Decompression Table Model E9011 Recalled for Structural Frame Defect
Pivotal Health Solutions is recalling 32 Decompression Table Model E9011 devices due to potentially insufficient rework on a lumbar frame part. The defect affects units distributed to CA, FL, TX, ID, GA, and TN.
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 recall involving a structural defect on a medical device that applies physical forces. No illnesses or injuries have been reported. The theoretical risk of frame failure during treatment warrants High severity per the rubric criterion for risk-of-harm products without reported injury.
Plain-English summary
Pivotal Health Solutions, Inc. is recalling 32 Decompression Table Model E9011 units that have been distributed due to a manufacturing defect. The device applies cervical and lumbar decompression therapy with practitioner-adjustable treatment settings.
The recall was initiated because of potentially insufficient rework on part E7130-B in the lumbar section of the device frame. Four additional units with the faulty part were manufactured but not yet distributed and are also being recalled.
The affected units were distributed to chiropractic offices and healthcare facilities in California, Florida, Texas, Idaho, Georgia, and Tennessee. If you own or operate one of these devices, contact Pivotal Health Solutions, Inc. immediately to report the serial number and receive instructions for service or replacement.
The recalled product
- Product
- Decompression Table Model E9011. This device applies cervical and/or lumbar decompression with practitioner definable target treatment location, treatment pounds, and patterns of treatment.
- Manufacturer
- Pivotal Health Solutions, Inc.
- Affected units
- 32
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 (20)
- UDI-DI 00850008449826
- Model Number: E9011
- Serial Numbers: WTN-DOC03132457209 WTN-DOC-3132457210
- WTN-DOC03132457235
- WTN-DOC03132457237
- WTN-DOC03132457238
- WTN-DOC03132457239 Expanded Recall serial numbers: WTN-DOC04262458492
- WTN-DOC04262458490
- WTN-DOC04262458487
- WTN-DOC04262458488
- WTN-DOC04262458489
- WTN-DOC0332457239
- WTN-DOC04082457899
- WTN-DOC04262458484
- WTN-DOC03132457210
- WTN-DOC04082457897
- WTN-DOC04082457898
- WTN-DOC03132457201
- WTN-DOC04192458307
- WTN-DOC04082457896
Distribution
Related recalls
Same manufacturer · Pivotal Health Solutions, Inc.
See all →- HighHeated massage tables recalled over heat components that can smolder
FDA (Devices) · 2025-12-03
- HighQ400 massage tables recalled over heat components that can overheat
FDA (Devices) · 2025-12-03
Same hazard · structural defect
See all →- SevereThomas Built School Buses Recalled for Weak Body Joints
NHTSA · 2026-10-22
- SevereGM Recalls 2026 Chevrolet Traverse and GMC Acadia for Seat Weld Defect
NHTSA · 2026-10-21
- SevereToyota Recalls Sienna Hybrid Vehicles Due to Second-Row Seat Back Defect
NHTSA · 2026-10-20
- SevereSubaru Recalls 2026 Forester and Crosstrek for Ball Joint Defect
NHTSA · 2026-10-19
- SevereVolvo Recalls 2025-2026 VNL Trucks for Loose Structural Bolts
NHTSA · 2026-10-15
Similar recalls
- HighDePuy Synthes LCP Plate Recall Due to Dimensional Tolerance Issues
FDA (Devices) · 2020-08-26
- HighDePuy ReClaim Reamer Extension Recalled Due to Broken Tabs
FDA (Devices) · 2013-03-27
- HighDePuy Universal Femoral Sleeves Recalled for Taper Dimension Issues
FDA (Devices) · 2021-02-17
- HighDePuy Orthopaedics Recalls RECLAIM Distal Reamer Extension Devices
FDA (Devices) · 2014-10-15
- ModerateDePuy P.F.C. SIGMA Revision Knee Distal Augment Recall
FDA (Devices) · 2018-09-05
- SevereDePuy LPS Diaphyseal Sleeves Recalled for Potential Taper Fracture
FDA (Devices) · 2013-02-27