Medical device shoulder pack recalled by DeRoyal Industries
DeRoyal Industries recalled 48 units of its shoulder pack medical device (Lot 57755295) on November 3, 2022. The specific reason for the recall was not disclosed in available documentation.
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: FDA Class II classification indicates potential for serious health consequences. No illnesses or injuries are reported, and the specific reason for recall was not disclosed in available documentation.
Plain-English summary
DeRoyal Industries Inc. initiated a voluntary recall of 48 units of the DeRoyal Shoulder Pack (Reference 89-9449.13, Lot 57755295 with expiration date April 1, 2025) beginning November 3, 2022.
The specific reason for the recall was not provided in publicly available FDA documentation. This is an FDA Class II recall, indicating the FDA determined the product poses potential for serious health consequences.
The recalled devices were distributed to 23 states including Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, and Mississippi.
The recall remains ongoing. Consumers and healthcare facilities in possession of affected units should contact DeRoyal Industries Inc. for further instructions regarding the recalled product.
The recalled product
- Product
- DeRoyal SHOULDER PACK, REF 89-9449.13
- Manufacturer
- DeRoyal Industries Inc
- Category
- Medical Device
- Affected units
- 48
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 (1)
- Lot Numbers: Lot 57755295 exp 4/1/2025
Distribution
Part of a larger recall action
This product is one of 156 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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