CLASS II ONGOING Device recall · Reported 16 Feb 2022 · FDA Enforcement Report
Curad Reusable Gel Hot/cold Pack recalled by MEDLINE INDUSTRIES, LP
MEDLINE INDUSTRIES, LP - Northfield is recalling Curad Reusable Gel Hot/cold Pack. The recall was initiated on 15 Dec 2021 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-0633-2022
- FDA event ID
- 89235
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield, Northfield, IL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 15 Dec 2021
- FDA classified
- 9 Feb 2022
- Reported
- 16 Feb 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Foreign Material
- Device type
- Other Medical Devices
Timeline
| 15 Dec 2021 | Recall initiated by company | |
| 9 Feb 2022 | Classified by FDA | +56 days |
| 16 Feb 2022 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The product contains natural rubber latex but the label states that it does not.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
CURAD REUSABLE GEL HOT/COLD PACK
Where it was distributed
US and Bahamas, Bermuda, Panama, Lebanon, Barbados, Honduras, Anguilla
Questions about this recall
Is Curad Reusable Gel Hot/cold Pack recalled?
Yes. MEDLINE INDUSTRIES, LP - Northfield recalled Curad Reusable Gel Hot/cold Pack on 15 Dec 2021. The recall is Class II and its status is Ongoing. Recall number Z-0633-2022.
Why was it recalled?
The product contains natural rubber latex but the label states that it does not.
Which lots are affected?
Item Numbers: 1) CUR959/CUR959H (Lots 69718070004, 69718090003, 69718100001, 69718100004, 69718110003, 69719010001, 69719030001, 69719030004, 69719040002, 69719070005, 69719080002, 69719080006, 69719090001, 69719090004, 69719100001, 69719100004, 69719110001, 69719110003, 69719110004, 69719120001, 69719120005, 69719120002, 69719120006, 69720010001, 69720020002, 69720040001, 69720050001, 69720060001, 69720060002, 69720080002, 69720090001, 69720090002, 69720100001, 69720100002, 69720110002, 69720120001, 69720120002, 69721010001, 69721020001, 69721030001, 69721030002, 69721050001, 69721050002, 69721050003, 69721060001, 69721060002, 69721070001, 69721080002, 69721090001) 2) TGT0114V1 (Lots 69718070004, 69718080002, 69718090002 , 69718100004, 69718110003, 69719010001, 69719030004, 69719040002, 69719050002, 69719050004, 69719060001, 69719060003, 69719070001, 69719070005, 69719080002, 69719080006, 69719090004, 69719100001, 69719100004, 69719100005, 69719110001, 69719110002, 69719110004, 69719110003, 69719120005, 69719120002, 69719120007, 69719120006, 69720010001, 69720070001, 69720070002, 69720080001, 69720080002, 69720100003)
Where was it sold?
US and Bahamas, Bermuda, Panama, Lebanon, Barbados, Honduras, Anguilla
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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