ModerateClass IITerminated

FDA Devices recall · Reported August 8, 2018

1) Vascular Dilator, Sterile EO, Rx Only, Catalog #: DIL-100-12; 2) Dilator, Sterile EO, Rx Only, Catalog #: DIL-600-11; 3) Tearaway Introducer, Sterile EO, Rx Only, Catalog #: a) INT-028-14; b) INT-028-24; c) INT-029-05; d) INT-106-01; e) INT-106-14; 4) Micro-Access Tearaway Introducer Kit, Sterile EO, Rx Only, Catalog #: KIT-010-14; 5) Mini Tear Away Introducer Kit, Sterile EO, Rx Only, Catalog #: KIT-027-04; 6) LI-11 Plus G, Sterile EO, Catalog #: KIT-042-11; 7) LI-12 Plus

Q: Which agency issued this recall?

This recall was issued by the FDA Devices on August 8, 2018. Severity: Moderate. Recall number: Z-2559-2018.

Q: Where was the recalled product distributed?

Distribution: U.S.: MN, PA, VA, CA, UT, FL, NY, GA, LA, MO, TX, MS, OH, WA, MA, IL, KY, NC, and Puerto Rico; OUS: Canada, Australia, France, Germany, Ireland, Italy, Netherlands, Poland, Slovakia, Switzerland, Belgium, United Kingdom, Korea.

Q: How do I check if my product is affected by a recall?

Check the product description and recall number (Z-2559-2018) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.

Q: Should I stop using a recalled medication or medical device?

Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

The products listed might contain unsafe levels of bacterial endotoxins (Pyrogens) that were introduced during a manufacturing step. Bacterial Endotoxins also called pyrogenic bac…

Recall #: Z-2559-2018
Affected scope: 9050
Initiated: May 2, 2018

Compiled from official public sources by the editorial team.

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Galt Medical Corporation recalled 1) Vascular Dilator, Sterile EO, Rx Only, Catalog #: DIL-100-12; 2) Dilator, Sterile … - a moderate-severity action.

1) Vascular Dilator, Sterile EO, Rx Only, Catalog #: DIL-100-12; 2) Dilator, Sterile … was recalled by Galt Medical Corporation in August 8, 2018. Reason: The products listed might contain unsafe levels of bacterial endotoxins (Pyrogens) that were introduced durin…. Check the official notice for the remedy. Verify recall #Z-2559-2018 with the FDA Devices before acting.

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The recall

Galt Medical Corporation issued this moderate-severity FDA Devices recall-The products listed might contain unsafe levels of bacterial endotoxins (Pyrogens) that were introduced durin….

Moderate
severity level: 9K units
affected scope: Class II
classification: August 8, 2018
reported

Sourced from official FDA Devices enforcement records. Verify recall #Z-2559-2018 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This FDA Devices action (record #Z-2559-2018) was formally reported on August 8, 2018, with the manufacturer initiating the action on May 2, 2018. It is classified under Moderate severity (Class II), with a current status of Terminated. Galt Medical Corporation is listed as the recalling firm, operating out of Garland, TX. Federal records list the affected scope as 9050.

The documented reason for this recall is: The products listed might contain unsafe levels of bacterial endotoxins (Pyrogens) that were introduced during a manufacturing step. Bacterial Endotoxins also called pyrogenic bacteria can activate the inflammatory proc… Distribution data in the federal record shows the product reached: U.S.: MN, PA, VA, CA, UT, FL, NY, GA, LA, MO, TX, MS, OH, WA, MA, IL, KY, NC, and Puerto Rico; OUS: Canada, Australia, France, Germany, Ireland, Italy, Netherlands, Poland, Slovakia, Switzerland, Belgium, United Kin…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

Within the same product category the archive holds 6 closely related recalls - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.

Where this recall sits in the database

Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.

Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.

Severity

Moderate

Affected scope

9050

Related Recalls

0 from same agency

Product description

1) Vascular Dilator, Sterile EO, Rx Only, Catalog #: DIL-100-12; 2) Dilator, Sterile EO, Rx Only, Catalog #: DIL-600-11; 3) Tearaway Introducer, Sterile EO, Rx Only, Catalog #: a) INT-028-14; b) INT-028-24; c) INT-029-05; d) INT-106-01; e) INT-106-14; 4) Micro-Access Tearaway Introducer Kit, Sterile EO, Rx Only, Catalog #: KIT-010-14; 5) Mini Tear Away Introducer Kit, Sterile EO, Rx Only, Catalog #: KIT-027-04; 6) LI-11 Plus G, Sterile EO, Catalog #: KIT-042-11; 7) LI-12 Plus G, Sterile EO, Catalog #: KIT-042-12; 8) Micro-Access Tearaway Introducer Kit, Sterile EO, Catalog #: a) KIT-900-13; b) KIT-900-14; c) KIT-900-17; d) KIT-900-29; e) KIT-901-02; f) KIT-901-02; 9) "Micro-Access" Kit, Sterile EO, Catolog #: KIT-900-88 10) Mini Stick II Microintroducer Kit. Sterile EO, Rx Only, Catalog #: a) KIT-045-05; b) KIT-045-15;

Reason for recall

The products listed might contain unsafe levels of bacterial endotoxins (Pyrogens) that were introduced during a manufacturing step. Bacterial Endotoxins also called pyrogenic bacteria can activate the inflammatory process and produce fever, chills, and hypotension in a patient.

Recall Profile

Structured summary of the FDA Devices recall record
Attribute	Value
Agency	U.S. Food and Drug Administration
Severity class	Moderate (Class II)
Status	Terminated
Recall number	Z-2559-2018
Date reported	August 8, 2018
Date initiated	May 2, 2018
Recalling firm	Galt Medical Corporation
Firm location	Garland, TX
Affected scope	9050
Distribution	U.S.: MN, PA, VA, CA, UT, FL, NY, GA, LA, MO, TX, MS, OH, WA, MA, IL, KY, NC, and Puerto Rico; OUS: Canada, Australia, France, Germany, Ireland, Italy, Netherlands, Poland, Slovakia, Switzerland, Belgium, United Kingdom, Korea

Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.

Scale of Impact

9050 units affected - limited or regional distribution scale.

Regional (<10K units) ✓ This recall

Multi-state (10K – 100K units) -

Large-scale (100K – 1M units) -

Massive (≥1M units) -

Bracket cutoffs follow federal recall-disclosure conventions; bar widths scale linearly within each bracket. Source: PlainRecalls analysis of U.S. Food and Drug Administration filings.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

Check the recall number (Z-2559-2018) and product description against the item you own. Search the archive
Confirm the current status with FDA Devices before acting, recall details can be updated.
Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next

This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.

Frequently Asked Questions

What product was recalled? ▼

Why was this product recalled? ▼

Which agency issued this recall? ▼

This recall was issued by the FDA Devices on August 8, 2018. Severity: Moderate. Recall number: Z-2559-2018.

Where was the recalled product distributed? ▼

Distribution: U.S.: MN, PA, VA, CA, UT, FL, NY, GA, LA, MO, TX, MS, OH, WA, MA, IL, KY, NC, and Puerto Rico; OUS: Canada, Australia, France, Germany, Ireland, Italy, Netherlands, Poland, Slovakia, Switzerland, Belgium, United Kingdom, Korea.

How do I check if my product is affected by a recall? ▼

Check the product description and recall number (Z-2559-2018) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.

Should I stop using a recalled medication or medical device? ▼

Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported August 8, 2018. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.