Agency classClass IIOur severity:High FDA (Devices)·Z-2565-2018·Announced 2018-08-08

Galt Medical Recalls Tearaway Introducers Due to Bacterial Endotoxins

Galt Medical Corporation is recalling specific lots of Tearaway Introducers because they may contain unsafe levels of bacterial endotoxins introduced during manufacturing.

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: The recall involves a medical device with a risk of harm (fever, chills, hypotension) due to bacterial endotoxins, but no specific injuries or illnesses are reported in the source text, fitting the 'High' criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Galt Medical Corporation is recalling specific lots of Tearaway Introducers. The recall involves 23,777 units distributed across 19 U.S. states, Puerto Rico, and 13 international countries. The affected products include various catalog numbers such as BNS-000-07, DIL-015-50, and DSS-005-11, among others.

The recall was initiated because the products might contain unsafe levels of bacterial endotoxins, also known as pyrogens, which were introduced during a manufacturing step. Bacterial endotoxins can activate the inflammatory process and produce fever, chills, and hypotension in a patient.

Healthcare providers and consumers should stop using the affected lots immediately. The specific lot numbers are listed in the structured product information. Users should contact Galt Medical Corporation for further instructions or to return the products.

The recalled product

Product: Tearaway Introducers, Catalog #: a) BNS-000-07, b) BNS-000-10; c) DIL-015-50; d) DSS-005-11; e) DSS-005-12; f) DSS-006-045; g) DSS-007-05; h) DSS-007-165; i) DSS-010-03; j) DSS-010-04; k) DSS-010-045; l) DSS-010-05; m) DSS-012-07; n) SPT-003-46
Manufacturer: Galt Medical Corporation
Category: Medical Device — Surgical Instruments
Hazard: bacterial-endotoxins
fever
hypotension
Affected units: 23,777

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 (20)

Lot #: a) 18024880
18043086
18066833
18073282
b) 18039555
18059249
18074835
c) 17363134
d) 17352818
18051601
e) 18019228
18047509
f) 18023833
g) 17356436
18018694
18018695
18040074
h) 18061579
i) 18015027
j) 18019038

Distribution

Distributed in 19 states:

Part of a larger recall action

This product is one of 8 recalled by Galt Medical Corporation 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 8 products in this recall →

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Same hazard · bacterial endotoxins