CLASS II Device recall · Reported 12 Dec 2018 · FDA Enforcement Report
Thermacare Heatwraps Joint Pain Therapy, 8 Heatwraps recalled by Pfizer
Pfizer is recalling Thermacare Heatwraps Joint Pain Therapy, 8 Heatwraps, distributed nationwide in the US. The recall was initiated on 2 Oct 2018 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0556-2019
- FDA event ID
- 81178
- Recalling firm
- Pfizer, New York, NY
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 2 Oct 2018
- FDA classified
- 4 Dec 2018
- Reported
- 12 Dec 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Other Medical Devices
Timeline
| 2 Oct 2018 | Recall initiated by company | |
| 4 Dec 2018 | Classified by FDA | +63 days |
| 12 Dec 2018 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The firm received complaints of the wrap coming apart and leaking granular material
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Thermacare HEATWRAPS JOINT PAIN THERAPY, 8 HEATWRAPS; MUSCLE PAIN THERAPY, 3 HEATWRAPS a) UPC 0573301311 b) UPC 0573301311 Product Usage: Provides heat therapy for temporary relief of minor muscular and joint aches and pains associated with overexertion, sprains, and arthritis.
Where it was distributed
US Nationwide Distribution and PR
Questions about this recall
Is Thermacare Heatwraps Joint Pain Therapy, 8 Heatwraps recalled?
Yes. Pfizer recalled Thermacare Heatwraps Joint Pain Therapy, 8 Heatwraps on 2 Oct 2018. The recall is Class II and its status is Terminated. Recall number Z-0556-2019.
Why was it recalled?
The firm received complaints of the wrap coming apart and leaking granular material
Which lots are affected?
a) UPC 0573301311 Bundled Lot Number 8054HA Carton/Pouch Number T26686 b) UPC 0573301311 Bundled Lot Number 8054HB Carton/Pouch Number T26686
Where was it sold?
US Nationwide Distribution and PR
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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