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.

13126–13150 of 22165

  • HighFDA (Devices)·Z-0580-2024·2023-12-27

    Exactech Equinoxe Shoulder System recalled for loss of vacuum

    Exactech is recalling specific models of its Equinoxe Shoulder System implants due to loss of vacuum in the inner-most vacuum bag. Four devices have been affected according to three complaints received.

    Product
    Exactech Equinoxe Shoulder System, Catalog Numbers: a) 314-23-02, b) 314-23-03, c) 314-23-13, d) 314-23-14, e) 314-23-15, f) 314-24-22, g) 314-24-23, h) 314-24-24, i) 314-24-32, j) 314-24-33, k) 314-24-34, l) 314-24-35
    Category
    Medical Device
    Distribution
    16 states
  • HighFDA (Devices)·Z-0571-2024·2023-12-27

    Injection Needle Recall Due to Cleaning Process Concerns

    Karl Storz Endoscopy is recalling injection needles used in general and visceral surgery because the manual cleaning process cannot be assured effective, which may expose patients to a higher risk of infection.

    Product
    Injection Needle, REF: 25207
    Category
    Medical Device
    Distribution
    38 states
  • HighFDA (Food)·F-0640-2024·2023-12-27

    Candy Shop Rainbow Belts recalled for undeclared gluten in gluten-free product

    Island Snacks, Inc. is recalling The Candy Shop Rainbow Belts because the product is labeled gluten-free but contains modified wheat flour. This poses a risk to consumers with celiac disease or gluten sensitivity.

    Product
    The Candy Shop Rainbow Belts Net Wt. 10.5 oz. (298g) SKU Code: 400255786276
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0588-2024·2023-12-27

    Exactech Vantage Mobile Bearing Tibial Inserts Recalled Due to Vacuum Loss

    Exactech is recalling Vantage Mobile Bearing Tibial Inserts due to loss of vacuum in the innermost vacuum bag. Three complaints involving four devices have been reported.

    Product
    Exactech Vantage Mobile Bearing Tibial Inserts, Catalog Numbers: a) 350-41-23, b) 350-42-03
    Category
    Medical Device
    Distribution
    16 states
  • HighFDA (Devices)·Z-0572-2024·2023-12-27

    Injection needles and cannulas recalled for cleaning process efficacy issues

    Karl Storz Endoscopy is recalling injection needles and cannulas because the manual cleaning process may not effectively remove contaminants, potentially exposing patients to infection risk.

    Product
    Injection Needle, 3 Fr., REF: 27030N; Injection Cannula, 6 Fr., REF: 27182A
    Category
    Medical Device
    Distribution
    38 states
  • HighFDA (Devices)·Z-0601-2024·2023-12-27

    Siemens epoc NXS Blood Analysis System Software Causes Erroneous Test Results

    Siemens epoc NXS blood analysis systems have a software defect causing incorrect test results to be printed or transmitted. Results may include data from previous patients, potentially leading to misdiagnosis.

    Product
    epoc NXS Host Blood Analysis System, Siemens Material Numbers 11413497 (EU), 11413475 (US), 11413506 (CA), 11413517 (MX), 11413518 (ROW), 11413498 (JP), 11413583 (CN, KR), 11413879 (IN) with software versions from 4.9.4 to the current version 4.11.11
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0569-2024·2023-12-27

    Orthopedic implant head recall due to incorrect adapter in packaging

    Biomet's Biolox ceramic hip implant heads were shipped with the wrong adapter component. The adapter had an incorrect neck length (M/+0 instead of S/-3.0) that differs in size marking.

    Product
    Biolox Ceramic Option Head Zimmer 12/14 40mm -3, Item Number 00-8777-040-01
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-0610-2024·2023-12-27

    LITe Decompression Snake Arm cannot attach due to incorrect clamp component

    Stryker Spine is recalling 9 units of the LITe Decompression Snake Arm due to an incorrect clamp component that prevents proper attachment to the arm post shaft. Affected units were distributed in the US and internationally.

    Product
    LITe Decompression Snake Arm, REF 48080230
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-0573-2024·2023-12-27

    Injection Needles Recalled for Inadequate Manual Cleaning Process

    Karl Storz is recalling 1,127 injection needles used in general and visceral surgery because the manual cleaning process cannot be adequately assured, potentially increasing infection risk for patients.

    Product
    Injection Needle, LUER-lock,0.8mm, REF: 26175PD
    Category
    Medical Device
    Distribution
    38 states
  • HighFDA (Devices)·Z-0575-2024·2023-12-27

    Surgical Injection Needles Recalled for Uncertain Manual Cleaning Efficacy

    Karl Storz Endoscopy injection needles used in surgery may not be reliably cleaned by hand, exposing patients to higher infection risk. The recall affects 4,878 units.

    Product
    Injection Needle, curved 23 cm, REF: 8598A; Injection Needle, straight, 23 cm, REF: 8598B; Injection Needle, distal 45-degrees, 23 cm, REF: 8598D
    Category
    Medical Device
    Distribution
    38 states
  • HighFDA (Devices)·Z-0607-2024·2023-12-27

    RAPIDPoint 500 Diagnostic Cartridges Recall Due to Sodium Sensor Measurement Bias

    Siemens is recalling RAPIDPoint 500 measurement cartridges because the sodium sensor can produce inaccurate readings, potentially leading to delayed diagnosis or incorrect treatment of electrolyte imbalances.

    Product
    RAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 250-Intended for in vitro diagnostic use and is designed to provide the determination in whole blood. SMN: 10491447
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0570-2024·2023-12-27

    Biomet Recalls Hip Implant Adapter Due to Wrong Specification in Packaging

    Biomet is recalling a hip implant adapter lot due to incorrect packaging containing the wrong adapter specification. The mismatch could result in incorrect implant selection during surgery if not detected before use.

    Product
    Biolox Ceramic Option Head Zimmer 12/14 40mm +0, Item Number 00-8777-040-02
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Food)·F-0607-2024·2023-12-27

    Frozen vegetarian pizza recalled for undeclared wheat allergen

    Shakespeare's Pizza Vegetarian Pizza is being recalled because it contains undeclared wheat, a common allergen. Affected products were distributed to retail stores in Missouri and Kansas and through online direct sales.

    Product
    Shakespeare's Pizza, Vegetarian Pizza, 25 oz, Keep Frozen; UPC 686 148 007 394; pack size 18 per case.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Drugs)·D-0155-2024·2023-12-27

    Nystatin Powder Recall Due to Incorrect Assay Strength on Label

    Fagron, Inc. is recalling 46 containers of Nystatin 500 MU bulk powder used for prescription compounding due to an incorrect assay value on the product label. The mislabeled strength could affect proper compounding of patient medications.

    Product
    NYSTATIN 500 MU, Activity (as is): 6482 Units/mg, bulk powder container, Rx Only, For Prescription Compounding, Fagron, Inc. - 2400 Pilot Knob Rd. St Paul, MN 55120. NDC 51552-0041-3, Bar code 3 51552 00413 9
    Category
    Drug
    Distribution
    0 states
  • HighFDA (Drugs)·D-0152-2024·2023-12-27

    Selenium Sulfide 2.25% Shampoo Recalled Due to Unsupported Expiry Date

    Private Label Partners, Inc. recalls Selenium Sulfide 2.25% Shampoo (3,396 bottles, Lot #220551) due to stability data insufficient to support the labeled expiration date. Affected product distributed in New Jersey.

    Product
    Selenium Sulfide 2.25% Shampoo, 180mL bottle, Rx Only, Manufactured for: Bi-Coastal Pharma Int. LLC, Shrewsbury, NJ 07702, NDC 42582-900-06.
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-0157-2024·2023-12-27

    Nystatin Bulk Powder Recall for Incorrect Label Assay Value

    Fagron, Inc. is recalling Nystatin 150 MU bulk powder for prescription compounding because the assay value on the label is incorrect.

    Product
    NYSTATIN 150 MU, Activity (as is): 6482 Units/mg, bulk powder container, Rx Only, For Prescription Compounding, Fagron, Inc. - 2400 Pilot Knob Rd. St Paul, MN 55120. NDC 51552-0041-1, Bar code 3 51552 00411 5
    Category
    Drug
    Distribution
    0 states
  • HighFDA (Devices)·Z-0587-2024·2023-12-27

    Exactech Vantage Ankle System Recalled Due to Vacuum Loss

    Exactech is recalling two catalog numbers of Vantage Ankle System devices due to loss of vacuum in the inner-most vacuum bag. Three complaints have been received relating to four affected devices.

    Product
    Exactech Vantage Ankle System, Catalog Numbers: a) 350-21-04, b) 350-22-03
    Category
    Medical Device
    Distribution
    16 states
  • HighFDA (Devices)·Z-0582-2024·2023-12-27

    Exactech Optetrak Knee Implant System Recalled for Vacuum Seal Failure

    Exactech is recalling specific catalog numbers of the Optetrak Knee Implant System due to loss of vacuum in the protective inner bag. Three complaints affecting four devices have been reported.

    Product
    Exactech Optetrak Knee System, Catalog Numbers: a) 200-02-26, b) 200-02-29, c) 200-02-32, d) 200-02-35, e) 200-02-38, f) 200-02-41, g) 200-03-32, h) 200-07-29, i) 200-07-32, j) 200-07-35, k) 204-21-13, l) 204-22-26, m) 208-23-18, n) 208-24-13
    Category
    Medical Device
    Distribution
    16 states
  • HighFDA (Devices)·Z-0559-2024·2023-12-27

    Philips Azurion Ceiling-Mount Systems Rotation Cover May Fall

    Philips is recalling Azurion ceiling-mount imaging systems because a rotation cover may fall if the L-arm collides with hospital equipment, potentially causing injury or affecting sterilization.

    Product
    Philips Azurion systems with monoplane fixed ceiling mounts: 722078 Azurion 7 M12 722079 Azurion 7 M20 722223 Azurion 7 M12 722224 Azurion 7 M20 722227 Azurion 5 M12 722228 Azurion 5 M20
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0584-2024·2023-12-27

    Exactech Optetrak Logic PS Knee System Vacuum Loss Recall

    Exactech is recalling certain Optetrak Logic PS Knee Systems due to potential loss of vacuum in the inner-most vacuum bag. The company has received 3 complaints involving 4 devices.

    Product
    Exactech Optetrak Logic PS Knee System, Catalog Numbers: 02-012-35-5009
    Category
    Medical Device
    Distribution
    16 states
  • HighFDA (Devices)·Z-0608-2024·2023-12-27

    RAPIDPoint 500 Measurement Cartridge Sodium Sensor May Cause Measurement Error

    Siemens RAPIDPoint 500 cartridges may produce inaccurate sodium measurements in blood samples, potentially delaying diagnosis or causing inappropriate treatment. The sodium sensor may show a negative bias, affecting patient care.

    Product
    RAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 400-Intended for in vitro diagnostic use and is designed to provide the determination in whole blood. SMN: 10491448
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0605-2024·2023-12-27

    Frozen pizza recalled for undeclared wheat allergen

    Shakespeare's Pizza recalls Four Cheese Pizza due to undeclared wheat allergen. The product was distributed in Missouri, Kansas, and through online sales.

    Product
    Shakespeare's Pizza, Four Cheese Pizza, 25 oz, Keep Frozen; UPC 686 148 000 050; pack size 20 per case.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-0604-2024·2023-12-27

    Shakespeare's Pizza frozen pizza recalled for undeclared wheat

    Shakespeare's Pizza is recalling 18,712 frozen pizzas due to undeclared wheat. The product was sold in retail stores in Missouri and Kansas and through online sales; consumers with wheat allergies should not consume it.

    Product
    Shakespeare's Pizza, Extra Cheese Pizza, 25 oz, Keep Frozen; UPC 686 148 007 370; pack size 20 per case.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-0577-2024·2023-12-27

    AcuMatch Hip System Recalled for Loss of Vacuum Integrity

    Exactech is recalling AcuMatch Hip System devices due to loss of vacuum in the inner-most vacuum bag, with 3 complaints reported affecting 4 devices. Vacuum loss could compromise device packaging integrity.

    Product
    AcuMatch Hip System, Catalog Number 142-32-27
    Category
    Medical Device
    Distribution
    16 states
  • HighFDA (Food)·F-0606-2024·2023-12-27

    Frozen Spinach Artichoke Pizzas Recalled for Undeclared Wheat

    Shakespeare's Pizza recalls 7,103 units of frozen Spinach Artichoke Pizza sold in Missouri and Kansas due to undeclared wheat. Consumers with wheat allergies should not consume the product.

    Product
    Shakespeare's Pizza, Spinach Artichoke Pizza, 25 oz, Keep Frozen; UPC 686 148 000 043; pack size 18 per case.
    Category
    Food
    Distribution
    2 states