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 the agency’s own highest classification or reported deaths or serious injuries, 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

20751–20775 of 114364

HighFDA (Drugs)·D-1164-2023·2023-09-27
TRP Natural Eyes Red Eye Relief eye drops recalled due to sterility concerns
TRP Natural Eyes Red Eye Relief PF sterile eye drops are being recalled due to lack of assurance of sterility. Approximately 196,442 units distributed to accounts in Rhode Island and Colorado may be affected.
Product
TRP Natural Eyes, Red 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: 17312-095-19.
Category
Drug
Distribution
2 states
HighFDA (Devices)·Z-2603-2023·2023-09-27
Orthopedic knee implant component lacks final sterilization before shipment
Encore Medical recalls 20 DJO Surgical Empowr Knee tibia baseplate components that were not sterilized before shipment. If implanted, these components may cause infection requiring treatment or revision surgery.
Product
DJO Surgical: Empowr Knee, Universal Tibia Baseplate, 6R, REF: 352-02-106
Category
Medical Device
Distribution
26 states
HighFDA (Devices)·Z-2596-2023·2023-09-27
Stryker ACM Bone Cement Mixer Nozzle May Break During Surgery
Stryker ACM bone cement mixing system nozzles may break or disassemble during surgical use, causing loss of function and risk of material fragments in the surgical site. Users should stop using affected units.
Product
Stryker ACM (Advanced Cement Mixing) System: Break-Away Femoral Nozzle-, Allows the user to mix bone cement with a constant high vacuum through the process. Catalog number: 0206-512-000.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-1518-2023·2023-09-27
Circle K Sweet & Spicy Mix recalled for undeclared soy and wheat allergens
Mount Franklin Foods is recalling Circle K Sweet & Spicy Mix nationwide due to potential undeclared soy and wheat allergens caused by mislabeling. Consumers with soy or wheat allergies should not consume the product.
Product
Circle K Sweet & Spicy Mix, Net Wt 7 oz; UPC 194283104613
Category
Food
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2608-2023·2023-09-27
Philips Patient Information Center iX Software Crashes Delay Patient Monitoring
Philips Patient Information Center iX software versions 4.x may crash due to an Intel Graphics Driver error, causing a blank screen. Users must manually reboot the system, potentially delaying the detection of patient condition changes.
Product
Patient Information Center iX with Software Version Number 4.x in the following: (1) Patient Information Center iX Product Number: 866389; (2) Patient Information Center iX Expand Product Number: 866390; (3) PIC iX Essentials Product Number: 867093; (4) PIC iX…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2601-2023·2023-09-27
Stryker ACM System Femoral Nozzle Recall for Potential Disassembly
Stryker is recalling its ACM Advanced Cement Mixing System due to a defect in the Break-Away Femoral Nozzle that can disassemble or break off during surgical use, risking loss of device function and foreign material in the surgical site.
Product
Stryker ACM (Advanced Cement Mixing)System: ACM Kit w/ Femoral Breakaway Nozzle, Restrictors & Prox. Press-Allows the user to mix bone cement with a constant high vacuum through the process Catalog Number: 0306-703-000
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1155-2023·2023-09-27
Eye Drops Recalled Due to Lack of Sterility Assurance
TRP Natural Eyes sterile eye drops are being recalled because the manufacturer cannot assure the product maintains sterility. The recall involves 196,111 units distributed to retailers in Rhode Island and Colorado.
Product
TRP Natural Eyes, Dryness 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:17312-178-15.
Category
Drug
Distribution
2 states
HighFDA (Devices)·Z-2615-2023·2023-09-27
Abbott Implantable Defibrillator Devices Recalled for Bluetooth Malfunction
Abbott is recalling certain implantable defibrillator devices manufactured before April 2022 due to a Bluetooth malfunction that results in loss of wireless communication and potential excessive battery drain.
Product
Gallant HF Cardiac Resynchronization Therapy Defibrillator: HF CRT-D REF CDHFA500Q Neutrino HF Cardiac Resynchronization Therapy Defibrillator: NxT HF CRT-D REF CDHFA600Q Entrant HF Cardiac Resynchronization Therapy Defibrillator : HF CRT-D REF CDHFA300Q The primary…
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2600-2023·2023-09-27
Stryker ACM Cement Mixing System nozzle may break during surgery
Stryker is recalling ACM Systems due to potential breakage of the femoral nozzle applicator tip during use. This could cause device failure and leave components in the surgical site.
Product
Stryker ACM (Advanced Cement Mixing) System: ACM Kit w/ Femoral Breakaway Nozzle & Prox. Med. Press-Allows the user to mix bone cement with a constant high vacuum through the process Catalog Number: 0306-573-000
Category
Medical Device
Distribution
Distributed nationwide
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 (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 (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-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 (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 (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 (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 (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 (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
2 states
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…
Category
Medical Device
Distribution
Distributed nationwide
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 (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 (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
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 (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…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1156-2023·2023-09-27
FDA Recalls TRP Natural Eyes Eye Drops for Sterility Concerns
FDA is recalling TRP Natural Eyes Dryness Relief eye drops due to lack of assurance of sterility. Approximately 83,898 units were distributed to accounts in Rhode Island and Colorado.
Product
TRP Natural Eyes, Dryness 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: 17312-096-19.
Category
Drug
Distribution
2 states

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20751–20775 of 114364