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

11051–11075 of 13748

ModerateFDA (Devices)·Z-1790-2022·2022-10-05
SporView Sterilization Biological Indicator Kit Recalled for Temperature Exposure
McKesson is recalling SporView Culture Set biological indicator kits (models CS-020 and CS-100) due to facility temperature excursions that may have compromised product effectiveness. Affected units were distributed nationwide between June and September 2021.
Product
a. SporView Culture Set SporView Sterilization Biological Indicator Kit Steam / EO Gas / Dry Heat / Chemical Vapor Model Number: CS-020 b. SPORVIEW CULTURE SET SporView Sterilization Biological Indicator Kit Steam / EO Gas / Dry Heat / Chemical Vapor Model Number: CS-100
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1798-2022·2022-10-05
AquaGuard Wound Dressing Recall Due to Facility Temperature Excursions
TIDI Products AquaGuard wound dressings received June–September 2021 were exposed to elevated storage temperatures that may have impacted product effectiveness. The FDA states adverse health consequences are unlikely.
Product
a. TIDI PRODUCTS, LLC AquaGuard DRESSING, AQUA GUARD MOISTR 7X7 (5/PK) 9CENCO Catalog #68751510104. b. TIDI PRODUCTS, LLC AquaGuard DRESSING, AQUA GUARD MOISTR BARR 10X12 (5/BX) Catalog #68751510105
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1796-2022·2022-10-05
Mckesson DermaCol Collagen Dressings Recalled for Storage Temperature Excursion
Mckesson recalls DermaCol collagen dressings exposed to temperature excursions during storage (June-August 2021). FDA stated adverse health consequences are unlikely.
Product
a. DERMARITE INDUSTRIES DermaCol Collagen Dressing DermaCol Without Border Collagen / Sodium Alginate / Carboxyl Methylcellulose (CMC) / Ethylenediamine-tetraacetic Acid (EDTA) 4 X 4 Inch 10 Count Model Number: 00303E. b. DERMARITE INDUSTRIES DermaCol Ag Silver Collagen Dress
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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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
0 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-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-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
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-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-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

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11051–11075 of 13748