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.

8101–8125 of 52968

  • HighFDA (Devices)·Z-2305-2024·2024-07-17

    Hip Procedure Kit Recalled for Excessive Ethylene Oxide Sterilization Residuals

    American Contract Systems Inc is recalling 393 units of the TPK Anterior Hip Pack nationwide due to ethylene oxide and ethylene chlorohydrin residuals exceeding safe limits for permanent exposure medical devices.

    Product
    TPK ANTERIOR HIP PACK 176483-Procedure Kit Catalog Number: TPAH21E
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2302-2024·2024-07-17

    Medical knee procedure kit recalled for excessive sterilization chemical residue

    American Contract Systems Inc is recalling TOTAL KNEE-Procedure Kits due to excessive ethylene oxide and ethylene chlorohydrin residues on the cast padding component. The recall affects 85 units distributed nationwide.

    Product
    TOTAL KNEE-Procedure Kit Catalog Number: SMTK21C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2342-2024·2024-07-17

    Blood Pump Rotor Spare Part Recalled for Loose Guide Sheaves

    Fresenius Medical Care recalls a blood pump rotor spare part used in dialysis systems in Canada due to reports of loose or dislodged guide sheaves after use. No injuries have been reported.

    Product
    191014: 2008K@HOME HD SYSTEM W/BIBAG (CANADA) - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0587-2024·2024-07-17

    Dianeal Low Calcium Dialysis Solution Recall: Sterility Risk from Connector Leaks

    Baxter Healthcare recalls 6,874 bags of Dianeal Low Calcium peritoneal dialysis solution due to potential leaks in the connector assembly that could compromise product sterility.

    Product
    DIANEAL LOW CALCIUM WITH DEXTROSE — DIANEAL LOW CALCIUM WITH DEXTROSE (SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE AND DEXTROSE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1469-2024·2024-07-17

    Gluten Free Cookies Recalled for Missing Ingredient Statement on Label

    C. Krueger Finest Baked Goods is recalling 3,347 Gluten Free White Chocolate Cherry Oatmeal Cookies due to missing ingredient statements on labels, preventing consumers from identifying allergens and dietary content.

    Product
    C. Kreuger Gluten Free White Chocolate Cherry Oatmeal Cookies, 2oz in plastic sleeve. 60 cookies per case. Storage for 30 days at ambient and 1 year frozen.
    Category
    Food
    Distribution
    50 states
  • HighFDA (Devices)·Z-2272-2024·2024-07-17

    Mobile Operating Table Charger Defect Poses Risk of Operational Failure

    Getinge USA Sales Inc is recalling 171 ALPHAMAXX mobile operating table units due to a defective charger unit that may cause inadequate charging and operational failure.

    Product
    ALPHAMAXX Mobile Operating Table, Model Number/Part Number: 113322B5
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-2328-2024·2024-07-17

    Cardinal Health Cardiac Catheterization Kits Recalled for Potential Syringe Design Defect

    Cardinal Health is recalling Presource Cardiac Catheterization Kits because the included syringes may have design defects that could cause inaccurate dosing or leakage, creating a risk of patient harm.

    Product
    Presource kits and trays, labeled as: 1) Cardiac Catheterization Kit, Catalog Number SAN69CCKRB; 2) Cardiac Catheterization Kit, Catalog Number SAN73CCV10; 3) Cardiac Catheterization Kit, Catalog Number SAN73CCV11; 4) Cardiac Catheterization Kit, Catalog Number SAN73CCV1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2326-2024·2024-07-17

    Decompression Table Model E9011 Recalled for Structural Frame Defect

    Pivotal Health Solutions is recalling 32 Decompression Table Model E9011 devices due to potentially insufficient rework on a lumbar frame part. The defect affects units distributed to CA, FL, TX, ID, GA, and TN.

    Product
    Decompression Table Model E9011. This device applies cervical and/or lumbar decompression with practitioner definable target treatment location, treatment pounds, and patterns of treatment.
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-2273-2024·2024-07-17

    ALPHAMAXX Mobile Operating Table Charger Defect Poses Equipment Failure Risk

    Getinge has recalled 7 ALPHAMAXX mobile operating tables due to a defective charger unit that may not charge properly, risking equipment operational failure during use.

    Product
    ALPHAMAXX Mobile Operating Table, Model Number/Part Number: 113322F5
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-2297-2024·2024-07-17

    Total Knee Procedure Kit Recalled for Excess Ethylene Oxide Residue

    American Contract Systems Inc is recalling a knee surgery procedure kit (24 units, Lot 939241) due to ethylene oxide sterilization residues in the cast padding exceeding safety exposure limits for permanent-implant devices.

    Product
    TOTAL KNEE - 297835 -Procedure Kit Catalog Number: RGTK10L
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2327-2024·2024-07-17

    Presource surgical kits recalled for syringe design defect risk

    Cardinal Health is recalling 136,753 Presource surgical kits nationwide because included Shenli syringes contain design modifications that could cause inaccurate dosing and device leakage, risking patient harm.

    Product
    Presource kits and trays, labeled as: 1) ANGIOGRAPHY PACK, Catalog Number SAN13BS605; 2) ANGIOGRAPHY PACK, Catalog Number SAN13BS606; 3) ANGIOGRAPHY PACK, Catalog Number SAN13BS607; 4) ANGIOGRAPHY PACK, Catalog Number SAN13BS608; 5) ANGIOGRAPHY PACK, Catalog Number SAN13BS6
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2312-2024·2024-07-17

    Knee Arthroscopy Kit Recalled for Elevated Sterilization Chemical Residues

    American Contract Systems Inc is recalling 60 units of the KNEE ARTHROSCOPY PACK-Procedure Kit nationwide due to ethylene oxide and ethylene chlorohydrin residuals in the cast padding component exceeding established safety limits.

    Product
    KNEE ARTHROSCOPY PACK-Procedure Kit Catalog Number: WEKA15B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2271-2024·2024-07-17

    ALPHAMAXX Operating Table Defective Charger Recalled for Operational Failure Risk

    Getinge Usa Sales Inc recalls 73 ALPHAMAXX mobile operating tables due to a defective charger unit that poses a risk of inadequate charging and operational failure.

    Product
    ALPHAMAXX Mobile Operating Table, Model Number/Part Number: 113322B4
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-2304-2024·2024-07-17

    Arthroscopy Procedure Kit Recalled Due to Ethylene Oxide Residue

    American Contract Systems Inc is recalling 27 arthroscopy procedure kits because ethylene oxide and ethylene chlorohydrin residuals in the cast padding exceeded safe exposure limits for permanent implants.

    Product
    ARTHROSCOPY PACK-Procedure Kit Catalog Number: TNAR22V
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2288-2024·2024-07-17

    Upper Extremity Cast Padding Recalled for Excessive Sterilization Gas Residuals

    American Contract Systems Inc. is recalling 192 units of cast padding due to excessive ethylene oxide and ethylene chlorohydrin residuals exceeding safe limits for skin-contact medical devices.

    Product
    UPPER EXTREMITY PK, STRL F G Catalog Number: IHUE40AG
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2316-2024·2024-07-17

    GE Vivid Ultrasound Systems Display Incorrect Patient Names

    GE Vivid ultrasound systems may display incorrect patient information due to slow DICOM response times. Seven affected units were distributed to healthcare facilities in IL, MA, NM, NY, and OK.

    Product
    GE Vivid Ultrasound products, Model Numbers: a) Vivid E90, H45581LB; b) Vivid E95, H45581DA
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-2284-2024·2024-07-17

    Medical Device Procedure Tray Recalled for Excessive Sterilant Chemical Residue

    American Contract Systems Inc is recalling the BPKN15C Knee Basin Pack procedure tray because sterilant residues (ethylene oxide and ethylene chlorohydrin) exceed safe limits for permanent-use medical devices.

    Product
    BPKN15C KNEE BASIN PACK BHS- Procedure tray Catalog Number: BPKN15C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2311-2024·2024-07-17

    Hand Pack Procedure Kit recalled for excess ethylene oxide residuals

    American Contract Systems Inc is recalling the HAND PACK-Procedure Kit (catalog WEHD16C) due to ethylene oxide and ethylene chlorohydrin residuals exceeding safety limits.

    Product
    HAND PACK-Procedure Kit Catalog Number: WEHD16C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2301-2024·2024-07-17

    Surgical Knee Arthroscopy Kit Recalled for Excessive Sterilization Gas Residuals

    American Contract Systems Inc is recalling its KNEE ARTHROSCOPY-Procedure Kit nationwide due to ethylene oxide and ethylene chlorohydrin residuals exceeding safe limits for permanent medical devices. The recall affects 28 units with lot numbers 975241 and 920241.

    Product
    KNEE ARTHROSCOPY-Procedure Kit Catalog Number: SLAR14G
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2280-2024·2024-07-17

    Arthroscopy Procedure Tray Recalled for Excess Sterilization Residue

    American Contract Systems recalls the ARTHROSCOPY WOLFSON PACK BHS Procedure tray because ethylene oxide residuals on the cast padding exceeded safety limits for permanent exposure medical devices.

    Product
    ARTHROSCOPY WOLFSON PACK BHS Procedure tray Catalog Number: BPAR65A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2283-2024·2024-07-17

    Orthopedic knee procedure tray recalled for sterilization residue levels

    American Contract Systems Inc is recalling 84 units of the ARTHRO KNEE BEACHES PACK BHS procedure tray because residual sterilization chemicals exceeded permissible exposure limits. The affected units were distributed nationwide.

    Product
    ARTHRO KNEE BEACHES PACK BHS- Procedure tray Catalog Number: BPKB46B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2291-2024·2024-07-17

    Knee Arthroscopy Pack Recalled for Excess Sterilization Residues

    American Contract Systems Inc. is recalling 84 knee arthroscopy packs (Catalog Number MEKA12R) distributed nationwide due to ethylene oxide and ethylene chlorohydrin residuals exceeding safe limits for permanent exposure medical devices.

    Product
    KNEE ARTHROSCOPY PACK Catalog Number: MEKA12R
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2347-2024·2024-07-17

    Blood Pump Rotor Spare Parts Recalled for Loose Guide Sheaves

    Fresenius Medical Care recalls 6 blood pump rotor spare parts used in dialysis machines due to loose or dislodged guide sheaves that developed after clinical use.

    Product
    RTLR190395: 2008K@HOME MACHINE, SHORT CAB,OLC/DP,HP - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2337-2024·2024-07-17

    Endoscopic Vessel Harvesting System Recalled for Altered Component Spacing

    Maquet Cardiovascular is recalling 600 units of the VASOVIEW HEMOPRO Endoscopic Vessel Harvesting System due to reports of C-Ring wire straightening and altered spacing between components. No adverse events have been reported.

    Product
    The VASOVIEW HEMOPRO Endoscopic Vessel Harvesting Systems is designed for use in conjunction with the 7 mm Extended Length Endoscope. The Harvesting Cannula has four lumens which house the Endoscope, C-Ring, distal lens washer tube, and harvesting tool for cutting and cauterizin
    Category
    Medical Device
    Distribution
    Distributed nationwide