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

11126–11150 of 13816

ModerateFDA (Devices)·Z-1801-2022·2022-10-05
Skin markers recalled due to storage temperature exposure
Mckesson Medical-Surgical Inc. recalls skin markers used in medical imaging that may have been exposed to excessive temperatures during storage prior to delivery. Affected units were received between June and September 2021.
Product
Skin markers: a. IZI MEDICAL PRODUCTS LLC Multi-Modality Markers SKIN MARKER RADIO 1.5MM 50BX Catalog #MM3005. b. SKIN MARKER MAMMO BB2.0 100B - Mammography Skin Marker Catalog # SDM-BB20.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1789-2022·2022-10-05
Collagen Powder Recalled Due to Temperature Exposure During Shipment
DermaCol 100 Collagen Powder was exposed to higher temperatures during storage from June to August 2021. The product's effectiveness may have been impacted, though the FDA determined no adverse health consequences are likely.
Product
DERMARITE INDUSTRIES DermaCol 100 Collagen Powder DermaCol 100 Collagen 1 Gram Model Number: 00300E
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1804-2022·2022-10-05
Dynarex Unna Boot Dressing products recalled due to temperature storage excursion
Mckesson Medical-Surgical is recalling Dynarex Unna Boot Dressing products exposed to temperature excursions during June-August 2021. The manufacturer states the deviation is unlikely to cause health consequences, but products may have reduced effectiveness.
Product
a. Dynarex DRESSING, UNNA BOOT 3"X10' (12/CS), Catalog # 3453. b. Dynarex DRESSING, UNNA BOOT BANDAGE 4"X10' (12/CS) Catalog # 3454
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1792-2022·2022-10-05
Sterilization Chemical Indicator Strips Recalled for Temperature Exposure
Mckesson Medical-Surgical is recalling SPS Medical sterilization indicator strips due to temperature excursions that may have reduced their effectiveness. Products distributed June–September 2021 are affected.
Product
a. SPS MEDICAL SUPPLY Steam Indicator Strip SPSmedical Sterilization Chemical Indicator Strip Steam 4 Inch Model Number: SIS-250. b. SPS MEDICAL SUPPLY SteamPlus Sterilization Integrator Sterilization Steam Plus Monitor Model Number: SSI-1000.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1806-2022·2022-10-05
McKesson Wound Dressing Products Recalled for Temperature Exposure
McKesson wound dressing products distributed nationwide are being recalled due to exposure to elevated temperatures during storage that may have reduced their effectiveness. No adverse health consequences have been reported.
Product
a. ADVANCED MEDICAL SOLUTIONS McKesson DRESSING, WOUND GELLING FIBERHIGH-ABSRB 4"X4 3/4" (10/BX) Catalog #87400. b. ADVANCED MEDICAL SOLUTIONS McKesson DRESSING, WND GELLING FIBER HIABSRB AG 4X4.75 (10/BX 10BX/CS Catalog #177400. c. ADVANCED MEDICAL SOLUTIONS McKesson DR
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1817-2022·2022-10-05
Starling Monitor Devices Recalled for Incorrect Device Identification Labeling
Baxter Healthcare is recalling Starling Monitor devices and accessories due to incorrect Unique Device Identification (UDI) information on labels and non-compliant barcodes. Approximately 9,671 units distributed nationwide are affected.
Product
Starling Monitor, Product code CMMST5 and Starling Monitor SV, Product code CMM-ST5 (same products); and accessories/spare parts Starling Battery Pack, Product Code CMABATT; and Starling Patient Cable, Product code CMASC10.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1807-2022·2022-10-05
Wound Dressing Units Recalled Due to Storage Temperature Excursions
KerraCel Ag wound dressing units distributed between June and September 2021 are being recalled due to facility temperature excursions that may have affected product effectiveness. The FDA states no adverse health consequences are likely.
Product
3M SYSTAGENIX/KCI KerraCel Ag DRESSING, WOUND KERRACEL AG 4X5 (10/CT 10CT/CS) Catalog #CWL1158
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1805-2022·2022-10-05
McKesson Calcium Alginate Wound Dressings Recalled for Temperature Exposure During Storage
McKesson Medical-Surgical is recalling multiple calcium alginate wound dressings due to facility temperature excursions that may have impacted product effectiveness. The FDA states the affected products are not likely to cause adverse health consequences.
Product
a. ADVANCED MEDICAL SOLUTIONS McKesson DRESSING, CALCIUM ALGINATE SHEET 4"X8" (5/BX 10BX/CS), Catalog #3563. b. ADVANCED MEDICAL SOLUTIONS McKesson DRESSING, CALCIUM ALGINATE AG2X2" (10/BX 10BX/CS) Catalog #3557. c. ADVANCED MEDICAL SOLUTIONS McKesson DRESSING, CALCIUM ALGINA
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1799-2022·2022-10-05
Surgitube Surgical Bandages Recalled for Temperature Exposure During Storage
McKesson is recalling Surgitube surgical bandages distributed between June and September 2021 that may have been exposed to elevated temperatures during storage. The FDA states the temperature exposure is unlikely to cause adverse health effects.
Product
a. DERMA SCIENCES, INC Surgitube BANDAGE, GAUZE SURGI WHT SZ15/8" 50YDS Catalog #GL-219. b. DERMA SCIENCES, INC Surgitube BANDAGE, GAUZE SURGI WHT SZ2 1" 50YDS Catalog # GL-220. c. DERMA SCIENCES, INC Surgitube BANDAGE, GAUZE SURGI WHT SZ4 25/8" 50YDS Catalog # GL-222. d. D
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1791-2022·2022-10-05
Sterilization Roll Recalled Due to Temperature Exposure During Manufacturing
SPS Medical Supply Crosstex sterilization rolls (model SCT3) are being recalled because they were exposed to high temperatures during manufacturing facility storage before shipment. Temperature exposure may have compromised the product's sterilization effectiveness.
Product
SPS MEDICAL SUPPLY Crosstex International Sterilization Roll Sani-Roll Ethylene Oxide (EO) Gas / Steam 3 Inch X 100 Foot Transparent / Blue Self Seal Paper / Film Model Number: SCT3.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1800-2022·2022-10-05
Wound Care Dressings Recalled Due to Temperature Exposure
Mckesson is recalling Shur-Conform and ALGICELL wound care dressings due to temperature exposure affecting product effectiveness. All affected units were distributed June through September 2021.
Product
a. INTEGRA LIFESCIENCE (WND CARE) Shur-Conform Oil Emulsion Oil Emulsion Impregnated Dressing Shur-Conform 3 X 8 Inch Knitted Cellulose Acetate Petrolatum Emulsion Sterile Model Number: 77042. b. INTEGRA LIFESCIENCE (WND CARE) ALGICELL Ag Silver Alginate Dressing Algicell Ag
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1788-2022·2022-10-05
McKesson LiquiBand Exceed Skin Adhesive Storage Temperature Exposure Recall
McKesson is recalling LiquiBand Exceed skin adhesive products nationwide due to facility temperature excursions between June and August 2021. The FDA states the affected products are not likely to cause adverse health consequences.
Product
a. Skin Adhesive McKesson LiquiBand Exceed 0.4 mL Liquid Dome Applicator Tip 2-Octyl Cyanoacrylate. Model Number: 122-LBXS. b. Skin Adhesive McKesson LiquiBand Exceed 0.8 mL Liquid Precision and Dome Applicator Tip 2-Octyl Cyanoacrylate. Ref: 122-LBX. c. ADVANCED MEDICAL SOLU
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1787-2022·2022-10-05
Saline wound flush recalled due to temperature exposure affecting effectiveness
Mckesson is recalling SafeWash Saline Wound Flush due to temperature exposure that may have reduced product effectiveness. The recall affects units distributed nationwide from June through September 2021.
Product
DERMARITE INDUSTRIES SafeWash Saline Saline Wound Flush SafeWash 7.1 oz. Can Sterile 0.9% Sodium Chloride Model Number: 00245
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
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
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-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-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-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-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-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-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-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

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11126–11150 of 13816