The Recall Desk

Hazard

Device Defect recalls

450 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
450
Critical
11
Severe
45
Most recent
2026-08-26

Of the 450 device defect recalls we have scored against our rubric, 11 (2%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 45 (10%) are Severe.

Which agencies issued them

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all device defect recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

26–50 of 450

  • HighFDA (Devices)·Z-0191-2026·2025-10-22

    Non-vented IV solution sets recalled from one lot because sets may leak

    Baxter is recalling 1,440 CLEARLINK System non-vented solution sets from one lot because the IV sets may leak.

    Product
    CLEARLINK SYSTEM Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves, 10 drops/mL, 100-inch (2.5 meters), Product Code 2C8425
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0202-2026·2025-10-22

    Three valve solution sets recalled from one lot because sets may leak

    Baxter is recalling 12,720 CLEARLINK System Continu-Flo solution sets with three luer activated valves from one lot because the IV sets may leak.

    Product
    CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, three CLEARLINK Luer Activated Valves, Backcheck Valve, 10 drops/mL, 120-inch (3.0 meters), Non-DEHP, Product Code 2R8537
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0189-2026·2025-10-22

    Stopcock extension solution sets recalled from two lots because sets may leak

    Baxter is recalling 49,200 Continu-Flo solution sets with a 4-way stopcock extension set because the IV sets may leak.

    Product
    CONTINU-FLO Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves, Backcheck Valve, Plus 4-Way Stopcock Extension Set with two CLEARLINK Luer Activated Valve, Pfoduct code 2C6255
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0197-2026·2025-10-22

    Forty four inch extension sets recalled because the IV sets may leak

    Baxter is recalling 15,552 CLEARLINK System 44-inch straight-type extension sets from one lot because the IV sets may leak.

    Product
    CLEARLINK SYSTEM EXTENSION SET, Straight-Type Extension Set, Standard Bore, CLEARLINK Luer Activated Valve, Retractable Collar, 44-inch (111 centimeters), Product code 2C8610
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0201-2026·2025-10-22

    Non-DEHP Continu-Flo sets recalled from one lot because sets may leak

    Baxter is recalling 48,096 CLEARLINK System non-DEHP Continu-Flo solution sets from one lot because the IV sets may leak.

    Product
    CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves. 10 drops/mL, 96-inch (2.4 meters). Non-DEHP, Product Code 2R8519
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0195-2026·2025-10-22

    Filtered solution sets recalled from one lot because IV sets may leak

    Baxter is recalling 106,176 CLEARLINK System Continu-Flo solution sets with a 0.2 micron filter from one lot because the IV sets may leak.

    Product
    CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, 0.2 Micron Filter, two CLEARLINK Luer Activated Valves, Backcheck Valve, 10 drops/mL, 104-inch (2.6 meters), Product Code 2C8571
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0203-2026·2025-10-22

    Paclitaxel infusion sets recalled from one lot because IV sets may leak

    Baxter is recalling 27,072 CLEARLINK System Paclitaxel Sets from one lot because the IV sets may leak.

    Product
    CLEARLINK System Paclitaxel Set, Non-Vented with Polyethylene Lined Tubing and CLEARLINK Luer Activated Valve, 0.2 Micron Filter, CLEARLINK Luer Activated Valve, 10 drops/mL, 107-inch (2.7 meters), Product Code 2R8858
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0199-2026·2025-10-22

    Extension IV sets recalled from one lot because the sets may leak

    Baxter is recalling 16,416 CLEARLINK System straight-type extension sets from one lot because the IV sets may leak.

    Product
    CLEARLINK SYSTEM EXTENSION SET, Straight-Type Extension Set, Standard Bore, CLEARLINK Luer Activated Valve, Retractable Collar, 7.9-inch (20 centimeters), Product Code 2C8634
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0192-2026·2025-10-22

    Continu-Flo solution sets recalled across six lots because sets may leak

    Baxter is recalling 473,040 CLEARLINK System Continu-Flo solution sets across six lots because the IV sets may leak.

    Product
    CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves, Backcheck Valve, 10 drops/mL, 112-inch (2.8 meters), Product Code 2C8519
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0200-2026·2025-10-22

    Filtered extension sets recalled across two lots because IV sets may leak

    Baxter is recalling 69,936 CLEARLINK System non-DEHP extension sets with a 1.2 micron filter across two lots because the IV sets may leak.

    Product
    CLEARLINK System Non_DEHP Extenstion Set, Straight-Type Extension Set, Standard Bore, 1.2 Micron Filter, CLEARLINK Luer Activated Valve, 19-inch (47 centimeters), Product Code 2H8603
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0129-2026·2025-10-15

    Shorter 8 French feeding tubes recalled because distal tips may detach

    Applied Medical Technology is recalling 840 NutraGlide 5 F - 8 F x 55 nasal feeding tubes whose distal tips may detach at lower than expected forces.

    Product
    NutraGlide Nasal Feeding Tube with Stylet and ENFit, 5 F - 8 F x 55, REF E NRT-06055-I The NutraGlide Nasal Feeding Tube is a feeding tube placed through the nose and ending in the stomach or intestine used for the administration of nutrition, fluids, and medications in neonatal
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0127-2026·2025-10-15

    Shorter 6 French feeding tubes recalled because distal tips may detach

    Applied Medical Technology is recalling 1,780 NutraGlide 5 F - 6 F x 55 nasal feeding tubes whose distal tips may detach at lower than expected forces.

    Product
    NutraGlide Nasal Feeding Tube with Stylet and ENFit, 5 F - 6 F x 55, REF E NRT-05055-I The NutraGlide Nasal Feeding Tube is a feeding tube placed through the nose and ending in the stomach or intestine used for the administration of nutrition, fluids, and medications in neonatal
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0128-2026·2025-10-15

    Nasal feeding tubes recalled because distal tips may detach too easily

    Applied Medical Technology is recalling 390 NutraGlide nasal feeding tubes whose distal tips may detach at lower than expected forces.

    Product
    NutraGlide Nasal Feeding Tube with Stylet and ENFit, 5 F - 6 F x 90, REF E NRT-05090-I The NutraGlide Nasal Feeding Tube is a feeding tube placed through the nose and ending in the stomach or intestine used for the administration of nutrition, fluids, and medications in neonatal
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0130-2026·2025-10-15

    Larger nasal feeding tubes recalled because distal tips may detach

    Applied Medical Technology is recalling 200 NutraGlide 5 F - 8 F nasal feeding tubes whose distal tips may detach at lower than expected forces.

    Product
    NutraGlide Nasal Feeding Tube with Stylet and ENFit, 5 F - 8 F x 90, REF E NRT-06090-I The NutraGlide Nasal Feeding Tube is a feeding tube placed through the nose and ending in the stomach or intestine used for the administration of nutrition, fluids, and medications in neonatal
    Category
    Medical Device
    Distribution
    2 states
  • CriticalFDA (Devices)·Z-2670-2025·2025-10-08

    Surgical valve pack kits recalled after cannulas may not retain shape

    Medline is recalling 828 VALVE PACK-LF kits because they contain lots of cannula products where the catheter may not retain its shape.

    Product
    Medline Kits: 1) VALVE PACK-LF, Model Number: DYNJ0415366P; 2) VALVE PACK-LF, Model Number: DYNJ0415366Q
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2672-2025·2025-10-08

    Vital sign monitors recalled over blood pressure measurement error messages

    Schiller is recalling 266 Argus PB-3000 vital sign monitors that may trigger an error message during blood pressure measurement when initial inflation pressure is set high.

    Product
    Argus PB-3000, Reference Numbers: 1A.701307,3.921002, 3.921030,3.921031, 3.921006
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2052-2025·2025-07-09

    Philips eL18-4 Ultrasound Transducers Recalled for Defective Refurbishment

    Philips Ultrasound is recalling Philips eL18-4 Transducers because they were refurbished beyond their useful life, which may affect device performance and patient safety.

    Product
    Philips eL18-4 Transducer.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1988-2025·2025-06-25

    Optima Coil System embolization coils recalled for defective radiopaque marker

    BALT USA is recalling the Optima Coil System because the radiopaque marker was not visible during angiography and was not manufactured to specification.

    Product
    Optima Coil System REFs/UDI-DI codes: OPTI0156BLK 00810068568875 OPTI0158BLK 00810068568882 OPTI0103BLK 00810068568851 OPTI0258BLK 00810068568929 OPTI0212BLK 00810068568912 OPTI0206BLK 00810068568905 OPTI0310BLK 00810068568943 OPTI0320BLK 00810068568950 OPTI0151HSS10 008
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1985-2025·2025-06-25

    Surgical Mesh Recalled for Potential Residual Adhesive Material

    Chamberlain Technologies LLC is recalling SURGIMESH XB surgical mesh due to potential residual adhesive material on the mesh surface. The affected product was distributed to Illinois, Nebraska, and California.

    Product
    SURGIMESH XB, Polymeric Surgical Mesh, X-Large Ellipse Barrier Mesh, Model/Catalog Number: Tintra E-3030
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-1992-2025·2025-06-25

    Fresenius 5008X HDF Hemodialysis Blood Tubing Sets recalled for potential blood leaks

    Fresenius Medical Care is recalling 5008X HDF Hemodialysis Blood Tubing Sets due to potential blood leaks between the venous chamber and tubing. The recall affects hemodialysis, hemodiafiltration, hemofiltration, and isolated ultrafiltration procedures nationwide.

    Product
    5008X HDF Hemodialysis Blood Tubing Set, 24 units per case, with the following models: a. 5008X Standard HDF Bloodline, Model Number: 03-5100-7. b. 5008X Standard HDF Bloodline w/CLIC, Model Number: 03-5100-7C. c. 5008X Standard HDF Bloodline w/ Twister, Model Number: 03-5150-
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1787-2025·2025-05-28

    Check-Flo Performer Introducer Medical Device Recall Notice

    Cook Incorporated is recalling Check-Flo Performer Introducer devices because some units from affected lots may contain an incorrectly sized introducer sheath.

    Product
    Check=Flo Performer Introducer, 14.0Fr, Reference Part Number(RPN) REF RCFW-14.0-0-38-30-RB, Order Number (GPN) REF G08957,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1786-2025·2025-05-28

    Check-Flo Performer Introducer medical device recall for incorrect sheath sizing

    Cook Incorporated is recalling Check-Flo Performer Introducer devices (10.0Fr) because affected units may contain an incorrectly sized introducer sheath, which could compromise proper device function.

    Product
    Check=Flo Performer Introducer, 10.0Fr, Reference Part Number(RPN) REF RCFW-10.0-0-38-30-RB, Order Number (GPN) REF G08686,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1720-2025·2025-05-14

    Washer Disinfector Aquadis 56 Model 56A pump seal defect recall

    Getinge Disinfection Ab is recalling Washer Disinfector Aquadis 56 (Model 56A) units due to a frequency inverter programming error that causes the circulation pump to start earlier than expected, leading to accelerated wear on the axial seal.

    Product
    Washer Disinfector Aquadis 56; Model Number: 56A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1644-2025·2025-04-30

    Amplatzer TorqVue LP Catheter Recalled for Shaft Breach Risk

    Abbott is recalling the Amplatzer TorqVue LP Catheter (Model 9-TVLPC4F90/080) due to a potential small breach in the proximal shaft that may not be visible and could lead to prolonged procedures, blood loss, or air embolism.

    Product
    Amplatzer TorqVue LP Catheter (TVLPC), Model no. 9-TVLPC4F90/080
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1457-2025·2025-04-16

    Medline Medical Procedure Kits with Aortic Root Cannula Recalled

    Medline is recalling medical procedure kits containing a Medtronic Aortic Root Cannula due to potential excess material in the male lures on the cannula. The recall affects 468 units distributed across nine US states.

    Product
    Medline medical procedure kits, containing Medtronic Aortic Root Cannula, labeled as follows: TOL DR R PACK
    Category
    Medical Device
    Distribution
    9 states