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.

10851–10875 of 22146

  • HighFDA (Devices)·Z-2307-2024·2024-07-17

    CUSTOM KNEE Medical Device Procedure Kit recalled for excess chemical residuals

    American Contract Systems Inc is recalling 174 units of the CUSTOM KNEE - 206061-Procedure Kit due to ethylene oxide and ethylene chlorohydrin residuals in the cast padding component. The residuals exceed the safety limits specified in ANSI/AAMI/ISO 10993-7:(R)2012 for permanent-contact medical devices.

    Product
    CUSTOM KNEE - 206061-Procedure Kit Catalog Number: UDKN68AE
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2286-2024·2024-07-17

    Procedure Tray Recalled Due to Excess Sterilization Residue

    American Contract Systems Inc is recalling HAND WRIST FOREARM-LF Procedure trays due to ethylene oxide sterilization residues exceeding safe limits for permanent exposure devices.

    Product
    HAND WRIST FOREARM-LF Procedure tray Catalog Number: CCHD17B
    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-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-2333-2024·2024-07-17

    Ophthalmic Injection Kit Recall Due to Unconfirmed Sterilization

    MICROspecialties is recalling the Synergetics I Pack Injection Kit because sterilization cannot be confirmed, potentially causing post-operative wound or injection site infections. Affected units are lot P62764979R distributed in Missouri.

    Product
    Synergetics I Pack Injection Kit- Tray for use with Ophthalmic injections Model/Catalog Number: 18060
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2323-2024·2024-07-17

    Welch Allyn CP150 Electrocardiograph recalled for missing electromagnetic interference absorber

    Baxter Healthcare is recalling the Welch Allyn CP150 Electrocardiograph because a critical manufacturing step—installation of an electromagnetic interference absorber—was omitted. This could cause device malfunction or interference with nearby medical equipment.

    Product
    Welch Allyn CP150 Electrocardiograph with Spirometry Option, Product Code: CP150A-1ENB. The Electrocardiograph is one of the tools that clinicians use to evaluate, diagnose, and monitor patient cardiac function.
    Category
    Medical Device
    Distribution
    0 states
  • 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
  • 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-2325-2024·2024-07-17

    Kosmos iOS Ultrasound Software Update Due to Measurement Accuracy Bug

    Echonous Inc is recalling Kosmos ultrasound software for iOS due to a bug causing inaccurate measurements in DICOM exports, potentially leading to incorrect diagnoses.

    Product
    Kosmos on iOS impacting iOS, Model Numbers: P007639, P007944, software is part of a general-purpose diagnostic ultrasound system.
    Category
    Medical Device
    Distribution
    32 states
  • 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-2282-2024·2024-07-17

    Procedure Tray Recalled for Excessive Ethylene Oxide Residuals

    American Contract Systems Inc is recalling 129 units of ARTHO KNEE BAPTIST SOUTH PACK Procedure trays (lot numbers 953241, 882241) due to ethylene oxide and ethylene chlorohydrin sterilization residuals exceeding safe limits for permanent-contact medical devices.

    Product
    ARTHO KNEE BAPTIST SOUTH PACK Procedure tray Catalog Number: BPKA49B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2309-2024·2024-07-17

    Orthopedic ORIF Hip Rod Procedure Kit Recalled for Sterilization Residuals

    American Contract Systems Inc is recalling its ORIF HIP IM RODDING FEMUR-Procedure Kit (28 units) because ethylene oxide and ethylene chlorohydrin residuals in the cast padding exceeded safe limits for permanent implants.

    Product
    ORIF HIP - IM RODDING FEMUR-Procedure Kit Catalog Number: UTHP44S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2285-2024·2024-07-17

    Foot-Ankle Procedure Tray Recalled for Excessive Sterilization Residue

    American Contract Systems Inc is recalling 107 units of FOOT ANKLE-LF Procedure tray distributed nationwide due to ethylene oxide and ethylene chlorohydrin residuals exceeding safety limits for permanent-implant devices.

    Product
    FOOT ANKLE-LF Procedure tray Catalog Number:CCFA51B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0590-2024·2024-07-17

    Bupropion Extended-Release Tablets Recalled for Dissolution Failure

    Amerisource Health Services is recalling Bupropion Hydrochloride 150mg extended-release tablets nationwide due to dissolution specification failures. The tablets dissolve faster than specified limits.

    Product
    BUPROPION HYDROCHLORIDE — BUPROPION HYDROCHLORIDE (BUPROPION HYDROCHLORIDE)
    Category
    Drug
    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-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 (Food)·F-1470-2024·2024-07-17

    C. Kreuger Gluten Free Peanut Butter Cookies recalled for missing ingredient statement

    C. Krueger Finest Baked Goods is recalling C. Kreuger Gluten Free Peanut Butter Cookies due to missing ingredient statement on labels, preventing consumers from identifying allergens. The recall affects 4,538 cookies distributed across all U.S. states.

    Product
    C. Kreuger Gluten Free Peanut Butter Cookies, 2oz in plastic sleeve. 60 cookies per case. Storage for 30 days at ambient and 1 year frozen.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Drugs)·D-0594-2024·2024-07-17

    Compounded Lidocaine-Epinephrine Injectable Recalled Nationwide for Subpotent Epinephrine

    Tailstorm Health Inc is recalling a compounded lidocaine-epinephrine injection nationwide due to subpotent epinephrine component. The recall affects 12,525 vials of lot number 2311003.

    Product
    Lidocaine HCL Injection, USP 2% 200mg/10mL (20mg/mL) and EPINEPHRINE HCl 1:200,000, 10 ml Single Dose Vial, Rx only, Compounded drug by Medivant Healthcare, 158 S Kyrene Rd, Chandler, AZ 85226, NDC 81483-0038-0, UPC 3 81483 00380 2
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2338-2024·2024-07-17

    Endoscopic Vessel Harvesting System Recalled for C-Ring Wire Straightening

    Maquet Cardiovascular recalled 2,463 VASOVIEW HEMOPRO 2 surgical systems due to C-Ring wire straightening and component misalignment affecting tool positioning. No injuries have been reported.

    Product
    The VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System 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
  • HighFDA (Devices)·Z-2334-2024·2024-07-17

    Medical Injection Kit Recall Due to Unconfirmed Sterilization

    MICROspecialties is recalling Synergetics I-Pack Injection Kits because some units may not have been properly sterilized, potentially causing post-operative wound or injection site infections.

    Product
    Synergetics I-Pack Injection Kit with Drape -For use with Ophthalmic injections Model/Catalog Number: 18061
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2276-2024·2024-07-17

    American Contract Systems Surgical Trays Recalled for Ethylene Oxide Residuals

    American Contract Systems is recalling MAJOR KNEE surgical procedure trays due to excessive ethylene oxide and ethylene chlorohydrin residuals from sterilization that exceed safety limits for permanent exposure devices.

    Product
    MAJOR KNEE - 302497- Procedure tray Catalog Number: ASKN23B
    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
  • HighNHTSA·23V860000·2024-07-12

    Airstream Basecamp Travel Trailers Recalled for Failing Spare Tire Bracket

    The spare tire carrier bracket on certain 2012-2023 Airstream Basecamp travel trailers may experience metal fatigue and break, causing the spare tire to detach and become a road hazard. Airstream is providing free replacement and reinforcement of the bracket.

    Product
    AIRSTREAM — 2023 AIRSTREAM BASECAMP
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·24303·2024-07-11

    TonGass Pool Drain Covers Recalled for Entrapment Hazard

    TonGass 8-inch round pool drain covers do not meet Virginia Graeme Baker Pool and Spa Safety Act standards and pose an entrapment hazard to swimmers and bathers. About 1,650 units sold on Amazon from September 2023 through June 2024 are affected.

    Product
    TonGass pool drain covers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·24300·2024-07-11

    Children's Lace Nightgowns Recalled for Burn Hazard

    Lovely Angel children's lace nightgowns sold on Temu.com violate federal flammability standards for sleepwear, posing a burn injury risk to children. About 4,360 units were sold between June 2023 and May 2024.

    Product
    Lovely Angel Children's Lace Nightgowns
    Category
    Consumer Product
    Distribution
    Distributed nationwide