Z-0555-2019Class II

Thermacare HeatWraps Menstrual a) UPC 0573302002 b) UPC 0573302044

Name: Z-0555-2019 Thermacare HeatWraps Menstrual a) UPC 0573302002 b) UPC 0573302044
Creator: Pfizer Inc.
Published: 2018-10-02
License: https://open.fda.gov/license/

Pfizer Inc / initiated 2018-10-02 / Terminated / root cause: design

FDA source

Pfizer Inc. began a recall of Thermacare HeatWraps Menstrual a) UPC 0573302002 b) UPC 0573302044 Product Usage: Provides heat therapy for temporary relief of minor menstrual cramp pain and... on 2018-10-02. FDA classified it as Class II and gives the reason as "The firm received complaints of the wrap coming apart and leaking granular material". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0555-2019
Classification: Class II
Status: Terminated
Initiated: 2018-10-02
Posted: 2018-12-05
Terminated: 2023-08-28
Recalling firm: Pfizer Inc
Product: Thermacare HeatWraps Menstrual a) UPC 0573302002 b) UPC 0573302044 Product Usage: Provides heat therapy for temporary relief of minor menstrual cramp pain and associated back aches.
Product code: IMD Pack, Hot Or Cold, Disposable
Reason for recall: The firm received complaints of the wrap coming apart and leaking granular material
Root cause tag: design
FDA 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 in commerce: 293880 units
Distribution: US Nationwide Distribution and PR
Product codes and lots: a) UPC 0573302002 Carton/Pouch Number T26691 b) UPC 0573302044 Carton/Pouch Number T26693

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0555-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0554-2019	Class II	Terminated	Voluntary: Firm initiated	2018-12-12	2018-12-04
Z-0555-2019	Class II	Terminated	Voluntary: Firm initiated	2018-12-12	2018-12-04
Z-0556-2019	Class II	Terminated	Voluntary: Firm initiated	2018-12-12	2018-12-04

Product code IMD

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)