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BLOOM43

PLEXAA LTD · Model B4301 · UDI-DI 05065023510009

IRT Prescription

510(k) clearances

6,884

Adverse events (12 deaths)

Recalls

281

Facilities

Description

BLOOM43 is a wearable medical device consisting of a preconditioning unit connected to a battery via a cable. The preconditioning unit integrates a user interface and a temperature-controlled heating element. Designed for preoperative use, BLOOM43 delivers supraphysiological preconditioning to the skin through the application of topical heat, which temporarily improves blood flow circulation. The battery can be securely attached to clothing or carried in a pocket for convenience. The preconditioning unit is intended to be placed within a bra, positioned against the breast skin (ideally centered over the nipple-areola complex), and worn for approximately 3 hours. It operates in a series of 30-minute active heating cycles within the range of 40°C (104°F) to 45.5°C (113.9°F), with an approximate skin temperature of 40°C (104°F) to 44°C (111.2°F), alternating with nonactive heating periods.

Recalls

Date	Firm	Reason
2026-02-18	Navajo Manufacturing Company	If heating pad is folded while in use, the power density increases in the folded area causing excessive temperatures, which can also be caused by placing pad under the body, then t
2024-02-08	EYE COMFORT CARE LLC	Due to a change in the safety clips for the heated eye masks, the wires to the safety clips may detach as a result of tugging and pulling and may cause a short in the heating eleme
2022-10-24	Whele LLC DBA Perch	The products may have the potential to burn customers. Firm has received complaints of burns, mild shocks, and rashes/irritation.
2022-10-24	Whele LLC DBA Perch	The products may have the potential to burn customers. Firm has received complaints of burns, mild shocks, and rashes/irritation.
2022-10-24	Whele LLC DBA Perch	The products may have the potential to burn customers. Firm has received complaints of burns, mild shocks, and rashes/irritation.
2016-09-15	Battle Creek Equipment Co.	Products manufactured with the SPT cord have a known failure mode of sparking,causing smoke, fire and burns.
2016-04-15	2k Innovations Inc.	During an FDA inspection it was found that the firm claims unapproved therapy and medical claims on product information and website.
2016-04-15	2k Innovations Inc.	During an FDA inspection it was found that the firm claims unapproved therapy and medical claims on product information and website.
2016-04-15	2k Innovations Inc.	During an FDA inspection it was found that the firm claims unapproved therapy and medical claims on product information and website.
2016-04-15	2k Innovations Inc.	During an FDA inspection it was found that the firm claims unapproved therapy and medical claims on product information and website.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.