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

21826–21850 of 90077

HighFDA (Drugs)·D-0115-2023·2023-01-18
TriMix Injectable Medication Recalled for Lack of Sterility Assurance
Northern VA Compounders PLLC is recalling TriMix Injection due to lack of sterility assurance. The injectable was distributed nationwide; affected patients should not use these vials and should contact their healthcare provider.
Product
TriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 60mcg/30mg/3mg/mL INJECTABLE, 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Food)·F-0249-2023·2023-01-18
Sanders Assorted Milk and Dark Sea Salt Caramels recalled for brush bristle contamination
Sanders Candy LLC is recalling Sanders Assorted Milk and Dark Sea Salt Caramels nationwide and in Canada due to cleaning brush bristles found in the product. Consumers should not eat affected candy and should return it to the retailer.
Product
Sanders Assorted Milk and Dark Sea Salt Caramels UPC 0-35900-31080-5 7oz Gift Box UPC 0-35900-29782-3 .5OZ Silver Box UPC 0-35900-29793-9 7OZ Silver Box
Category
Food
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0943-2023·2023-01-18
McCormick Medical Distribution PORT TRAY recalled for potential sterility breaches
Stradis Healthcare is recalling McCormick Medical Distribution PORT TRAY units due to potential pinhole leaks in the outer bag that could compromise sterility. Affected units were distributed nationwide.
Product
McCormick Medical Distribution PORT TRAY, 25 trays per case. Distributed by McCormick Medical Distribution.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0227-2023·2023-01-18
Pietrzyk Pierogi Recalled Due to Undeclared Soy Lecithin
Pietrzyk Foods is recalling The Holy Gouda Pierogi due to undeclared soy lecithin. Consumers with soy allergies should not consume this product.
Product
PIETRZYK PIEROGI THE HOLY GOUDA PIEROGI, NET WT. 26.5oz (742g), 1 DOZEN UPC 850014236069
Category
Food
Distribution
1 state
HighFDA (Drugs)·D-0118-2023·2023-01-18
TriMix Injectable Recalled for Lack of Sterility Assurance
Northern VA Compounders PLLC is recalling TriMix Injection (11.8mcg/18mg/0.6mg/mL) due to lack of assured sterility. Patients using affected vials should contact their healthcare provider immediately.
Product
TriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 11.8mcg/18mg/0.6mg/mL INJECTABLE, packaged in 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0109-2023·2023-01-18
Prostaglandin E1 Injection Recall Due to Sterility Assurance Failure
Northern VA Compounders has recalled Prostaglandin E1 Injection Solution due to lack of assurance of sterility in the compounding process. The affected lot was distributed nationwide.
Product
Prostaglandin (E1) Injection Solution, 10 mcg/ml, packaged in 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0912-2023·2023-01-18
Medtronic Vanta LT Neurostimulation Programmer Software Anomalies Recall
Medtronic is recalling 362 units of the Vanta/Seqenita LT Clinician Programmer Application due to software anomalies that display error messages affecting pain therapy neurostimulation system programmer functionality.
Product
Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems for pain therapy, Model Number CT900B
Category
Medical Device
Distribution
0 states
HighFDA (Drugs)·D-0122-2023·2023-01-18
BiMix Injection Recalled for Lack of Assurance of Sterility
Northern VA Compounders has recalled BiMix Injection due to lack of assurance of sterility. Patients using affected lots should consult their healthcare provider.
Product
BiMix Injection (Papaverine HCl/Phentolamine Mesylate) 30mg/0.5mg/mL INJECTABLE, packaged in 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0925-2023·2023-01-18
Guarded Luer Connectors Recalled for Compromised Sterility in Blister Packaging
International Medical Industries recalls 228,000 Prep-Fill Guarded Luer Connectors due to unsealed blister packages compromising product sterility. The Class II recall affects medical devices distributed nationwide.
Product
Prep-Fill Guarded Luer Connector (GLC): a. Part Number 57-400, Female Lock - Female Lock Guarded Luer Connector, Sterile; b. Part number 57-400W, Female Lock - Female Lock Guarded Luer Connector, Sterile; c. Part number 57-401, Female Lock - Male Lock Guarded Luer…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0125-2023·2023-01-18
Compounded Injectable Drug Recalled for Lack of Sterility Assurance
Northern VA Compounders PLLC is recalling 1,200 vials of BiMix STD 001 injectable nationwide due to lack of assurance of sterility. The compounded drug cannot be verified as sterile.
Product
BiMix STD 001 (Papaverine HCl/Phentolamine Mesylate) 30mg/1mg/mL INJECTABLE, 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Food)·F-0259-2023·2023-01-18
Sweet Potato Biscuits Recalled Due to Unlabeled Milk and Wheat Allergens
Hippos and Hashbrowns is recalling Take & Bake Sweet Potato Biscuits due to missing allergen labels for milk and wheat. Approximately 158 units were distributed in Texas.
Product
Take & Bake Sweet Potato Biscuits 44216-26522 packaged in metal tin with clear plastic nonflexible lid
Category
Food
Distribution
1 state
HighFDA (Devices)·Z-0935-2023·2023-01-18
PICC Kit Recall: Outer Bag Pinhole Leaks May Compromise Sterility
Stradis Healthcare is recalling PICC Kits due to potential pinhole leaks in the outer bag that may compromise kit sterility. No illnesses or injuries have been reported.
Product
PICC KIT, 10/CS, ACCESS MEDICAL LABEL
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0260-2023·2023-01-18
Take & Bake Maple Pecan Biscuits recalled for missing allergen labels
Hippos and Hashbrowns is recalling Take & Bake Maple Pecan Biscuits sold in Texas because the product labels fail to declare milk and wheat allergens. Consumers with allergies should not consume this product.
Product
Take & Bake Maple Pecan Biscuits no UPC packaged in metal tin with clear plastic nonflexible lid
Category
Food
Distribution
1 state
HighFDA (Devices)·Z-0945-2023·2023-01-18
Fluid Filter Transfer Kit Recalled Over Potential Sterility Breaches
Stradis Healthcare is recalling approximately 1,175 Tacy Medical fluid filter transfer kits due to potential pinhole leaks in the outer bag that may compromise sterility. The kits were distributed nationwide in nine states.
Product
Tacy Medical, Inc Fluid Filter Transfer Kit, Sterile, 60 kits per bag, 5 bags per case. Manufactured for Tracy Medical, Inc.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0932-2023·2023-01-18
PHS Lacertaion Tray Sterile Kit Recall Due to Seal Leakage Risk
Stradis Healthcare recalls PHS Lacertaion Tray sterile surgical kits due to potential pinhole leaks in outer packaging near the seal that could compromise sterility. 300 units affected across 10 US states.
Product
PHS Lacertaion Tray, Sterile, 20 per case, Manufactured for Professional Hosptial Supply, Inc.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0258-2023·2023-01-18
Take & Bake Cinnabiscuits Recalled: Missing Allergen Labels for Milk and Wheat
Hippos and Hashbrowns is recalling Take & Bake Cinnabiscuits because the product label fails to list milk and wheat as allergens. Consumers with these allergies may unknowingly consume the product.
Product
Take & Bake Cinnabiscuits UPC 44216-26552 packaged in metal tin with clear plastic nonflexible lid
Category
Food
Distribution
1 state
HighFDA (Drugs)·D-0112-2023·2023-01-18
Prostaglandin E1 Injection Vials Recalled for Sterility Issues
Northern VA Compounders PLLC is recalling Prostaglandin E1 Injection Solution vials nationwide due to lack of assurance of sterility. Patients should contact their healthcare provider.
Product
Prostaglandin (E1) Injection Solution, 40mcg/ml, 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0919-2023·2023-01-18
Anspach Adult Rotating Craniotome Attachment ball bearings may detach during surgery
The Anspach Adult Rotating Craniotome Attachment (CRANI-A-R) may have ball bearings that detach during surgical use. The FDA recommends users follow inspection intervals to prevent potential serious patient injury.
Product
6.5 cm Adult Rotating Craniotome Attachment. Use with XMax¿, microMax, and eMax¿ Systems Ref: CRANI-A-R intended for cutting and shaping bone including the spine and cranium
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0930-2023·2023-01-18
Medline CISION Sterile Surgical Blades Recalled for Sterile Packaging Breach Risk
Medline Industries is recalling CISION Sterile Blades used in surgical procedures due to potential for the blade to puncture the sterile outer packaging, breaching sterility. No injuries reported.
Product
Medline CISION Sterile Blades. Labeled as follows with corresponding Item Number. a. STERILE BLADE NO. 10 CARBON STEEL, Item Number: CISION10CS; b. STERILE BLADE NO. 10 CARBON STEEL RIB, Item Number: CISION10CSR; c. STERILE BLADE NO. 11 CARBON STEEL, Item Number…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0116-2023·2023-01-18
TriMix Injection Recalled Due to Lack of Sterility Assurance
Northern VA Compounders is recalling TriMix Injection due to lack of sterility assurance. The compounded injectable medication may not meet required sterility standards.
Product
TriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 100mcg/30mg/3mg/mL INJECTABLE, 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Food)·F-0254-2023·2023-01-18
Martinelli's Gold Medal Apple Juice Recalled for Elevated Patulin Levels
S Martinelli & Company is recalling Martinelli's Gold Medal Apple Juice due to elevated patulin levels detected during product testing. Distribution was limited to California, Texas, New York, Washington, Utah, Georgia, Oregon, and Arizona.
Product
Martinelli's Gold Medal Apple Juice 1 liter (33.8 oz.) glass bottle UPC: 4124400102 6 Bottles per bundled shrink-wrapped pack/case.
Category
Food
Distribution
8 states
HighFDA (Devices)·Z-0915-2023·2023-01-18
Medtronic Vanta/Seqenita LT Neurostimulation Programmer Software Anomalies Recalled
Medtronic recalls the Vanta/Seqenita LT Clinician Programmer Application due to software anomalies generating error messages that may affect device operation. The recall affects 22 units distributed worldwide.
Product
Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems for pain therapy, Model Number CT900E
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0954-2023·2023-01-18
Orthopedic Implant Cage Recalled for Incorrect Internal Material
Specific lots of CoreLink FLXFIT 15 orthopedic implant cages contain stainless steel internal components instead of the specified titanium alloy. The 18 affected units were distributed nationwide.
Product
CoreLink LLC, FLXFIT 15, 32MM X 8MM, CAGE, REF: AT3208
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0123-2023·2023-01-18
TriMix Plus 002 Injectable Medication Recalled for Sterility Concerns
FDA is recalling TriMix Plus 002, a compounded injectable medication, due to lack of assurance of sterility. The affected lot may not meet required sterility standards.
Product
TriMix Plus 002 (PGE1/Papaverine HCl/Phentolamine Mesylante) 25mcg/30mg/2mg/mL INJECTABLE, packaged in 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0936-2023·2023-01-18
HCT 500mL Sterile Medical Bags Recalled for Potential Pinhole Leaks
Stradis Healthcare is recalling HCT 500mL sterile medical bags due to potential pinhole leaks near the seal that could compromise sterility. The recall affects 644 units distributed across nine U.S. states.
Product
HCT 500mL BAGS, 2 Port, Sterile, Triple Packaged, 10 EVA BAGS/Pack, 7 Packs PER CASE. Distributed by Health Care Technology.
Category
Medical Device
Distribution
Distributed nationwide

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21826–21850 of 90077