EXP Pharmaceutical Services Recalls Specimen Retriever Bags Due to Registration Issues
EXP Pharmaceutical Services Corp is recalling two units of specimen retriever bags because the company failed to register as a medical device establishment or establish its own quality system.
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. The hazard is a regulatory compliance failure (lack of registration and quality system) rather than a direct physical defect or reported injury, fitting the 'Moderate' criteria for administrative or low-risk issues.
Plain-English summary
EXP Pharmaceutical Services Corp is recalling two units of specimen retriever bags (OEM Catalog number 2444). The product is a sterile, single-use pouch made of Tyvek/Mylar, originally manufactured by Covidien and repackaged by EXP.
The recall was initiated because EXP did not register as a medical device establishment, did not list the devices being recalled, and did not establish its own quality system. Instead, the company relied on its vendors being registered and having their own quality systems.
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 these specific units and contact the recalling firm for further instructions.
The recalled product
- Product
- Medical Device Exchange BAG, SPECIMEN RETRIEVER ENDO; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 2444; EXP (repackager), Covidien (OEM) Specimen retriever bag.
- Manufacturer
- EXP Pharmaceutical Services Corp
- Affected units
- 2
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 2444.
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.
See all 42 products in this recall →Related recalls
Same manufacturer · EXP Pharmaceutical Services Corp
See all →- ModerateEXP Pharmaceutical Services Recalls Unregistered Medical Device Repackaging
FDA (Devices) · 2015-08-05
- ModerateEXP Pharmaceutical Services Recalls Tracheal Stent Sizing Devices
FDA (Devices) · 2015-08-05
- ModerateEXP Pharmaceutical Services Recalls Unregistered Airway Stent Systems
FDA (Devices) · 2015-08-05
- ModerateEXP Pharmaceutical Services Recalls Versaport Bladeless Trocar Devices
FDA (Devices) · 2015-08-05
- ModerateEXP Pharmaceutical Services Recalls Stryker Round Fluted Bur Devices
FDA (Devices) · 2015-08-05
Same hazard · regulatory non compliance
See all →- ModerateLimitless Cryo Spa LLC Recalls Glypto Devices for Lack of 510(k) Clearance
FDA (Devices) · 2026-10-14
- SevereSempio Recalls Ready-to-Eat Chicken Stew Imported Without Reinspection
USDA FSIS · 2026-09-25
- ModerateMedline Polycarbonate Syringes Recalled for Unapproved Design Changes
FDA (Devices) · 2026-07-01
- SevereMedline polycarbonate syringes recalled for unapproved design changes
FDA (Devices) · 2026-07-01
- ModerateMedline 10mL Polycarbonate Syringes Recalled for Unapproved Design Changes
FDA (Devices) · 2026-07-01
Similar recalls
- ModerateRecall of Sterile Specimen Containers Due to Packaging Defect
FDA (Devices) · 2016-12-21
- CriticalCustomed Recalls EENT Surgical Packs Due to Packaging Integrity Concerns
FDA (Devices) · 2014-09-10
- SevereCustomed Recalls OB Packs Due to Potential Packaging Integrity Compromise
FDA (Devices) · 2014-09-10
- HighMedical Device Packs Recalled for Improper Sterilization Process
FDA (Devices) · 2023-11-01
- SevereCustomed Recalls EO Sterilized ENT Surgical Packs Due to Packaging Integrity Concerns
FDA (Devices) · 2014-09-10
- SevereCustomed Recalls Laparoscopy Packs Due to Potential Packaging Integrity Issues
FDA (Devices) · 2014-09-10