The Recall Desk

Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means deaths or serious injuries are reported, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

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7626–7650 of 89529

  • HighFDA (Devices)·Z-1447-2025·2025-04-02

    Medline procedure kits recalled for syringe quality defects

    Medline Industries is recalling 1,711 procedure kits containing plastic syringes affected by manufacturing defects. The syringes may leak or break, posing a risk to patient safety during medical procedures.

    Product
    Medline procedure kits labeled as: 1) CLOVIS ROBOTIC-LF, Pack Number DYNJ61061D; 2) CSMC/GYN LAPAROSCOPIC PACK-LF, Pack Number DYNJ0665103I; 3) DAVINCI PACK-RFD, Pack Number DYNJ47762O; 4) DAVINCI ROBOT PACK SLRMC, Pack Number DYNJ81236; 5) GENERAL ROBOTICS PACK, Pack
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1438-2025·2025-04-02

    Medline Surgical Procedure Kits Recalled for Defective Plastic Syringes

    Medline Industries recalls 3,860 surgical procedure kits with defective plastic syringes that may leak or break during use. The affected kits are distributed in the US and Canada.

    Product
    Medline procedure kits labeled as: 1) AV FISTULA PACK, Pack Number DYNJ80088; 2) AV FISTULA PACK-LF, Pack Number DYNJ0131782J; 3) CABG, Pack Number DYNJ906462B; 4) CABG ACCESSORY PACK-LF, Pack Number DYNJ0261346U; 5) CARDIAC CATH PACEMAKER-LF, Pack Number DYNJ42997C;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1425-2025·2025-04-02

    Lap Pack Convenience Kits Recalled for Sterility Assurance Concerns

    American Contract Systems is recalling 500 Lap Pack - 170307 convenience kits distributed in Arizona due to sterility assurance concerns with procedure trays.

    Product
    Brand Name: Banner Health Systems Product Name: Lap Pack - 170307 Model/Catalog Number: BHLP62H Software Version: N/A Product Description: Convenience Kit Component: No
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1448-2025·2025-04-02

    Medline C-section procedure kits recalled for syringe quality defects

    Medline is recalling C-section procedure kits because plastic syringes in the kits may leak or break. The defect was identified in connection with an FDA safety alert and poses a potential risk to patient health.

    Product
    Medline procedure kits labeled as: 1) C SECTION, Pack Number DYNJ57622; 2) C SECTION PACK, Pack Number DYNJ48483B; 3) C SECTION PACK, Pack Number DYNJ61573; 4) C SECTION PACK, Pack Number DYNJ66801; 5) C SECTION PACK-LF, Pack Number DYNJ0367951P; 6) C SECTION PACK-LF
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1468-2025·2025-04-02

    Progressa bed surfaces recalled for mattress dips when head elevated

    Baxter Healthcare's Progressa Bed Surfaces may develop dips in the mattress when the head of the bed is elevated, as air bladders inside can shift out of position. This could reduce the bed's effectiveness at preventing pressure ulcers.

    Product
    Progressa Bed Surfaces, intended to be used to treat or prevent pulmonary or other complications associated with immobility, Product Codes P7520A19, P7520A20S, P7520A21, P7520A22S, P7520A23, P7520A24S, P7520A3, P7520A31, P7520A37, P7520A39, P7520A45, and P7520A4S.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1414-2025·2025-04-02

    Baxter TruSystem 7500 U Medical Device Software Malfunction Recall

    Baxter is recalling the Stationary column TruSystem 7500 U due to a software issue that prevents the upper back section from being adjustable when emergency mode is enabled.

    Product
    Baxter Stationary column TruSystem 7500 U, Product Code 1730731
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1411-2025·2025-04-02

    Baxter surgical table software issue blocks emergency back adjustment

    Baxter is recalling 112 units of the TruSystem 7500 surgical table due to a software issue preventing upper back adjustment during emergency mode. No injuries have been reported.

    Product
    Baxter Floor mounting column TruSystem 7500, Product Code 1717021
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1454-2025·2025-04-02

    Helix Elite Quality Control Material Recalled for Delayed Detection and QC Failure

    Microbiologics Inc is recalling its Helix Elite RSV quality control material (Lot HE0044-131) because the RSV component may produce delayed test results and could fail quality control checks. This Class II recall affects 28 units distributed worldwide.

    Product
    Helix Elite Inactivated Standard: Inactivated Influenza A/B and Respiratory Syncytial Virus, Multi-analyte, unassayed quality control material, Catalog Number HE0044N
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1462-2025·2025-04-02

    Medline Surgical Procedure Kits Recalled for Defective Plastic Syringes

    Medline Industries is recalling 1,228 surgical procedure kits containing defective plastic syringes. The syringes may leak or break during use, potentially affecting patient safety.

    Product
    Medline procedure kits labeled as: 1) BREAST PACK-LF, Pack Number DYNJ0956628O; 2) BREAST SURGERY FOAKS, Pack Number DYNJ63577C; 3) CHEST BREAST -LF, Pack Number DYNJCEN04C; 4) DIEP PACK, Pack Number DYNJ60669G; 5) FACE LIFT PACK, Pack Number DYNJ64670B; 6) FREE FLAP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1450-2025·2025-04-02

    Medline Medical Procedure Kits With Plastic Syringes Recalled for Quality Issues

    Medline medical procedure kits containing plastic syringes are being recalled due to identified leaks, breakage, and quality issues that may pose a risk to patient health.

    Product
    Medline procedure kits labeled as: 1) L S GYN PACK, Pack Number DYNJ65616C; 2) MAIN CYSTO, Pack Number DYNJ61371A; 3) OB PACK-LF, Pack Number DYNJ20720C; 4) PELVISCOPY PACK-LF, Pack Number DYNJ0415776N; 5) POSTERIOR EYE PACK-LF, Pack Number PHS656483I; 6) ROBOTICS PA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1467-2025·2025-04-02

    Checkpoint Guardian Intraoperative Lead: Potential Electrical Exposure Risk

    Adhesive may not fully encapsulate metallic components on Checkpoint Guardian Intraoperative Leads, creating potential for electrical current leakage. This could cause inconsistent muscle responses and incorrect surgical actions.

    Product
    Brand Name: Checkpoint Guardian Intraoperative Lead Product Name: Checkpoint Guardian Intraoperative Lead, Medium Model/Catalog Number: REF# 9525 (Medium) Product Description: The Checkpoint Guardian Intraoperative Leads are single-patient disposable accessories for providing
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1449-2025·2025-04-02

    Medline Procedure Kits With Defective Syringes Recalled Nationwide

    Medline is recalling 268 procedure kits nationwide due to plastic syringes affected by a March 2024 FDA safety alert. The syringes may leak, break, or have quality issues that could affect patient care.

    Product
    Medline procedure kits labeled as: 1) CSMC/ABDOMINAL HYST PACK-LF, Pack Number DYNJ0665086F; 2) MAJOR VAGINAL HARPER PACK-LF, Pack Number DYNJ0161768D; 3) ROBOT LAP TOTAL HYST, Pack Number DYNJ907811A; 4) VAG HYSTE PACK-LF, Pack Number DYNJ0773613J; 5) VAG HYSTERECTOMY
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1429-2025·2025-04-02

    Medline Arterial Pressure Monitoring Line Kits Recalled for Manufacturing Defect

    Medline is recalling certain arterial pressure monitoring line kits due to excess material on female luer fittings. The affected kits were distributed worldwide, including the United States.

    Product
    namic convenience kits labeled as: KIT,ARTERIAL,60,(152CM),PG; medical convenience kit, REF 70036160
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0297-2025·2025-04-02

    Compounded Fentanyl-Ropivacaine Epidural Injection Recalled Due to Sterility Assurance Concerns

    QuVa Pharma is recalling 1,765 cassettes of compounded epidural injection due to lack of sterility assurance. The affected lots were distributed nationwide to institutional and office locations.

    Product
    fentaNYL Citrate PF 200 mcg/100 mL (2 mcg/ml) /0.2% ROPivacaine HCl 200 mg/100 mL (2 mg/mL), 100 ml in NS Yellow CADD FSFF, Injection for Epidural Use (Not intended For IV Use), Compounded, For Institutional or Office Use Only, QuVa Pharma, 1075 West Park One Drive, Suite 100, Su
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1427-2025·2025-04-02

    CardioMEMS Heart Failure Monitoring System Recalled for Data Migration Issues

    St. Jude Medical is recalling the CardioMEMS Heart Failure System due to data migration issues resulting in duplicated or missing patient information.

    Product
    CardioMEMS Heart Failure (HF) System that consist of: -CardioMEMS Hospital System Model CM3100 -CardioMEMS Backend Web Application Model CM4000 -Merlin.net Patient Care Network (PCN) Heart Failure Web Application Model MN6000 The CardioMEMS" HF System provides pulmonary art
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1426-2025·2025-04-02

    Cardiac catheterization kit recalled due to sterility concerns

    American Contract Systems recalls 460 Cardiac Cath Lab Pack kits due to sterility assurance issues with procedure trays. Facilities should verify affected lots have been removed from clinical use.

    Product
    Brand Name: Banner University Med Ctr. Product Name: Cardiac Cath Lab Pack-170278 Model/Catalog Number: GSCC40G Software Version: N/A Product Description: Convenience Kit Component: No
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1408-2025·2025-04-02

    Premier Solo Diamond dental burs recalled due to material hardness defect

    Premier Dental Products Co is recalling Premier Solo Diamond Large dental burs because the material hardness does not meet specifications and may cause the burs to bend during use. 77 units in six U.S. states are affected.

    Product
    Premier Solo Diamond - Large Invented Cone; SKU: 807016C.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1421-2025·2025-04-02

    Baxter TruSystem 7500 Hybrid IMRIS Upper Back Adjustment Software Malfunction

    A software issue in the Baxter TruSystem 7500 Hybrid MR IMRIS system prevents the upper back section from being adjusted when emergency mode is enabled. The recall affects 24 units distributed nationwide.

    Product
    Baxter TruSystem 7500 Hybrid MR IMRIS, Product Code 2067886
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1460-2025·2025-04-02

    Medline ReNewal Electrophysiology Catheters Recalled for Elevated Bacterial Endotoxin Levels

    Medline is recalling ReNewal Reprocessed Livewire Steerable Electrophysiology Catheters used in cardiac procedures because the devices may contain higher than expected levels of bacterial endotoxin.

    Product
    Medline ReNewal Reprocessed Livewire Steerable Electrophysiology Catheters, Medline Item Numbers: 401582R, 401904R, 401904R, 401905R, 401933R, and 401991R
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1415-2025·2025-04-02

    Baxter Floor Mounting Column TS 7500 U Software Issue Affects Emergency Function

    Baxter is recalling 33 units of the Floor Mounting Column TS 7500 U due to a software defect that prevents upper back adjustment when emergency mode is enabled.

    Product
    Baxter Floor mounting column TS 7500 U, Product Code 1730732
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1443-2025·2025-04-02

    Medline CV Neonatal Procedure Kits Recalled Due to Syringe Quality Issues

    Medline is recalling CV Neonatal Pack procedure kits (Pack Number DYNJ67356) because the plastic syringes may leak or break, potentially harming patients. The recall affects 96 units distributed nationwide and in Canada.

    Product
    Medline procedure kits labeled as: 1) CV NEONATAL PACK, Pack Number DYNJ67356
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1440-2025·2025-04-02

    Medline Procedure Kits Recalled for Defective Syringes Posing Patient Risk

    Medline is recalling 808 medical procedure kits containing plastic syringes with quality defects that may leak or break during use. Affected customers should stop using these kits and contact Medline for replacement instructions.

    Product
    Medline procedure kits labeled as: 1) CT BIOPSY PACK, Pack Number DYNJ62734A; 2) E R C P PACK, Pack Number DYNJ44115A; 3) LARGE BIOPSY PACK NTX, Pack Number DYNJ68393A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1466-2025·2025-04-02

    Checkpoint Guardian Intraoperative Lead adhesive defect electrical leakage risk

    The adhesive on Checkpoint Guardian Intraoperative Leads may not fully cover metallic wire components, leading to potential electrical current leakage. This could result in inconsistent muscle responses and affect surgical effectiveness.

    Product
    Brand Name: Checkpoint Guardian Intraoperative Lead Product Name: Checkpoint Guardian Intraoperative Lead, Small Model/Catalog Number: REF# 9524 (Small) Product Description: The Checkpoint Guardian Intraoperative Leads are single-patient disposable accessories for providing s
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0294-2025·2025-04-02

    Testosterone Gel Recalled Nationwide Due to Benzene Contamination

    Strides Pharma is recalling Testosterone Gel 1% nationwide due to the presence of benzene, a toxic substance. Patients should contact their healthcare provider about alternative treatment options.

    Product
    TESTOSTERONE — TESTOSTERONE (TESTOSTERONE)
    Category
    Drug
    Distribution
    Distributed nationwide