Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported March 15, 2023
Tri-Staple 2.0 Black Intelligent Reload, Product Number SIG60AXT
Affected lots have the potential for a broken sled vane, which may cause the reload to misfire leading to non-functional staple line closure, transecting tissue without forming st…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Covidien, LP recalled Tri-Staple 2.0 Black Intelligent Reload, Product Number SIG60AXT - a moderate-severity action.
Tri-Staple 2.0 Black Intelligent Reload, Product Number SIG60AXT was recalled by Covidien, LP in March 15, 2023. Reason: Affected lots have the potential for a broken sled vane, which may cause the reload to misfire leading to non…. Check the official notice for the remedy. Verify recall #Z-1228-2023 with the FDA Devices before acting.
The recall
Covidien, LP issued this moderate-severity FDA Devices recall-Affected lots have the potential for a broken sled vane, which may cause the reload to misfire leading to non….
- Moderate
- severity level
- Class II
- classification
- March 15, 2023
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1228-2023 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1228-2023) was formally reported on March 15, 2023, with the manufacturer initiating the action on January 25, 2023. It is classified under Moderate severity (Class II), with a current status of Ongoing. Covidien, LP is listed as the recalling firm, operating out of North Haven, CT. Federal records list the affected scope as 264 US; 5056 OUS.
The documented reason for this recall is: Affected lots have the potential for a broken sled vane, which may cause the reload to misfire leading to non-functional staple line closure, transecting tissue without forming staples, and tissue hang-up. These conditi… Distribution data in the federal record shows the product reached: Worldwide distribution - US Nationwide distribution in the states of Arkansas, California, Florida, Georgia, Louisiana, Massachusetts, New York, North Carolina, Ohio, Washington and the countries of Australia, Austria,…. 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, 3 from FDA Devices - 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.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 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.
Affected scope
264 US; 5056 OUS
Related Recalls
6
3 from same agency
Product description
Tri-Staple 2.0 Black Intelligent Reload, Product Number SIG60AXT
Reason for recall
Affected lots have the potential for a broken sled vane, which may cause the reload to misfire leading to non-functional staple line closure, transecting tissue without forming staples, and tissue hang-up. These conditions may be associated to a delay to treatment, unspecified infection, hemorrhage/blood loss/bleeding, failure to anastomose, peritonitis, sepsis, pneumothorax, tissue trauma, or death.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-1228-2023 |
| Date reported | March 15, 2023 |
| Date initiated | January 25, 2023 |
| Recalling firm | Covidien, LP |
| Firm location | North Haven, CT |
| Affected scope | 264 US; 5056 OUS |
| Distribution | Worldwide distribution - US Nationwide distribution in the states of Arkansas, California, Florida, Georgia, Louisiana, Massachusetts, New York, North Carolina, Ohio, Washington and the countries of Australia, Austria, Belgium, Canada, Ca… |
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.
- Check the recall number (Z-1228-2023) 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? ▼
Tri-Staple 2.0 Black Intelligent Reload, Product Number SIG60AXT. Recalled by Covidien, LP. Units affected: 264 US; 5056 OUS.
Why was this product recalled? ▼
Affected lots have the potential for a broken sled vane, which may cause the reload to misfire leading to non-functional staple line closure, transecting tissue without forming staples, and tissue hang-up. These conditions may be associated to a delay to treatment, unspecified infection, hemorrhage/blood loss/bleeding, failure to anastomose, peritonitis, sepsis, pneumothorax, tissue trauma, or death.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 15, 2023. Severity: Moderate. Recall number: Z-1228-2023.
Where was the recalled product distributed? ▼
Distribution: Worldwide distribution - US Nationwide distribution in the states of Arkansas, California, Florida, Georgia, Louisiana, Massachusetts, New York, North Carolina, Ohio, Washington and the countries of Australia, Austria, Belgium, Canada, Canary Islands, Denmark, Finland, France, Germany, Ireland, Italy, Kuwait, Netherlands, New Caledonia, Norway, Poland, Portugal, Spain, Sweden, Switzerland, United Kingdom..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1228-2023) 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.
Nearby Recalls in This Category
Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
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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 March 15, 2023. 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.