The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-0065-2017·Announced 2016-10-19

Winco TMM4 Series Treatment Chair Recalled for Non-Conforming Component

Winco Mfg. is recalling 264 TMM4 Series Multi-Purpose Treatment 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 TMM4 Series Multi-Purpose Treatment Chair. The recall was initiated because a non-conforming component caused the arms of the stretcher chair to no longer meet design specifications.

The affected chairs 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 applies to all identified serial numbers.

The TMM4 Series chair is intended to provide caregivers with a single platform for receiving, transporting, performing procedures on, recovering, and discharging patients in a monitored outpatient environment. Users should contact Winco Mfg., LLC for further instructions regarding the recall.

The recalled product

Product
TransMotion Medical, TMM4 Series Multi-Purpose Treatment 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 environment.
Manufacturer
Winco Mfg., LLC
Category
Medical Device — Treatment Chair
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

Distributed in 29 states:

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 →

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