DeRoyal Recalls Pneugel Tennis Elbow Straps Due to Mold Complaints
DeRoyal Industries is recalling 791 units of Pneugel Tennis Elbow Straps because of complaints regarding mold on the product.
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 without reported illnesses or injuries, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
DeRoyal Industries Inc is recalling 791 units of Pneugel(R) Tennis Elbow Straps, Universal, Ref 12840000. The recall was initiated after the company received complaints of mold on the tennis elbow straps.
The affected product is a prescription-only medical device used for lateral and medial epicondylitis. The recall covers lots 47001, 49894, and 51311, which were distributed nationwide in the United States.
Consumers with this product should stop using it and contact DeRoyal Industries Inc for further instructions.
The recalled product
- Product
- PNEUGEL(R) TENNIS ELBOW STRAP, UNIVERSAL, REF 12840000, QTY: 1 Each, Rx Only, Product Usage: Lateral and medial epicondylitis
- Manufacturer
- DeRoyal Industries Inc
- Hazard
- Affected units
- 791
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 (3)
- Lots: 47001
- 49894
- and 51311
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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