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.

10126–10150 of 22145

  • HighFDA (Devices)·Z-3116-2024·2024-09-18

    Medline Semi-Rigid Suction Liners Recalled for Potential Suction Loss

    Medline is recalling 1,800 units of semi-rigid suction liners used in anesthesia turnover kits due to reported adverse events related to potential loss of suction during intermittent use. Affected lots were manufactured between September and November 2023.

    Product
    Medline convenience kits containing semi-rigid suction liners labeled as follows: ANES TURNOVER KIT-LF, Pack Number DYNJAA10338J
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3089-2024·2024-09-18

    Proton Therapy System Software Allows Safety Verification Mechanisms to Be Disabled

    The IBA Proton Therapy System (PROTEUS 235 and related models) has a software defect allowing safety parameter verification mechanisms to be deactivated during clinical use. This affects 35 units distributed worldwide.

    Product
    IBA Proton Therapy System - PROTEUS 235 ProteusPLUS and ProteusONE Software versions: PTS-8 versions, PTS-10 versions, PTS-11 versions, and PTS-12 versions
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3058-2024·2024-09-18

    Medline Biopsy Tray Convenience Kits Recalled for Syringe Leaks and Breakage

    Medline BIOPSY TRAY-LF medical convenience kits (Pack DYNDH1229, Lot 22FBA002) are recalled due to plastic syringe leaks, breakage, and quality issues that may pose risks to patient health.

    Product
    Medline Convenience kits, labeled as: BIOPSY TRAY-LF, Pack Number DYNDH1229
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2986-2024·2024-09-18

    Medline medical convenience kits recalled due to syringe quality defects

    Medline is recalling multiple medical convenience kits worldwide that contain plastic syringes with defects that may leak or break, posing a risk to patient safety.

    Product
    Medline Convenience kits labeled as: 1) STERILE LIDOCAINE SYRINGE PACK, Pack Number DYNDM1076A ; 2) PEDIATRIC EP PACK , Pack Number DYNJ45158A ; 3) CARDIAC MINOR-LF, Pack Number DYNJ51939; 4) CARDIAC MINOR SURGICOUNT PACK , Pack Number DYNJ56573; 5) PEDIATRIC EP PACKMH
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3049-2024·2024-09-18

    Medline Medical Convenience Kits Recalled Due to Defective Plastic Syringes

    Medline is recalling medical convenience kits containing plastic syringes with quality defects including leaks and breakage. The kits, distributed worldwide, may pose a risk to patient health.

    Product
    Medline Convenience kits labeled as: 1) OFFICE PACK FOR HYSTEROSCOPY, Pack Number C040100; 2) LAVH CDS, Pack Number CDS760049AD; 3) LAVH CDS, Pack Number CDS760049AF; 4) MAJOR LITHOTOMY CDS-LF, Pack Number CDS760056G ; 5) ABDOMINAL HYSTERECTOMY CDS-LF , Pack Number CDS76008
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3122-2024·2024-09-18

    FilmArray 2.0 Diagnostic Instruments Recalled for Calibration Error Affecting Test Results

    BioFire Diagnostics is recalling FilmArray 2.0 diagnostic instruments that may have been incorrectly calibrated, leading to false positive and false negative results for infectious disease tests including Salmonella, Giardia, Norovirus, and MRSA.

    Product
    FILMARRAY 2.0 INSTRUMENT, REF: FLM2-ASY-0001, FLM2-ASY-0001-W
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3006-2024·2024-09-18

    Medline Convenience Kits with Plastic Syringes Recalled for Defects

    Medline medical convenience kits containing plastic syringes are being recalled due to identified quality issues including leaks and breakage that may pose a risk to patient health. Products were distributed worldwide.

    Product
    Medline Convenience kits labeled as: 1) COMPREHENSIVE PROCEDURE PACK, Pack Number 7791 ; 2) LAVH CDS, Pack Number CDS760049AC; 3) LAPAROSCOPY CDS , Pack Number CDS760051AB; 4) LAPAROSCOPY CDS , Pack Number CDS760051AC; 5) LAPAROSCOPY CDS , Pack Number CDS760051AD; 6) ABDOM
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3001-2024·2024-09-18

    Medline Convenience Kits with Plastic Syringes Recalled for Leaks and Breakage

    Medline Industries is recalling medical convenience kits containing plastic syringes due to leaks, breakage, and other quality defects that may pose a risk to patient health. Kits are distributed worldwide.

    Product
    Medline Convenience kits labeled as: 1) ZALE STEREOTACTIC CDS , Pack Number CDS983173G ; 2) ZALE OTOLOGY CDS, Pack Number CDS983181D ; 3) BGMC GENERAL LAPAROSCOPY PK-LF, Pack Number DYNJ0664747A ; 4) NC3G MEDIASTINOSCOPY PACK-LF, Pack Number DYNJ0796243D ; 5) MEDIASTIN
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3010-2024·2024-09-18

    Medline Medical Convenience Kits Recalled for Syringe Leaks and Breakage

    Medline is recalling medical convenience kits due to plastic syringe leaks, breakage, and quality issues that may pose a risk to patient health.

    Product
    Medline Convenience kits labeled as: 1) CVC INSERTION PACK, Pack Number CVI4720A ; 2) CVC INSERTION PACK, Pack Number CVI4720AH; 3) CATHETER INSERTION KIT CLABSI , Pack Number CVI4880; 4) CHEST INSERTION PACK-LF , Pack Number DYNJ17634D ; 5) URETEROSCOPY, Pack Number D
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3055-2024·2024-09-18

    Medline Convenience Kits With Syringes Recalled for Quality Defects

    Medline is recalling medical convenience kits containing syringes due to quality issues including leaks and breakage. These defects may pose a risk to patient health and were identified in relation to an FDA Safety Alert issued March 19, 2024.

    Product
    Medline Convenience kits, containing Shenli syringes, labeled as: 1) LOCAL PACK, Pack Number DYNJ34129C ; 2) FTMC LOCAL PACK-LF, Pack Number DYNJ54607A ; 3) LOCAL PACK, Pack Number DYNJ61839B
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3022-2024·2024-09-18

    Medline Convenience Kits with Defective Syringes Recalled Due to Leaks and Breakage

    Medline Convenience kits containing plastic syringes are recalled worldwide due to leaks, breakage, and quality issues posing risks to patients. Multiple lot numbers from 2020–2023 are affected.

    Product
    Medline Convenience kits labeled as: SCS-LF, DYNJ902314D
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3008-2024·2024-09-18

    Medline Esophagectomy Convenience Kits Recalled for Syringe Leaks and Breakage

    Medline Industries recalls esophagectomy convenience kits containing plastic syringes with leaks and breakage issues. The defects may pose a risk to patient health during surgical procedures.

    Product
    Medline Convenience kits labeled as: PUH ESOPHAGECTOMY CDS, Pack Number CDS984309I
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3041-2024·2024-09-18

    Medline Medical Convenience Kits with Plastic Syringes Recalled Due to Leaks and Breakage

    Medline Industries is recalling medical convenience kits containing plastic syringes with leaks, breakage, and other quality issues that may pose a risk to patient health.

    Product
    Medline Convenience kits labeled as: 1) CHEST TUBE INSERTION TRAY, Pack Number DYNDA2063; 2) PULL D/C PACK, Pack Number DYNDA2080; 3) STERILE 3CC SYR W/ 23GX1 NDL, Pack Number DYNDA2495; 4) STERILE 1CC SYR W/ 25GX5/8 NDL, Pack Number DYNDA2497; 5) ARTHROGRAM TRAY, Pack
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2998-2024·2024-09-18

    Medline surgical convenience kits recalled due to defective plastic syringes

    Medline is recalling multiple surgical and medical convenience kits containing plastic syringes affected by a safety alert. Leaks, breakage, and quality issues may affect patient safety during medical procedures.

    Product
    Medline Convenience kits labeled as: 1) BIOPSY PROCEDURE PACK, Pack Number 00-400162J; 2) BIOPSY PROCEDURE TRAY , Pack Number 00-400405C ; 3) BIOPSY DRAPE PACK , Pack Number 00-400762H ; 4) BIOPSY PROCEDURE PACK , Pack Number 00-400832N ; 5) BIOPSY PROCEDURE PACK , Pack Num
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2975-2024·2024-09-18

    HeNe Laser System Allows Key Removal While Operating

    Pacific LaserTech's 25-LHP-828 HeNe laser systems allow the key to be removed while operating, violating federal safety requirements. Four units distributed nationwide lack proper controls to prevent unintended laser operation.

    Product
    25-LHP-828, HeNe Laser System, 35 mW
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3133-2024·2024-09-18

    Biolox Taper Sleeve Mislabeling: Wrong Component Size in Hip Replacement

    Zimmer GmbH is recalling Biolox Option Taper Sleeves due to mislabeling where packaging labels one neck size but contains the opposite size. These components are used in hip replacement surgery.

    Product
    Biolox Option Taper Sleeve, Type 1 Taper, -6mm Neck - Indicated for use in total hip replacement with cemented or non-cemented femoral and acetabular components. Item Number: 650-1064
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3102-2024·2024-09-18

    Siemens Atellica IM CA 19-9 Test Kit Recall: Measurement Bias in Samples

    Siemens is recalling Atellica IM CA 19-9 test kits (Lot 56434535) due to positive bias in measurement of tumor marker levels in some samples, particularly from Asia Pacific regions.

    Product
    Atellica IM CA 19-9 (250 Test - REF)-In vitro diagnostic use in the quantitative measurement of the CA 19-9 tumor-associated antigen in human serum using the Atellica CI and Atellica IM Analyzers SMN: 11206239
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1805-2024·2024-09-18

    Walmart Macaroni Salad Recalled Due to Foreign Material

    Reser's Fine Foods recalls Walmart Original Freshness Guaranteed Macaroni Salad (16oz) distributed in nine U.S. states due to possible foreign material contamination. No illnesses have been reported.

    Product
    UPC 78742 12653, Walmart Original Freshness Guaranteed Macaroni Salad 16oz, refrigerated, packaged in a clear plastic tub with printed labels on top, bottom and side. There are 12 tubs per case.
    Category
    Food
    Distribution
    9 states
  • HighFDA (Devices)·Z-2988-2024·2024-09-18

    Medline Nerve Block Kits Recalled for Defective Plastic Syringes

    Medline is recalling nerve block convenience kits for defective plastic syringes that may leak or break, creating a patient safety risk during medical procedures.

    Product
    Medline Convenience kits, labeled as: 1) NERVE BLOCK TRAY-LF, Pack Number DYNJRA0377B; 2) PERIPHERAL NERVE BLOCK, Pack Number PAIN0137
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3047-2024·2024-09-18

    Medline convenience kits recalled for syringe leaks and breakage defects

    Medline is recalling surgical convenience kits with plastic syringes that may leak or break. The defects pose a risk to patient safety during procedures.

    Product
    Medline Convenience kits labeled as: 1) UROLOGY MINOR CDS , Pack Number CDS980371J ; 2) UROLOGY MINOR CDS , Pack Number CDS980371K ; 3) CIRCUMCISION TRAY 1.1 , Pack Number CIT6260A ; 4) CIRCUMCISION TRAY 1.3 CM BELL , Pack Number CIT7740; 5) CIRCUMCISION TRAY , Pack Nu
    Category
    Medical Device
    Distribution
    0 states
  • HighNHTSA·23V882000·2024-09-12

    2024 Nissan Altima Recall for Potential Steering Bolt Loosening

    Nissan is recalling approximately 5 certain 2024 Altima vehicles because bolts connecting the electronic power steering unit to the steering rack may loosen, potentially causing loss of steering control or lock-up. Dealers will replace the steering gear assembly at no cost.

    Product
    NISSAN — 2024 NISSAN ALTIMA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·24360·2024-09-12

    Cadet Apex72 Electric Heaters Recalled Due to Fire Hazard

    Glen Dimplex Americas is recalling about 12,900 Cadet-branded Apex72 electric heaters because the fan can malfunction and fail to turn on, causing the unit to overheat and ignite internally. One heater fire has been reported with no injuries.

    Product
    Cadet-branded Apex72 Electric Heaters
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·24361·2024-09-12

    GOETAS Pool Drain Covers Recalled for Entrapment Hazard

    GOETAS pool drain covers do not meet Virginia Graeme Baker Pool and Spa Safety Act requirements and pose an entrapment hazard to swimmers. About 2,500 units sold on Amazon.com from March 2022 through July 2024 are affected.

    Product
    GOETAS Pool Drain Covers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·23V881000·2024-09-12

    2022-2023 Mercedes-Benz Metris Fuel Pump May Fail Unexpectedly

    The fuel pumps in certain 2022-2023 Mercedes-Benz Metris vehicles may shut down unexpectedly, causing loss of drive power and increasing the risk of a crash.

    Product
    MERCEDES-BENZ — 2022 MERCEDES-BENZ METRIS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V869000·2024-09-12

    2024 Chevrolet Equinox door strikers may fracture and open unexpectedly

    General Motors is recalling certain 2024 Chevrolet Equinox and related models because door strikers may fracture, potentially causing doors to open unexpectedly while driving.

    Product
    CHEVROLET — 2024 CHEVROLET EQUINOX
    Category
    Vehicle
    Distribution
    Distributed nationwide