Affinity Four Birthing Bed
Medical device recall Z-2750-2016. Published in FDA’s Enforcement Report on Sep 14, 2016.
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 Sep 14, 2016. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- 16 states named in where it went
- 94 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?
FDA’s record gives no reason in a field of its own.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Affinity Four Birthing Bed Model P3700 The primary packaging is pictured below, and utilizes a metal packing brace, standard corrugated cardboard and plastic banding. When possible these beds are shipped as a quantity of two (2) together as shown with the nylon strapping. These are shipped in standard freight containers. There is no secondary packaging.
94 beds, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Affected Bed Lot Numbers: R062AA7482 R064AA7505 R042AA7318 R041AA7300 R062AA7483 R064AA7506 R042AA7320 R041AA7302 R062AA7484 R027AA7180 R042AA7321 R041AA7303 R046AA7345 R036AA7274 R042AA7323 R041AA7305 R039AA7278 R041AA7308 R042AA7324…
Every code shown here, 1,059 characters
Affected Bed Lot Numbers: R062AA7482 R064AA7505 R042AA7318 R041AA7300 R062AA7483 R064AA7506 R042AA7320 R041AA7302 R062AA7484 R027AA7180 R042AA7321 R041AA7303 R046AA7345 R036AA7274 R042AA7323 R041AA7305 R039AA7278 R041AA7308 R042AA7324 R039AA7279 R039AA7276 R036AA7263 R039AA7281 R046AA7337 R039AA7275 R039AA7284 R046AA7346 R039AA7277 R063AA7503 R053AA7396 R061AA7475 R061AA7471 R053AA7400 R039AA7283 R061AA7472 R053AA7402 R039AA7285 R061AA7473 R053AA7404 R040AA7286 R061AA7474 R042AA7319 R039AA7282 R043AA7325 R046AA7342 R040AA7287 R043AA7327 R050AA7395 R040AA7289 R043AA7328 R056AA7443 R040AA7290 R043AA7329 R061AA7477 R040AA7292 R046AA7336 R040AA7291 R040AA7293 R046AA7339 R040AA7295 R040AA7294 R046AA7338 R041AA7301 R040AA7288 R063AA7492 R041AA7304 R040AA7296 R063AA7493 R041AA7307 R040AA7297 R063AA7494 R041AA7309 R042AA7322 R063AA7495 R041AA7310 R043AA7326 R063AA7496 R041AA7311 R043AA7330 R063AA7497 R041AA7312 R043AA7331 R063AA7498 R042AA7313 R043AA7332 R063AA7501 R042AA7314 R043AA7333 R063AA7502 R042AA7315 R041AA7298 R064AA7504 R042AA7316 R041AA7299
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 Distribution to the states of : CA, FL, IN, KS, LA, MI, MO, NC, NY, OK, OR, PA, TN, TX, WA, WY Foreign:BULGARIA, INDIA, UNITED ARAB EMIRATES
The states and territories these words name
16 states and territories.
Every one of them
- California
- Florida
- Indiana
- Kansas
- Louisiana
- Michigan
- Missouri
- North Carolina
- New York
- Oklahoma
- Oregon
- Pennsylvania
- Tennessee
- Texas
- Washington
- Wyoming
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 Jul 15, 2016.
- FDA classified it on Sep 8, 2016.
- FDA’s Enforcement Report published it on Sep 14, 2016.
- FDA terminated it on Mar 23, 2017.
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.”
- 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.