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.

10576–10600 of 53042

  • HighFDA (Devices)·Z-0558-2024·2023-12-27

    Philips Allura Medical Imaging Systems Ceiling Mount May Fall

    Philips is recalling Allura imaging systems where the ceiling-mounted rotation cover may fall during equipment collisions, risking injury or sterility issues. Approximately 9,991 units are affected worldwide.

    Product
    Philips Allura systems with monoplane fixed ceiling mounts: 722001 Allura Xper FD10C 722003 Allura Xper FD10 722006 Allura Xper FD20 722010 Allura Xper FD10 722012 Allura Xper FD20 722015 Allura Xper FD20 OR Table 722016 Integris H5000 C / Allura 9C 722018 Integris…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0583-2024·2023-12-27

    Exactech Optetrak Logic Knee System Recalled for Vacuum Bag Failure

    Exactech is recalling certain Optetrak Logic Knee System devices due to loss of vacuum in the inner-most vacuum bag. The company has received three complaints involving four affected devices.

    Product
    Exactech Optetrak Logic Knee System, Catalog Numbers: a) 02-012-47-3011, b) 02-012-47-5009, c) 02-012-47-5011, d) 02-012-65-3013
    Category
    Medical Device
    Distribution
    16 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-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-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 (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 (Devices)·Z-0604-2024·2023-12-27

    Abbott Hematology Analyzers Recalled for Unlabeled Latex Component

    Abbott CELL-DYN Ruby and Sapphire hematology analyzers contain latex that is not labeled on the device, posing a risk to users with latex allergies. The recall affects 670 devices distributed across 33 states, Puerto Rico, and Brazil.

    Product
    Abbott CELL-DYN Ruby, Model CD-Ruby, List number 08H67-01, and Abbott CELL-DYN Sapphire, Model CD Sapphire, list number 08H00-01. Multi-parameter, automated hematology analyzer.
    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-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 (Drugs)·D-0156-2024·2023-12-27

    Nystatin Bulk Powder Recalled Due to Incorrect Label Strength

    Fagron Inc. is recalling 9 containers of Nystatin 2 BU bulk powder because the assay value on the label is incorrect, which could affect dosing accuracy in pharmacy compounding.

    Product
    NYSTATIN 2 BU, 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 51552-0041-4, Bar code 3 51552 00414 6
    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 (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
  • 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 (Devices)·Z-0565-2024·2023-12-27

    CardioQuip Modular Cooler-Heater Device Recalled for Potential Bacterial Contamination

    CardioQuip is recalling the Modular Cooler-Heater (Model MCH-1000i) due to potential bacterial contamination that could cause patient infection. Four units were distributed in California, Texas, Pennsylvania, Washington, Ohio, and Nebraska.

    Product
    CardioQuip Modular Cooler-Heater, Model: MCH-1000(i), Power: 115V-60Hz, 16A
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-0606-2024·2023-12-27

    RAPIDPoint 500 Measurement Cartridges Recalled for Sodium Sensor Bias

    Siemens is recalling RAPIDPoint 500 Systems Measurement Cartridges because the sodium sensor can develop a negative measurement bias that could delay diagnosis of serious electrolyte disorders or cause treatment errors.

    Product
    RAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 100 -Intended for in vitro diagnostic use and is designed to provide the determination in whole blood. SMN: 10844813
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-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-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-0605-2024·2023-12-27

    Venous probe connection cable defects in Cardiohelp-i extracorporeal support systems

    Maquet Medical Systems USA is recalling venous probe connection cables for the Cardiohelp-i System due to insulation and wire breaks. Defective cables may prevent the system from receiving critical blood flow and temperature information.

    Product
    Venous probe connection cable (REF 701069333 and 701048804) used with the Cardiohelp-i System, part numbers 701072780 and 701041802
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0639-2024·2023-12-27

    Vegan pumpkin pie products recalled due to foreign object contamination

    Willamette Valley Pie Company is recalling vegan pumpkin pie products distributed in 12 states due to foreign object contamination. The voluntary recall was initiated in November 2023.

    Product
    Bulk Frozen Cases: The 9" Vegan Pumpkin Pie bulk case has UPC 22518 84081 and the label is read in parts: 9" Vegan Pumpkin Pie WFM, BAKED BULK, 6 units/case. KEEP FROZEN - TRANSPORT AND STORE AT LESS THAN ZERO DEGREES F. Just Thaw and serve. Remove from freezer, removed plastic…
    Category
    Food
    Distribution
    12 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 (Devices)·Z-0574-2024·2023-12-27

    Injection needles recalled due to cleaning efficacy concerns

    Karl Storz Endoscopy is recalling injection needles used in general and visceral surgery due to concerns that the manual cleaning process cannot ensure adequate sterilization, which may increase infection risk.

    Product
    Injection Needle, single cvd. 70 degrees, REF: 738750; Injection Needle, single cvd. 80 degrees, REF: 738752; Injection Needle, bayonet, 13 cm, REF: 738756; Injection Needle, angular, 13 cm, REF: 738758; Needle, bayonet-shaped, REF: 810505; Needle, Septum, angular, REF: 810506
    Category
    Medical Device
    Distribution
    38 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 (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