, food bolus, and foreign bodies in the gastrointestinal tract.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1770-2022·2022-09-28
Dialysis water-treatment unit recalled for missing ferrite cores in cables
Fresenius is recalling 6 units of the AquaC UNO H reverse osmosis unit used with hemodialysis systems due to missing ferrite cores in internal ethernet cables affecting electromagnetic compatibility.
Product
AquaC UNO H [120V, 60Hz, 1700VA, US-Version- a reverse osmosis unit intended for use with hemodialysis systems. Fresenius Part Number: 24-0970-1 Vivonic Part Number: G02000966-US
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1653-2022·2022-09-21
Baxter CLEARLINK System Non-DEHP Solution Set recalled due to leak reports
Baxter Healthcare Corporation is recalling the CLEARLINK System Non-DEHP Solution Set nationwide due to increased customer reports of leaks in the in-line injection site device.
Product
Baxter CLEARLINK System, Non-DEHP Solution Set with DUO-VENT Spike, Product Code 2R8403. An in-line injection site.
Category
Medical Device
Distribution
Distributed nationwide
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-1732-2022·2022-09-21
Exactech GXL Acetabular Hip Implant Liners Recalled for Accelerated Wear
Exactech GXL acetabular hip implant liners may have been packaged in non-conforming bags, which could contribute to accelerated device wear. Approximately 17,929 units were distributed worldwide.
Product
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION GXL LINER NEUTRAL, 32MM ID GROUP 1 CUPS, REF 130-32-51 b. NOVATION GXL LINER NEUTRAL, 36MM ID, GROUP 2 CUPS, REF 130-36-52 c. NOVATION GXL LINER NEUTRAL, 40MM ID, GROUP 3 CUPS, REF 1
Category
Medical Device
Distribution
Distributed nationwide
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-1723-2022·2022-09-21
ICU Medical IV Connector Extension Set Recalled for Manufacturing Defect
ICU Medical is recalling intravascular administration set connectors due to a manufacturing defect that creates a visible gap in the connector housing. The defect affects approximately 5.8 million units distributed nationwide and internationally.
Product
6.5 IN (17 cm) APPX 0.78 ml, EXT SET w/Clave CLEAR, Clave 4-WAY Stopcock, Spiros, RED CAP. Accessory for intravascular administration set.
Category
Medical Device
Distribution
51 states
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
51 states
HighFDA (Devices)·Z-1750-2022·2022-09-21
Surpria 64 Software Error May Prevent Image Reconstruction During Scanning
Surpria 64 CT scanner software versions V3.11 and V3.22 may encounter errors that prevent image reconstruction, requiring repeat scans that expose patients to additional radiation. 16 units nationwide are affected.
Product
Surpria 64: Software Version V3.11, V3.22
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1742-2022·2022-09-21
ZAP-X Radiosurgery System Software Issue May Cause Treatment Misalignment
A software issue in the ZAP-X Radiosurgery System may cause incorrect treatment positioning in patients with large rotational deviations. The alignment algorithm could miscalculate treatment table offset values, potentially affecting treatment delivery.
Product
ZAP-X Radiosurgery System
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-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-1725-2022·2022-09-21
GXL Acetabular Hip Implant Liners Recalled Due to Packaging Defect
Exactech is recalling specific GXL acetabular hip implant liners due to non-conforming packaging that may cause accelerated device wear. The recall affects 1,017 devices distributed worldwide.
Product
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. 0 DEG ACUMATCH CONSTRAINED LINER SZ E 28MM ID, REF 144-28-05; b. 0 DEG ACUMATCH CONSTRAINED LINER SZ F 28MM ID, REF 144-28-06; c. 0 DEG ACUMATCH CONSTRAINED LINER SZ G 28MM ID, REF 144-28-07
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1730-2022·2022-09-21
GXL Acetabular Liners Recalled Due to Non-Conforming Packaging and Accelerated Wear Risk
Exactech's GXL acetabular hip implant liners are being recalled because they were packaged in non-conforming bags that may cause accelerated wear of the devices.
Product
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION CONSTRAINED LINER 28MM ID GROUP 1, REF 134-28-41 b. NOVATION CONSTRAINED LINER 32MM ID GROUP 2, REF 134-32-42 c. NOVATION CONSTRAINED LINER 36MM ID GROUP 3, REF 134-36-43 d.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1706-2022·2022-09-21
Roadrunner PC Hydrophilic Wire Guide Recalled Due to Sterility Compromise
Cook Incorporated is recalling 496 units of the Roadrunner PC Hydrophilic Wire Guide due to packaging failure that may compromise sterility. No illnesses have been reported.
Product
Roadrunner PC Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN)RFPC-35-180 ORDER NUMBER (GPN) G07937. For vascular catheter positioning and exchange in diagnostic and interventional procedures.
Category
Medical Device
Distribution
Distributed nationwide

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11151–11175 of 13816