Winco TMM3 Video-Fluoroscopy Stretcher-Chair Recalled for Non-Conforming Component
Winco Mfg., LLC is recalling 264 TMM3 Series Video-Fluoroscopy Stretcher-Chairs because a non-conforming component caused the arms to no longer meet design specifications.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any injuries, illnesses, or deaths, fitting the criteria for a moderate severity score.
Plain-English summary
Winco Mfg., LLC is recalling 264 units of the TransMotion Medical TMM3 Series Video-Fluoroscopy Swallow Study Stretcher-Chair. The recall is due to a non-conforming component that caused the arms of the TMM4 Stretcher chair to no longer meet design specifications.
The affected products were distributed worldwide, including in the United States (specifically AR, CA, CO, CT, FL, GA, IL, KS, LA, MD, MI, MN, MO, MS, NC, NJ, NM, NV, NY, OH, OK, PA, RI, TN, TX, VA, WA, WI, and Puerto Rico) and in Canada, Australia, Italy, Panama, Switzerland, and Taiwan. The recall covers all identified serial numbers.
The source text does not specify specific actions for consumers or healthcare facilities, nor does it report any injuries or illnesses associated with the defect.
The recalled product
- Product
- TransMotion Medical, TMM3 Series Video-Fluoroscopy Swallow Study Stretcher-Chair. Intended use is to provide the caregiver a single platform for receiving, transporting within a facility, performing procedures, recovery and discharge of patients in a monitored outpatient…
- Manufacturer
- Winco Mfg., LLC
- Hazard
- Affected units
- 264
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 (1)
- All identified serial numbers.
Distribution
Part of a larger recall action
This product is one of 3 recalled by Winco Mfg., LLC 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 3 products in this recall →Related recalls
Same manufacturer · Winco Mfg., LLC
See all →- ModerateWinco TMM4 Series Treatment Chair Recalled for Non-Conforming Component
FDA (Devices) · 2016-10-19
- ModerateWinco TMM5 Mobile Surgical Stretcher-Chair Recalled for Design Non-Conformance
FDA (Devices) · 2016-10-19
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Same hazard · structural defect
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- Severe
- Severe
- Severe
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