DeRoyal Recalls PneuGel Tennis Elbow Supports Due to Mold Complaints
DeRoyal Industries is recalling 56 units of PneuGel tennis elbow supports because of complaints regarding mold on the straps.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves mold contamination on a medical device. No illnesses or injuries are reported in the source text, fitting the criteria for a moderate severity score.
Plain-English summary
DeRoyal Industries Inc is recalling 56 units of PneuGel tennis elbow supports, reference number 200A10. The product is a prescription-only medical device used for lateral and medial epicondylitis. The recall was initiated after the company received complaints about mold on the tennis elbow straps.
The affected units were distributed nationwide in the United States. The specific lot numbers involved in this recall are 42249787, 42490802, 42737908, 42944296, 43000801, 43031421, 43036118, 43068890, 43134851, 4363109, and 43454441.
Consumers who possess these specific units should stop using the product and contact DeRoyal Industries Inc for further instructions on how to proceed with the recall.
The recalled product
- Product
- TENNIS ELBOW SUPPORT, PneuGel(TM), UNIVERSAL, REF 200A10, QTY: 1 Each, Rx Only, Product Usage: Lateral and medial epicondylitis
- Manufacturer
- DeRoyal Industries Inc
- Hazard
- Affected units
- 56
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 (11)
- Lots: 42249787
- 42490802
- 42737908
- 42944296
- 43000801
- 43031421
- 43036118
- 43068890
- 43134851
- 4363109
- and 43454441
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by DeRoyal Industries Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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