Hazard

Insulation Defect recalls

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

What the numbers show

Total: 11
Critical: 0
Severe: 0
Most recent: 2025-06-11

Of the 11 insulation defect recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all insulation 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.

1–11 of 11

HighFDA (Devices)·Z-1897-2025·2025-06-11
Signature Laparoscopic Bullet Tip Grasper Instrument Insulation Defect Recall
Silex Medical is recalling 6 units of the Signature Laparoscopic Bullet Tip Grasper with Rotating Shaft due to incomplete insulation on the shaft near the rotator wheel, which could expose users to electrical hazards.
Product
Signature Laparoscopic Instruments, Bullet Tip Grasper with Rotating Shaft and Monopolar Electrosurgical Footswitch Connector. Model/REF Number: 5863030.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1899-2025·2025-06-11
Signature Laparoscopic Atraumatic Grasper Instrument Insulation Defect Recall
Silex Medical is recalling Signature Laparoscopic Atraumatic Grasper instruments (Model 5864000) due to incomplete insulation on the shaft that leaves an exposed area near the rotator wheel, posing an electrical safety risk during surgical use.
Product
Signature Laparoscopic Instruments, Atraumatic Grasper with Rotating Shaft and Monopolar Electrosurgical Footswitch Connector. Model/REF Number: 5864000.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1893-2025·2025-06-11
Signature Laparoscopic Dolphin Nose Grasper Instrument Insulation Defect
Silex Medical is recalling 2 units of a Signature Laparoscopic Instruments Dolphin Nose Grasper with Rotating Shaft due to incomplete insulation on the shaft, leaving an exposed area near the rotator wheel.
Product
Signature Laparoscopic Instruments, Dolphin Nose Grasper with Rotating Shaft and Monopolar Electrosurgical Footswitch Connector. Model/REF Number: 5860020.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1898-2025·2025-06-11
Signature Laparoscopic Alligator Grasper Instrument Recall Safety Issue
Silex Medical is recalling the Signature Laparoscopic Alligator Grasper with Rotating Shaft (Model 5863050) because insulation on the tube does not fully extend to the proximal end of the shaft, leaving an exposed uninsulated area near the rotator wheel.
Product
Signature Laparoscopic Instruments, Alligator Grasper with Rotating Shaft and Monopolar Electrosurgical Footswitch Connector. Model/REF Number: 5863050.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1896-2025·2025-06-11
Signature Laparoscopic Sharp Tooth Grasper Insulation Defect Recall
Silex Medical recalls the Signature Laparoscopic Sharp Tooth Grasper due to incomplete insulation on the shaft near the rotator wheel, which creates an electrical hazard during use.
Product
Signature Laparoscopic Instruments, Sharp Tooth Grasper with Rotating Shaft and Monopolar Electrosurgical Footswitch Connector. Model/REF Number: 5863020.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1894-2025·2025-06-11
Signature Laparoscopic Allis Clamp Grasper with Rotating Shaft Recalled
Silex Medical is recalling the Signature Laparoscopic Instruments Allis Clamp Grasper due to incomplete insulation on the shaft, leaving an exposed area that could pose an electrical hazard during surgical procedures.
Product
Signature Laparoscopic Instruments, Allis Clamp Grasper with Rotating Shaft and Monopolar Electrosurgical Footswitch Connector. Model/REF Number: 5862030.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1900-2025·2025-06-11
Signature Laparoscopic Atraumatic Grasper Insulation Defect Recall
Silex Medical is recalling Signature Laparoscopic Instruments (Model 5881033) because insulation on the shaft does not fully extend to the proximal end, leaving an exposed area near the rotator wheel.
Product
Signature Laparoscopic Instruments, 20mm Atraumatic Grasper with Rotating Shaft and Monopolar Electrosurgical Footswitch Connector. Model/REF Number: 5881033.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1895-2025·2025-06-11
Signature Laparoscopic Debakey Grasper Instruments Recalled for Insulation Defect
Silex Medical is recalling 8 units of Signature Laparoscopic Debakey Grasper instruments (Model 5862100) due to incomplete insulation on the shaft near the rotator wheel, which could expose the user or patient to electrical contact.
Product
Signature Laparoscopic Instruments, Debakey Grasper with Rotating Shaft and Monopolar Electrosurgical Footswitch Connector. Model/REF Number: 5862100.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1882-2024·2024-05-29
Cascade IOMAX Cortical Module recalled for potential electrical shock hazard
Cadwell Industries is recalling the Cascade IOMAX Cortical Module because an incorrectly installed insulator could cause electrical arcing and potential patient shock.
Product
Cascade IOMAX Cortical Module, REF: 190296-200
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1509-2024·2024-04-17
Medical Device Recall: Blood Pressure Monitors With Defective Power Cord Insulation
Baxter Healthcare is recalling Connex ProBP 3400 blood pressure monitors due to power cord insulation defects that fail to meet electrical safety standards. Approximately 11,154 units are affected globally.
Product
Hillrom Welch Allyn Connex ProBP 3400 Digital Blood Pressure Device, marketed under the following models: a) PROBP 3400, SUREBP, BLUETOOTH, MOBILE,EU, Product Code 34BFST-2; b) PROBP 3400, SUREBP, BLUETOOTH, MOBILE,UK, Product Code 34BFST-4; c) PROBP 3400, SUREBP, BLUETOOT
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-0605-2024·2023-12-27
Venous probe connection cable defects in Cardiohelp-i extracorporeal support systems
Maquet Medical Systems USA is recalling venous probe connection cables for the Cardiohelp-i System due to insulation and wire breaks. Defective cables may prevent the system from receiving critical blood flow and temperature information.
Product
Venous probe connection cable (REF 701069333 and 701048804) used with the Cardiohelp-i System, part numbers 701072780 and 701041802
Category
Medical Device
Distribution
Distributed nationwide