EXP Pharmaceutical Services Recalls Unregistered Medical Device Exchange Surgical Gowns
EXP Pharmaceutical Services Corp is recalling 10 units of Medical Device Exchange Surgical Gowns because the company failed to register as a medical device establishment or establish a quality system.
What this means for you
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, but the source text identifies the issue as a regulatory compliance failure (lack of registration and quality system) rather than a direct physical defect or reported injury, fitting the criteria for a moderate severity voluntary or administrative recall.
Plain-English summary
EXP Pharmaceutical Services Corp is recalling 10 units of Medical Device Exchange Surgical Gowns - Flyte Hood Pouch, Tyvek/Mylar, Sterile, Single Use Only. The product is identified by OEM Catalog number 408-800. The gowns are intended for person protection during surgery.
The recall was initiated because EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system. Instead, the company relied on its vendors being registered and having their own quality systems. The agency classification for this recall is Class II.
The affected units were distributed in the District of Columbia and the states of Colorado, California, Florida, Texas, and Arkansas. Consumers and healthcare facilities should stop using the recalled gowns and contact EXP Pharmaceutical Services Corp for instructions on return or disposal.
The recalled product
- Product
- Medical Device Exchange Surgical Gown - Flyte Hood Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 408-800 EXP (repackager) Stryker (OEM) Person protection during surgery.
- Manufacturer
- EXP Pharmaceutical Services Corp
- Category
- Medical Device — Surgical Gowns
- Affected units
- 10
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)
- OEM Catalog number 408-800
Distribution
Part of a larger recall action
This product is one of 42 recalled by EXP Pharmaceutical Services Corp 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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