PX200 Emergency Relief Bed
Medical device recall Z-1238-2022. Published in FDA’s Enforcement Report on Jun 15, 2022.
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 Jun 15, 2022. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word, and 3 states named
- 130 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?
Product label was printed without the UDI number and warning label was printed with the incorrect weight capacity. The correct weight limit is 400 lbs., but the label states 500 lbs.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
PX200 Emergency Relief Bed; Model No. PXEXEB362280A6TTZZH4C19
130, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
UDI-DI: 00817463026399 Serial Numbers: PXR769629 PXR769630 PXR769631 PXR769632 PXR769633 PXR769634 PXR769635 PXR769636 PXR769637 PXR769638 PXR769639 PXR769640 PXR769641 PXR769642 PXR769643 PXR769644 PXR769645 PXR769646 PXR769647 PXR769648…
Every code shown here, 1,338 characters
UDI-DI: 00817463026399 Serial Numbers: PXR769629 PXR769630 PXR769631 PXR769632 PXR769633 PXR769634 PXR769635 PXR769636 PXR769637 PXR769638 PXR769639 PXR769640 PXR769641 PXR769642 PXR769643 PXR769644 PXR769645 PXR769646 PXR769647 PXR769648 PXR769649 PXR769650 PXR769651 PXR769652 PXR769653 PXR769654 PXR769655 PXR769656 PXR769657 PXR769658 PXR769730 PXR769731 PXR769732 PXR769733 PXR769734 PXR769735 PXR769736 PXR769737 PXR769738 PXR769739 PXR769740 PXR769741 PXR769742 PXR769743 PXR769744 PXR769745 PXR769746 PXR769747 PXR769748 PXR769749 PXR769750 PXR769751 PXR769752 PXR769753 PXR769754 PXR769755 PXR769756 PXR769757 PXR769758 PXR769759 PXR769760 PXR769761 PXR769762 PXR769763 PXR769764 PXR769765 PXR769766 PXR769767 PXR769768 PXR769769 PXR769770 PXR769771 PXR769772 PXR769773 PXR769774 PXR769775 PXR769776 PXR769777 PXR769778 PXR769779 PXR769780 PXR769781 PXR769782 PXR769783 PXR769784 PXR769785 PXR769786 PXR769787 PXR769788 PXR769789 PXR769790 PXR769791 PXR769792 PXR769793 PXR769794 PXR769795 PXR769796 PXR769797 PXR769798 PXR769799 PXR769800 PXR769801 PXR769802 PXR769803 PXR769804 PXR769805 PXR769806 PXR769807 PXR769808 PXR769809 PXR769810 PXR769811 PXR769812 PXR769813 PXR769814 PXR769815 PXR769816 PXR769817 PXR769818 PXR769819 PXR769820 PXR769821 PXR769822 PXR769823 PXR769824 PXR769825 PXR769826 PXR769827 PXR769828 PXR769829
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.
US Nationwide distribution in the states of MA, NJ, and PA.
The states and territories these words name
- Massachusetts
- New Jersey
- Pennsylvania
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.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
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 Apr 21, 2022.
- FDA classified it on Jun 6, 2022.
- FDA’s Enforcement Report published it on Jun 15, 2022.
- FDA terminated it on Sep 19, 2024.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Oakworks Inc, of New Freedom, PA.
- 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.”
- 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
-
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.