Hearth Record

Power-PRO 2, Model No. 6507, Item No. 650705550001 (US); 650700000000 (International)

Medical device recall Z-0479-2023. Published in FDA’s Enforcement Report on Dec 21, 2022.

FDA’s own record, on accessdata.fda.gov

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 Dec 21, 2022. Copied from openFDA on Oct 20, 2026.

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.

Source:

What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.

What’s wrong with it?

Cot may experience unintended motion due to damaged cables. Potential risk of soft tissue injury to patients such as scrapes or bruises resulting from the cot lowering faster than expected.

Source:

FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.

Which ones are recalled?

Power-PRO 2, Model No. 6507, Item No. 650705550001 (US); 650700000000 (International)

465 (403 US; 62 OUS), in FDA’s words.

Source:

FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.

Codes to check against yours

UDI-DI (GTIN) 07613327504460 Serial Numbers 2204000343 2204000345 2204000348 2204000351 2204000369 2204000370 2204000382 2204000430 2204000673 2204000682 2205000094 2205000095 2205000096 2205000097 2205000098 2205000099 2205000100…

Every code shown here, 1,991 characters

UDI-DI (GTIN) 07613327504460 Serial Numbers 2204000343 2204000345 2204000348 2204000351 2204000369 2204000370 2204000382 2204000430 2204000673 2204000682 2205000094 2205000095 2205000096 2205000097 2205000098 2205000099 2205000100 2205000101 2205000102 2205000104 2205000105 2205000109 2205000110 2205000111 2205000113 2205000115 2205000117 2205000119 2205000123 2205000124 2205000125 2205000128 2205000129 2205000130 2205000132 2205000135 2205000137 2205000139 2205000142 2205000143 2205000151 2205000170 2208001658 2208001660 2203001748 2204000431 2204000651 2204000663 2204000665 2204000667 2204000670 2204000671 2204000680 2203001948 2203001955 2204000075 2204000094 2204000097 2204000632 2204000633 2204000635 2204000637 2204000647 2204000676 2204000683 2202001579 2202001585 2203002650 2203002651 2203002652 2203002653 2203002654 2203002666 2204000077 2204000078 2204000086 2112001508 2204000681 2204000684 2203001720 2203001925 2203001928 2203001929 2203001932 2203002660 2203002664 2203002665 2204000080 2204000084 2204000089 2204000105 2204000112 2204000675 2202001560 2202001593 2202001594 2203001721 2203001723 2203001744 2203001926 2203001931 2203001945 2203002663 2204000074 2204000076 2204000085 2204000092 2204000109 2204000114 2204000116 2204000117 2204000118 2204000269 2204000271 2204000273 2204000274 2204000275 2204000279 2204000282 2204000283 2204000284 2204000285 2204000286 2204000287 2204000288 2204000289 2204000290 2204000291 2204000292 2204000346 2204000352 2204000381 2204000408 2204000429 2204000433 2204000452 2204000453 2204000636 2204000638 2204000639 2204000640 2204000641 2204000643 2204000645 2204000648 2204000649 2204000652 2204000653 2204000655 2204000656 2204000657 2204000658 2204000662 2205000141 2204000277 2112001535 2204000103 2202001299 2202001314 2202001315 2202001523 2202001539 2202001541 2202001570 2202001572 2202001592 2204000081 2204000098 2204000272 2202000816 2203001944 2203001937 2203001947 2203001934 2203001954 2204000276 2202001580…

FDA’s list runs to 4,157 characters. The first part is shown; the rest is on FDA’s record.

Source:

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 (Nationwide) and Foreign to countries of: Australia, Canada, Netherlands, and United Kingdom.

These words name no state.

What FDA means by nationwide

“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”

openFDA, its enforcement report fields.

The words say it went outside the United States too.

Source:

What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.

Is it still going on?

Ongoing, in FDA’s file.

“A recall which is currently in progress.”

openFDA, on “On-Going”, its enforcement report fields.

Source:

What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.

  • The firm began the recall on Nov 11, 2022.
  • FDA classified it on Dec 14, 2022.
  • FDA’s Enforcement Report published it on Dec 21, 2022.
Source:

FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.

Who is recalling it?

  • Stryker Medical Division of Stryker Corporation, of Portage, MI.
  • Who began it, in FDA’s words: Voluntary: Firm initiated.
  • How the firm first told its customers: Letter.
Source:

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 4,157 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.
Source:

Hearth Record wrote these lines; the quotations are FDA’s.

Sources

  • 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.

Source:

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.

How to read a record

Four things every record does, shown on an example record made up for this guide.

An example record, made up for this guide

An example nursing home

Made up for this guide: no real place is shown

Not fully inspected in over two years (CMS flag)

11 health citations at the latest inspection cycle

The state average is 14.3.

Source:

CMS, State and US Averages and Health Deficiencies. Released Oct 28, 2026. Updated monthly.

From the homeNone yet. Replies and paid listings aren’t open, and when they open they will sit here, below the record.

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Every fact names its source.

Who published it, when, and how often it changes sit beside each fact, with a link to the agency’s own file.

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