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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4301–4325 of 39968

  • 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-1417-2025·2025-04-02

    Baxter TruSystem 7500 Hybrid software issue disables upper back adjustment

    Baxter TruSystem 7500 Hybrid affected by software issue that prevents the upper back section from being operable or adjustable when emergency mode is enabled. Affects 10 units distributed nationwide.

    Product
    Baxter TruSystem 7500 Hybrid (FC), Product Code 1854085
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1416-2025·2025-04-02

    Baxter TruSystem 7500 Hybrid medical device software defect in emergency mode

    Baxter is recalling 2 units of TruSystem 7500 Hybrid (MC) due to a software issue that disables the upper back section adjustment when emergency mode is activated.

    Product
    Baxter TruSystem 7500 Hybrid (MC), Product Code 1773204
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1420-2025·2025-04-02

    Baxter TruSystem 7500 Hybrid Plus software issue affects emergency mode operation

    Baxter is recalling 48 TruSystem 7500 Hybrid Plus units due to a software issue that prevents the upper back section from being adjusted when emergency mode is enabled.

    Product
    Baxter TruSystem 7500 Hybrid Plus (SC), Product Code 1854088
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1461-2025·2025-04-02

    Medline Procedure Kits Recalled for Syringe Leaks and Breakage

    Medline Industries is recalling 2,161 medical procedure kits containing plastic syringes with leaks and breakage issues. The affected syringes pose a potential risk to patient health and are distributed in the US and Canada.

    Product
    Medline procedure kits labeled as: 1) BILLINGS CLINIC SC HEAD & NECK, Pack Number DYNJ33656C; 2) BLEPH/RHINO PACK, Pack Number DYNJ64669A; 3) DB ENT CSTM PACK-LF, Pack Number DYNJ33585C; 4) DENTAL PACK, Pack Number DYNJ54064; 5) EAR PACK, Pack Number DYNJ68678C; 6) EN
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1435-2025·2025-04-02

    Medline procedure kits with plastic syringes recalled for leaks and breakage

    Medline procedure kits containing plastic syringes are recalled for leaks, breakage, and other quality defects identified in an FDA Safety Alert. The recall affects 340 units distributed nationwide in the US and Canada.

    Product
    Medline procedure kits labeled as: 1) BILATERAL FACET TRAY, Pack Number DYNJRA0869A; 2) PAIN MANAGEMENT TRAY-LF, Pack Number DYNJRA1749
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1423-2025·2025-04-02

    Baxter NovumIQ Syringe Infusion Pumps Recalled for Gasket Defect Risk

    Baxter Healthcare is recalling 149 NovumIQ syringe infusion pumps with incorrectly installed gaskets that could allow fluid ingress during cleaning or after IV fluid spills.

    Product
    Baxter NovumIQ Syringe INFUSION SYSTEM , REF 40800BAXUS
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1437-2025·2025-04-02

    Medline Procedure Kits Recalled Due to Defective Plastic Syringe Quality Issues

    Medline is recalling 9,246 units of medical procedure kits containing defective plastic syringes with leaks and breakage that may pose a risk to patient health. The kits were distributed nationwide in the US and in Canada.

    Product
    Medline procedure kits labeled as: 1) ANGIO DRAPE PACK (DRLUL)-LF, Pack Number DYNJ47718D; 2) ANGIO PACK, Pack Number DYNJ69678; 3) ANGIOGRAPHY CV RAD PACK, Pack Number DYNJ64936A; 4) ANGIOGRAPHY DRAPE PACK, Pack Number DYNJ49621C; 5) ANGIOGRAPHY PACK, Pack Number DYNJ
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1409-2025·2025-04-02

    Baxter Operating Table Column Software Issue Limits Emergency Mode Function

    Baxter Healthcare is recalling 403 TS7500 MOBIUS operating table columns due to a software issue that prevents the upper back section from being adjustable when emergency mode is activated.

    Product
    Baxter Operating table column TS7500 MOBIUS, Product Code 1704695
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1413-2025·2025-04-02

    Baxter Mobile column TruSystem 7500 U emergency mode software issue affects back adjustment

    A software issue in the Baxter Mobile column TruSystem 7500 U prevents the upper back section from being operable or adjustable when emergency mode is enabled. Approximately 40 units distributed nationwide are affected.

    Product
    Baxter Mobile column TruSystem 7500 U, Product Code 1730720
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1442-2025·2025-04-02

    Medline General Endoscopy Procedure Kit Recalled Due to Syringe Defects

    Medline is recalling General Endoscopy procedure kits due to plastic syringe defects that may leak or break. The affected kits pose potential risk to patient health during medical procedures.

    Product
    Medline procedure kits labeled as: 1) GENERAL ENDOSCOPY PACK, Pack Number DYNJ44673G
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1444-2025·2025-04-02

    Medline surgical procedure kits recalled for syringe leaks and breakage

    Medline procedure kits containing plastic syringes are recalled due to identified leaks, breakage, and quality issues that may pose a risk to patient health. The affected kits were distributed nationwide in the US and Canada.

    Product
    Medline procedure kits labeled as: 1) A & A KNEE PACK-LF, Pack Number DYNJHS0136D; 2) ABD CLOSURE PACK, Pack Number DYNJ56987B; 3) ADULT PERC PACK-LF, Pack Number PHS170994005A; 4) BASIC PACK, Pack Number DYNJ54836B; 5) BASIC PACK, Pack Number DYNJ58678A; 6) BASIC PACK, Pa
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1433-2025·2025-04-02

    NexGen LPS Flex knee prosthesis recalled for labeling inconsistency

    Zimmer recalls 76 NexGen LPS Flex knee prosthesis units due to conflicting plate compatibility information on the product label.

    Product
    NexGen LPS Flex, Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis, Model Number 00-5962-042-10
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1434-2025·2025-04-02

    Prelude IDEAL 4F Hydrophilic Sheath Introducer contains incorrect 5F dilators

    Merit Medical Systems is recalling Prelude IDEAL 4F Hydrophilic Sheath Introducer units (Lot H3082668) that contain 5F dilators instead of the labeled 4F dilators, which may result in procedure delay.

    Product
    Prelude IDEAL 4 F Hydrophilic Sheath Introducer, REF: PID4F16021PW/D
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1412-2025·2025-04-02

    Baxter Mobile Column TruSystem 7500 Software Defect Prevents Back Adjustment

    Baxter Healthcare is recalling the Mobile column TruSystem 7500 due to a software issue that prevents the upper back section from being adjusted when emergency mode is enabled. Approximately 1,596 units distributed nationwide are affected.

    Product
    Baxter Mobile column TruSystem 7500, Product Code 1717023
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1432-2025·2025-04-02

    Orthofix Pillar SA Ti Spacer System Mislabeled for Anterior Height

    Orthofix is recalling Pillar SA Ti Spacer System spinal implants because the product label lists an incorrect anterior height of 10mm, while the actual device measures 10.5mm. This labeling discrepancy could affect surgical planning during implantation.

    Product
    Orthofix Pillar SA Ti Spacer System Intervertebral Body Fusion Spinal Device, sterile, implant grade titanium alloy: (1) REF 82-3300SP, 33mm W x 24mm D x 10mm H, 7 degrees; (2) REF 82-3700SP, 37mm W x 28mm D x 10mm H, 7 degrees; and (3) REF 82-4000SP, 40mm W x 32mm D x 10mm
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1280-2025·2025-03-26

    Smiths Medical ProPort Implantable Port Housing May Separate Due to Manufacturing Defect

    Smiths Medical is recalling 9,506 ProPort implantable venous access ports due to a manufacturing defect that may cause the port housing and reservoir to separate. No injuries have been reported.

    Product
    smiths medical ProPort Plastic Venous Access System, PolyFlow Polyurethane Catheter, 1.9mm (5.8Fr) O.D. x 1.0mm I.D., 6Fr Introducer, REF 21-4153-24
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1278-2025·2025-03-26

    Smiths Medical ProPort Implantable Venous Ports Recalled for Separation Defect

    Smiths Medical has recalled 643 ProPort Plastic implantable venous access ports that may separate due to a manufacturing defect. The recall affects units distributed worldwide.

    Product
    smiths medical ProPort Plastic Venous Access System, Silicone Catheter, 2.8mm (8.4Fr) O.D. x 1.0mm I.D., 9 Fr Introducer, REF 21-4151-24
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1287-2025·2025-03-26

    Smiths Medical ProPort Venous Ports Recalled for Potential Housing Separation

    Smiths Medical is recalling ProPort Low Profile Plastic Venous Access Systems because the plastic port housing and reservoir may separate due to a manufacturing defect. Approximately 8,515 units worldwide are affected.

    Product
    smiths medical ProPort Low Profile Plastic Venous Access System, PolyFlow Polyurethane Catheter, 1.9mm (5.8Fr) O.D. x 1.0mm., 6Fr Introducer, REF 21-4183-24
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1277-2025·2025-03-26

    Smiths Medical ProPort Plastic Venous Access System Recalled

    Smiths Medical is recalling the ProPort Plastic Venous Access System due to a manufacturing defect that may cause the plastic port housing and reservoir to separate.

    Product
    smiths medical ProPort Plastic Venous Access System, Silicone Catheter, 2.87,,O.D. (8.4Fr) s 1.0mm I.D., REF 21-4150-24
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1283-2025·2025-03-26

    Smiths Medical ProPort Plastic Implantable Ports Recalled for Port Housing Separation

    Smiths Medical is recalling 1961 units of ProPort Plastic Implantable Ports worldwide due to a manufacturing defect that may cause the port housing and reservoir to separate. This Class I recall affects patients dependent on venous access systems.

    Product
    smiths medical ProPort Plastic Venous Access System, PolyFlow Catheter, 2.6 (7.8Fr) O.D. x 1.6mm I.D., 8.5Fr Introducer, REF 21-4171-24
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1286-2025·2025-03-26

    Smiths Medical ProPort Implantable Port May Separate Due to Manufacturing Defect

    Smiths Medical is recalling ProPort Plastic Venous Access Ports because the port housing and reservoir may separate due to a manufacturing defect. Contact your physician if you have an affected device.

    Product
    smiths medical ProPort Plastic Venous Access System, Implantable Venous Access Systems, 82-24
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1284-2025·2025-03-26

    Smiths Medical ProPort Venous Access System Recalled for Port Separation Risk

    Smiths Medical is recalling ProPort Plastic Venous Access Systems due to a manufacturing defect that can cause the port housing and reservoir to separate. This may result in device failure affecting patients worldwide.

    Product
    smiths medical ProPort Plastic Venous Access System, Pre-assembled with PolyFlow Polyurethane Catheter, 2.6mm O.D. (7.8Fr) x 1.6mm I.D., REF 21-4172-24
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1279-2025·2025-03-26

    Smiths Medical ProPort Implantable Port Component Separation Due to Manufacturing Defect

    Smiths Medical is recalling ProPort Plastic implantable port systems because the plastic port housing and port reservoir may separate due to a manufacturing defect. The recall affects 2,311 units distributed worldwide.

    Product
    smiths medical ProPort Plastic Venous Access System, PolyFlow Polyurethane Catheter, 1.9mm O.D. (5.8 Fr) x 1.0mm I.D., REF 21-4152-24
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1288-2025·2025-03-26

    Smiths Medical ProPort Implantable Port Plastic Housing May Separate

    The ProPort Low Profile Plastic Venous Access System is being recalled because the port housing and port reservoir may separate due to a manufacturing defect, affecting approximately 2,236 units distributed worldwide.

    Product
    smiths medical ProPort Low Profile Plastic Venous Access System, Silicone Catheter, 2.8mm (8.4Fr) O.D. x 1.0mm I.D., 9Fr Introducer, REF 21-4187-24
    Category
    Medical Device
    Distribution
    0 states