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.

301–325 of 450

  • HighFDA (Devices)·Z-0086-2019·2018-10-17

    OrthoSensor VERASENSE Sensors Recalled Due to Post-Surgical Fluid Presence

    Orthosensor, Inc. is recalling 84 VERASENSE sensors for Zimmer Biomet Persona CR G-H/7-12 Left because fluid was reported inside the posterior lateral corner post-surgery.

    Product
    OrthoSensor VERASENSE for Zimmer Biomet Persona CR G-H/7-12 Left, REF ZBH-PSNCRGH712-L.
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-0093-2019·2018-10-17

    NeoMed Enteral Feeding Tubes Recalled for Tethered Plug Defect

    Neomed Inc is recalling NeoMed Enteral Feeding Tubes because the tethered plug may inadvertently open after closure, potentially compromising the device's seal.

    Product
    NeoMed Enteral Feeding Tubes with Enteral Only Connectors, French sizes 4.0Fr, 5.0Fr, 6.5Fr, 8.0Fr, and lengths 40cm, 60cm, 90cm. The product consists of a polyurethane feeding tube with an attached hub and tethered plug to close the hub when the feeding tube is not in use. P
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0082-2019·2018-10-17

    OrthoSensor VERASENSE Sensors Recalled Due to Fluid Inside Posterior Lateral Corner

    Orthosensor, Inc. is recalling 41 VERASENSE sensors for Zimmer Biomet Persona CR E-F/3-11 Left knees because fluid was reported inside the posterior lateral corner after surgery.

    Product
    OrthoSensor VERASENSE for Zimmer Biomet Persona CR E-F/3-11 Left, REF ZBH-PSNCREF311-L.
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-0084-2019·2018-10-17

    OrthoSensor VERASENSE Sensors Recalled Due to Post-Surgical Fluid Presence

    Orthosensor, Inc. is recalling 56 VERASENSE sensors for Zimmer Biomet Persona CR C-D/3-9 Left because some were reported to have fluid inside the posterior lateral corner post-surgery.

    Product
    OrthoSensor VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Left, REF ZBH-PSNCRCD39-L.
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-3020-2018·2018-09-19

    Stryker Wingspan Stent System Recalled for Coating Damage

    Stryker Neurovascular is recalling Wingspan Stent Systems because use-related coating damage was reported on the delivery catheter shafts.

    Product
    Wingspan Stent System, Rx Only, Sterile EO, Catalog #: M003WE0250090, M003WE0300090, M003WE0350090, M003WE0400090, M003WE0450090, M003WE0250150, M003WE0300150, M003WE0350150, M003WE0400150, M003WE0450150, M003WE0250200, M003WE0300200, M003WE0350200, M003WE0400200, M003WE0450200
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2925-2018·2018-09-05

    Stryker Mako Vizadisc Hip Procedure Tracking Kit Recall for Detection Failure

    Mako Surgical Corporation is recalling specific lots of the Stryker Mako Vizadisc Hip Procedure Tracking Kit because damaged reflective material may prevent camera detection.

    Product
    Stryker Mako Vizadisc Hip Procedure Tracking Kit
    Category
    Medical Device
    Distribution
    35 states
  • HighFDA (Devices)·Z-2947-2018·2018-09-05

    Civco Needle Guide Recall Due to Missing or Inadequate Adhesive

    Civco Medical Instruments is recalling 3 units of CIVCO Needle Guides because missing or inadequate adhesive may fail to hold the cannula in place.

    Product
    CIVCO Needle Guide, REF 676-150, QTY 24, STERILE EO
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2513-2018·2018-07-25

    Medtronic Tri-Staple 2.0 Reloads Recalled for Missing Sled Component

    Medtronic is recalling Tri-Staple 2.0 Intelligent Reloads because a missing sled component may prevent staple formation, leading to bleeding or leakage.

    Product
    Tri-Staple 2.0 Intelligent Reload for use with Signia stapling system 30 mm Medium/Thick, Item Code SIG30AMT
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2347-2018·2018-07-11

    FHC Depth Stop Adapter Recalled for Potential Lead Damage

    FHC, Inc. is recalling the microTargeting Drive System because the Depth Stop Adapter may damage implanted leads if over-tightened, potentially requiring replacement.

    Product
    microTargeting" Drive System, Product Number 66-ZD-MD
    Category
    Medical Device
    Distribution
    46 states
  • SevereFDA (Devices)·Z-2349-2018·2018-07-11

    FHC Depth Stop Adapter Recalled for Potential Lead Damage

    FHC, Inc. is recalling the microTargeting STar Drive System (Manual) because the Depth Stop Adapter may damage the lead and stylet if the screw is over-tightened.

    Product
    microTargeting" STar" Drive System (Manual), Product Number ST-DS-MA
    Category
    Medical Device
    Distribution
    46 states
  • HighFDA (Devices)·Z-2357-2018·2018-07-11

    FHC Depth Stop Adapter Recall for Lead Damage Risk

    FHC, Inc. is recalling the microTargeting STar Drive System (Manual) because the Depth Stop Adapter can damage implanted leads if over-tightened, requiring replacement.

    Product
    microTargeting" STar" Drive System (Manual) Distributed by Medtronic, Product Number FC8001
    Category
    Medical Device
    Distribution
    46 states
  • HighFDA (Devices)·Z-2365-2018·2018-07-11

    Zimmer Biomet Recalls 24 Hip Prosthesis Units Distributed to Japan

    Zimmer Biomet is voluntarily recalling 24 hip prosthesis units distributed solely to Japan. The recall was initiated in May 2018 and terminated in May 2020.

    Product
    Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size 10; 00-7713-010-00
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1823-2018·2018-05-23

    Medtronic Endo GIA Vascular Reloads Recalled for Missing Sled Component

    Medtronic is recalling specific Endo GIA vascular reloads because a missing sled component may prevent staple formation, potentially causing bleeding or leakage.

    Product
    Endo GIA" 45mm Gray Curved Tip Articulating Vascular Reload with Tri-Staple" Technology( Item Code EGIA45CTAV) Product Usage: The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows of titanium staples and simultaneously divides the tissue
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1833-2018·2018-05-23

    Medtronic Endo GIA Universal Stapler Kits Recalled for Missing Sled Component

    Medtronic is recalling Endo GIA Universal stapler kits because a missing sled component may prevent staple formation, risking bleeding or leakage.

    Product
    BOX KIT00714 KIT SLEEVE Product Usage: The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows of titanium staples and simultaneously divides the tissue between the two, triple-staggered rows. The size of the staples is determined by the s
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1876-2018·2018-05-23

    Nipro Blood Tubing Set Recalled Due to Potential Heparin Line Occlusion

    Nipro Medical Corporation is recalling specific blood tubing sets used in hemodialysis because the heparin line may be occluded.

    Product
    Nipro Blood Tubing set with Priming Set and Transducer Protectors. Each device is packaged in a film pouch with 24 lines per case. The Nipro¿ Set - Blood Tubing Set with Transducer Protector and Priming Set are disposable bloodlines intended to provide extracorporeal access
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-1818-2018·2018-05-23

    Medtronic Endo GIA Stapler Loading Units Recalled for Missing Sled Component

    Medtronic is recalling 171,271 Endo GIA Auto Suture Universal Articulating Loading Units because a missing sled component may prevent staple formation, leading to bleeding or leakage.

    Product
    Endo GIA" Auto Suture" Universal Articulating Loading Unit 45mm- 3.5mm( Item Code 030455) Product Usage: The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows of titanium staples and simultaneously divides the tissue between the two, tr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1709-2018·2018-05-16

    Datascope recalls BEQ-TOP 5210 ECC Set custom tubing kits

    Datascope is recalling 18 custom tubing kits because a seal defect may cause balloon collapse, increasing resistance to flow in the venous line.

    Product
    BEQ-TOP 5210 ECC Set - Respiratory, Custom Tubing Kit, Catalog No. 701055604R01
    Category
    Medical Device
    Distribution
    13 states
  • SevereFDA (Devices)·Z-1707-2018·2018-05-16

    Datascope recalls Better Bladder device in custom tubing kits

    Datascope is recalling the Better Bladder device in some custom tubing kits because seal separation may cause the balloon to collapse, potentially reducing blood flow in ECMO circuits.

    Product
    Small Patient ECC Pack BEQ-TOP 22301, Catalog No. 701049513
    Category
    Medical Device
    Distribution
    13 states
  • HighFDA (Devices)·Z-1624-2018·2018-05-16

    Boston Scientific Recalls Pinnacle Anterior Apical Pelvic Floor Repair Kits

    Boston Scientific is voluntarily recalling 34 Pinnacle Anterior Apical pelvic floor repair kits due to a Class II safety concern. The devices were distributed worldwide.

    Product
    PFR Kit- Pinnacle, Anterior Apical; Model #M0068317100. Indicated for tissue reinforcement in women with pelvic organ prolapse.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1546-2018·2018-05-09

    Medi-Vac Suction Canister Liners Recalled for Missing Valve

    Cardinal Health is recalling 3,600 Medi-Vac Flex Advantage Suction Canister Liners distributed in Massachusetts because they may be missing a one-way valve.

    Product
    Medi-Vac(TM) Flex Advantage(TM) Suction Canister Liner, Material Numbers: a) REF 6561-910C b) REF 6561-916K c) REF 6561-920C To remove blood and/or body fluids. These fluids may be suctioned during surgical procedures or other applications requiring the removal of built up
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1094-2018·2018-03-28

    Centurion Infant IV Securement Kit Recalled by FDA

    Centurion Medical Products Corporation is recalling Infant IV Securement Kits due to a Class II FDA recall. The kits are used to assist with IV placement and securement.

    Product
    INFANT IV SECUREMENT KIT
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0993-2018·2018-03-21

    Zimmer Biomet Recalls Juggerknot 2.9mm Suture Anchors for Hip Arthroplasty

    Zimmer Biomet is recalling 50 units of Juggerknot 2.9mm suture anchors used in hip arthroplasty. The recall is limited to the state of Texas.

    Product
    JUGGERKNOT 2.9MM 2 #2 MB Product Usage: For use in hip arthroplasty
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0830-2018·2018-03-07

    Cook Inc. Recalls Percutaneous Gastrostomy Sets Due to Wire Guide Defect

    Cook Inc. is recalling 615 units of Mallinckrodt Institute Percutaneous Gastrostomy Sets because wire guides may be loaded backwards into the holder.

    Product
    Mallinckrodt Institute Percutaneous Gastrostomy Set Product Usage: Intended for the percutaneous placement of a catheter for gastroenteric feeding
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0809-2018·2018-03-07

    Aesculap proSA Tool Set Recalled for Incorrect Valve Pressure Adjustment

    Aesculap Implant Systems LLC is recalling proSA Tool Sets because the adjusting pin does not set the correct valve opening pressure for the shunt system.

    Product
    proSA Tool Set used to adjust and verify the proSA Adjustable Shunt System Shunt, central nervous system and components
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0504-2018·2018-02-07

    Beaver Optimum Safety Sideport Knife Recalled Due to Retracted Shield

    Beaver-Visitec is recalling 526,220 units of Optimum Safety Sideport Knives because the protective shield retracted, exposing the blade.

    Product
    bvi Beaver Optimum Safety Sideport Knife: (a) Straight 15o, REF 378235 (b) Straight 22.5o, REF 378236 (c) Straight 30o, REF 378237 (d) Straight 45o, REF 378238 Product Usage: Specialty blades and knives are used for stab and cut incisions in ophthalmic, ENT and other
    Category
    Medical Device
    Distribution
    Distributed nationwide