Affinity Four Birthing Bed-used as a birthing bed for women of child bearing age in an LDR (Labor, Delivery,…
Medical device recall Z-2156-2021. Published in FDA’s Enforcement Report on Aug 4, 2021.
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 Aug 4, 2021. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word, and 10 states named
- 1,096 Beds 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?
Latch mechanism on the Lift-Off foot section of the Affinity Four Birthing Bed is damaged, it could potentially cause the installed foot section to be improperly engaged onto the bed, could result in injury to the user due to a fall.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Affinity Four Birthing Bed-used as a birthing bed for women of child bearing age in an LDR (Labor, Delivery, Recovery) or LDRP (Labor, Delivery, Recovery, Postpartum) setting within the acute care Labor and Delivery market Model Numbers: P3700B, P3700C, P3700D, & P3700E
1,096 Beds, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial Numbers: US Serial Numbers: P328AA3855 P314AA3735 P311AA3734 P311AA3733 P304AA3675 I067AA5445 O351AA1238 J130AA8820 K226AA1383 I135AA6134 O161AA3 P314AA3737 P343AA3930 P343AA3929 P343AA3920 P343AA3919 P343AA3918 P314AA3736…
Every code shown here, 1,994 characters
Serial Numbers: US Serial Numbers: P328AA3855 P314AA3735 P311AA3734 P311AA3733 P304AA3675 I067AA5445 O351AA1238 J130AA8820 K226AA1383 I135AA6134 O161AA3 P314AA3737 P343AA3930 P343AA3929 P343AA3920 P343AA3919 P343AA3918 P314AA3736 P323AA3813 P323AA3812 P322AA3811 P322AA3810 P322AA3809 P322AA3808 I004AA4998 I156AA6325 P295AA3605 I267AA7216 J155AA8988 J161AA9040 J168AA9110 J168AA9099 J162AA9047 J154AA8977 P346AA3966. OUS: Serial Numbers: I299AA7436 O004AA0116 M117AA5556 M115AA5531 M115AA5527 P286AA3531 N124AA8303 M055AA5218 M053AA5199 P106AA2178 M160AA5829 M166AA5877 M053AA5198 M172AA5924 M180AA5992 M180AA5990 P288AA3551 M054AA5210 M054AA5202 P274AA3445 N199AA8761 M054AA5205 N083AA7986 M166AA5872 N121AA8271 P275AA3452 P283AA3524 P274AA3441 N017AA7471 P288AA3552 N272AA9378 N017AA7473 M049AA5176 P281AA3497 P279AA3471 N018AA7480 P280AA3486 N089AA8038 M166AA5880 M075AA5294 N090AA8040 N083AA7988 O197AA0505 O196AA0502 O108AA0048 N074AA7913 N124AA8304 M053AA5193 M052AA5182 P280AA3490 P077AA1935 P276AA3466 P008AA1340 N121AA8268 M055AA5217 O102AA0004 M052AA5187 M052AA5179 O193AA0496 M167AA5881 M054AA5208 O270AA0973 P276AA3469 P276AA3468 N272AA9377 N269AA9354 O275AA1002 O270AA0976 O270AA0969 O269AA0965 O197AA0511 N090AA8043.2 N075AA7929 P276AA3465 M054AA5206 O102AA0003 O060AA0560.2 O060AA0557 N272AA9387 P083AA1984 P030AD1533 P030AA1533 P276AA3464 P274AA3443 P094AA2085 P094AA2083 P093AA2080 P094AA2089 P094AA2091 P078AA1947 O324AA1021 O016AA0202 N128AA8319 N024AA7514 N018AA7478 N017AA7476 M111AA5521 M105AA5471 M104AA5469 M104AA5467 M090AA5413 M090AA5412 M090AA5409 M090AA5407 M055AA5213 M054AA5209 M054AA5201 M052AA5188 M052AA5186 M052AA5184 M052AA5183 M049AA5175 M049AA5174 P190AA2741 P300AA3633 J011AA7835 J011AA7833 L160AA3472 L159AA3463 L175AA3633 L071AA2745 N129AA8337 K006AA0517 K293AA1756 O213AA06O2 O213AA0609 O213AA0607 O213AA0602 O212AA0600 N198AA8751 N122AA8281 N122AA8280 N122AA8279 N122AA8278 N209AA8850 N002AA7346 M325AA7097 M322AA7084 M285AA6767 L075AA2765 I325AA7566…
FDA’s list runs to 12,110 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 Nationwide distribution in the states of AL, CA, IA, MS, NC, NY, OH, PA, TX, VA and the countries of Australia, Austria, Azerbaijan, Belgium, Chile, China, Denmark, Finland, France, Germany, Ireland, Israel, Italy, Jordan, Kuwait, Netherlands, New Zealand, Norway, Portugal, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, Taiwan, United Arab Emirates, United Kingdom.
The states and territories these words name
- Alabama
- California
- Iowa
- Mississippi
- North Carolina
- New York
- Ohio
- Pennsylvania
- Texas
- Virginia
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.
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 May 28, 2021.
- FDA classified it on Jul 28, 2021.
- FDA’s Enforcement Report published it on Aug 4, 2021.
- FDA terminated it on Jun 6, 2024.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Hill-Rom, Inc., of Batesville, IN.
- 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 12,110 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.