Food, drugs, devices › Winco Mfg., LLC
Device recall: TransMotion Medical, TMM3 Series Video-Fluoroscopy Swallow Study Stretcher-Chair. Intended use is to provide the caregiv
FDA enforcement event 74922 is a device recall by Winco Mfg., LLC of Ocala, FL, initiated 29 Jun 2016 and classified Class II, with 3 product records.
FDA defines Class II as 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. 91% of the 1,232 device enforcement events initiated in 2016 carry the same class.
Status: Terminated, terminated 27 Sep 2017. Initiation: voluntary: firm initiated. Winco Mfg., LLC has 5 enforcement events on this register, with a median of 4 product records per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Winco Mfg., LLC, Ocala, FL.
Reason for recall
"Non-conforming component caused arms of TMM4 Stretcher chair to no longer meet design specifications."
Distribution
"Worldwide Distribution -- USA, including 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 the countries of Canada,…"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0064-2017 | 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 environment. | 264 Stretcher Chairs | Class II | Terminated | 19 Oct 2016 |
| Z-0065-2017 | 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. | 264 Stretcher Chairs | Class II | Terminated | 19 Oct 2016 |
| Z-0066-2017 | TransMotion Medical, TMM5 Series Mobile Surgical 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 environment. | 264 Stretcher Chairs | Class II | Terminated | 19 Oct 2016 |
Context
Other enforcement events for Winco Mfg., LLC
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 2 Apr 2015 | Winco XL Convalescent Recliner - with Steel Casters Long term patient recliner (Nursing, Rehabilitation, Geriatric Home | Device | Class II | 13 |
| 6 Sep 2013 | PREMIER CARE RECLINER 5570 with Urethane armrests, Multiple side-table options, 3 position lock-bar, Fully upholstered, | Device | Class II | 4 |
| 24 Sep 2012 | PREMIER LIFECARE RECLINER 5400 WITH CAL TB 133 UPGRADE PURCHASED JAN 01, 2011 TO AUGUST 20, 2012 A multi position reclin | Device | Class II | 4 |
| 10 Jul 2012 | Caremor Cliner"***Manufactured By Winco***Ocala, FL 34474 www.wincomfg.com***Model No. 536 Serial No. 536A-101475***" Li | Device | Class II | 2 |
All 5 events for Winco Mfg., LLC
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Non-conforming component caused arms of TMM4 Stretcher chair to no longer meet design specifications."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. 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.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide Distribution -- USA, including 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 the countries of Canada,…"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 27 Sep 2017. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.