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

16251–16275 of 27769

HighFDA (Drugs)·D-1154-2023·2023-09-27
TRP Natural Eyes sterile eye drops recalled for lack of sterility assurance
TRP Natural Eyes Blur Relief eye drops are being recalled due to lack of assurance of sterility. The product was distributed to accounts in Rhode Island and Colorado.
Product
TRP Natural Eyes, Blur Relief, Sterile Eye Drops, Homeopathic 0.5 FL OZ (15 mL), Manufactured in Jordan, exclusively for TRP Company, Inc., 1575 Delucchi Lane, Reno, NV 89502, NDC: 17312-002-11.
Category
Drug
Distribution
2 states
HighFDA (Drugs)·D-1151-2023·2023-09-27
FDA Recalls TRP Natural Eyes Eye Drops Due to Sterility Assurance Issue
The FDA is recalling TRP Natural Eyes Aging Eye Relief eye drops due to lack of assurance of sterility. The affected lot DB001 (expiration 06/24) was distributed to accounts in Rhode Island and Colorado.
Product
TRP Natural Eyes, Aging Eye Relief, Sterile Eye Drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusively for TRP Company, Inc., 1575 Delucchi Lane, Reno, NV 89502 NDC: 17312-027-15.
Category
Drug
Distribution
2 states
HighFDA (Drugs)·D-1160-2023·2023-09-27
FDA Recalls Eye Ointment Product Due to Sterility Assurance Failure
The FDA is recalling Major LubriFresh PM eye ointment due to lack of assurance of sterility. Approximately 282,564 units were distributed to accounts in Rhode Island and Colorado.
Product
MAJOR LUBRIFRESH PM — MAJOR LUBRIFRESH PM (MINERAL OIL AND WHITE PETROLATUM)
Category
Drug
Distribution
2 states
HighFDA (Devices)·Z-2598-2023·2023-09-27
Stryker ACM Advanced Cement Mixing System Nozzle May Disassemble
Stryker is recalling the ACM bone cement mixing system because the break-away femoral nozzle may disassemble or break off during surgery, potentially causing loss of device function and components to fall into the surgical site.
Product
Stryker ACM (Advanced Cement Mixing) System: ACM Kit w/ Femoral Breakaway Nozzle-Allows the user to mix bone cement witha constant high vacuum through the process Catalog Number: 0306-563-000
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2620-2023·2023-09-27
Copan Transfer Pipette Recalled Due to Plastic Defects
Copan Diagnostics is recalling 2,592 units of 300µL transfer pipettes due to plastic defects that may affect aspiration capability. Affected units were distributed in California.
Product
COPAN REF: 2U045S01 300uL Transfer Pipette Individually wrapped pipettes, 1000 pcs.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-2589-2023·2023-09-27
Flexible Intubation Endoscopes Recalled Due to Unconfirmed Sterility
Karl Storz Endoscopy is recalling 218 units of Five S 5 3x65 flexible intubation endoscopes because sterility assurance cannot be confirmed. The affected devices were distributed worldwide including throughout the United States and Canada.
Product
Five S 5 3x65, REF: 0915612-06, sterile for single use, Sterile EO, Rx Only
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-1537-2023·2023-09-27
F-Bombs Cookie Dough Truffles recalled for undeclared food dyes
Fox Confections is recalling F-Bombs Cookie Dough Truffles for containing undeclared FD&C Yellow #5 and Yellow #6 dyes. These undeclared food colorants require immediate consumer notification.
Product
F-Bombs Cookie Dough Truffles: 12 ounce plastic packaging, plastic packaging is packed into 4x4x2 cardboard boxes. UPC 850036018032
Category
Food
Distribution
0 states
HighFDA (Devices)·Z-2626-2023·2023-09-27
FLUIDSHIELD 3 N95 Mask Filtration Failure (Lot AM2164811)
O&M Halyard recalls FLUIDSHIELD 3 N95 masks in orange size small (Lot AM2164811) after one sample failed filtration efficiency testing. The affected masks may not provide adequate respiratory protection.
Product
FLUIDSHIELD 3 N95 Particulate Filter Respirator and Surgical Mask with SO SOFT* Lining, Orange, size small, Product Code 46827
Category
Medical Device
Distribution
11 states
HighFDA (Drugs)·D-1161-2023·2023-09-27
FDA Recalls TRP Natural Eyes Sterile Eye Drops for Lack of Sterility
The FDA is recalling TRP Natural Eyes Pink Eye Relief eye drops due to lack of assurance of sterility. The product was distributed to accounts in Rhode Island and Colorado.
Product
TRP Natural Eyes, Pink Eye Relief, Sterile Eye drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusively for TRP Company, Inc., 1575 Delucchi Lane, Reno, NV 89502 NDC: 17312-013-15.
Category
Drug
Distribution
2 states
HighFDA (Drugs)·D-1157-2023·2023-09-27
Sterile Eye Drops Recalled for Lack of Sterility Assurance TRP Natural Eyes
TRP Natural Eyes sterile eye drops have been recalled because their sterility cannot be confirmed. About 8,000 units distributed to medical accounts in Rhode Island and Colorado are affected.
Product
TRP Natural Eyes, Eye Lid Relief PF, Sterile Eye Drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusively for TRP Company, Inc., 1575 Delucchi Lane, Reno, NV 89502, NDC: 17312-417-19.
Category
Drug
Distribution
2 states
HighFDA (Food)·F-1545-2023·2023-09-27
Radish Turnip Cake Recalled for Undeclared Wheat Starch and Sulfites
Southern Taiwan LLC is recalling Radish Turnip Cake distributed in Washington due to undeclared wheat starch and sulfites. The product poses a risk to consumers with wheat or sulfite allergies.
Product
Radish Turnip Cake (w/o shrimp): The product comes in a 900g ( 32 ounce), clear plastic package marked with UPC # 425404904110. Ingredients: White Radish, Mushrooms, Fried Dried shallot, White Rice Flour.
Category
Food
Distribution
1 state
HighFDA (Drugs)·D-1167-2023·2023-09-27
octiq Lubricating Eye Drops Recalled Due to Sterility Assurance Defect
Innovus Pharmaceuticals recalled octiq Lubricating Eye Drops due to lack of assurance of sterility. The affected lot was distributed to accounts in Rhode Island and Colorado.
Product
octiq Lubricating Eye Drops, Dextran 70.01%, Hypromellose 0.3%, 0.5 FL OZ Each (2X 15 mL Bottles), Manufactured for Innovus Pharmaceuticals, Inc., Englewood, CO 80112, Made in Jordan, NDC:57483-610-15.
Category
Drug
Distribution
2 states
HighFDA (Drugs)·D-1159-2023·2023-09-27
TRP Natural Eyes Floaters Relief Recalled for Lack of Sterility Assurance
TRP Natural Eyes Floaters Relief sterile eye drops are being recalled because the manufacturer cannot assure the product meets sterility standards. It was distributed to two direct accounts in Rhode Island and Colorado.
Product
TRP Natural Eyes, Floaters Relief, Sterile Eye drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusively for TRP Company, Inc., 1575 Delucchi Lane, Reno, NV 89502, NDC: 17312-098-15.
Category
Drug
Distribution
2 states
HighFDA (Devices)·Z-2604-2023·2023-09-27
DJO Surgical Orthopedic Implants Recalled for Sterilization Failure
DJO Surgical orthopedic implants (lot 878B1171) were shipped without sterilization and may cause infection if implanted, potentially requiring treatment, monitoring, or revision surgery. Contact your healthcare provider to verify your lot number.
Product
DJO Surgical: Delta Ceramic Femoral Head, 44 mm + 4.0 mm, REF: 400-03-443
Category
Medical Device
Distribution
26 states
HighFDA (Food)·F-1538-2023·2023-09-27
Red Velvet Truffles Recalled for Undeclared Yellow Food Colorants
Fox Confections is recalling 138 packages of F-Bombs Red Velvet Truffles sold in Illinois and Ohio retail locations because they contain undeclared FD&C Yellow #5 and Yellow #6 food colorants, which federal regulations require to be clearly labeled.
Product
F-Bombs Red Velvet Truffles: 12 ounce plastic packaging, plastic packaging is packed into 4x4x2 cardboard boxes. UPC 850036018049
Category
Food
Distribution
0 states
HighFDA (Devices)·Z-2617-2023·2023-09-27
PDS II Surgical Sutures Recalled for Tensile Strength Defect
ETHICON is recalling specific lots of PDS II surgical sutures after internal testing confirmed some units did not meet tensile strength requirements. Approximately 868,363 units were distributed in the United States and globally.
Product
PDS II (polydioxanone) Suture, Product Numbers Z844G-50, D10065-05, D10085-05, D6776-05, D6776-05, D9297-05, D9297-05, Z259H-50, Z259H-50, Z259H-50, Z259H-50, Z259H-50, Z259H-50, Z259H-50, Z259H-50, Z259H-50, Z259H-50, Z259H-50, Z259H-50, Z259H-50, Z259H-50, Z259H-50, Z416H-50, Z
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1171-2023·2023-09-27
Rasagiline Tablets Recalled Due to Failed Dissolution Specifications
Aurobindo Pharma USA Inc. is recalling Rasagiline 0.5mg tablets for failing dissolution specifications. Patients using this medication should contact their healthcare provider.
Product
Rasagiline Tablets 0.5mg, 30-count bottle, Rx only, Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A., NDC 0378-1270-93
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2593-2023·2023-09-27
APK2 Wheelchair Cushion Battery Pack Defect Can Cause Overheating
Aquila Corporation recalls 117 APK2 wheelchair cushions with defective battery packs that can overheat. The risk could result in property damage and injury.
Product
APK2 Pressure-Sensing Wheelchair Cushions
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2599-2023·2023-09-27
Stryker ACM Cement Mixer Nozzle Risk of Disassembly During Surgery
Stryker is recalling certain ACM (Advanced Cement Mixing) systems due to risk that the Break-Away Femoral Nozzle may disassemble or break during use, potentially causing loss of function and components entering the surgical site.
Product
Stryker ACM (Advanced Cement Mixing) System: ACM Kit w/ Femoral Breakaway Nozzle & Solid Blades-Allows the user to mix bone cement with a constant high vacuum through the process Catalog Number: 0306-564-000
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2616-2023·2023-09-27
PDS Plus Antibacterial Sutures Recalled for Tensile Strength Defect
Ethicon is recalling PDS Plus Antibacterial sutures from specific lots that failed internal tensile strength testing. The defective sutures could fail during or after surgery, creating a risk of serious patient harm.
Product
PDS Plus Antibacterial (polydioxanone) Suture, Product Numbers PDP072H40, PDP259H50, PDP416H50, PDP441H50, PDP442H50, PDP489G50, PDP489H40, PDP497G51, PDP497H16, PDP497H40, PDP498H40, PDP502V05, PDP507V05, PDP510V05, PDP515V05, PDP662H50, PDP663H50, PDP684H40, PDP9615H40, PDP9625
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1158-2023·2023-09-27
TRP Natural Eyes Eye Ointment Recalled for Lack of Sterility Assurance
TRP Natural Eyes sterile eye ointment (NDC 17312-165-13, Lot 180001, EXP 01/25) is being recalled due to lack of assured sterility. The product was distributed to accounts in Rhode Island and Colorado.
Product
TRP Natural Eyes, Eye Lid Relief, Sterile Eye ointment, Homeopathic 0.14 oz (4 grams), Manufactured in Jordan, exclusively for TRP Company, Inc., 1575 Delucchi Lane, Reno, NV 89502, NDC: 17312-165-13.
Category
Drug
Distribution
2 states
HighFDA (Devices)·Z-2624-2023·2023-09-27
FDA Recalls ALKP Chemistry Analyzer Slides for Potential Diagnostic Errors
Ortho-Clinical Diagnostics is recalling VITROS XT Chemistry ALKP Slides worldwide because high alkaline phosphatase samples may cause the analyzer to report falsely low results, potentially missing or delaying liver disease diagnoses.
Product
VITROS XT Chemistry Products ALKP Slides
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2625-2023·2023-09-27
Philips Tempus Pro Patient Monitor Software Error Impairs Critical Monitoring
Certain Philips Tempus Pro Patient Monitors may display an error message when laryngoscopes are disconnected, requiring a 60-100 second restart that prevents vital sign monitoring and airway visualization during intubation. This may lead to treatment delays or hypoxia.
Product
Philips Tempus Pro Patient Monitor, REF: 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R, 00-1004, and 00-1007, when Used With Tempus Pro Video Laryngoscope, REF 01-2044
Category
Medical Device
Distribution
42 states
HighFDA (Devices)·Z-2623-2023·2023-09-27
VITROS XT Chemistry TBIL-ALKP Slides recalled for incorrect liver enzyme readings
Ortho-Clinical Diagnostics is recalling VITROS XT Chemistry TBIL-ALKP Slides because they may report incorrectly low liver enzyme values, potentially leading to missed or delayed liver disease diagnoses. Approximately 52,456 units were distributed worldwide.
Product
VITROS XT Chemistry Products TBIL-ALKP Slides
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1162-2023·2023-09-27
TRP Natural Eyes Pink Eye Relief drops recalled for sterility assurance issues
TRP Natural Eyes Pink Eye Relief sterile eye drops (Lot FP001, expires 07/24) are being recalled due to lack of assurance of sterility. Consumers with this product should stop using it and consult their healthcare provider.
Product
TRP Natural Eyes, Pink Eye Relief PF, Sterile Eye drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusively for TRP Company, Inc., 1575 Delucchi Lane, Reno, NV 89502 NDC: 17312-094-19.
Category
Drug
Distribution
2 states

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16251–16275 of 27769