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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Surgical Equipment

Medline Surgical Kits Recalled for Incorrect Suture and Needle Sizes

Agency Publication Date: November 25, 2024
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Summary

Medline Industries has issued a voluntary recall for 816 surgical convenience kits because some suture packages inside the kits contain the incorrect needle type, needle size, suture diameter, or suture length. The recall affects several specialized kits, including those used for open-heart surgery, pacemaker implants, and shoulder repairs. Using the wrong suture or needle during a procedure could lead to difficulties in wound closure or surgical delays while medical staff search for the correct replacement components. No injuries or incidents have been reported to date.

Risk

The inclusion of incorrect suture or needle sizes in surgical kits can cause tissue trauma or lead to inadequate wound closure during surgery. Additionally, discovering the error during a procedure may cause unexpected delays that increase the time a patient is under anesthesia.

What You Should Do

  1. The recalled products include several types of Medline surgical convenience kits: Open Heart CDS, Dr. Davies CV, Pacer Implant Pack, Thoracotomy Morristown, and Shoulder Repair Pack-LF.
  2. Check the catalog number (REF) and lot number on your product packaging. Affected catalog numbers include CDS840132O, DYNJ903016G, DYNJ59194A, DYNJ904220F, and DYNJ82607. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled surgical kits immediately and remove them from your facility's inventory.
  4. Contact Medline Industries or your medical supply distributor to arrange for the return, replacement, or correction of the kits.
  5. Call the FDA at 1-888-463-6332 for additional questions regarding this recall.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Medline Open Heart CDS
Variants: Non-sterile, 1 kit/case
Model / REF:
CDS840132O
Lot Numbers:
24BBF701 (Exp 10/31/2024)
UDI:
10195327245276
40195327245277

Convenience kit containing incorrect needle and suture sizes.

Product: Medline Dr. Davies CV
Variants: Non-sterile, 1 kit/case
Model / REF:
DYNJ903016G
Lot Numbers:
24DBP801 (Exp 8/31/2025)
24CBJ749 (Exp 11/30/2024)
UDI:
10195327657154
40195327657155

Convenience kit containing incorrect needle and suture sizes.

Product: Medline Pacer Implant Pack
Variants: Sterile, 4 kits/case
Model / REF:
DYNJ59194A
Lot Numbers:
24DLA916 (Exp 12/31/2025)
24BLA030 (Exp 11/30/2025)
UDI:
10193489573480
40193489573481

Convenience kit containing incorrect needle and suture sizes.

Product: Medline Thoracotomy Morristown
Variants: Non-sterile, 1 kit/case
Model / REF:
DYNJ904220F
Lot Numbers:
24DLA070 (Exp 11/30/2024)
UDI:
10195327362300
40195327362301

Convenience kit containing incorrect needle and suture sizes.

Product: Medline Shoulder Repair Pack-LF
Variants: Sterile, 2 kits/case
Model / REF:
DYNJ82607
Lot Numbers:
24ABO552 (Exp 9/30/2025)
UDI:
10195327198930
40195327198931

Convenience kit containing incorrect needle and suture sizes.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95638
Status: Active
Manufacturer: MEDLINE INDUSTRIES, LP - Northfield
Sold By: Healthcare facilities; Direct distribution
Manufactured In: United States
Units Affected: 3 products (408 kits; 360 kits; 48 kits)
Distributed To: Alabama, Georgia, Massachusetts, New Jersey, Pennsylvania

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.