MedX Holdings Recalls Cervical Extension Machines Due to Missing Safety Tests
MedX Holdings is recalling four cervical extension machines because required safety re-testing was not completed during manufacturing.
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: The recall involves a medical device where required safety tests (HiPot, Continuity, load, friction) were not completed, creating a risk of harm (electrical shock or mechanical failure) even though no injuries have been reported.
Plain-English summary
MedX Holdings, Inc. is recalling four units of the Cervical Extension Machine for Physical Therapy. The recall was initiated after a review of Device History Records (DHRs) revealed that HiPot, Continuity, load, and friction re-testing was not completed on these specific devices during the manufacturing process.
The affected units are identified by serial numbers 02511166, 02511167, 02511171, and 02511170. These devices were distributed worldwide, including in the United States (specifically Missouri, Illinois, Idaho, and Minnesota) and internationally to Germany and South Korea.
Consumers and healthcare facilities should stop using the affected devices immediately and contact MedX Holdings, Inc. for instructions on how to return or dispose of the units.
The recalled product
- Product
- Cervical Extension Machine for Physical Therapy
- Manufacturer
- MedX Holdings, Inc.
- Affected units
- 4
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)
- Serial Numbers: 02511166
- 02511167
- 02511171
- 02511170.
Distribution
Part of a larger recall action
This product is one of 2 recalled by MedX Holdings, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · MedX Holdings, Inc.
See all →- HighMedX Lumbar Extension Machines Recalled for Incomplete Safety Testing
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Same hazard · electrical shock
See all →- High
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