RecallRadar

FDA Device recall Z-0946-2018

ACE (TM) BRAND, DELUXE ANKLE BRACE, 207736, UPC 0 51131 20387 7

On 2018-03-21 the FDA classified a Class II recall of ACE (TM) BRAND, DELUXE ANKLE BRACE, 207736, UPC 0 51131 20387 7 by 3m Health Care Business, citing 3M discovered that the Futuro" Quick Strap Ankle Brace (Cat. #47736EN) and ACE" Brand Deluxe Ankle brace (Cat. #207736) do not have the correct labeling. The products contain natu….

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0946-2018
ClassificationClass II
Statusterminated
Initiated2018-01-31
Published2018-03-21
Last updated2026-09-13 11:54 UTC
Company3m Health Care Business
Distributionn/a

Product

ACE (TM) BRAND, DELUXE ANKLE BRACE, 207736, UPC 0 51131 20387 7

Reason

3M discovered that the Futuro" Quick Strap Ankle Brace (Cat. #47736EN) and ACE" Brand Deluxe Ankle brace (Cat. #207736) do not have the correct labeling. The products contain natural latex rubber, but do not include the appropriate caution statement.

Identifiers

upc051131203877
code_infoAll lots

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0946-2018%22

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