Severity
Moderate
FDA Devices recall · Reported August 1, 2018
Blast Bandages (part# BLAST) with Lot# 0617 were not terminally sterilized.
Tactical Medical Solutions, Inc. recalled BLAST Bandage, sterile. - a moderate-severity action.
BLAST Bandage, sterile. was recalled by Tactical Medical Solutions, Inc. in August 1, 2018. Reason: Blast Bandages (part# BLAST) with Lot# 0617 were not terminally sterilized.. Check the official notice for the remedy. Verify recall #Z-2538-2018 with the FDA Devices before acting.
The recall
Tactical Medical Solutions, Inc. issued this moderate-severity FDA Devices recall-Blast Bandages (part# BLAST) with Lot# 0617 were not terminally sterilized..
Sourced from official FDA Devices enforcement records. Verify recall #Z-2538-2018 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
This FDA Devices action (record #Z-2538-2018) was formally reported on August 1, 2018, with the manufacturer initiating the action on April 17, 2018. It is classified under Moderate severity (Class II), with a current status of Terminated. Tactical Medical Solutions, Inc. is listed as the recalling firm, operating out of Anderson, SC. Federal records list the affected scope as 1,097 units.
The documented reason for this recall is: Blast Bandages (part# BLAST) with Lot# 0617 were not terminally sterilized. Distribution data in the federal record shows the product reached: Domestic distribution to AL, AP, AZ, CA, CO, CT, DC, FL, GA, ID, IL, IN, KS, KY, MA, MD, ME, MI, MO, MS, NC, ND, NM, NY, OH, PA, SC, TX, VA, WI. International distribution to Austria, Canada, France, Kenya, Latvia,…. 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 its category - 40,422 medical devices recalls on record
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
1,097 units
Related Recalls
6
0 from same agency
BLAST Bandage, sterile.
Blast Bandages (part# BLAST) with Lot# 0617 were not terminally sterilized.
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2538-2018 |
| Date reported | August 1, 2018 |
| Date initiated | April 17, 2018 |
| Recalling firm | Tactical Medical Solutions, Inc. |
| Firm location | Anderson, SC |
| Affected scope | 1,097 units |
| Distribution | Domestic distribution to AL, AP, AZ, CA, CO, CT, DC, FL, GA, ID, IL, IN, KS, KY, MA, MD, ME, MI, MO, MS, NC, ND, NM, NY, OH, PA, SC, TX, VA, WI. International distribution to Austria, Canada, France, Kenya, Latvia, Netherlands, New Ze… |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
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.
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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 1, 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.