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

29326–29350 of 114616

HighFDA (Drugs)·D-1255-2022·2022-07-27
HYDROmorphone Injection Recalled Due to Lack of Sterility Assurance
Nephron Sterile Compounding Center recalled 22,805 pre-filled syringes of HYDROmorphone HCl Injection due to lack of sterility assurance. Six lot numbers were distributed nationwide.
Product
HYDROmorphone HCl Injection, USP, 10 mg/50 mL (0.2 mg/mL) syringes, 5 x 50 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th Street Extension, West Columbia SC 29172, NDC: 69374-529-50
Category
Drug
Distribution
Distributed nationwide
HighFDA (Food)·F-1457-2022·2022-07-27
Dark chocolate truffles recalled for undeclared tree nut allergens
Queen Bee Gardens is recalling Dark Mint Classic Truffles for undeclared tree nuts including pecans, almonds, coconut, macadamia nuts, and walnuts. Products were distributed to retail locations in CO, NM, WY and nationwide online.
Product
Dark Mint Classic Truffle. Net wt. 1.4 oz. PLU Code: 788394 11035 1. Ingredients: Dark chocolate, honey, butter (pasteurized cream & salt), cream, dry milk, whey, agar, algin, lecithin & peppermint oil. Decoration: "Ivory" chocolate & artificial color.
Category
Food
Distribution
Distributed nationwide
HighFDA (Food)·F-1471-2022·2022-07-27
Honey Caramels Almond Coconut Recalled for Undeclared Tree Nuts
Queen Bee Gardens is recalling Honey Caramels Almond Coconut due to potential presence of undeclared tree nuts (pecans, almonds, coconut, macadamia nuts, walnuts). Consumers allergic to tree nuts should not consume this product.
Product
Honey Caramels Almond Coconut. Product available in 5.87 oz. bag, 1 lb. bag, 3 lb. bag, 6 lb. bag. PLU Code for 5.87 oz bag: 788394 12004 6. Ingredients: Honey, butter (pasteurized cream & salt), cream, almonds, coconut, nonfat dry milk, whey, natural flavors, lecithin…
Category
Food
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1452-2022·2022-07-27
SurgiCount+ System software error bypasses sponge tracking alerts
A software error in SurgiCount+ System Application may allow duplicate surgical sponges to be counted without the required documentation prompt. This could allow surgical cases to close without proper verification that all sponges were accounted for.
Product
SurgiCount+ System Application, Software Version 2.0.17, Catalog Number 0694-002-090. Used for counting, displaying, recording and locating the number of RFID-tagged absorbent articles used during surgical procedures.
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-1408-2022·2022-07-27
Nonsterile convenience kit recall due to sterile component mislabeling
ROi CPS LLC is recalling 40 nonsterile convenience kits (Lot #92605) because sterile components were incorrectly packaged as nonsterile. The affected kits were distributed in Missouri.
Product
Nonsterile convenience kit: regard Item #830014016, LD00199P - C Section Mother.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1424-2022·2022-07-27
Randox Cholesterol In Vitro Diagnostic Kits Fail Stated Performance Specifications
Randox Cholesterol diagnostic kits fail to meet stated performance specifications. Calibration issues cause quality control results to fall outside acceptable ranges, potentially delaying test results.
Product
Randox Cholesterol- For the quantitative in vitro determination of Cholesterol in serum and plasma. Catalog Number: CH2O0
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-1487-2022·2022-07-27
Chocolate Cashew Candy Recalled for Undeclared Tree Nuts
Queen Bee Gardens is recalling Honeymoons Ivory Chocolate Cashew candy because it may contain undeclared tree nuts including pecans, almonds, coconut, macadamia nuts, and walnuts, which can cause severe allergic reactions.
Product
Honeymoons Ivory Chocolate Cashew. PLU Code: 788394 14900 9
Category
Food
Distribution
Distributed nationwide
HighFDA (Food)·F-1461-2022·2022-07-27
Queen Bee Gardens Huckleberry Truffles Recalled for Undeclared Tree Nuts
Queen Bee Gardens is recalling Huckleberry Truffles because they may contain undeclared tree nuts (pecans, almonds, coconut, macadamia, walnuts). Products were sold at retail locations in Colorado, New Mexico, Wyoming, and nationwide via internet.
Product
Huckleberry Truffle. Net wt. 1.4 oz. PLU Code: 788394 11057 3. Ingredients: Dark chocolate (sugar, chocolate liquor processed with potassium carbonate, cocoa butter, milk fat [butter], HONEY, "Ivory" chocolate (sugar, cocoa butter, whole & non-fat milk solids, sunflower…
Category
Food
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1264-2022·2022-07-27
Lidocaine HCl injection syringes recalled due to sterility assurance failure
Nephron Sterile Compounding Center has recalled 37,310 syringes of Lidocaine HCl Injection USP 1% nationwide due to lack of assurance of sterility. Affected lots expire between August and October 2022.
Product
Lidocaine HCl Injection, USP 1%, 50 mg/5 mL (10 mg/mL) syringe, packaged in 5 x 5 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-985-05
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1409-2022·2022-07-27
Aesculap Aeos Digital Microscope robotic arm malfunction requires system restart
Aesculap Implant Systems is recalling the UR5 robotic arm component in its Aeos Digital Microscope System due to malfunction that prevents arm movement and requires system restart.
Product
Universal Robot UR5 arm, PV010204 subcomponent of Aesculap Aeos Digital Microscope System, PV010
Category
Medical Device
Distribution
1 state
HighFDA (Food)·F-1444-2022·2022-07-27
Cheesecake Bite Products Recalled for Undeclared Soy Allergen Mislabeling
Chuckanut Bay Foods LLC is recalling cheesecake bite products with labels declaring sunflower lecithin when they actually contain soy lecithin. Soy is a major allergen not properly disclosed to consumers.
Product
Item 35001-12, Chocolate Covered CHEESECAKE BITES NY SIGNATURE. Edible brand. Distributed by Wish Foods, LLC. Perishable - Keep Refrigerated. There are 8 pieces per pack and 12 packs per case. Net Wt. 6.4 oz. UPC 8 50014 91804 0. Item 39401-12, Chuckanut Bay DIPPED…
Category
Food
Distribution
13 states
HighFDA (Food)·F-1464-2022·2022-07-27
Bee Energy Bar recalled due to undeclared tree nuts
Queen Bee Gardens is recalling Bee Energy Bars due to undeclared tree nuts including pecans, almonds, coconut, macadamia nuts, and walnuts. Consumers with tree nut allergies should not consume this product.
Product
Bee Energy Bar. Net wt. 1.5 oz. PLU Code: 788394 18559 5. Ingredients: Dark chocolate (sugar, chocolate liquor, cocoa butter, milk fat [butter], sunflower lecithin, pure vanilla), honey, almonds, butter (pasteurized cream, salt), coconut, gluten free oats, dried…
Category
Food
Distribution
Distributed nationwide
HighFDA (Food)·F-1436-2022·2022-07-27
Chuckanut Bay Cheesecake Bites Recalled for Undeclared Soy Lecithin
Chuckanut Bay Foods is recalling Cheesecake Bites that contain undeclared soy lecithin, listed on the label as sunflower lecithin. Consumers with soy allergies may face serious risk.
Product
Item 38180-12, Chuckanut Bay Cheesecake Bites New York + Chocolate. Perishable - Keep Refrigerated. There are 8 pieces per plastic clamshell pack and 12 packs per case. Net wt. per pack 6.4 oz. UPC 6 03812 38180 2. The label is read in parts: "***INGREDIENTS: CREAM…
Category
Food
Distribution
13 states
ModerateFDA (Drugs)·D-1282-2022·2022-07-27
Aspirin-Dipyridamole Capsules Recalled for Capsule Breakage Defect
Glenmark Pharmaceuticals is recalling Aspirin and Extended-Release Dipyridamole Capsules due to capsule breakage defects. Approximately 168,936 bottles were distributed nationwide.
Product
ASPRIN AND EXTENDED-RELEASE DIPYRIDAMOLE — ASPRIN AND EXTENDED-RELEASE DIPYRIDAMOLE (ASPRIN AND EXTENDED-RELEASE DIPYRIDAMOLE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1386-2022·2022-07-27
Stryker Trevo Trak 21 Microcatheter recalled for missing carton product illustration
Stryker Neurovascular is recalling 71 Trevo Trak 21 Microcatheter units because the product carton label is missing the required product drawing or illustration.
Product
Trevo Trak 21 Microcatheter, REF: 90338. TREVO NXT 3X32+TRAK21 2-PACK - CE, REF: 91412; TREVO NXT 4X28+TRAK21 2-PACK - CE, REF: 91413; TREVO NXT 4X41+TRAK21 2-PACK - CE, REF: 91414; TREVO NXT 6X37+TRAK21 2-PACK - CE, REF: 91415; TREVO NXT 4X28+TRAK21+CAT6 3-PACK - CE…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1422-2022·2022-07-27
Laboratory Reagent Recalled Due to Inaccurate Calibration Curves
Randox Laboratories is recalling Soluble Transferrin Receptor reagent (TF10159) due to calibration curve defects causing inaccurate test results on Siemens Atellica CH analyzers.
Product
Soluble Transferrin Receptors (STFR), Catalog Number TF10159 (Research Use Only). IVD
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1423-2022·2022-07-27
Soluble Transferrin Receptor Calibrator Recall Due to Lab Errors
Randox Laboratories is recalling Soluble Transferrin Receptors Calibrator kits used in lab analyzers. The calibrators can produce incorrect test results, with some values potentially underestimated by up to 30 percent.
Product
Soluble Transferrin Receptors Calibrator Series (STFR CAL), Catalog Number TF10161. IVD
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1392-2022·2022-07-27
GreenLight HPSEA Laser Fiber Recall Due to Card Incompatibility Error
Boston Scientific is recalling GreenLight HPSEA Laser Fibers due to an incompatibility with the fiber card that causes an error message and requires equipment replacement during procedures.
Product
GreenLight HPSEA Laser Fibers, UPN 0010-2092
Category
Medical Device
Distribution
7 states
ModerateFDA (Drugs)·D-1340-2022·2022-07-27
FDA Recalls Launch Sequence Euphoria Capsules as Unapproved Drug
Launch Sequence Euphoria Capsules were marketed without FDA approval. Consumers should discontinue use immediately and contact the manufacturer.
Product
Launch Sequence Euphoria Capsules, 10- count tins, ASIN B08ZJX4V9J, UPC Code 661020846864.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1244-2022·2022-07-27
OTC Hydrogen Peroxide Solution Recalled for Isopropyl Alcohol Contamination
Vi-Jon's hydrogen peroxide topical solution has been recalled due to cross-contamination with low levels of isopropyl alcohol. Multiple brands are affected nationwide in the USA and Canada.
Product
HYDROGEN PEROXIDE — HYDROGEN PEROXIDE (HYDROGEN PEROXIDE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1451-2022·2022-07-27
LumiraDx SARS-CoV-2 Antibody Quality Control Recalled Due to Unauthorized Modification
LumiraDx is recalling SARS-CoV-2 antibody quality control products because modifications to the test were made outside the scope of FDA-approved authorization. The recall affects 99 units distributed across 13 U.S. states.
Product
LumiraDx SARS-CoV-2 Antibody (Ab) Liquid Quality Control
Category
Medical Device
Distribution
13 states
ModerateFDA (Devices)·Z-1404-2022·2022-07-27
X80 RADiant Photoelectric Therapy System Compatibility Issue
Xstrahl Limited is recalling specific lot codes of the X80 RADiant Photoelectric Therapy System due to a potential compatibility issue with replacement treatment applicators. Devices were distributed in Florida, California, and Kentucky.
Product
X80 RADiant Photoelectric Therapy System
Category
Medical Device
Distribution
3 states
ModerateFDA (Devices)·Z-1394-2022·2022-07-27
Triton Sponge System Software Instructions Updated for Proper Sponge Handling
Stryker is updating the Instructions for Use for the Triton Sponge System software (versions 4.6.5, 4.8.7, 4.9.6) to clarify proper handling technique for sponges and calibration placard. The FDA Class III recall affects 51 units distributed nationwide.
Product
Triton Sponge System (Software), GAUS-3, Software Versions 4.6.5, 4.8.7, 4.9.6
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1390-2022·2022-07-27
Erythropoietin Control Product Instructions Contain Incorrect CE Marking
R & D Systems is replacing Instructions for Use (IFU) for Quantikine IVD Erythropoietin Human Serum Controls due to an incorrect CE marking designation that should not appear on the self-certified product.
Product
Quantikine IVD Erythropoietin Human Serum Controls for use as quantitative controls for the determination of Erythropoietin concentrations in human serum and plasma. IFU, Part Number 750095
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1393-2022·2022-07-27
NeuRx Diaphragm Pacing System Labeling Revised for Storage Clarity
Synapse Biomedical revised labeling for the NeuRx Diaphragm Pacing System to clarify that temperature range symbols indicate storage conditions, not transport or package conditions. The revision affects 71 units distributed in the United States.
Product
NeuRx Diaphragm Pacing System (NeuRx DPS), Affected part numbers: Part # Part Name 20-0035 NeuRx DPS System Kit 20-0036 NeuRx Diaphragm Pacing System, Patient Kit, SCI 20-0028 NeuRx DPS Surgical Kit, HDE 20-0040 NeuRx Diaphragm Pacing…
Category
Medical Device
Distribution
19 states

How to read this listing

Filters

29326–29350 of 114616