Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported June 26, 2024
MONOCRYL (poliglecaprone 25) Suture - Intended for use in general soft tissue approximation and/or ligation where an absorbable material is indicated PRODUCT CODE: Y315H Y345H Y359H Y398H Y416H Y417H Y426H Y427H Y935H Y936H Y945H
Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Ethicon, Inc. recalled MONOCRYL (poliglecaprone 25) Suture - Intended for use in general soft tissue approximati… - a moderate-severity action.
MONOCRYL (poliglecaprone 25) Suture - Intended for use in general soft tissue approximati… was recalled by Ethicon, Inc. in June 26, 2024. Reason: Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromi…. Check the official notice for the remedy. Verify recall #Z-2148-2024 with the FDA Devices before acting.
The recall
Ethicon, Inc. issued this moderate-severity FDA Devices recall-Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromi….
- Moderate
- severity level
- 306K units
- affected scope
- Class II
- classification
- June 26, 2024
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2148-2024 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2148-2024) was formally reported on June 26, 2024, with the manufacturer initiating the action on May 10, 2024. It is classified under Moderate severity (Class II), with a current status of Ongoing. Ethicon, Inc. is listed as the recalling firm, operating out of Raritan, NJ. Federal records list the affected scope as 306000 units, a scale large enough to require multi-state distribution tracking.
The documented reason for this recall is: Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection . Distribution data in the federal record shows the product reached: Worldwide distribution - US Nationwide including PR and the countries of AR, AU, AU, BE, BR, CA, CA, CL, CN, CO, CR, EC, IL, JP, JP, KW, MX, NZ, PA, PR, PR, SA, SG, UY, ZA.. 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
306000 units
Related Recalls
6
3 from same agency
Product description
MONOCRYL (poliglecaprone 25) Suture - Intended for use in general soft tissue approximation and/or ligation where an absorbable material is indicated PRODUCT CODE: Y315H Y345H Y359H Y398H Y416H Y417H Y426H Y427H Y935H Y936H Y945H
Reason for recall
Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-2148-2024 |
| Date reported | June 26, 2024 |
| Date initiated | May 10, 2024 |
| Recalling firm | Ethicon, Inc. |
| Firm location | Raritan, NJ |
| Affected scope | 306000 units |
| Distribution | Worldwide distribution - US Nationwide including PR and the countries of AR, AU, AU, BE, BR, CA, CA, CL, CN, CO, CR, EC, IL, JP, JP, KW, MX, NZ, PA, PR, PR, SA, SG, UY, ZA. |
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-2148-2024) 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? ▼
MONOCRYL (poliglecaprone 25) Suture - Intended for use in general soft tissue approximation and/or ligation where an absorbable material is indicated PRODUCT CODE: Y315H Y345H Y359H Y398H Y416H Y417H Y426H Y427H Y935H Y936H Y945H. Recalled by Ethicon, Inc.. Units affected: 306000 units.
Why was this product recalled? ▼
Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 26, 2024. Severity: Moderate. Recall number: Z-2148-2024.
Where was the recalled product distributed? ▼
Distribution: Worldwide distribution - US Nationwide including PR and the countries of AR, AU, AU, BE, BR, CA, CA, CL, CN, CO, CR, EC, IL, JP, JP, KW, MX, NZ, PA, PR, PR, SA, SG, UY, ZA..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2148-2024) 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 June 26, 2024. 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.