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.

Filters

Agency

Category

Minimum severity

Clear filters

5551–5575 of 13543

  • ModerateFDA (Devices)·Z-2702-2024·2024-08-28

    Medline Dental Procedure Kits Recalled Due to Dimensional Variation

    Medline Industries is recalling certain dental procedure kits due to dimensional variations that may cause difficulty fitting into the outer canister. The recall affects 99 units distributed worldwide.

    Product
    Medline medical procedure kits labeled as follows: DENTAL, REF DYNJ909211A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2713-2024·2024-08-28

    Medline Medical Procedure Kits Recalled for Dimensional Variation Affecting Outer Canister Fit

    Medline Industries is recalling certain C-Section surgical kits due to dimensional variations that could cause difficulty fitting into the outer canister. The recall affects 1,753 units distributed worldwide.

    Product
    Medline medical procedure kits labeled as follows: a) C-SECTION CDS, REF CDS983998C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2694-2024·2024-08-28

    Medline Soft Suction Canister Liner Recalled for Dimensional Variation

    Medline Industries recalls soft suction canister liners due to dimensional variation that may cause difficulty fitting the product into the outer canister. The issue affects units distributed worldwide.

    Product
    LINER, SOFT, SUCTION CANISTER, 1500CC, REF DYNDSCL1500
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2639-2024·2024-08-28

    C-Flow Bag Decanter Packaging Defects Prompt Sterile Barrier Recall

    Microtek Medical Inc. recalls C-Flow Bag Decanters (10,366 cases) due to pin holes and tears in sterile barrier packaging discovered during quality testing. The defects could allow bacterial contamination.

    Product
    C-Flow Bag Decanter, REF 2000S. Packaged on a form, fill and seal machine with a poly/Tyvek material then placed 50 products to a case (cs).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2709-2024·2024-08-28

    Medline medical procedure kits recalled due to dimensional variation

    Medline Industries is recalling 1,700 medical procedure kits due to a dimensional variation that may cause fitting difficulty into the outer canister. The affected kits were distributed in the US and internationally.

    Product
    Medline medical procedure kits labeled as follows: a) KIT CANISTER SUCT W 12FT, REF DYKM2169
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2699-2024·2024-08-28

    Medical Device Liner Recalled for Dimensional Variation Affecting Fit

    Medline Industries has recalled 316,125 units of its MED-SOFT Single Liner with Solidifier due to a dimensional variation that may cause difficulty when inserting the product into the outer canister.

    Product
    1,5L MED-SOFT SINGLE LINER WITH SOLIDIFIER, REF OR1920PG
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2447-2024·2024-08-21

    Plum 360 Infusion Battery Recall Due to Manufacturing Defect

    ICU Medical is recalling Plum 360 Infusion System replacement batteries due to a manufacturing defect that may cause loss of capacity and decreased runtime earlier than expected. Approximately 11,961 units were distributed worldwide.

    Product
    Replacement Battery List Number SUB0000864, found in Plum 360 Infusion System, List Number 30010. Product description is PLUM 360 Infuser. OUS units marketed with the following descriptions: Bomba de infusi¿n Plum 360 compatible con el software ICU Medical MedNet, Plum 360 Inf
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2448-2024·2024-08-21

    Plum A+ and Plum A+3 Infusion Pump Batteries Recalled for Capacity Loss Defect

    ICU Medical is recalling Plum A+ and Plum A+3 infusion pump batteries due to a manufacturing defect that may cause premature capacity loss and reduced runtime. Approximately 14,744 units were distributed worldwide.

    Product
    Replacement Battery List Number SUB0000594 and SUB0000864 found in Plum A+ & Plum A+3 Infusion Systems, Pump List Numbers: 11005, 11971, 12391, 12618, 20678, 20679, 20792, 60529, 12348, 11973. OUS units marketed with the following descriptions: Plum A+ Mednet TM Firmware New 1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2543-2024·2024-08-21

    RMU-2000 Automated Chest Compression Device Recalled Due to Motor Failure

    Defibtech is recalling the RMU-2000 Automated Chest Compression Device because a motor defect may cause the device to stop delivering compressions, potentially delaying critical therapy and resulting in patient injury or death.

    Product
    RMU-2000 Automated Chest Compression Device
    Category
    Medical Device
    Distribution
    5 states
  • SevereFDA (Devices)·Z-2449-2024·2024-08-21

    Plum 360/A+ Spare Battery Defect Causes Accelerated Capacity Loss

    ICU Medical is recalling 130,826 units of Plum 360/A+ spare batteries due to a manufacturing defect that causes earlier-than-expected battery capacity loss and reduced runtime.

    Product
    Plum 360/A+ spare batteries. Item Number: SUB0000864.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2577-2024·2024-08-21

    Merit Medical Catheter Kits Recalled for Syringe Leaks and Breakage Issues

    Merit Medical convenience kits containing defective plastic syringes are being recalled due to leaks, breakage, and quality issues that may harm patients. The recall affects approximately 4,027 kits distributed nationwide.

    Product
    Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: SafeSheath CSG/Worley advanced CSG (Introducer Catheter kit), REF: FCL-083-02/A WOR-CSG-B1-09/A WOR-CSG-B2-09/A WOR-CSG-BL1-09/A WOR-CSG-E-90/A For the int
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2561-2024·2024-08-21

    Merit Medical convenience kits recalled for syringe leaks and breakage

    Merit Medical is recalling 1,390 convenience kits containing plastic syringes with identified quality issues including leaks and breakage. The kits, distributed nationwide, may pose a risk to patient health.

    Product
    Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K04 (Custom Syringe Kit), REF:K04-00791A An intravascular administration set is a device used to administer fluids from a container to a patient's vascular syst
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2616-2024·2024-08-21

    BioButton Remote Monitoring Device Software Accuracy Issue

    A software anomaly causes the BioButton remote monitoring wearable device to report skin temperature readings slightly out of specification, affecting accurate health data collection in home and healthcare settings.

    Product
    BioButton REF BIOST06040 with Software version 3.0.20 The BioButton System is a remote monitoring wearable device intended for continuous collection of physiological data in home and healthcare settings while the patient is at rest.
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-2563-2024·2024-08-21

    Merit Medical convenience kits with syringe quality issues recalled nationwide

    Merit Medical is recalling convenience kits containing syringes with quality issues including leaks and breakage that may pose a risk to patients receiving intravenous fluid administration.

    Product
    Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K08-PI (Custom Fluid Management Kit), REF: K08-02042 K08-02948 K08-03026 K08-03119 An intravascular administration set is a device used to administer fluids
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2617-2024·2024-08-21

    Spinal Cord Stimulation Devices May Reset During Charging, Causing Transient Therapy Loss

    Boston Scientific spinal cord stimulation implants may reset during routine charging, causing brief loss of therapy. Patients may experience undesired sensations when stimulation restarts, potentially leading to surgical intervention requests.

    Product
    WAVEWRITER ALPHA: Model: SC-1216, 16 IPG KIT, REF: M365SC12160; Model: SC-1232, 32 IPG KIT, REF: M365SC12320
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2566-2024·2024-08-21

    Merit Medical Pressure Monitoring Kits with Defective Syringes Recalled

    Merit Medical is recalling 69 convenience kits containing defective syringes that may leak or break, potentially risking patient safety during medical procedures. The kits were distributed nationwide.

    Product
    Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K11 (Custom Pressure Monitoring Kit), REF: K11-00382C To support fluid administration into the body and physiological pressure monitoring. To support various v
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2557-2024·2024-08-21

    Merit Medical convenience kits recalled for syringe leaks and breakage

    Merit Medical convenience kits containing recalled syringes have quality issues including leaks and breakage that may pose a risk to patient health. The recall affects 2,388 kits distributed nationwide.

    Product
    Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Rapid Response Waste Management System Kit, REF BRC-BAL-INT-SL/B An endoscope and accessories is a device used to provide access, illumination, and allow observ
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2570-2024·2024-08-21

    Merit Medical Convenience Kits Recalled for Defective Plastic Syringes

    Merit Medical is recalling 7,442 convenience kits containing defective syringes that may leak or break, posing a risk to patient health.

    Product
    Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: ReSolve (Catheter and Tip Suction kit), REF: RTT14038MB/A The ReSolve Thoracostomy Tray is indicated for the percutaneous removal of air and fluid from the pleu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2560-2024·2024-08-21

    Merit Medical Syringes in Convenience Kits Recalled for Leaks and Breakage

    Merit Medical convenience kits containing plastic syringes are recalled due to leaks, breakage, and quality defects that may pose a risk to patient health. Approximately 3,647 kits were distributed nationwide.

    Product
    Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K02 (Custom Syringe Kit), REF: K02-00873A, Inject fluids into, or withdraw fluids from, the body.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2569-2024·2024-08-21

    Merit Medical pericardiocentesis kits recalled for syringe defects

    Merit Medical convenience kits containing plastic syringes have been recalled nationwide. The syringes have quality issues including leaks and breakage that may pose a risk to patient health.

    Product
    Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: PC (Pericardiocentesis Tray - Fluid drainage tray), REF: PC101/B PC801 PC801/A PC802 PC802/A The Pericardiocentesis Kit is intended to withdraw fluid from
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2544-2024·2024-08-21

    Beckman Coulter DxI 9000 Access analyzer software causes delayed test results

    Beckman Coulter has recalled 183 DxI 9000 Access analyzers due to a software issue that causes delays in test result reporting. When connected to a Laboratory Automation System, software versions 1.17 and below send out-of-sequence messages, potentially delaying patient treatment.

    Product
    Beckman Coulter DxI 9000 Access Immunoassay Analyzer, Catalog #C11137.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2558-2024·2024-08-21

    Merit Medical Convenience Kits with Recalled Syringes Pose Quality Risks

    Merit Medical is recalling convenience kits containing syringes with quality defects including leaks and breakage that may pose patient safety risks in cardiac and vascular procedures.

    Product
    Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Custom Procedure Kit (Angiography/angioplasty kit), REF: K12T-10773 K12T-09284D K12T-10621 K12T-10800 K12T-12491 To support various vascular or cardiac dia
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2562-2024·2024-08-21

    Merit Medical Convenience Kits with Defective Syringes Recalled

    Merit Medical convenience kits containing plastic syringes are recalled due to leaks, breakage, and quality issues that may pose risks to patients undergoing cardiac and vascular procedures.

    Product
    Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K04 (Custom Syringe Kit), REF: K05-00203M K05-00511J K05-00547J K05-00612Q K05-00819A K05-01030H K05-01274D K05-01646 K05-01688A K05-01717B K05-01880K
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2618-2024·2024-08-21

    Aurora 7 Surgical Light Heads Recalled for Cracked Weld Frames

    DKK Dai-Ichi Shomei is recalling 555 Aurora 7 surgical light heads because frame welds can crack, causing the frame to sag, the housing to crack, or the light head to detach.

    Product
    Aurora Series, Aurora 7 lighthead; Models: LED7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2620-2024·2024-08-21

    Surgical light heads may detach due to weld defects

    DKK Dai-Ichi Shomei is recalling 293 Aurora surgical light heads because the frame welds can crack, potentially causing the light head to detach during use. No injuries have been reported.

    Product
    Aurora 3 Series, Aurora 7 lighthead; Models: AUT7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.
    Category
    Medical Device
    Distribution
    Distributed nationwide