Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported December 4, 2024
(1) Medline Open Heart CDS, REF CDS840132O, packaged 1 kit/case, non-sterile; and (2) Medline Dr. Davies CV, REF DYNJ903016G, packaged 1 kit/case, non-sterile.
Some of the suture packages within the convenience kits contain the incorrect needle type/size and suture diameter/length.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Medline Industries, LP - Northfield recalled (1) Medline Open Heart CDS, REF CDS840132O, packaged 1 kit/case, non-sterile; and (2) Me… - a moderate-severity action.
(1) Medline Open Heart CDS, REF CDS840132O, packaged 1 kit/case, non-sterile; and (2) Me… was recalled by Medline Industries, LP - Northfield in December 4, 2024. Reason: Some of the suture packages within the convenience kits contain the incorrect needle type/size and suture dia…. Check the official notice for the remedy. Verify recall #Z-0532-2025 with the FDA Devices before acting.
The recall
Medline Industries, LP - Northfield issued this moderate-severity FDA Devices recall-Some of the suture packages within the convenience kits contain the incorrect needle type/size and suture dia….
- Moderate
- severity level
- Class II
- classification
- December 4, 2024
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0532-2025 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0532-2025) was formally reported on December 4, 2024, with the manufacturer initiating the action on October 15, 2024. It is classified under Moderate severity (Class II), with a current status of Ongoing. Medline Industries, LP - Northfield is listed as the recalling firm, operating out of Northfield, IL. Federal records list the affected scope as 408 kits.
The documented reason for this recall is: Some of the suture packages within the convenience kits contain the incorrect needle type/size and suture diameter/length. Distribution data in the federal record shows the product reached: US Nationwide distribution in the states of AL, GA, MA, NJ, and PA.. 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
408 kits
Related Recalls
6
3 from same agency
Product description
(1) Medline Open Heart CDS, REF CDS840132O, packaged 1 kit/case, non-sterile; and (2) Medline Dr. Davies CV, REF DYNJ903016G, packaged 1 kit/case, non-sterile.
Reason for recall
Some of the suture packages within the convenience kits contain the incorrect needle type/size and suture diameter/length.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-0532-2025 |
| Date reported | December 4, 2024 |
| Date initiated | October 15, 2024 |
| Recalling firm | Medline Industries, LP - Northfield |
| Firm location | Northfield, IL |
| Affected scope | 408 kits |
| Distribution | US Nationwide distribution in the states of AL, GA, MA, NJ, and PA. |
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-0532-2025) 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? ▼
(1) Medline Open Heart CDS, REF CDS840132O, packaged 1 kit/case, non-sterile; and (2) Medline Dr. Davies CV, REF DYNJ903016G, packaged 1 kit/case, non-sterile.. Recalled by Medline Industries, LP - Northfield. Units affected: 408 kits.
Why was this product recalled? ▼
Some of the suture packages within the convenience kits contain the incorrect needle type/size and suture diameter/length.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 4, 2024. Severity: Moderate. Recall number: Z-0532-2025.
Where was the recalled product distributed? ▼
Distribution: US Nationwide distribution in the states of AL, GA, MA, NJ, and PA..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0532-2025) 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 December 4, 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.