STERIS Boot Assembly, Traction Device Recalled Due to Locking Pin Detachment Risk
Baxter Healthcare is recalling STERIS Boot Assembly traction devices due to an incorrectly oriented locking pin that may cause the boot to detach during surgery, posing patient safety risks.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II device with structural defect that could cause patient harm during surgery. No illnesses, injuries, or hospitalizations have been reported. Per rubric, risk-of-harm products without reported injury qualify as High severity (score 3).
Plain-English summary
Baxter Healthcare Corporation is recalling the STERIS Boot Assembly, Traction Device, OT 1000 (Part Number REF 10009192). The device is a traction mechanism used during surgical procedures.
A customer reported that an incorrectly oriented locking pin caused the boot to detach from the traction system. If the affected device is used during surgery, the boot may detach from the traction system, potentially causing patient harm and delaying surgical procedures.
Affected product includes lot numbers 23-140, 23-268, and 23-314 (UDI/DI 00615521000851). The recalled units were distributed nationwide with presence in Alabama.
Healthcare facilities should verify whether they have any of the affected lot numbers in use and contact Baxter Healthcare Corporation immediately with any questions.
The recalled product
- Product
- STERIS Boot Assembly, Traction Device, OT 1000, Part Number REF 10009192
- Manufacturer
- Baxter Healthcare Corporation
- Affected units
- 14
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- UDI/DI 00615521000851
- Lot Numbers: 23-140
- 23-268
- 23-314
Distribution
Related recalls
Same manufacturer · Baxter Healthcare Corporation
See all →- HighBaxter Recalls Likorall Overhead Lifts Due to Motor Shaft Breakage Risk
FDA (Devices) · 2026-10-21
- ModerateBaxter Recalls Two VOLARA Systems Due to Potential Flow Rate Inaccuracy
FDA (Devices) · 2026-09-30
- ModerateBaxter Recalls PRO+ MRS Mattress Due to UDI Labeling Error
FDA (Devices) · 2026-09-30
- ModerateBaxter PRO+ 36-inch Mattress Recalled for UDI Labeling Error
FDA (Devices) · 2026-09-30
- ModerateBaxter PRO+ Mattress Recalled for UDI Labeling Error
FDA (Devices) · 2026-09-30
Same hazard · equipment defect
See all →- SeverePhilips Allura Centron patient table mattress defect poses fall risk
FDA (Devices) · 2025-02-26
- HighMEDLINE Surgical Convenience Kits Recalled Due to Defective Smoke Evacuation Equipment
FDA (Devices) · 2024-12-11
- HighSurgical instrument kits recalled due to loose metal flakes
FDA (Devices) · 2024-11-20
- HighMedline Medical Convenience Kits With Defective Syringes Recalled Worldwide
FDA (Devices) · 2024-09-18
- HighMerit Medical Convenience Kits with Recalled Syringes Pose Leak Risk
FDA (Devices) · 2024-08-21
Similar recalls
- HighHip Traction Boot Assembly Defect Could Cause Device Detachment
FDA (Devices) · 2024-03-27
- HighAllen Medical Systems Recalls Traction Boots Due to Assembly Defect
FDA (Devices) · 2013-03-27
- HighSteris Recalls Fine Traction Devices Due to Bearing Defect
FDA (Devices) · 2013-07-31
- SevereSteris Recalls OT1000 Series Orthopedic Surgical Tables Due to Pivot Pin Issue
FDA (Devices) · 2016-07-27
- SevereSteris Recalls OT1000 Series Orthopedic Surgical Tables Due to Bond Separation
FDA (Devices) · 2021-03-03
- SevereSynthes Sternal Zip Flex System Recalled for Implant Cutting Risk
FDA (Devices) · 2013-11-06