FDA Medical Device Recalls (openFDA)
Pfizer Inc.: Thermacare Muscle Pain Therapy HeatWraps: a) UPC 0573301314 b) UPC 0573301303 Product Usage: Provides heat therapy for temporary relief of minor muscular and joint aches and pains associated with overexertion, sprains, and arthritis.
- Recall number
- Z-0554-2019
- Recalling firm
- Pfizer Inc.
- Product
- Thermacare Muscle Pain Therapy HeatWraps: a) UPC 0573301314 b) UPC 0573301303 Product Usage: Provides heat therapy for temporary relief of minor muscular and joint aches and pains associated with overexertion, sprains, and arthritis.
- Status
- Terminated
- Initiated
- 2018-10-02
- Posted
- not on file
- Terminated
- 2023-08-28
- Reason
- The firm received complaints of the wrap coming apart and leaking granular material
- Root cause
- Device Design
- Action
- Pfizer, Inc. initiated the recall by letter on 10/02/2018 to the direct accounts. The notice instructed the direct consignees to conduct a sub-recall by notifying any of their accounts to determine if they had any of the affected lot(s) in their inventory at any of their locations. If so, the recalling firm requested that they discontinue distributing the product lot and promptly return the affected product to Pfizer Inc. (c/o Stericycle Inc.). The firm expanded the scope of their recall to the consumer level and disseminated a notice on 11/27/2018 to its direct accounts. The firm issued a press release on 11/26/2018.
- Quantity
- 119232 units
- Distribution
- US Nationwide Distribution and PR
- Lot, serial or model codes
- a) UPC 0573301314 Carton/Pouch Lot Number S68516 b) UPC 0573301303 Carton/Pouch Lot Number T26686
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- IMD
- Firm FEI
- 2416101
- Firm city
- New York
- Firm state
- NY
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28