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

9326–9350 of 27393

HighFDA (Devices)·Z-1810-2022·2022-10-05
Insulin Infusion Sets Recalled for Incorrect Dosing Information in Instructions
Autosoft 90 insulin infusion sets are recalled because the instructions incorrectly state insulin fill values for two cannula sizes, potentially causing patients to receive fewer insulin units than intended.
Product
Autosoft 90, model numbers 1000282, 1002817, 1002818, 1002819, 1002820, 1002821, 1002822, 1002823, and 1002824. Infusion sets used with Tandem Insulin Subcutaneous Infusion Pump.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1760-2022·2022-09-28
BD MaxGuard Administration Set Recalled for Incorrect Expiration Labeling
CAREFUSION is recalling BD MaxGuard 15 Drop Administration Sets with incorrect expiration year labels (showing 2027 instead of 2025). Use of expired product may compromise integrity and risk infection.
Product
BD MaxGuard 15 Drop Administration Set with 4 Needleless Y-Sites, REF: MX9433
Category
Medical Device
Distribution
39 states
HighFDA (Devices)·Z-1776-2022·2022-09-28
FDA Recalls Grappler Suture Anchors Due to Potential Breakage Risk
Paragon 28, Inc. is recalling Grappler Suture Anchors (REF: P44-110-3010-SK, Lot 5007499) due to risk that the anchor may break upon insertion, potentially leaving debris in patients and delaying surgery.
Product
Grappler Suture Anchor, Titanium, 3.0 x 10mm, Sterile Kit, REF: P44-110-3010-SK, for use within the Grappler Suture Anchor System
Category
Medical Device
Distribution
Distributed nationwide
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-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
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-1768-2022·2022-09-28
Absorbable Gelatin Sponge Hemostat Recalled for Endotoxin Contamination
GELITA MEDICAL GMBH recalled 3,596 boxes of ORCA FOAM hemostats after routine testing found higher than acceptable endotoxin levels. The surgical devices were distributed across the United States.
Product
ORCA FOAM STANDARD CUBE 10x10x10 mm, Absorbable Gelatin Sponge Hemostat, USP, REF ORCA FOAM
Category
Medical Device
Distribution
Distributed nationwide
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-1757-2022·2022-09-28
BD MaxGuard Extension Sets Recalled for Mislabeled Expiration Dates
CAREFUSION is recalling 17,250 BD MaxGuard Extension Set units with labels listing incorrect expiration year 2027 instead of 2025. Using expired products could compromise device integrity and create infection risk to patients and healthcare workers.
Product
BD MaxGuard Extension Set with 2 Needleless Y-Site, REF: MX9059
Category
Medical Device
Distribution
39 states
HighFDA (Devices)·Z-1773-2022·2022-09-28
Ethicon PDS II Surgical Sutures Recalled for Incorrect Material
Ethicon recalls PDS II surgical sutures distributed in Japan due to potential incorrect material composition that could affect treatment outcomes. No injuries have been reported.
Product
PDS II (polydioxanone) Suture, Product Code Z771D 4-0 PDS Suture, Violet, 8x18" (45cm), SH-1 Control Release Needles
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1752-2022·2022-09-28
BD MaxGuard Extension Set labeled with incorrect expiration year 2027
46,900 BD MaxGuard Extension Sets are labeled with expiration year 2027 but should expire in 2025. Using expired product may compromise integrity and cause leaks, risking infection.
Product
BD MaxGuard Extension Set with 4-way stopcock, REF: M4058
Category
Medical Device
Distribution
39 states
HighFDA (Devices)·Z-1769-2022·2022-09-28
Hemodialysis Water Purification Unit Recalled for Missing EMI Shielding
Fresenius is recalling 24 units of the AquaC UNO H reverse osmosis unit because internal ethernet cables lack ferrite cores, compromising electromagnetic compatibility in hemodialysis water purification systems.
Product
AquaC UNO H [120V, 60Hz, 1000VA, US-Version - a reverse osmosis unit intended for use with hemodialysis systems. Fresenius Part Number: 24-10VA-1 Vivonic Part Number: G02000970-US
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-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-1759-2022·2022-09-28
BD MaxGuard Extension Set Recalled for Incorrect Expiration Year
CAREFUSION's BD MaxGuard Extension Set is being recalled because product labels incorrectly list expiration year 2027 instead of 2025. Using expired product may compromise integrity, potentially causing leaks and infection risk.
Product
BD MaxGuard Extension Set with 1.2 Micron Filter and Needleless Y-Site, REF: MX9171
Category
Medical Device
Distribution
39 states
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-1754-2022·2022-09-28
BD MaxGuard Extension Set Mislabeled with Wrong Expiration Year
BD MaxGuard Flow Controller Extension Set labels incorrectly list 2027 expiration instead of 2025. Use of expired product could compromise device integrity and create infection risk.
Product
BD MaxGuard Flow Controller Extension Set with Needleless Y-Site, REF: MFS106
Category
Medical Device
Distribution
39 states
HighFDA (Devices)·Z-1775-2022·2022-09-28
Puritan Bennett 560 Ventilator Recalled for Loss of Gas Supply
Covidien is recalling the Puritan Bennett 560 Ventilator due to a manufacturing error in turbine components that causes loss of gas supply and device inoperability. Six incidents have been confirmed from customers outside the United States.
Product
Puritan Bennett 560 Ventilator, PB560, CFN 4096600
Category
Medical Device
Distribution
1 state
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
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-1707-2022·2022-09-21
Roadrunner PC Hydrophilic Wire Guide Recalled Due to Packaging Integrity Failure
Cook Incorporated is recalling 2,407 units of Roadrunner PC Hydrophilic Wire Guide due to failed packaging integrity testing that may compromise device sterility. No illnesses or injuries have been reported.
Product
Roadrunner PC Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): RFSPC-35-180 ORDER NUMBER (GPN) G09608. For vascular catheter positioning and exchange in diagnostic and interventional procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1751-2022·2022-09-21
iSED Tubing Spare Part Recalled for Potential Biohazard Leak Risk
Alcor Scientific is recalling iSED Primary Pump Tubing Spare Part Kits due to potential biohazard leak from the Probe Tube when installed on the iSED ESR Analyzer. Affected lot (4/22) includes 38 units distributed nationwide and internationally.
Product
iSED Primary Pump Tubing Spare Part Kit- (IVD) tubing is used to move sample and wash solution from the aspiration needle, through the reading chamber, and to the waste on the iSED Automated ESR Analyzer PN: 112-13-002
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1749-2022·2022-09-21
FUJIFILM Surpria Imaging Software May Fail During Scanning
Surpria software versions V3.11 and V3.22 may encounter processing errors that prevent image reconstruction, potentially requiring additional scans and exposing patients to unnecessary radiation.
Product
Surpria: Software Version V3.11, V3.22
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1731-2022·2022-09-21
GXL Acetabular Liners Packaged Improperly May Experience Accelerated Wear
Exactech is recalling certain GXL acetabular hip implant liners because non-conforming packaging may cause accelerated wear. No injuries have been reported.
Product
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. GXL NEUTRAL LINER, G0 28MM ID, 130-28-50; b. GXL NEUTRAL LINER, G00 22MM ID, 130-22-70; c. NOVATION GXL LIPPED LINER, G0 28MM ID, 132-28-50; d. NOVATION GXL LIPPED LINER, G00 22MM ID, 132
Category
Medical Device
Distribution
Distributed nationwide

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9326–9350 of 27393