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.

20026–20050 of 50413

  • HighFDA (Devices)·Z-1951-2021·2021-06-30

    LEGION Knee Prosthesis Component Recalled for Manufacturing Surface Damage

    Smith & Nephew is recalling 5 units of a knee prosthesis component due to surface damage from a manufacturing error. The affected lot was distributed in specific U.S. states.

    Product
    LEGION Posterior Stabilized OXINIUM Femoral Component, REF 71421216, Size 6, Left, Nonporous Femoral Component, A/P 65.5 MM, M/L 73 MM, For Cemented Use Only, ZR-2.5NB,Sterile. Knee prosthesis component.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1916-2021·2021-06-30

    Transducer Cover Lacks FDA 510(k) Clearance for Surgical Use

    Exact Medical Manufacturing is recalling 500 ultrasound transducer covers lacking FDA 510(k) clearance for body cavity use. The affected lot was distributed to Florida, Montana, New York, Ohio, Georgia, and Puerto Rico.

    Product
    Transducer Cover 18x147cm, Kit, VIP Film w/ Bands & EMM Gel- Ultrasonic Transducer Cover Item ID: E6360
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-1914-2021·2021-06-30

    Ultrasonic Probe Covers Lack FDA Clearance for Body Use

    Exact Medical Manufacturing recalls ultrasonic transducer probe covers marketed without required FDA 510(k) clearance for use in body openings. Approximately 129,600 units distributed to FL, MT, NY, OH, GA, and Puerto Rico.

    Product
    Probe Cover Elastic Poly 6" x 48"- Ultrasonic Transducer Cover Item ID: E5322N
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-1936-2021·2021-06-30

    OneTouch Ultra Blue test strips recalled for temperature exposure damage

    Cardinal Health is recalling 5,356 boxes of OneTouch Ultra Blue test strips after units were exposed to freezing temperatures during shipping, which may cause inaccurate glucose readings.

    Product
    ONETOUCH ULTRA BLUE TEST STRIPS 100 COUNT Item Number: 2990174
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1927-2021·2021-06-30

    Cardiac assessment system may display test reports in wrong patient records

    GE Healthcare's Case Cardiac Assessment System and CardioSoft diagnostic application may display one patient's cardiac test report in another patient's medical record under certain conditions. No patient injuries have been reported.

    Product
    Case Cardiac Assessment System for Exercise Testing and CardioSoft Diagnostic System Exercise Stress Testing ECG application
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0686-2021·2021-06-30

    Clio Vanilla Greek Yogurt Mini Bars Recalled for Possible Metal Fragments

    Clio LLC is recalling Clio Vanilla Greek Yogurt Mini Bars due to the possibility of metal fragments in the product. Consumers should not consume affected yogurt bars.

    Product
    Clio Vanilla Greek Yogurt Mini Bars wrapped in a Chocolate Coating 6.2oz pouch x 6 pouches per case, UPC: 854021008077
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1932-2021·2021-06-30

    AeroChamber PLS Spacer Recalled Due to Temperature Exposure During Shipping

    Cardinal Health is recalling AeroChamber PLS spacers exposed to freezing temperatures during shipping, which may cause inaccurate drug delivery results. Affected units shipped between February and March 2021 in Florida, Georgia, and South Carolina.

    Product
    AEROCHAMBER PLS W/MASK LRG BLU Item Number: 1496033
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1917-2021·2021-06-30

    Ultrasonic Probe Cover Recalled for Missing FDA 510(k) Clearance

    Exact Medical Manufacturing is recalling ultrasonic probe covers lacking required FDA 510(k) clearance for use in natural or surgical body openings. The 51,300 affected units were distributed across six U.S. states and Puerto Rico.

    Product
    Probe Cover, 6" x 96", PE, w 3 elastic bands- Ultrasonic Transducer Cover Item ID: E6443N
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Food)·F-0693-2021·2021-06-30

    Clio Peach Less Sugar Yogurt Bars recalled for possible metal fragments

    Clio LLC is recalling Clio Peach Less Sugar Yogurt Bars due to the possible presence of metal fragments in the product. The 10-pack boxes with best buy dates between 2/7/2021 and 6/20/2021 were distributed nationwide.

    Product
    Clio Peach Less Sugar Yogurt Bars wrapped in a Chocolate Coating 50g x 10 Clio Retail 10-pack, UPC code: 854021008213
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0690-2021·2021-06-30

    Clio Honey Greek Yogurt Bars Recalled for Possible Metal Fragments

    Clio LLC is recalling Clio Honey Greek Yogurt Bars due to the possibility of metal fragments in the product. The recall affects 5,423 cases distributed nationwide with best-by dates between March 7, 2021 and July 11, 2021.

    Product
    Clio Honey Greek Yogurt Bars wrapped in a Chocolate Coating 50g x 10 Clio Retail 10-pack, UPC code: 861703000168
    Category
    Food
    Distribution
    Distributed nationwide
  • HighNHTSA·21V492000·2021-06-30

    2021 Volkswagen Jetta Air Bag Control Module Welding Defect Recall

    Volkswagen is recalling 2020-2021 Jetta vehicles because the air bag control module was welded in an incorrect position. This can cause air bags to deploy improperly during a crash or deploy unexpectedly, increasing injury risk.

    Product
    VOLKSWAGEN — VOLKSWAGEN JETTA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1901-2021·2021-06-30

    Sterile Colorectal Anoscopes and Proctoscopes Recalled Due to Falsified Sterilization Records

    Adler MicroMed recalls 1,858 sterile colorectal anoscopes and proctoscopes due to falsified sterilization records by the service provider, raising concerns about product sterility.

    Product
    Sapi Med sterile disposable colorectal anoscopes and proctoscopes. REF/Product Description: A.4083/THE BEAK - Surgical proctoscope. Disposable & sterile. Transparent. Self light; A.4519/MPR Short - Multi Purpose Rectoscope. 190mm long. Sterile & Disposable…
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Food)·F-0697-2021·2021-06-30

    Clio Greek Yogurt Bars Recalled for Possible Metal Fragments

    Clio LLC is recalling Clio Vanilla and Strawberry Club pack Greek Yogurt Bars nationwide due to the possibility of metal fragments in the product. Consumers should not eat the affected bars.

    Product
    Clio Vanilla / Strawberry Club pack Greek Yogurt Bars wrapped in a Chocolate Coating 50g x 12 , 16pc tray, 24g x 24 (12pc tray), 55g x 16 (8pc tray). UPC codes: 854021008121, 854021008138, and 854021008022
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1906-2021·2021-06-30

    SARS-CoV-2 IgG II Calibrator Results Potentially Multiplied by 1000

    Beckman Coulter's Access SARS-CoV-2 IgG II Calibrator may return test results inflated by up to 1000-fold due to software errors, potentially misrepresenting patient immune status.

    Product
    Access SARS-CoV-2 lgG II Calibrator, REF C69058, IVD, CE UDI: (01)15099590742751
    Category
    Medical Device
    Distribution
    31 states
  • HighFDA (Devices)·Z-1912-2021·2021-06-30

    Ultrasound Transducer Probe Covers Recalled for Missing FDA Clearance

    Exact Medical Manufacturing is recalling ultrasound transducer probe covers due to lack of FDA 510(k) clearance for use in natural or surgical body openings. The covers were distributed across six U.S. states and Puerto Rico.

    Product
    6" x 48" Elastic Poly Probe Cover, Tele Fold, sq. end,2 band - Ultrasonic Transducer Cover Item ID: A-AU-10- 058N
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Food)·F-0692-2021·2021-06-30

    Clio Mixed Berry Yogurt Bars Recalled for Possible Metal Fragments

    Clio LLC is recalling Clio Mixed Berry Less Sugar Yogurt Bars due to possible metal fragments in the product. Consumers should not eat the affected bars and should contact the company or return them to the retailer.

    Product
    Clio Mixed Berry Less Sugar Yogurt Bars wrapped in a Chocolate Coating 10 Clio Retail 10-pack, UPC code: 854021008190
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1918-2021·2021-06-30

    Hays Ultrasound Kit Recalled for Missing FDA Clearance

    Exact Medical Manufacturing recalls 10,020 units of Hays Ultrasound Kit (H1000SE) due to lack of FDA 510(k) clearance for use in body openings. The recall affects units in FL, MT, NY, OH, GA, and Puerto Rico.

    Product
    Hays Ultrasound kit Item ID: H1000SE
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-1937-2021·2021-06-30

    OneTouch Ultrasoft Lancets recalled due to temperature exposure during shipping

    Cardinal Health is recalling 531 boxes of OneTouch Ultrasoft Lancets shipped February-March 2021 due to temperature exposure during shipment that may cause inaccurate test results.

    Product
    ONETOUCH ULTRASOFT LANCETS 100 COUNT Item Number: 3007788
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·21157·2021-06-30

    Children's Nightgowns Recalled for Flammability Standard Violation

    About 4,900 Booph children's nightgowns sold on Amazon from March through June 2021 are being recalled because they fail to meet federal flammability standards for sleepwear, posing a burn risk to children.

    Product
    Children's Nightgowns
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0679-2021·2021-06-30

    O'Brien's Own Gourmet Granola Recalled for Undeclared Milk

    O'Brien's Own Gourmet Granola blueberry muffin flavor is recalled because the product contains whey but does not declare milk on the label, creating a risk for consumers with milk allergies.

    Product
    O'Brien's Own Gourmet Granola, blueberry muffin, Net Wt. 12 OZ , UPC 6 09132 49665 3, Manufactured and Distributed by O'Brien's Own Gourmet Granola, Center Point, IA.
    Category
    Food
    Distribution
    1 state
  • HighNHTSA·21E060000·2021-06-29

    Cummins Recalls L9 Diesel Engines Due to Excessive Ammonia Exhaust

    Cummins is recalling specific L9 Diesel Engines because software calibration may allow excessive ammonia into the tailpipe, increasing injury risk.

    Product
    ENGINE AND ENGINE COOLING:EXHAUST SYSTEM:MANIFOLD/HEADER/MUFFLER/TAIL PIPE recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V490000·2021-06-29

    2021-2022 VanLeigh Beacon RV Egress Window May Not Fully Open

    VanLeigh is recalling 2021-2022 Beacon recreational vehicles because a rear ladder can interfere with the rear egress window, preventing it from fully opening in emergencies.

    Product
    VANLEIGH — VANLEIGH BEACON
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21E059000·2021-06-29

    Aftermarket LED Headlight Bulbs Recalled for Excessive Glare

    Shenzhenshi Axi Technology is recalling OXILAM LED headlight bulbs sold on Amazon because they create excessive glare, failing federal safety standards.

    Product
    EXTERIOR LIGHTING:HEADLIGHTS:BULBS recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V486000·2021-06-29

    Porsche Recalls 2020-2021 Taycan Models for Powertrain Software Fault

    Porsche is recalling certain 2020-2021 Taycan models due to a software monitoring fault that can incorrectly shut down the powertrain, causing loss of motive power and increasing crash risk.

    Product
    PORSCHE — PORSCHE TAYCAN
    Category
    Vehicle
    Distribution
    Distributed nationwide