The Recall Desk

Archive

September 2024 recalls

704 recalls were announced in September 2024.

What the numbers show

Critical
8
Severe
103
High
393
Moderate
199
Low
1

Of the 704 recalls this month scored against our rubric, 1% are Critical, 15% are Severe.

Which agencies issued them

201–300 of 704

  • HighFDA (Devices)·Z-3067-2024·2024-09-18

    Dental Composite Resin Recall Due to Red Particulate Contamination

    Ultradent Products recalls Transcend Econo Kit dental composite due to red particulates in the material from a manufacturing issue. Affected lot C1464 was distributed to dental professionals in 34 U.S. states and internationally.

    Product
    Brand Name: Transcend Product Name: Transcend Econo Kit (UB) - Singles Model/Catalog Number: 4817- Software Version: N/A Product Description: Transcend universal composite is a light-cured, tooth shade resin composite material (Bis-GMA-based) to be used for direct and…
    Category
    Medical Device
    Distribution
    35 states
  • HighFDA (Devices)·Z-3038-2024·2024-09-18

    Medline Medical Convenience Kits Recalled for Syringe Defects

    Medline Convenience kits containing plastic syringes are being recalled due to leaks, breakage, and quality issues that may pose a risk to patient health. Multiple kit types have been distributed worldwide.

    Product
    Medline Convenience kits labeled as: 1) ADMIT KIT , Pack Number DYKA1225B; 2) BRANSON SUPPLEMENTAL PACK , Pack Number DYNDA3019; 3) L & D PACK-LF , Pack Number DYNJ16121O ; 4) FAMILY PLANNING PACK, Pack Number DYNJ59783C ; 5) NEW LIFE PACK , Pack Number DYNJ69208A…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3052-2024·2024-09-18

    Medline surgical convenience kits recalled due to defective plastic syringes

    Medline Industries is recalling multiple surgical convenience kits containing defective plastic syringes. The syringes may leak or break, posing a risk to patient health during medical procedures.

    Product
    Medline Convenience kits labeled as: 1) SPECIAL PROCEDURE PACK ARTERI , Pack Number 00-399024X ; 2) ARTHROSCOPY TRAY, Pack Number AM110A ; 3) HIP , Pack Number BM200A ; 4) SHOULDER ARTHROSCOPY, Pack Number BM230A ; 5) KNEE ARTHROSCOPY, Pack Number BM240A ; 6) PODIATRY…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3042-2024·2024-09-18

    Medline Medical Convenience Kits Recalled Due to Defective Plastic Syringes

    Medline is recalling multiple medical convenience kits containing plastic syringes due to identified leaks, breakage, and quality issues. These defects may pose a risk to patient health.

    Product
    Medline Convenience kits labeled as: 1) ANGIOGRAPHY DRAPE PACK, Pack Number 00-401327AA; 2) CORONARY ANGIO PACK-LF, Pack Number 00-401594R ; 3) IR NEURO INTERVENTIONAL PACK, Pack Number 00-401808S ; 4) NEURO CDS , Pack Number CDS780056K ; 5) NEURO CDS , Pack Number…
    Category
    Medical Device
    Distribution
    0 states
  • HighNHTSA·24V695000·2024-09-18

    2016–2023 Mazda MX-5 Air Bag Control Module Software Defect

    Mazda is recalling 2016–2023 MX-5 Miata vehicles because a software error in the air bag control module may cause front air bags to deploy with excessive force during a crash, increasing injury risk.

    Product
    MAZDA — MAZDA MX-5
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2990-2024·2024-09-18

    Medline Convenience Kits Recalled for Syringe Leaks and Breakage

    Medline is recalling convenience kits containing plastic syringes following an FDA safety alert. Identified leaks, breakage, and quality issues in these kits may pose a risk to patient health. The affected kits are distributed worldwide.

    Product
    Medline Convenience kits labeled as: 1) KIT MANIFOLD CSTM-NORTHRIDGE, Pack Number 129736 ; 2) KIT LEFT HEART-VA MED, Pack Number 132701; 3) KIT MANIFOLD CSTM-RENAISSANC, Pack Number 134085 ; 4) KIT LEFT HEART- LEXINGTON , Pack Number 142643 ; 5) KIT ANGIO CSTM-SETON…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3063-2024·2024-09-18

    Siemens Atellica CH diagnostic reagent batch may produce biased results

    A specific lot of Siemens Atellica CH urinary/cerebrospinal fluid protein reagent (lot 130414) may produce biased quality control results and inaccurate patient test outcomes. Approximately 229 units were distributed in the United States and 935 internationally.

    Product
    Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP); Siemens Material Number (SMN): 11097543
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3011-2024·2024-09-18

    Medline Recalls Dialysis Convenience Kits Due to Syringe Quality Issues

    Medline is recalling dialysis convenience kits containing plastic syringes affected by an FDA Safety Alert. Leaks and breakage may pose a risk to patient health.

    Product
    Medline Convenience kits labeled as: 1) DIALYSIS CATH ACCESS KIT, Pack Number DYNDA2516B ; 2) DIALYSIS CATH ACCESS KIT, Pack Number DYNDA2516BH; 3) DIALYSIS PACK , Pack Number DYNJ36932A ; 4) DIALYSIS AV SHUNT #668229-V-LF, Pack Number DYNJ58502C ; 5) DIALYSIS ACCESS…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-1796-2024·2024-09-18

    Asli Cinnamon Powder Recalled Due to Lead Contamination

    Sands Impex Inc. is recalling Asli Cinnamon Powder due to lead contamination. The affected product is a 7-ounce pouch with lot number DDDLUS distributed across five states.

    Product
    Asli Cinnamon Powder, 7oz clear plastic pouch, UPC 703440150723
    Category
    Food
    Distribution
    5 states
  • HighFDA (Devices)·Z-3099-2024·2024-09-18

    Spacelabs Ultraview DM4 Monitor Recalled for Inadequate Battery Safety Warnings

    Zoe Medical is recalling 1506 units of the Spacelabs Ultraview DM4 Vital Signs Monitor due to inadequate labeling about damaged or expired battery risks. The lack of proper warnings could affect device safety.

    Product
    Spacelabs Ultraview DM4 Vital Signs Monitor (all variations -M, -N, -MF, -NF, -MW, -NW, -MFW, -NFW), Model Number 91331
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-1803-2024·2024-09-18

    Reser's Rotisserie Chicken Salad Base Recalled for Foreign Material

    Reser's Fine Foods is recalling 38 cases of Rotisserie Chicken Salad Base (UPC 71117 14743) due to foreign material contamination. The affected product was distributed in nine states with a 'Use By' date of September 13, 2024.

    Product
    UPC 71117 14743, Reser s Rotisserie Chicken Salad Base 2lb. (32oz), refrigerated, packaged in an opaque plastic tub with a white printed plastic lid. There are 6 tubs per case.
    Category
    Food
    Distribution
    9 states
  • HighFDA (Devices)·Z-3128-2024·2024-09-18

    Medtronic Venous Cannulae: Wrong Product in Incorrect Packaging

    Medtronic Perfusion Systems is recalling 290 units of DLP Single Stage Venous Cannulae due to a manufacturing error where straight-tip cannulae were placed into packaging labeled for right-angle metal-tip cannulae.

    Product
    Medtronic DLP Single Stage Venous Cannulae with right angle metal tip, REF 67312
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3037-2024·2024-09-18

    Medline Medical 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 quality issues that may pose patient safety risks. The recall affects multiple pack types distributed worldwide.

    Product
    Medline Convenience kits labeled as: 1) EP DRAPE PACK-LF, Pack Number DYNJ0209716K ; 2) MERCY COMBINED PACK-LF, Pack Number DYNJ0233004D ; 3) E P DRAPE PACK-LF , Pack Number DYNJ0373061J ; 4) PACEMAKER DRAPE PACK-LF , Pack Number DYNJ0406118K ; 5) FEMORAL ANGIOGRAPHY…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3056-2024·2024-09-18

    Medical Convenience Kits Recalled for Syringe Leaks and Breakage

    Medline Industries is recalling multiple medical convenience kits containing plastic syringes that may leak or break, posing a risk to patient health. The affected kits have been distributed worldwide.

    Product
    Medline Convenience kits, labeled as: 1) SUTURING SET PACK ASSY P791011, Pack Number 59112; 2) SUTURE SET, Pack Number DYNDL1984; 3) CLOSING PACK, Pack Number DYNJ68267A ; 4) SUTURING KIT, Pack Number MNS15015 ; 5) SUTURING KIT, Pack Number MNS15015H; 6) SUTURING…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3123-2024·2024-09-18

    BioFire FILMARRAY TORCH Module Recall Due to Calibration Errors

    BioFire is recalling FILMARRAY TORCH modules because calibration errors may cause false positive or negative results for pathogens like Salmonella and MRSA.

    Product
    FILMARRAY TORCH MODULE BOX, HTFA-ASY-0003, HTFA-ASY-0003-W, HTFA-ASY-0003U
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3009-2024·2024-09-18

    Medline Convenience Kits Recalled Due to Leaks and Breakage in Syringes

    Medline Industries is recalling convenience kits containing plastic syringes with leaks, breakage, and other quality issues. The defects were identified in an FDA Safety Alert and may pose a risk to patient health.

    Product
    Medline Convenience kits labeled as: 1) GYN ENDOSCOPY KIT , Pack Number CDS981309O ; 2) GB GENERAL ENDO , Pack Number CDS984155F ; 3) ENDOSCOPY KIT , Pack Number DYKE1112 ; 4) ENDOSCOPY KIT , Pack Number DYKE1133A; 5) ENDOSCOPY PACK, Pack Number DYKE1264 ; 6)…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3065-2024·2024-09-18

    Siemens Dimension Vista Bilirubin Reagent Cartridges Recalled Due to Underfilled Wells

    Siemens Healthcare Diagnostics is recalling one lot of Dimension Vista Total Bilirubin Flex Reagent Cartridges due to underfilled wells during manufacturing. The defect may result in inaccurate test results for calibrators, quality control, and patient samples.

    Product
    Dimension Vista¿ Total Bilirubin (TBIL) Flex Reagent Cartridge; Siemens Material Number (SMN): 10445146;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3023-2024·2024-09-18

    Medline Convenience Kits with Plastic Syringes Recalled for Leaks and Breakage

    Medline Convenience kits with plastic syringes affected by an FDA safety alert are being recalled due to leaks, breakage, and quality issues that may harm patients.

    Product
    Medline Convenience kits labeled as: 1) CENTRAL LINE CDS, Pack Number CDS930092U ; 2) SMALL WOUND TRAY, Pack Number DYNDA1822; 3) RADIOLOGY UTILITY TRAY, Pack Number DYNDA2865; 4) BLOOD CULTURE SET , Pack Number DYNDH1495A ; 5) LACERATION TRAY , Pack Number DYNDL1050; 6)…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3050-2024·2024-09-18

    Medline Medical Convenience Kits Recalled for Syringe Quality Defects

    Medline medical convenience kits containing plastic syringes are being recalled due to identified leaks, breakage, and quality issues that may pose a risk to patient health. The FDA Safety Alert issued March 19, 2024, identifies affected syringes used in multiple types of medical procedures.

    Product
    Medline Convenience kits labeled as: 1) LABOR & DELIVERY CDS, Pack Number CDS830039AD; 2) FETAL SURGERY CDS-LF, Pack Number CDS840214P ; 3) OB PROCEDURE-LF , Pack Number CDS981335C ; 4) ROBOTIC PACK-LF , Pack Number CDS981757P ; 5) GYN ROBOTIC , Pack Number CDS981826J…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2985-2024·2024-09-18

    Medline Convenience Kits Recalled Due to Plastic Syringe Quality Issues

    Medline is recalling specific convenience kits because they contain plastic syringes with leaks, breakage, or other quality issues that may pose a risk to patient health.

    Product
    Medline Convenience kits, labeled as: 1) DYNJ39451D , Pack Number HOOD PACK ; 2) DYNJ59573A , Pack Number ICU RESPIRATORY BRONCH PACK ; 3) DYNJ80281A , Pack Number OSC BRONCH PACK
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3121-2024·2024-09-18

    Medline Surgical Convenience Kits Recalled Due to Suction Loss Risk

    Medline Industries is recalling 1,076 surgical convenience kits due to reported adverse events from potential suction loss during use. Products were manufactured from September to November 2023.

    Product
    Medline convenience kits containing semi-rigid suction liners labeled as follows: a) LAMINECTOMY CDS, Pack Number CDS981510L; b) ORTHO TRAUMA-LF, Pack Number DYNJ900720D; c) ORTHO TRAUMA-LF, Pack Number DYNJ900720F; d) KNEE ARTHROSCOPY, Pack Number DYNJ908090C; e)…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3115-2024·2024-09-18

    Medline Semi-Rigid Suction Liners Recalled Due to Loss of Suction

    Medline is recalling 444 NICU admit kits containing semi-rigid suction liners due to potential loss or low suction during intermittent use. Affected units were distributed in the US, Canada, and Panama.

    Product
    Medline convenience kits containing semi-rigid suction liners labeled as follows: NICU ADMIT KIT, Pack Number DYKA1014G
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1797-2024·2024-09-18

    Yummy Monkey Organics Popcorn Recalled for Missing Milk Allergen Label

    Yummy Monkey Organics Butter & Yeast Popcorn is recalled due to missing milk allergen declaration on the label, creating a risk for milk-sensitive consumers. The recall affects specific batches distributed in California and Oregon.

    Product
    Yummy Monkey Organics Butter & Yeast Popcorn, Made With Purified Ghee & Nutritional Yeast. UPC 9 96692 66641 2, packaged in a Clear Polyethylene Gusseted Re-closable Bag measured 9 x 12 x 2". Net Wt: 5.25 oz (149g). Manufactured By: Yummy Monkey Organics, LLC 243 Grimes St.…
    Category
    Food
    Distribution
    2 states
  • 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-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)…
    Category
    Medical Device
    Distribution
    0 states
  • 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-3127-2024·2024-09-18

    Proton Therapy System May Display Insufficient Images During Treatment Planning

    FDA recalls the PROBEAT-V proton beam therapy system due to a software issue where the 3D image positioning mode may display insufficient images, potentially affecting treatment planning accuracy.

    Product
    Brand Name: PROBEAT Product Name: PROBEAT-V Model/Catalog Number: N/A Software Version: N/A Product Description: The PROBEAT-V is a proton beam irradiation system, which provides a therapeutic proton beam for clinical treatment. It is designed to deliver a proton beam with…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3046-2024·2024-09-18

    Medline Medical Convenience Kits Recalled Due to Plastic Syringe Quality Issues

    Medline is recalling specific medical convenience kits because they contain plastic syringes affected by an FDA Safety Alert. The syringes have leaks, breakage, or other quality issues that may pose a risk to patient health.

    Product
    Medline Convenience kits labeled as: 1) LAVH CDS, Pack Number CDS760049AB; 2) TUBAL LIGATION CDS, Pack Number CDS760053D ; 3) TUBAL LIGATION CDS, Pack Number CDS760053G ; 4) TUBAL LIGATION CDS, Pack Number CDS760053I ; 5) TUBAL LIGATION CDS, Pack Number CDS760053J ; 6)…
    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-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-3069-2024·2024-09-18

    Sterile Surgical Kit Contains Non-Sterile Component Without Label

    A non-sterile Mastisol component was included in certain sterile craniotomy packs without proper labeling. If users assume the component is sterile, it could increase infection risk during surgery.

    Product
    CRANIOTOMY PACK, Pack Number DYNJ46552O
    Category
    Medical Device
    Distribution
    3 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-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…
    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-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)…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3101-2024·2024-09-18

    Siemens Atellica IM CA 19-9 Assay Recalled for Positive Bias

    Siemens Healthcare Diagnostics is recalling Atellica IM CA 19-9 kits due to positive bias in some samples, particularly in the Asia Pacific population.

    Product
    Atellica IM CA 19-9 (250 Test)- 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:10995489
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3105-2024·2024-09-18

    Medline semi-rigid suction liners recalled due to potential suction loss

    Medline Industries is recalling specific lots of semi-rigid suction liners due to potential loss of suction or low suction during use. About 1.25 million units distributed in the US, Canada, and Panama are affected.

    Product
    Medline Semi-rigid suction liners labeled as follows: a) SEMI RIGID SUCTION LINER, REF OR515; b) SEMI RIGID SUCTION LINER WITH TUBING, REF OR526K; c) SEMI RIGID SUCTION LINER WITH TUBING, REF OR527K; d) SEMI RIGID SUCTION LINER WITH TUBING, REF OR529K
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-1807-2024·2024-09-18

    American Outdoor Products Astronaut Strawberries Recalled for Elevated Lead Levels

    American Outdoor Products' Astronaut Strawberries are being recalled due to elevated lead levels. The recall affects approximately 14,235 units distributed nationwide.

    Product
    American Outdoor Products - Astronaut Strawberries, packaged in 0.5oz (14g) metallic plastic pouches. Sold individually or in 6, 12, 40, or 160 count cases. One unit is also included in the Outerspace Survival Dessert Kit. Shelf stable.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3013-2024·2024-09-18

    Medline CYSTO PACK Convenience Kits Recalled for Defective Syringes

    Medline is recalling CYSTO PACK convenience kits containing defective plastic syringes with leaks and breakage that may risk patient health. Affected worldwide; specific lot numbers provided.

    Product
    Medline Convenience kits labeled as: 1) CYSTO PACK, Pack Number DYNJ42742D; 2) CYSTO PACK, Pack Number DYNJ42799
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3070-2024·2024-09-18

    Medline Sterile Medical Kit with Mislabeled Non-sterile Component Recalled

    Medline's KIT PEDI CRANI LAMI sterile kits contain a non-sterile Mastisol component not labeled as such, raising infection risk. 485 units were distributed in Texas, Illinois, and California.

    Product
    KIT PEDI CRANI LAMI, Pack Number DYNJ907372A
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-3126-2024·2024-09-18

    Proton Beam Therapy System Displays Insufficient CBCT Images on Button Press

    Hitachi's PROBEAT-CR proton therapy system may display insufficient CBCT images during image positioning when the Float Image Selection button is pressed. This could affect treatment planning accuracy.

    Product
    Brand Name: PROBEAT Product Name: PROBEAT-CR Model/Catalog Number: N/A Software Version: N/A Product Description: The PROBEAT-CR is a proton beam irradiation system, which provides a therapeutic proton beam for clinical treatment. It is designed to deliver a proton beam…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3040-2024·2024-09-18

    Medline Medical Convenience Kits Recalled for Plastic Syringe Defects

    Medline is recalling multiple medical convenience kits containing plastic syringes with quality issues including leaks and breakage. These kits are used for chest procedures and may pose risks to patient health.

    Product
    Medline Convenience kits labeled as: 1) CHEST TUBE TRAY , Pack Number CHT2120; 2) CHEST TUBE INSERTION TRAY , Pack Number DYNDA2475; 3) CHEST TUBE INSERTION TRAY , Pack Number DYNDA2941A ; 4) PERICARDIAL DRAIN KIT , Pack Number DYNDA2998; 5) KIT, BEDSIDE THORACENTESIS…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3078-2024·2024-09-18

    Multiple Syringe Models Recalled for Deviation from FDA Clearance Specifications

    Sol-Millennium Medical is recalling multiple syringe models because the distributed products are substantially different from FDA-cleared specifications, with major changes to the intended use.

    Product
    Syringes with Low Dead Space labeled as: a) SOL-M 1ml Slip Tip Syringe w/o needle (low dead space), Model No. 180011LDS, UPC 840368511899; b) SOL-M 1ml Slip Tip Syringe w/o needle (low dead space), Model No. P180011LDS, UPC 810018097554; c) SOL-M 1ml Luer Lock Syringe…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3029-2024·2024-09-18

    Medical Convenience Kits with Defective Plastic Syringes Recalled Worldwide

    Medline medical convenience kits containing defective plastic syringes are being recalled due to leaks, breakage, and quality issues that may harm patients. The kits were distributed worldwide and are used for invasive procedures like biopsies and lumbar punctures.

    Product
    Medline Convenience kits labeled as: 1) INFECTION DRIVELINE MANAGEMENT KIT, Pack Number DM645; 2) PICU LINE TRAY, Pack Number DYNDC1960A; 3) ULTRASOUND GUIDE BREAST BIOPSY, Pack Number DYNDH1319; 4) MINI INTERVENTIONAL PACK, Pack Number DYNDH1324A; 5) BONE MARROW…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3075-2024·2024-09-18

    SOL-CARE and SOL-M syringes recalled for unapproved design modifications

    Sol-Millennium Medical Inc. is recalling SOL-CARE and SOL-M syringes with safety needles because the devices are substantially different from FDA-cleared versions, with major modifications to intended use.

    Product
    Syringes with exchangeable needles labeled as: SOL-CARE: 1) SOL-CARE 10ml Luer Lock Syringe w/Safety Needle 21G*1 1/2 (needle aside), Model No. 102115SN, UPC 818392019858; 2) SOL-CARE 10ml Luer Lock Syringe w/Safety Needle 22G*1 1/2 (needle aside), Model No. 102215SN…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-3096-2024·2024-09-18

    Smith & Nephew Recalls Rotation Medical Tendon Staples Due to Seal Defects

    Smith & Nephew is recalling Rotation Medical Tendon Staples because packaging defects may compromise sterility. The recall affects 6,465 units distributed worldwide.

    Product
    ROTATION MEDICAL TENDON STAPLES (8) (broad indication)-Intended for fixation of prosthetic material to soft tissues. Product Number: 2504-1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3062-2024·2024-09-18

    Guidewire for Hemodialysis Catheters Recalled Due to Incorrect Assembly

    Bard is recalling Guidewire 70cm x 1mm (REF 5583705) for hemodialysis catheters due to incorrect assembly. The stiff end may be positioned at the wrong location, risking injury during insertion into a patient.

    Product
    Guidewire 70cm x 1mm (0.038 ) REF 5583705 These accessories are intended for use with Bard 14.5 Fr. Long-Term Dual Lumen Hemodialysis Catheters. Please refer to the applicable catheter Instructions for Use for directions on the use of these accessories.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2994-2024·2024-09-18

    Medline Vascular IVC Filter Placement Kits Recalled for Syringe Defects

    Medline is recalling vascular IVC filter placement kits containing defective plastic syringes due to leaks and breakage that may pose health risks. The affected kits are distributed worldwide.

    Product
    Medline Convenience kits labeled as: KIT VASCULAR IVC FILTER PLACEM, Pack Number DYKMBNDL37AH
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3019-2024·2024-09-18

    Medline Medical Convenience Kits Recalled for Defective Syringes

    Medline Industries recalls numerous sterile procedure kits containing plastic syringes affected by an FDA Safety Alert from March 2024. The syringes may leak or break, posing potential risk to patient health.

    Product
    Medline Convenience kits labeled as: 1) MYELOGRAM PACK, Pack Number 00-399025L ; 2) BIOPSY PROCEDURE PACK , Pack Number 00-399227G ; 3) BIOPSY PROCEDURE PACK, Pack Number 00-399607N; 4) THORACENTESIS TRAY, Pack Number 00-400616J ; 5) SPECIAL PROCEDURE PACKX-RAY , Pack…
    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 (Drugs)·D-0657-2024·2024-09-18

    Barrier Therapy Skin Protectant Cream recalled for microbial contamination

    Prequel Skin is recalling Barrier Therapy Skin Protectant Cream due to microbial contamination. The recall affects approximately 30,946 tubes distributed nationwide and online.

    Product
    BARRIER THERAPY SKIN PROTECTANT CREAM (1% colloidal oatmeal), 10 FL OZ/296 ML- tube, Distributed By: Prequel, LOS ANGELES, CA 90069. UPC 8 10129 11007 4
    Category
    Drug
    Distribution
    Distributed nationwide
  • 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…
    Category
    Medical Device
    Distribution
    0 states
  • 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 (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…
    Category
    Medical Device
    Distribution
    0 states
  • 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-3005-2024·2024-09-18

    Medline Medical Convenience Kits Recalled Due to Syringe Quality Issues

    Medline is recalling specific medical convenience kits because they contain plastic syringes affected by a March 2024 FDA Safety Alert regarding leaks and breakage.

    Product
    Medline Convenience kits labeled as: 1) URETEROSCOPY CDS SC-LF, Pack Number CDS983922F ; 2) URETEROSCOPY TRAY-RF, Pack Number DYNJ27442U ; 3) URETHROPLASTY PACK, Pack Number DYNJ39700B ; 4) RRP PACK, Pack Number DYNJ44109B ; 5) PROSTATECTOMY PACK-LF , Pack Number…
    Category
    Medical Device
    Distribution
    0 states
  • 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-2982-2024·2024-09-18

    Medline Medical Convenience Kits Recalled Due to Syringe Quality Issues

    Medline is recalling medical convenience kits due to quality issues in plastic syringes, including leaks and breakage that may affect patient safety. Affected products include tracheostomy kits and airway packs distributed worldwide.

    Product
    Medline Convenience kits, labeled as: 1) TRACH CDS-LF , Pack Number CDS983142B ; 2) MER TRACH CDS , Pack Number CDS984376B ; 3) Flexible LMA Pack with Syringe and Lube, Size 1, Pack Number DYND300010P; 4) Flexible LMA Pack with Syringe and Lube, Size 1.5, Pack Number…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2992-2024·2024-09-18

    Medline Medical Convenience Kits with Defective Syringes Recalled

    Medline Industries is recalling convenience kits containing plastic syringes with leaks, breakage, and quality defects identified by an FDA Safety Alert. These defects may pose risks to patient safety during medical procedures.

    Product
    Medline convenience kits labeled as: 1) ANGIOGRAPHY DRAPE PACK, Pack Number 00-398281J ; 2) ANGIOGRAPHY DRAPE PACK, Pack Number 00-398650AG; 3) ANGIOGRAPHY DRAPE PACK, Pack Number 00-398650AI; 4) ANGIOGRAPHY DRAPE PK, Pack Number 00-398712S ; 5) CATH LAB PACK , Pack Number…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3106-2024·2024-09-18

    Medline Semi-Rigid Suction Liners Recalled for Potential Suction Loss

    Medline Industries is recalling anesthesia circuit kits due to reported adverse events indicating potential loss of suction during intermittent use. Approximately 29,585 units distributed in the US, Canada, and Panama are affected.

    Product
    Medline convenience kits containing semi-rigid suction liners labeled as follows: a) ANESTHESIA CIRCUIT-LF, Pack Number DYNJAA0311C; b) ANESTHESIA CIRCUIT-LF, Pack Number DYNJAA0323C; c) ANESTHESIA CIRCUIT ADULT, Pack Number DYNJAA0378A; d) ADULT ANESTHESIA CIRC LAGUNA…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3034-2024·2024-09-18

    Medline Convenience Kits With Syringes Recalled for Leaks and Breakage

    Medline convenience kits containing plastic syringes are being recalled worldwide due to leaks and breakage that may pose patient health risks. The kits are linked to an FDA Safety Alert issued March 19, 2024.

    Product
    Medline Convenience kits labeled as: 1) KIT, MIDSTREAM, W/BZK/FUNNL,3O, Pack Number DYND30212; 2) PROCESSING KIT 3 PTE0000204 , Pack Number DYNJ65728A ; 3) 30ML KIT, Pack Number DYNJ82155A ; 4) DISSECTION, Pack Number DYNJ85191; 5) FLAP HARVEST PACK , Pack Number…
    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…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-3066-2024·2024-09-18

    Ultradent Recalls Vit-l-escence Composite Due to Red Particulates

    Ultradent is recalling Vit-l-escence Singles A3 composite restorative material because a manufacturing issue resulted in red particulates being present in the expressed composite.

    Product
    Brand Name: Vit-l-escence Product Name: Vit-l-escence Singles A3 Model/Catalog Number: 1203- Software Version: N/A Product Description: Vit-l-escence composite is a light-cured, microhybrid, Bis-GMA esthetic composite restorative material. It is 75% filled by weight, 52%…
    Category
    Medical Device
    Distribution
    34 states
  • ModerateFDA (Devices)·Z-3094-2024·2024-09-18

    Reprocessed Surgical Sealer/Divider Recalled for Potential Packaging Seal Defect

    Medline Industries is recalling the ReNewal Reprocessed Covidien LigaSure Impact Sealer/Divider due to a potential incomplete seal on the packaging tray. The recall affects 230 units nationwide.

    Product
    Medline ReNewal Reprocessed Covidien LigaSure Impact, Sealer/Divider, Nano-Coated, Compatible w/ FT10 18cm FT10 SW Version 4.0.1.15 or lower. Item Number: LF4418CR.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0658-2024·2024-09-18

    Fluoride Dental Product Recalled Due to Label Mix-Up

    Just Right 5000 fluoride dental product is being recalled due to a label mix-up affecting 120 direct customers nationwide.

    Product
    Just Right 5000, 1.1% Sodium Fluoride, Candy Apple Flavor, Net Wt. 3.4oz (97g), Rx Only, Manufactured for Elevate Oral Care, LLC in the U.S.A with imported pump, 346 Pike Rd, Suite 5, West Palm Beach, FL 33411, NDC 57511-002-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3120-2024·2024-09-18

    Medline recalls surgical convenience kits in Class II recall

    Medline Industries is voluntarily recalling 720 units of convenience kits containing semi-rigid suction liners used in eye surgery and related procedures. The specific reason for the recall has not been disclosed.

    Product
    Medline convenience kits containing semi-rigid suction liners labeled as follows: a) AMB VITRECTOMY, Pack Number DYNJ59921B; b) AMB VITRECTOMY, Pack Number DYNJ59921BH; c) AMB OCULOPLASTICS MUSC, Pack Number DYNJ59923B; d) AMB OCULOPLASTICS MUSC, Pack Number…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3073-2024·2024-09-18

    Medtronic InterStim Handset May Fail to Pair with Communicator

    Medtronic is recalling 211 InterStim Smart Programmer handsets that may not complete the pairing process with the communicator during initial setup.

    Product
    Medtronic Handset with Communicator, Model TH90Q01, InterStim Smart Programmer and Communicator Kits, containing the Model HH90 Handset and the TM90 Communicator.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1806-2024·2024-09-18

    Walmart Macaroni Salad Recalled Due to Foreign Material

    Reser's Fine Foods is recalling Walmart Original Freshness Guaranteed Macaroni Salad due to foreign material contamination. Affected product has UPC 78742 02670 with a Use By date of Sep 18, 2024.

    Product
    UPC 78742 02670, Walmart Original Freshness Guaranteed Macaroni Salad 3lb. (48oz), refrigerated, packaged in an opaque printed plastic tub with a plastic white printed lid. There are 6 tubs per case.
    Category
    Food
    Distribution
    9 states
  • ModerateFDA (Devices)·Z-3129-2024·2024-09-18

    Medical Action Industries Recalls Foam Protective Pouches Due to Labeling Error

    Medical Action Industries is recalling foam protective pouches because they were improperly labeled with incorrect GMDN codes, leading to product misuse.

    Product
    Foam Protective Pouches, model numbers 6010 (50 each/case), 6010-1 (350 each /case), 6060 (8 rolls/case), 6070 (75 each/case), 6106 (250 each/case), 6141 (250 each/case), 6203 (40 each/case), 6805 (50 each/case), 6805-1 (175 each/case), 6810 (50 each/case), 6810-1 (350…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3132-2024·2024-09-18

    Zimmer GmbH Recalls Mislabeled Biolox Option Taper Sleeve for Hip Replacement

    Zimmer GmbH is recalling 69 units of Biolox Option Taper Sleeves due to incorrect packaging labels. The outer box may identify the wrong neck size, potentially leading to the use of the wrong device.

    Product
    Biolox Option Taper Sleeve, Type 1 Taper, Standard Neck - Indicated for use in total hip replacement with cemented or non-cemented femoral and acetabular components. Item Number: 650-1066
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3095-2024·2024-09-18

    Medline ReNewal Reprocessed Ethicon Harmonic ACE+7 Shears Recalled for Packaging Seal

    Medline is recalling 46 units of reprocessed Ethicon Harmonic ACE+7 Shears due to a potential incomplete seal on the packaging tray.

    Product
    Medline ReNewal Reprocessed Ethicon Harmonic ACE+7 Shears w/ Adv. Hemostasis Use Only w/GEN11 SW v2018-1 and Lower 5mm x 36cm. Item Number: HARH36R.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1802-2024·2024-09-18

    Reser's Spicy Pickle Potato Salad Recalled for Foreign Material

    Reser's American Classics Spicy Pickle Potato Salad (16 oz, UPC 71117 19084) is being recalled due to possible foreign material contamination. The voluntary recall affects products distributed across nine states.

    Product
    UPC 71117 19084, Reser's American Classics Spicy Pickle Potato Salad 16oz, refrigerated, packaged in an opaque printed plastic tub with a plastic red printed lid. There are 6 tubs per case.
    Category
    Food
    Distribution
    9 states
  • ModerateFDA (Food)·F-1804-2024·2024-09-18

    Amazon Fresh Macaroni Salad recalled for foreign material contamination

    Reser's Fine Foods is recalling Amazon Fresh Fresh Classic Macaroni Salad due to foreign material contamination. The product was distributed in nine states with a use-by date of September 13, 2024.

    Product
    UPC 95515 04502, Amazon Fresh Fresh Classic 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
  • ModerateFDA (Devices)·Z-3103-2024·2024-09-18

    Diagnostic test shows measurement bias at critical threshold

    Siemens Healthcare Diagnostics is recalling ADVIA Centaur CA 19-9 test kits due to positive bias in measurements around the critical threshold of 35 U/mL, affecting diagnostic accuracy.

    Product
    ADVIA Centaur CA 19-9 (50 Test)-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: 10491379 SMN: 11206239
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3112-2024·2024-09-18

    Medline Suction Liners Recalled Due to Potential Loss of Suction

    Medline is recalling 1,616 units of semi-rigid suction liners (ENDO KIT, pack numbers DYKE1350D and DYKE1514B) manufactured September to November 2023 that may lose or provide reduced suction during use.

    Product
    Medline convenience kits containing semi-rigid suction liners labeled as follows: a) ENDO KIT, Pack Number DYKE1350D; b) ENDO KIT, Pack Number DYKE1514B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3098-2024·2024-09-18

    Vital Signs Monitor Recalled Due to Inadequate Battery Warning Labels

    Zoe Medical is recalling 6,429 Spacelabs Ultraview DM3 Vital Signs Monitors because labeling does not adequately warn users about risks from damaged or expired batteries.

    Product
    Spacelabs Ultraview DM3 Vital Signs Monitor (all variations -M, -MT, -N, -NT), Model Number 91330
    Category
    Medical Device
    Distribution
    0 states
  • ModerateNHTSA·24T010000·2024-09-18

    Goodyear Recalls Hercules Tires for Missing Identification Markings

    Goodyear is recalling specific Hercules Terra Trac AT X-Venture tires because they lack the required week and year code on the tire identification number.

    Product
    TIRES:MARKINGS recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3079-2024·2024-09-18

    FDA Recalls Syringe Tip Caps Due to Unapproved Device Modifications

    Sol-Millennium Medical Inc. is recalling certain Syringe Tip Cap models because they were modified without proper FDA clearance. The modified devices differ from their approved specifications.

    Product
    Syringe Tip Caps labeled as: 1) SOL-M Syringe Tip Cap, Blue, Model No. STCB01, UPC N/A; 2) SOL-M Syringe Tip Cap, Red, Model No. STCB02, UPC N/A; 3) SOL-M Red Cap, Model No. 110101150020, UPC N/A 4) SOL-M Syringe Tip Cap Tray, Black, Model Number STCT01, UPC N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·24V693000·2024-09-17

    2024 Kia EV9 Remote Smart Parking Assist Software Error Recall

    Kia is recalling certain 2024 EV9 vehicles because a software error in the remote smart parking assist feature may miscalculate stopping distances, increasing crash risk.

    Product
    KIA — KIA EV9
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24V672000·2024-09-16

    2024 Harley-Davidson Motorcycles Recalled for Electrical Short Circuit Risk

    Harley-Davidson is recalling certain 2024 motorcycles because the voltage regulator output wire may rub on the crankcase, causing an electrical short circuit. This could result in loss of electrical and drive power while riding, increasing crash risk.

    Product
    HARLEY-DAVIDSON — HARLEY-DAVIDSON FLHX, FLTRX, FLTRXSE, FLHXSE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24V685000·2024-09-13

    2024 Ford Explorer Hybrid: Fire Risk from Battery Cable Chafing

    Ford is recalling certain 2024 Ford Explorer vehicles with 3.3L Hybrid engines due to a defect in which the 12-Volt battery cable may chafe against the high voltage cable and short circuit, increasing fire risk. No injuries have been reported.

    Product
    FORD — FORD EXPLORER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24V682000·2024-09-13

    Ford Recalls 2022 F-150 Trucks for Flickering Parking Lights

    Ford is recalling 2022 F-150 vehicles because parking lights may flicker when headlights are on, reducing visibility and increasing crash risk.

    Product
    FORD — FORD F-150
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24V684000·2024-09-13

    2022–2024 Ford Maverick: Rearview Camera Display May Freeze

    Ford is recalling 2022–2024 Maverick vehicles with Connected Touch Radios because the rearview camera display may freeze in reverse, reducing rear visibility and increasing crash risk. Dealers will update the software free of charge.

    Product
    FORD — FORD MAVERICK
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24V683000·2024-09-13

    2024 Ford Bronco Sport Control Module Software Update for Battery Detection

    Certain 2024 Ford Bronco Sport vehicles are recalled because their control modules may fail to detect battery charge changes, potentially resulting in loss of drive power or hazard lights and increasing crash risk.

    Product
    FORD — FORD BRONCO SPORT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24V688000·2024-09-13

    Mercedes-Benz Recalls 2024 Models for Software Error Affecting Safety Systems

    Mercedes-Benz is recalling certain 2024 models because a software error may deactivate safety systems, including automatic braking, increasing crash risk.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ E 350, E 450, CLE 300, AMG CLE53
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24V691000·2024-09-13

    2025 Hyundai Tucson glove box airbag warning label may be missing

    Certain 2025 Hyundai Tucson vehicles may lack glove box airbag warning labels that inform drivers of risks to infants and children in the front seat. Hyundai will mail replacement labels at no cost.

    Product
    HYUNDAI — HYUNDAI TUCSON
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • ModerateNHTSA·24V686000·2024-09-13

    2025 Rivian R1S Recall: Missing Cruise Control Markings

    Rivian is recalling 33 2025 R1S vehicles because the steering column control module may be missing cruise control markings. Without proper markings, drivers may not know how to use the cruise control, potentially increasing crash risk.

    Product
    RIVIAN — RIVIAN R1S
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalCPSC·24359·2024-09-12

    About 866,000 AirJet and HydroJet Spa Pumps Recalled for Fire Hazard

    AirJet and HydroJet spa pumps can overheat and ignite, posing a fire hazard. One death has been reported, and consumers should stop using the pumps immediately.

    Product
    AirJet and HydroJet Spa Pumps
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereCPSC·24358·2024-09-12

    Petzl GYM, PANDION, and PANJI Climbing Harnesses Recalled for Fall Hazard

    Petzl America is recalling three climbing harness models because they can be worn backwards, allowing the rope or carabiner to attach to a non-weight-bearing strap instead of the proper attachment point. This can cause users to fall from height and suffer serious injury or death.

    Product
    Petzl GYM, PANDION and PANJI climbing harnesses
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·026-2024·2024-09-12

    Dearborn Sausage Recalls Brookside Wieners Due to Undeclared Allergens

    Dearborn Sausage Company is recalling approximately 1,944 pounds of Brookside Brand wieners because swapped labels failed to declare pork and soy.

    Product
    Dearborn Sausage Company Inc — Dearborn Sausage Company, Inc. Recalls Wiener Products Due to Misbranding and Undeclared Allergens
    Category
    Food
    Distribution
    1 state
  • HighCPSC·24363·2024-09-12

    Bright Builder Fort Kits recalled for button cell battery ingestion hazard

    Intellio Toys is recalling Bright Builder fort kits because the included flashlights have button cell batteries in compartments that open easily without tools. Swallowed button cell batteries can cause serious internal injuries, chemical burns, and death.

    Product
    Bright Builder Fort Kits with Flashlights
    Category
    Consumer Product
    Distribution
    Distributed nationwide

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