Severity 3 of 5

High recalls

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

What “high” means here

Severity 3 (High) recalls have a known hazard but no confirmed illness, injury, or property damage in the source text. The risk is theoretical-but-real: a pathogen pre-emptively pulled from shelves before anyone got sick, an allergen mislabeling on an uncommon allergen, a precautionary correction on a device that hasn't yet malfunctioned in the field. Most allergen recalls land here, as do most preventive food recalls based on routine sampling. You should still stop using the product, but you don't need to panic.

The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.

11601–11625 of 53044

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
HighFDA (Drugs)·D-1163-2023·2023-09-27
TRP Natural Eyes Red Eye Relief Recalled for Sterility Failure
TRP Natural Eyes Red Eye Relief sterile eye drops have been recalled due to lack of assurance of sterility. The recall affects 8,868 units distributed to accounts in Rhode Island and Colorado.
Product
TRP Natural Eyes, Red 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: 17312-058-15.
Category
Drug
Distribution
2 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
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 (Food)·F-1519-2023·2023-09-27
Trail Mix Products Recalled for Undeclared Soy and Wheat Allergens
Mount Franklin Foods LLC is recalling Circle K Get Up Trail Mix and 7 Select Go! Smart Rise & Shine products nationwide because they may contain undeclared soy and/or wheat allergens due to mislabeling.
Product
1. Circle K Get Up Trail Mix, Net Wt 2 oz, UPC 194283102893 2. Circle K Get Up Trail Mix, Net Wt 6 oz, UPC 194283104262 3. 7 Select Go! Smart Rise & Shine, Net Wt 2.5 oz, UPC 00052548681500
Category
Food
Distribution
Distributed nationwide
HighNHTSA·23V653000·2023-09-27
Peterbilt 567 and 579 Trucks: Fuel Tank Puncture Risk from Loose U-bolts
PACCAR is recalling 2021-2024 Peterbilt 567 and 579 trucks. U-bolts securing the air tank can contact and wear through the fuel tank over time. A punctured tank can leak fuel, increasing the risk of fire.
Product
PETERBILT — PETERBILT 579, 567
Category
Vehicle
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2606-2023·2023-09-27
DJO Surgical Reverse Shoulder System Components Recalled Due to Missing Sterilization
Reverse shoulder implant components were shipped without final sterilization, potentially leading to infection and possible revision surgery if implanted. Encore Medical is recalling 64 units distributed across the US and internationally.
Product
DJO Surgical: Reverse Shoulder System (RSP) Semi Humeral Socket Insert, 32mm, REF: 508-01-032; Baseplate, Glenoid HA-Coat, RSP, 6.5mm X 30mm, REF: 508-32-104; Reverse Shoulder System (RSP) Glenoid, Neutral Head W/ Retaining Screw, 36mm, REF: 508-36-101
Category
Medical Device
Distribution
26 states
HighFDA (Devices)·Z-2612-2023·2023-09-27
TyTek PneumoDart Decompression Device: Updated Instructions for Needle Placement
Tytek Medical is updating instructions for the TyTek PneumoDart to better identify needle decompression risks and improve placement guidance. Approximately 22,026 units distributed before October 5, 2020 are affected.
Product
TyTek PneumoDart- Intended for introduction into the body to facilitate removal of air from the pleural cavity in patients with a tension pneumothorax Model Number: TM-317
Category
Medical Device
Distribution
3 states
HighFDA (Drugs)·D-1165-2023·2023-09-27
TRP Natural Eyes Stye Relief sterile eye ointment recalled for lack of sterility assurance
FDA is recalling TRP Natural Eyes Stye Relief sterile eye ointment due to lack of assurance of sterility. The product was distributed to two accounts in Rhode Island and Colorado.
Product
TRP Natural Eyes, Stye 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: 17312-014-13.
Category
Drug
Distribution
2 states
HighFDA (Drugs)·D-1175-2023·2023-09-27
Humanrace Suncare SPF 30 Sunscreen Recalled for Subpotent Protection
HUMANRACE is recalling Humanrace Suncare Ozone Face Protection Daily Moisturizer SPF 30 because the product does not contain the declared SPF level. Affected consumers should discontinue use immediately.
Product
Humanrace Suncare, Ozone Face Protection Daily Moisturizer, Broad Spectrum Sunscreen SPF 30, packaged as a 53mL (1.8 fl oz.) bottle, 100% mineral, Active Ingredient: Zinc oxide 15%, Snow Mushroom, Dist. By: @Humanrace 2022 Beverly Hills, CA 90210, USA, NDC 82779-01
Category
Drug
Distribution
Distributed nationwide
HighFDA (Food)·F-1536-2023·2023-09-27
F-Bombs Cookies & Cream Truffles recalled for undeclared yellow food dyes
Fox Confections LLC is recalling F-Bombs Cookies & Cream Truffles distributed in Illinois and Ohio due to undeclared FD&C Yellow #5 and Yellow #6 food colorants that may cause allergic reactions in sensitive individuals.
Product
F-Bombs Cookies & Cream Truffles: 12 ounce plastic packaging, plastic packaging is packed into 4x4x2 cardboard boxes. UPC 850036018025
Category
Food
Distribution
2 states
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-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-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