EXP Pharmaceutical Services Recalls Unregistered Auto Suture Endo Universal Devices
EXP Pharmaceutical Services Corp is recalling three Auto Suture Endo Universal devices because the company failed to register as a medical device establishment or establish its own 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 indicates the hazard is administrative (failure to register and establish quality systems) 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 three units of Auto Suture Endo Universal 65 4mm devices. These sterile, single-use devices are packaged in Tyvek/Mylar pouches and are intended for use in laparoscopic general and plastic surgery. The devices were distributed in the District of Columbia and the states of Colorado, California, Florida, Texas, and Arkansas.
The recall was initiated because EXP Pharmaceutical Services Corp 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 the fact that its vendors were registered and had their own quality systems. The agency has classified this recall as Class II.
Consumers and healthcare facilities that have received these specific devices should stop using them and contact EXP Pharmaceutical Services Corp for further instructions. The recall involves a limited quantity of three units.
The recalled product
- Product
- Medical Device Exchange - Auto Suture Endo Universal 65¿¿ 4mm; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 173054; EXP (repackager), Tyco (OEM) Laparoscope, General & Plastic Surgery
- Manufacturer
- EXP Pharmaceutical Services Corp
- Affected units
- 3
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 173054.
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 Specimen Retriever Bags Due to Registration Issues
FDA (Devices) · 2015-08-05
Same hazard · regulatory non compliance
See all →- ModerateMedline 10mL Polycarbonate Colored Syringes in Convenience Kits Recalled
FDA (Devices) · 2026-07-01
- ModerateMedline 10mL Polycarbonate Colored Syringes Convenience Kits Recalled
FDA (Devices) · 2026-07-01
- SevereMedline 10mL Polycarbonate Syringes in Medical Procedure Kits Recalled
FDA (Devices) · 2026-07-01
- 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