The Recall Desk

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.

15801–15825 of 53092

  • HighFDA (Devices)·Z-1836-2022·2022-10-05

    Cook Newton Wire Guide Recalls Due to Potential Sterility Compromise

    Cook Incorporated is recalling certain Newton Wire Guide surgical guidewires because packaging seals may be breached, potentially compromising device sterility.

    Product
    Newton Wire Guide (LT Taper/10cm Distal Flexibility), Guidewire Reference Part Number/GPN: TSFNA-35-145 G00701 TSCFNA-35-145-3 G00561
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1819-2022·2022-10-05

    VenaCure EVLT procedure kit fiber component fails dimensional specification

    Angiodynamics is recalling 40 VenaCure EVLT procedure kit units with fiber components that fail dimensional specifications. The defect may damage the sheath, necessitating removal from the patient and potential additional surgical intervention.

    Product
    VenaCure EVLT KIT WITH SPOTLIGHT OPS SHEATH 55CM Ref./ Catalog No.: EVLT55OPS (each box contains 5 Procedure Kits). For use in the treatment of varicose veins.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1849-2022·2022-10-05

    Leica Surgical Operating Microscopes recalled for illumination adjustment defect

    Leica Microsystems recalls 25 Leica Surgical Operating Microscopes (Part Number 10448999) due to a photodiode component change causing inaccurate illumination adjustment when BrightCare Plus with Luxmeter is used.

    Product
    Leica Surgical Operating Microscopes, Arveo, Part Number 10448999
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1814-2022·2022-10-05

    Olympus POWERSEAL Electrosurgical Device Recalled for Retention Ring Malfunction

    Olympus POWERSEAL electrosurgical devices are recalled for a component defect that may prevent the retention ring from securing the rotation knob, potentially delaying treatment.

    Product
    Olympus POWERSEAL 5MM, 37CM, CURVED JAW SEALER & DIVIDER, DOUBLE-ACTION Model Number: PS-0537CJDA. An electrosurgical device use in laparoscopic/minimally invasive or open surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0742-2022·2022-10-05

    VIDAS CMV IgM diagnostic test kits recalled for invalid calibrations

    bioMerieux is recalling 480 VIDAS CMV IgM test kits with invalid calibrations distributed across 18 U.S. states. The calibration errors may affect diagnostic test accuracy.

    Product
    VIDAS CMV IgM, 30 tests, REF 30205-01, IVD, Rx.
    Category
    Medical Device
    Distribution
    18 states
  • HighFDA (Devices)·Z-1815-2022·2022-10-05

    Olympus POWERSEAL 5MM Electrosurgical Sealer Recalled Due to Loose Retention Ring

    Olympus is recalling POWERSEAL 5MM electrosurgical sealers due to a component defect that may cause the rotation knob to loosen and delay surgical treatment.

    Product
    Olympus POWERSEAL 5MM, 44CM, CURVED JAW SEALER & DIVIDER, DOUBLE-ACTION Model Number: PS-0544CJDA. An electrosurgical device use in laparoscopic/minimally invasive or open surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1546-2022·2022-10-05

    Antidepressant Medication Recalled for Excessive Active Ingredient Potency

    Leading Pharma, LLC is recalling Clomipramine Hydrochloride Capsules (25mg) with Lot B14221 due to testing that found 110.6% of the labeled active ingredient strength. The medication was distributed nationwide.

    Product
    CLOMIPRAMINE HYDROCHLORIDE — CLOMIPRAMINE HYDROCHLORIDE (CLOMIPRAMINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1545-2022·2022-10-05

    Inhalation Drug Recalled Due to Sterility Assurance Failure

    Cipla recalls Budesonide Inhalation Suspension ampules due to inability to assure sterility. Affected lots GA20080, GA20081, and GA20094 expire January 2024.

    Product
    BUDESONIDE — BUDESONIDE (BUDESONIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1843-2022·2022-10-05

    Torq-Flex Wire Guide Guidewires Recalled Due to Packaging Seal Defect

    Cook Incorporated is recalling Torq-Flex Wire Guide guidewires because the packaging chevron seal may be breached, potentially compromising device sterility. The affected units were distributed domestically and internationally.

    Product
    Torq-Flex Wire Guide Australian Modification, Guidewire Reference Part Number/GPN STF-18-40-AUST G07304
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1816-2022·2022-10-05

    Siemens Magnesium Test Cartridges May Produce Erroneous Results Without Alert

    Siemens Dimension Magnesium Flex reagent cartridges may produce inaccurate test results without triggering warning flags. Some results may show magnesium levels 15–59% lower than actual values.

    Product
    Dimension Magnesium (MG) Flex reagent cartridge Siemens Material Number (SMN)/REF (Catalog Number):10444963/DF57
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1786-2022·2022-10-05

    Mobile X-Ray System Recalled for Software Calibration Error in Radiation Dose Meter

    Micro-X Rover mobile X-ray systems recalled due to a software calibration error that causes incorrect radiation dose readings. The malfunction may impede proper radiation exposure management decisions.

    Product
    MICRO-X ROVER MOBILE X-RAY SYSTEM, MXU-RV19
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1847-2022·2022-10-05

    Medical Guidewire Recalled for Packaging Defect Affecting Sterility

    Cook Incorporated is recalling Movable Core Wire Guide (Tefcor) guidewires due to a packaging defect where the chevron seal may be breached, potentially compromising device sterility.

    Product
    Movable Core Wire Guide (Tefcor), Guidewire (OUS ONLY) Reference Part Number/GPN TMT-35-145 G01677
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1543-2022·2022-10-05

    FDA Recalls Neoral Cyclosporine for Out-of-Specification Ethanol Content

    Novartis is recalling Neoral cyclosporine 25 mg capsules nationwide due to a manufacturing quality deviation. Lot APCD162 (expiration 01/2023) was found to have out-of-specification ethanol content during stability testing.

    Product
    NEORAL — NEORAL (CYCLOSPORINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1789-2022·2022-10-05

    Alida's Wheat Saoka Pita Bread recalled for undeclared soy allergen

    Alida's Wheat Saoka Pita Bread is recalled for undeclared soy lecithin found in the pan-grease canola oil. The product label does not disclose soy, posing a risk to soy-allergic consumers. Distributed in Washington state only.

    Product
    Alida's Wheat Saoka Pita Bread, 5 pieces per package. Net Wt. 16.25 oz. UPC 8 60004 65931 0. Product contains ingredients: Wheat Flour, White Flour, Water, Wheat Gluten, Yeast, Sorbitan monostearate, ascorbic acid, salt, Canola Oil. CONTAINS: Wheat, Gluten.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-1824-2022·2022-10-05

    Cook guidewires recalled for compromised sterility due to packaging breach

    Cook Incorporated is recalling Amplatz extra Stiff Wire Guides because packaging seals may be completely breached, potentially compromising device sterility.

    Product
    Amplatz extra Stiff Wire Guide, Stiff Guidewire (OUS ONLY); Reference Part Number: THSF-35-145-AES-SGH (GPN G06801) THSF-38-80-AES-SGH (GPN G06874)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1842-2022·2022-10-05

    Cook Rosen Curved Wire Guide Recall: Sterility Concerns

    Cook Incorporated is recalling specific lots of Rosen Curved Wire Guide guidewires due to a complete breach of the packaging seal that may compromise device sterility. Affected devices were distributed nationwide in the US and worldwide.

    Product
    Rosen Curved Wire Guide, Guidewire Reference Part Number/GPN THSCF-35-220-1.5-ROSEN G01623 THSCF-35-80-1.5-ROSEN G01774 THSCF-35-180-1.5-ROSEN G01264 THSCF-35-145-1.5-ROSEN G01261
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1834-2022·2022-10-05

    Cook Guidewire Devices Recalled for Packaging Defect and Sterility Compromise

    Cook Incorporated is recalling fixed core wire guide devices due to packaging defects that may compromise device sterility. Approximately 5,669 units were distributed in the US and 5,286 internationally.

    Product
    Fixed Core Wire Guide (Straight), Guidewire Reference Part Number/GPN: C-SF-18-30 G02261 C-SF-25-40 G01937 TSF-18-260 G00590 C-SF-25-50 G01938 TSF-35-180 G00652 C-SF-18-40 G02255 TSF-25-145 G00617 TSF-32-145 G00638 C-SF-15-50 G02274 TSF-18-145 G00587 TSF-18-50 G00593…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·22V737000·2022-10-04

    2022-2023 Coachmen Recreational Vehicles Recall: Unintended Awning Movement

    Forest River is recalling certain 2022-2023 Coachmen recreational vehicles with a software issue that may cause the awning to unintentionally extend or retract while parked, increasing injury risk. Owners should contact dealers for a free ECM software update.

    Product
    COACHMEN — COACHMEN GALLERIA, NOVA, BEYOND
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighUSDA FSIS·PHA-10012022-01·2022-10-01

    USDA Issues Public Health Alert for Chili Cheese Wieners Due to Listeria

    USDA FSIS issued a public health alert for ready-to-eat chili cheese wieners produced by Family Fare due to possible Listeria monocytogenes contamination.

    Product
    FSIS Issues Public Health Alert for Ready-To-Eat Chili Cheese Wieners Due to Possible Listeria Contamination
    Category
    Food
    Distribution
    1 state
  • HighNHTSA·22V729000·2022-09-30

    2021-2022 Forest River Travel Trailers: Fresh Water Tank Dislodgement

    Forest River is recalling 2021-2022 Ozark, Wildwood, and Salem travel trailers because the fresh water tank may dislodge when full or overfilled, creating a road hazard and increasing crash risk.

    Product
    FOREST RIVER — FOREST RIVER WILDWOOD, SALEM, OZARK
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·22V731000·2022-09-30

    Ford F-53 Rear Stabilizer Brackets May Separate from Vehicle

    Ford is recalling 2020-2021 F-53 recreational vehicles because rear stabilizer bar attachment brackets may break and separate, creating a road hazard and increasing crash risk. Dealers will inspect and replace the brackets free of charge.

    Product
    FORD — FORD F53
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·22V730000·2022-09-30

    2022 Ford Maverick brake lights may illuminate unintended due to ABS defect

    Ford is recalling 2022 Maverick vehicles with an ABS module defect that may cause brake lights to illuminate without driver input. This could confuse other drivers and increase crash risk.

    Product
    FORD — FORD MAVERICK
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·22V733000·2022-09-30

    2020 Mercedes-Benz CLS450 improperly secured battery defect recall

    Mercedes-Benz is recalling 2019-2022 CLS450 and related models. The 12V battery in the trunk may not be properly secured, which could cause electrical failure and disable safety features like the emergency call system, hazard lights, and automatic door locks in a crash.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ E 450, AMG E53, AMG CLS53, CLS 450
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·22E083000·2022-09-29

    Chrysler Recalls Mopar Headlamp Assemblies for Dim Amber Reflectors

    Chrysler is recalling specific Mopar headlamp assemblies because the amber side reflex reflector may not reflect brightly enough, potentially reducing vehicle visibility.

    Product
    EXTERIOR LIGHTING:HEADLIGHTS recall
    Category
    Vehicle
    Distribution
    Distributed nationwide