EXP recalls 12mm Dilating Tip Trocars due to registration violations
EXP Pharmaceutical Services Corp is recalling 12mm Dilating Tip Trocars because the company failed to register as a medical device establishment or maintain 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 driven by regulatory compliance failures (lack of registration and quality system) rather than a specific product defect or reported injury, fitting the criteria for a moderate severity voluntary or administrative recall.
Plain-English summary
EXP Pharmaceutical Services Corp is recalling 12 units of 12mm Dilating Tip Trocars with Stability Sleeves (OEM Catalog number D12LT). These sterile, single-use devices are intended for use with laparoscopes in general and plastic surgery. The products were distributed in the District of Columbia and the states of Colorado, California, Florida, Texas, and Arkansas.
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, which does not satisfy regulatory requirements for the repackager.
Consumers and healthcare facilities should stop using these devices and contact EXP Pharmaceutical Services Corp for further instructions or a refund.
The recalled product
- Product
- Medical Device Exchange - Dilating Tip Trocar w/Stability Sleeve 12mm; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number D12LT; EXP (repackager), Ethicon (OEM) Laparoscope, General & Plastic Surgery
- Manufacturer
- EXP Pharmaceutical Services Corp
- Affected units
- 12
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 D12LT.
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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