CURAD Reusable Gel Hot/Cold Pack Contains Undisclosed Natural Rubber Latex
Medline Industries is recalling 494,273 CURAD Reusable Gel Hot/Cold Packs because the product contains natural rubber latex that is not disclosed on the label. Consumers with latex allergies face risk of allergic reaction.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This recall involves allergen mislabeling for a known and serious allergen (latex). The FDA Class II classification and absence of any reported illnesses or injuries support a High severity score per the rubric criterion for allergen mislabeling without reported adverse events.
Plain-English summary
Medline Industries, LP (Northfield) is recalling 494,273 units of CURAD Reusable Gel Hot/Cold Packs due to a labeling mismatch. The product contains natural rubber latex, but this ingredient is not listed on the package label.
The failure to disclose the presence of latex creates a hazard for consumers with latex allergies, who may experience allergic reactions if exposed to the product.
The affected product was distributed in the United States and internationally to Bahamas, Bermuda, Panama, Lebanon, Barbados, Honduras, and Anguilla. Consumers with latex allergies who own an affected CURAD Reusable Gel Hot/Cold Pack can identify it using the item numbers and lot codes provided by the FDA.
If you own an affected product and have a latex allergy, stop using it immediately and contact Medline Industries or your healthcare provider for guidance.
The recalled product
- Product
- CURAD REUSABLE GEL HOT/COLD PACK
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Affected units
- 494,273
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
Distribution scope not specified by the agency.
Related recalls
Same manufacturer · MEDLINE INDUSTRIES, LP - Northfield
See all →- CriticalIntubation trays recalled after laryngoscope handle lights failed to illuminate
FDA (Devices) · 2025-10-01
- SevereMedline Medical Convenience Kits with Defective Laryngoscope Handles
FDA (Devices) · 2025-10-01
- HighGood Neighbor alcohol prep pads recalled for alcohol below labeled concentration
FDA (Drugs) · 2025-09-03
- HighSurgical kits recalled because Foley tray inserts carry incorrect product information
FDA (Devices) · 2025-09-03
- HighSurgery trays recalled because they contain recalled tourniquet cuffs
FDA (Devices) · 2025-09-03
Same hazard · allergen latex
See all →- HighHalyard DAVINCI TRUCUSTOM Foley Catheter Kits Recalled for Latex Labeling Deficiency
FDA (Devices) · 2026-09-02
- ModerateAVID Medical Recalls Halyard Total Joint Kits for Latex Labeling Error
FDA (Devices) · 2026-09-02
- ModerateAVID Medical Recalls Halyard Total Joint Kits for Latex Labeling Deficiency
FDA (Devices) · 2026-09-02
- ModerateWelch Allyn DuraShock Aneroid Gauge Sets Reusable Blood Pressure Cuff Recall
FDA (Devices) · 2025-04-23
- HighWelch Allyn Reusable Blood Pressure Cuff Kits Recalled for Undeclared Rubber
FDA (Devices) · 2025-04-23
Similar recalls
- HighFDA Recalls Medline Leg Bags for Undeclared Latex
FDA (Devices) · 2023-12-20
- HighMedline Leg Bags Recalled Due to Undeclared Latex
FDA (Devices) · 2023-12-20
- HighMedical Device Recall: Medline Leg Bag with Undeclared Latex
FDA (Devices) · 2023-12-20
- HighFabric bandages recalled over open package seals affecting product sterility
FDA (Devices) · 2025-12-17
- HighSoft Cream Spread Recalled for Undeclared Milk Allergen
FDA (Food) · 2023-07-26
- HighHigh Liner Foods Recalls Summer Herb Crusted Cod for Undeclared Milk
FDA (Food) · 2017-08-23