Powered stretcher chair used during facial and eye surgeries
Medical device recall Z-0996-2015. Published in FDA’s Enforcement Report on Jan 28, 2015.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Jan 28, 2015. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Not named no state, in where it went
- 1,127 units how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“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.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
The firm is finding that the stretcher chair controllers are moving the chairs involuntarily.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Powered stretcher chair used during facial and eye surgeries. One chair per package.
1,127 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
TMM supplier model numbers: EHA34-23MKKJ-600 EHA14-21BKKJ-042 EHA35-23MKKJ-591 The following Model numbers and Serial numbers are included in this recall: Model Number: TM10-E Serial number: 4678 Model Number: TM12 Serial numbers: 3362…
Every code shown here, 1,999 characters
TMM supplier model numbers: EHA34-23MKKJ-600 EHA14-21BKKJ-042 EHA35-23MKKJ-591 The following Model numbers and Serial numbers are included in this recall: Model Number: TM10-E Serial number: 4678 Model Number: TM12 Serial numbers: 3362 3468 3810 4335 4336 4626 5068 5069 Model Number: TM9 Serial numbers: 2335 2337 2338 2679 2701 2785 2786 2787 2788 2789 2931 2981 2982 2983 3025 3398 3470 3471 3472 3473 3477 3478 3793 3794 4274 4275 4301 4302 4303 4304 4305 4306 4307 4755 4756 4757 4758 4759 4760 4761 Model Number: TM9-E Serial numbers: 3537 3750 3751 3752 4113 4425 4426 4427 4428 4429 4430 4431 4432 4433 4434 4435 4436 4437 4561 4562 4790 4791 4792 4793 4794 4795 4796 4797 4798 4799 4800 4801 4802 4803 4804 4805 4806 4807 4808 4809 4972 5122 5123 5124 5125 5126 5127 5128 5129 5130 5131 5132 5133 5134 5135 5136 5137 5138 5139 5140 5141 5142 5170 5177 Model Number: TMM5-100 Serial numbers: 1110 1111 1112 1113 1114 1115 1116 1117 1118 1119 1120 1121 1122 1123 1124 1125 1126 1127 1128 1129 1130 1131 1132 1133 1134 1135 1136 1137 1138 1139 1348 1349 1350 1684 1685 1686 1687 1688 1689 1690 2998 2999 Model Number: TMM5-101 Serial number: 2956 Model Number: TMM5-102 Serial numbers: 3056 3057 Model Number: TMM5-103 Serial number: 3107 Model Number: TMM5-104 Serial numbers: 3103 3126 3198 3199 3214 3215 3216 Model Number: TMM5-106 Serial numbers: 3337 3338 3339 3340 3341 3342 3343 3344 Model Number: TMM5-114 Serial numbers: 5107 5108 Model Number: TMM5-B Serial numbers: 0212 0303 0304 0306 0321 0329 0330 0332 0333 0346 0347 0348 0349 0350 0357 0358 0359 0360 0361 0362 0363 0371 0372 0374 0377 0378 0382 0384 0385 0386 0392 0393 0394 0396 0427 0428 0429 0430 0431 0520 0521 0522 0547 0548 0549 0550 0551 0552 0581 0582 0583 0584 0585 0586 0587 0588 0589 0590 0591 0592 0593 0594 0671 0672 0673 0674 0675 0695 0696 0697 0698 0753 0754 0758 0759 0760 0761 0766 0771 0788 0789 0790 0791 0792 0793 0794 0795 0796 0801 0831 0839 0840 0841 0877 0883 0884 0885 0895 0908 0909 0910 1023 1024…
FDA’s list runs to 7,865 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Worldwide Distribution - US Distribution and the countries including Canada, Australia, Chile, China, Costa Rica, Germany, Algeria, Israel, Italy, South Korea, Malaysia, Nigeria, Netherlands, Poland, Portugal, Saudi Arabia, Singapore, Thailand, and Venezuela.
These words name no state.
The words say it went outside the United States too.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Nov 14, 2014.
- FDA classified it on Jan 16, 2015.
- FDA’s Enforcement Report published it on Jan 28, 2015.
- FDA terminated it on Jul 11, 2015.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- TransMotion Medical Inc, of Sharon Center, OH.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 7,865 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.