The Recall Desk

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.

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Any3+ (High and above)4+ (High and above)5+ (High and above)

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21251–21275 of 27363

  • HighFDA (Drugs)·D-1492-2022·2022-09-14

    CORRECTDOSE Children's Allergy Relief Recalled Due to Manufacturing Process Control Deviations

    CORRECTDOSE Children's Allergy Relief (Diphenhydramine HCl 12.5 mg per 5 mL) is being recalled nationwide. The FDA determined products were manufactured under conditions with inadequate process control.

    Product
    CORRECTDOSE Children's ALLERGY RELIEF (Diphenhydramine HCl 12.5 mg per 5 mL), 2.04 FL. OZ (60 mL) packaged in 12- 5mL individual doses, Distributed by Correct Dose Inc, Braintree MA 02184. NDC 62320-302-05 UPC 8 60003 67144 3
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1709-2022·2022-09-14

    Piantedosi Burger Rolls Recalled for Cronobacter and Botulinum Contamination

    Piantedosi Baking Co. is recalling frozen Gourmet Burger Rolls due to potential contamination with Cronobacter sakazakii and Clostridium botulinum. The recall affects 18,119 units across 15 states.

    Product
    Gourmet Burger Roll 12-pack (033474501322)
    Category
    Food
    Distribution
    15 states
  • HighFDA (Devices)·Z-1701-2022·2022-09-14

    Obstetric and gynecology surgical packs recalled for unvalidated sterilization exposure

    American Contract Systems is recalling 15 obstetric and gynecology surgical packs that underwent multiple sterilization cycles without validation. This could compromise product sterility and increase infection risk during procedures.

    Product
    Various ob/gyn packs
    Category
    Medical Device
    Distribution
    13 states
  • HighFDA (Drugs)·D-1484-2022·2022-09-14

    Acetaminophen Oral Solution 160 mg Recalled for Manufacturing Control Deviations

    Acetaminophen Oral Solution 160 mg/5 mL (290,270 cups) recalled nationwide due to CGMP manufacturing control deviations. Product was distributed to institutional healthcare facilities.

    Product
    Acetaminophen Oral Solution 160 mg / 5 mL, 5 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Major Pharmaceuticals, 17177 N Laurel Park Dr., Suite 233, Livonia, MI 48152, NDC 0904-6738-70
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1692-2022·2022-09-14

    Banana Nut Pound Cake Recalled Due to Undeclared Soy Allergen

    Select Bakery Gourmet Banana Nut Pound Cake contains undeclared soy, posing a risk to consumers with soy allergies. The product was distributed in Georgia, North Carolina, and South Carolina.

    Product
    Select Bakery Gourmet Banana Nut Pound Cake Net Wt. 3oz (85g) & 5 oz (142g) Select Bakery, Inc., Rockwell, N.C. 28138 UPC 0 28598 10058 2
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-1722-2022·2022-09-14

    Brioche-Style Slider Rolls Recalled Due to Bacterial Contamination Risk

    Piantedosi Baking Co. is recalling 18,119 frozen Brioche-Style Slider Roll 24-packs distributed across 15 states due to potential contamination with Cronobacter sakazakii and Clostridium botulinum.

    Product
    Brioche-Style Slider Roll 24-pack (033474512021)
    Category
    Food
    Distribution
    15 states
  • HighFDA (Devices)·Z-1677-2022·2022-09-14

    CARTO VIZIGO Guiding Sheath Recalled Due to Water-Damaged Sterile Packaging

    Biosense Webster is recalling 98 units of CARTO VIZIGO 8.5F guiding sheaths due to water damage to packaging that may have compromised the sterile barrier, creating a potential infection risk.

    Product
    CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath, REF: D138501. Used to introduce various cardiovascular catheters into the heart.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·22V687000·2022-09-14

    2022 Volkswagen Taos Engine Stall Software Safety Recall

    Volkswagen is recalling certain 2022 Taos vehicles with all-wheel drive due to engine control unit software that may cause engine stall when coming to a stop, increasing crash risk. Dealers will provide free software updates.

    Product
    VOLKSWAGEN — 2022 VOLKSWAGEN TAOS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1486-2022·2022-09-14

    Acetaminophen Oral Solution Recalled for Manufacturing Process Control Failures

    Plastikon Healthcare LLC is recalling acetaminophen oral solution (650 mg per 20.3 mL cup) distributed nationwide due to manufacturing process control failures.

    Product
    Acetaminophen Oral Solution 650 mg / 20.3 mL, 20.3 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Major Pharmaceuticals, 17177 N Laurel Park Dr. Suite 233, Livonia, MI 48152, NDC 0904-6820-76
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1706-2022·2022-09-14

    Frozen Finger Rolls Recalled Due to Potential Bacterial Contamination

    Piantedosi Baking Co. is recalling 18,119 trays of frozen finger rolls distributed across 15 states due to potential contamination with Cronobacter sakazakii and Clostridium botulinum.

    Product
    Finger Roll 24-pack (033474400885))
    Category
    Food
    Distribution
    15 states
  • HighFDA (Devices)·Z-1702-2022·2022-09-14

    Hysterectomy and Vaginal Packs Recalled for Improper Sterilization Validation

    American Contract Systems recalled 29 hysterectomy and vaginal packs distributed to health systems in 13 states due to exposure to multiple sterilization cycles without validation.

    Product
    Various hysterectomy, vaginal packs
    Category
    Medical Device
    Distribution
    13 states
  • HighFDA (Devices)·Z-1698-2022·2022-09-14

    Medical device convenience packs exposed to unvalidated sterilization cycles

    American Contract Systems, Inc. is recalling 116 convenience packs distributed to U.S. health systems and distributors in 13 states because they were exposed to multiple sterilization cycles without validation, potentially compromising device sterility assurance.

    Product
    Various convenience packs
    Category
    Medical Device
    Distribution
    13 states
  • HighFDA (Food)·F-1695-2022·2022-09-14

    Select Bakery pound cake recalled for undeclared soy and food dyes

    Select Bakery Gourmet Old Fashion Pound Cake (5 oz) is being recalled due to undeclared soy allergen and artificial food dyes (Yellow #5, Yellow #6, Red #40). The product was distributed in Georgia, North Carolina, and South Carolina.

    Product
    Select Bakery Gourmet Old Fashion Pound Cake Net Wt. 5 Oz (142g) Select Bakery, Inc., Rockwell, N.C. 28138 UPC 0 28598 10062 9
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-1719-2022·2022-09-14

    B & W frozen burger rolls recalled for contamination risk

    B & W Gourmet Burger Rolls are being recalled due to potential contamination with Cronobacter sakazakii and Clostridium botulinum. Affected products were distributed across 15 states.

    Product
    B & W Gourmet Burger Roll 12-pack (033474504644)
    Category
    Food
    Distribution
    15 states
  • HighFDA (Devices)·Z-1686-2022·2022-09-14

    FDA Recalls Sensation Plus Catheter for Undersized Dilator Manufacturing Defect

    Datascope Corporation recalls certain lots of Sensation Plus 8Fr 50cc Intra-Aortic Balloon Catheters due to undersized dilators. The manufacturing defect affects approximately 10,427 units distributed internationally and awaiting U.S. distribution.

    Product
    Sensation Plus 8Fr 50cc Intra-Aortic Balloon Catheter
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1680-2022·2022-09-14

    Medical embolization coil system recalled for untested alternate supplier material

    BALT USA recalls the Optima Coil System because devices were distributed with material from an alternate supplier before required testing was approved. No illnesses or injuries have been reported.

    Product
    Optima Coil System Model OPTI0520CSF10. For endovascular embolization.
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1699-2022·2022-09-14

    Surgical instrument convenience packs recalled for inadequate sterilization validation

    American Contract Systems is recalling 118 convenience packs of surgical instruments because they were exposed to multiple sterilization cycles without validation of the product's ability to withstand repeated sterilizations.

    Product
    Various convenience packs
    Category
    Medical Device
    Distribution
    13 states
  • HighFDA (Drugs)·D-1488-2022·2022-09-14

    Diphenhydramine Solution Recalled Due to Manufacturing Control Deviations

    Plastikon Healthcare LLC is recalling Diphenhydramine HCl Oral Solution nationwide due to manufacturing control deficiencies that did not meet Current Good Manufacturing Practice standards.

    Product
    Diphenhydramine HCl Oral Solution 12.5 mg / 5 mL, 5 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Major Pharmaceuticals, 17177 N Laurel Park Dr. Suite 233, Livonia, MI 48152, NDC 0904-6740-70
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1675-2022·2022-09-14

    VITROS XT 3400 Chemistry System May Produce Inaccurate Test Results

    The VITROS XT 3400 Chemistry System may produce inaccurate test results during shutdown due to electrical current shifts. The FDA has classified this Class II recall, affecting 506 units distributed worldwide.

    Product
    VITROS XT 3400 Chemistry System with Version 3.7.2 and below Product Code: 6844458
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1695-2022·2022-09-14

    Cysto Packs Recalled Due to Inadequate Sterilization Validation

    American Contract Systems is recalling Cysto Packs distributed to health systems and distributors because the devices were exposed to multiple sterilization cycles without validation for multiple exposures.

    Product
    Various Cysto Packs
    Category
    Medical Device
    Distribution
    13 states
  • HighFDA (Food)·F-1693-2022·2022-09-14

    Blueberry Pound Cake Recalled for Undeclared Soy and Food Colorings

    Select Bakery Gourmet Blueberry Pound Cake (5 oz) is recalled due to undeclared soy and food colorings. The product was distributed in Georgia, North Carolina, and South Carolina.

    Product
    Select Bakery Gourmet Blueberry Pound Cake Net Wt. 5 Oz (142g) Select Bakery, Inc., Rockwell, N.C. 28138 UPC 0 28598 10060 5
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-1689-2022·2022-09-14

    Select Bakery Cheerwine bakery product recall for undeclared allergens and additives

    Select Bakery is recalling Cheerwine net weight 3 oz bakery products due to undeclared soy, Red #40, and sulfites. Products were distributed in Georgia, North Carolina, and South Carolina.

    Product
    Select Bakery Cheerwine Net Wt. 3 oz (85g) Select Bakery, Inc., Rockwell, N.C. 28138 UPC 0 28598 10033 9
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-1687-2022·2022-09-14

    Charlie's Brand Spinach Salad With Honey Dijon Dressing Recalled for Undeclared Fish Allergen

    Charlie's brand Spinach Salad With Honey Dijon Dressing is recalled due to undeclared fish (anchovy) in the Worcestershire sauce dressing. Consumers with fish allergies are at risk.

    Product
    Charlie's brand perishable and refrigerated Spinach Salad With Honey Dijon Dressing, item # 028-09048, packaged in a clear hinged container, net weight per container: 6 oz. UPC 0 45009 85415 5. There are 8/6oz. Spinach Salad With Honey Dijon Dressing containers in the Spinach S
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-1682-2022·2022-09-14

    ChemoLock Chemotherapy Port Connectors Recalled for Disconnection Risk

    ICU Medical recalls ChemoLock and ChemosafeLock port connectors used in chemotherapy delivery systems due to spring defects that may prevent proper connection or cause unintended disconnection, potentially delaying treatment or exposing patients to caustic substances.

    Product
    Product Description/Item: ChemoLock Vial Spike, 20mm/011-CL-80S; ChemoLock Bag Spike/CL-10; ChemoLock w/Mini Bag Spike/CL-17; 8 IN (20cm) APPX 1.0ml, EXT SET, MicroClave Clear, ChemoLock PORT, YCONN/CL3950; 31" (79 cm) Appx 3.4 ml, Admin Set w/20 Drop Integrated ChemoLock Dri
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1681-2022·2022-09-14

    ChemoLock Infusion Ports Recalled for Unintended Disconnection Risk

    ICU Medical recalls ChemoLock chemotherapy infusion ports for potential unintended disconnection due to spring variation, which may delay therapy and expose patients to caustic substances.

    Product
    Product Description/Item: ChemoLock Bag Spike, 10 units/CL-10-10; ChemoLock BAG SPIKE w/ ADDITIVE PORT, DRY SPIKE/CL-12; APPX 1.5ml,ChemoLock BAG SPIKE WITH ADDITIVE PORT/CL-13; ChemoLock Port/CL2100; ChemoLock Port, 5 Units/CL2100-5; ChemoLock Port/CL2100T; Clave Bag Spike
    Category
    Medical Device
    Distribution
    Distributed nationwide