The Recall Desk

Agency

U.S. Food and Drug Administration

The FDA regulates food, drugs, biologics, medical devices, and tobacco. We aggregate Class I, II, and III enforcement actions across its three recall streams.

Visit the official FDA site →

About FDA recalls

The FDA is the single biggest source of US product recalls by volume. Its enforcement workload splits into three streams — Foods (everything from infant formula to leafy greens to nutritional supplements), Drugs (prescription medicines, over-the-counter products, and active pharmaceutical ingredients), and Medical Devices (everything from implants to home blood-pressure monitors). The Recall Desk ingests all three from the openFDA enforcement endpoint every six hours.

FDA classifies every recall as Class I, II, or III. Class I means there is a reasonable probability that using the product will cause serious health consequences or death — these are the recalls you should treat as urgent. Class II means the product may cause temporary or medically reversible harm. Class III means the product is unlikely to cause adverse health consequences but still violates FDA rules. We map these classifications into our 1–5 severity score using the rubric on the methodology page.

Medical-device recalls are the highest-volume stream by far — software-update letters, calibration corrections, and IFU updates all show up in enforcement reports alongside genuine hazard recalls. We try to surface the severe ones first, but when in doubt, click through to the FDA notice itself for the clinical detail.

5201–5225 of 88106

  • HighFDA (Devices)·Z-0478-2026·2025-11-19

    Spinal fixation screws recalled for not meeting performance standards

    Orthofix is recalling 624 Virata preassembled polyaxial screws used in the Virata Spinal Fixation System because the screws do not meet performance standards.

    Product
    Virata Preassembled Polyaxial Screw, utilized in the Virata Spinal Fixation System. The following sizes are affected: 1. POLYAXIAL SCREW, CC, 5.5mm X 30mm; Item Number: TL1-10755030. 2. POLYAXIAL SCREW, CC, 5.5mm X 35mm; Item Number: TL1-10755035. 3. POLYAXIAL SCREW…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0172-2026·2025-11-19

    Cinnamon powder recalled over elevated levels of lead and chromium

    Singh Trading, doing business as Roshni Foods, is recalling 48 cases of Roshni Cinnamon Powder 3.5 oz because it may contain elevated levels of lead and chromium.

    Product
    Roshni Cinnamon Powder, 3.5 oz (100g). This product is packaged in clear plastic pouches.
    Category
    Food
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-0484-2026·2025-11-19

    Laboratory cuvette arrays recalled over barcodes the analyser cannot read

    Becton Dickinson is recalling 29,760 BD Kiestra Isolate Suspension Cuvette Arrays because formatting errors in the 2D barcodes stop the analyser reading the expiration date.

    Product
    BD Kiestra" Isolate Suspension Cuvette Array; Catalog No.: 246100;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0465-2026·2025-11-19

    DigitalDiagnost C90 systems recalled over ceiling carriages resisting vertical movement

    Philips is recalling 223 DigitalDiagnost C90 systems because some ceiling suspension telescopic carriages may be difficult to move vertically.

    Product
    DigitalDiagnost C90 (1) High Performance, (2) Flex/Value/Chest/ER; Model Number: (1) 712034, (2) 712035;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0500-2026·2025-11-19

    Platelet reactivity tests recalled after an uncleared device was distributed

    Accriva Diagnostics is recalling 125 boxes, 3,125 tests, of VerifyNow PRUTest because a device without premarket clearance was incorrectly packaged and distributed.

    Product
    VerifyNow PRUTest Platelet Reactivity Test REF 85225 UDI-DI code: 10711234150078 The VerifyNow PRUTest is a whole blood test used in the laboratory or point of care setting to measure the level of platelet P2Y12 receptor blockade.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0479-2026·2025-11-19

    ACL restoration implants recalled from one lot held in sales stock

    Miach Orthopaedics is recalling 167 BEAR Implants from a single lot, in an action the record says was limited to sales force trunk stock.

    Product
    BEAR Implant (Bridge-Enhanced ACL Restoration); Model/Catalog: 1000;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0466-2026·2025-11-19

    Radiography systems recalled over ceiling carriages that are hard to move

    Philips is recalling 284 Radiography 7300 C systems because some ceiling suspension telescopic carriages may be difficult to move vertically.

    Product
    Radiography 7300 C; Model Number: 712037;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0464-2026·2025-11-19

    DigitalDiagnost 4 systems recalled over ceiling carriages hard to move

    Philips is recalling 12 DigitalDiagnost 4 systems because some ceiling suspension telescopic carriages may be difficult to move vertically.

    Product
    DigitalDiagnost 4 (1) High Performance, (2) Flex/Value; Model Number: (1) 712031, (2) 712032;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·H-0147-2026·2025-11-12

    Frozen crab paste recalled over undeclared fish soy and wheat

    New York Mutual Trading is recalling about 21 cases of frozen crab paste sold to restaurants over undeclared fish, soy and wheat. The FDA has classified the recall as Class I.

    Product
    Frozen Crab Paste; 3.5 OZ (100g); Imported by Mutual Tading Co. Inc. UPC# 72546723040 "Not for retail Sale" Frozen Crab Paste IM-2 in w/Tray; 500g; Imported by Mutual Trading Co. Inc. UPC# 72546607852 "Not for retail Sale" Frozen Crab Paste; 17.6 OZ (500g); Imported by Mutual…
    Category
    Food
    Distribution
    8 states
  • CriticalFDA (Food)·H-0155-2026·2025-11-12

    Crunchy taco dinner kits recalled over an undeclared milk allergen

    Teasdale Foods is recalling 336 cases, 4,032 units, of Giant/Martin's Crunchy Taco Dinner Kit over undeclared milk. The FDA has classified the recall as Class I.

    Product
    Giant/Martin's Crunchy Taco Dinner Kit, Net Wt 9.4 OZ (266g), UPC: 068826757516, DISTRIBUTED BY: ADUSA DISTRIBUTION, LLC SALISBURY, NC 28147 Product consists of 12 taco shells, 1 sauce packet, and 1 seasoning packet within a carton; packed 12 cartons per case
    Category
    Food
    Distribution
    11 states
  • CriticalFDA (Food)·H-0170-2026·2025-11-12

    Pastured large eggs recalled over potential Salmonella contamination in Texas

    Kenz Henz is recalling 16,400 dozen Pastured Grade AA Large Eggs distributed in Texas because the eggs may be contaminated with Salmonella. The FDA has classified the recall as Class I.

    Product
    " Product Name: Pastured Grade AA Large Eggs " Product Description: Egg Carton, 12 eggs per dozen " Pack/Julian Date(s): Julian date 241(Aug 30) to 244 (Sep 2) and 246 (Sep 4) to 247 (Sep 5), Best by Dates 10/11 to 10/14/25 and 10/16 to 10/17.
    Category
    Food
    Distribution
    1 state
  • CriticalFDA (Food)·H-0171-2026·2025-11-12

    Repackaged shell eggs recalled over potential Salmonella contamination in retail brands

    Eggs Unlimited is recalling 92,476 units of shell eggs sold under Big Y, Simple Truth, Stater Bros, That's Smart, Lindsey's Gold and Marketside labels over potential Salmonella.

    Product
    Big Y Brown Jumbo A 12ct Eggs; UPC: 018894319146 Simple Truth Cage Free Brown Large AA 12ct; UPC: 011110797698 Stater Bros Cage Free Large AA 18ct; 074175001650 That's Smart Cage Free Large AA 60ct; 193476006192 Lindsey s Gold Free Range Brown Large A 12ct; 860011334408…
    Category
    Food
    Distribution
    3 states
  • CriticalFDA (Food)·H-0153-2026·2025-11-12

    Farm shell eggs recalled over potential Salmonella contamination in New York

    Jacob King is recalling approximately 15 dozen in-shell chicken eggs distributed from a farm in Addison, New York, over potential Salmonella. The FDA has classified it Class I.

    Product
    In-shell chicken eggs distributed on Jacob King's farm in Addison, NY
    Category
    Food
    Distribution
    1 state
  • CriticalFDA (Devices)·Z-0374-2026·2025-11-12

    Cranial perforators recalled as inadequate weld recall expands to smaller sizes

    Integra LifeSciences is recalling 5,109 CODMAN Disposable Perforators, 9mm, extending an existing 14 mm recall for inadequate welds. The FDA has classified it Class I.

    Product
    CODMAN Disposable Perforator 9mm. Cranial Perforator.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0373-2026·2025-11-12

    Eleven millimetre cranial perforators recalled over inadequate welds

    Integra LifeSciences is recalling 16,251 CODMAN Disposable Perforators, 11mm, extending an existing 14 mm recall for inadequate welds. The FDA has classified it Class I.

    Product
    CODMAN Disposable Perforator 11mm. Cranial Perforator.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·H-0156-2026·2025-11-12

    Soft taco dinner kits recalled over an undeclared milk allergen

    Teasdale Foods is recalling 3,654 cases, 21,924 units, of Casa Mamita Soft Taco Dinner Kit sold at ALDI over undeclared milk. The FDA has classified the recall as Class I.

    Product
    Casa Mamita Soft Taco Dinner Kit, Net Wt 13.4 OZ (379g), UPC: 4099100318715, DIST. & SOLD EXCLUSIVELY BY: ALDI BATAVIA, IL 60510 Product consists of 10 flour tortillas, 1 sauce packet, and 1 seasoning packet within a carton; 6 cartons are packed into a mixed case with 6…
    Category
    Food
    Distribution
    11 states
  • CriticalFDA (Devices)·Z-0427-2026·2025-11-12

    Insulin pumps recalled over false vibration motor failure stopping delivery

    Tandem Diabetes Care is recalling 17,745 Tandem Mobi insulin pumps because a software issue can trigger a false vibration motor failure that halts insulin delivery. The FDA classified it Class I.

    Product
    Tandem Mobi Insulin Pump: Description/Catalog: Tandem insulin pumps are battery-operated infusion pumps capable of both basal and bolus delivery of insulin. The pumps utilize a motor-driven mechanism to deliver insulin from within a disposable cartridge, through an infusion…
    Category
    Medical Device
    Distribution
    53 states
  • HighFDA (Food)·H-0161-2026·2025-11-12

    Waterfront Bistro shrimp recalled over potential Cesium-137 contamination

    AquaStar is recalling 3,600 cases of Waterfront Bistro Frozen Raw EZ-Peel White Shrimp 21/25 because the shrimp may be contaminated with Cesium-137.

    Product
    Waterfront Bistro Frozen Raw EZ-Peel White Shrimp 21/25, net wt. 2lbs., UPC 021130123223. Product was sold at Shaw s and Star Market, Albertson's, Eagle, Carrs-Safeway, and Safeway.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0151-2026·2025-11-12

    Amoxicillin clavulanate oral suspension recalled as subpotent in the clavulanate component

    Teva Pharmaceuticals USA is recalling 4,680 cartons of Amoxicillin and Clavulanate Potassium for Oral Suspension 200 mg/28.5 mg per 5 mL because the clavulanate component is subpotent.

    Product
    Amoxicillin and Clavulanate Potassium for Oral Suspension USP, 200 mg/28.5 mg per 5mL, 100 mL (when reconstituted), Rx only, manufactured in Canada by: Teva Canada Limited, Toronto, Canada M1B 2K9; Manufactured For: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054 NDC…
    Category
    Drug
    Distribution
    3 states
  • HighFDA (Drugs)·D-0155-2026·2025-11-12

    Pain relief caplets recalled because the box names the wrong drug

    Aero Healthcare is recalling two lots of AERO TAB caplets because the outer box states acetaminophen and caffeine while the inner pouch correctly states aspirin and caffeine.

    Product
    AEROTAB PAIN RELIEVER — AEROTAB PAIN RELIEVER (PAIN RELIEVER)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0151-2026·2025-11-12

    Veggie burgers recalled after equipment tested positive for Listeria

    Dr. Praeger's Sensible Foods is recalling 648 master cases of California Veggie Burgers because the product was made on equipment that tested positive for Listeria.

    Product
    Dr. Praeger's, California Veggie Burgers, 10oz, Plastic wrapped burgers inside of a retail box. 6 packages per master case. Keep Frozen
    Category
    Food
    Distribution
    3 states
  • HighFDA (Drugs)·D-0152-2026·2025-11-12

    Clomipramine 25 mg capsules recalled over nitrosamine above the intake limit

    Zydus Pharmaceuticals is recalling clomiPRAMINE Hydrochloride Capsules USP 25 mg after N-Nitroso Desmethyl-Clomipramine was found above the FDA acceptable intake limit.

    Product
    CLOMIPRAMINE HYDROCHLORIDE — CLOMIPRAMINE HYDROCHLORIDE (CLOMIPRAMINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide