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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 Sterile Basic Eye Packs Recalled for Open Packaging Seals

Agency Publication Date: November 14, 2025
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Summary

Medline Industries, LP has recalled 1,024 units of its MEDLINE STERILE BASIC EYE PACK 16 because the pouch packaging may have open seals. This defect could compromise the sterility of the instruments contained in the kits. The recall affects kits with reference numbers DYNJ37743D and DYNJ37743F with specific lot numbers distributed in Missouri.

Risk

Open seals on sterile packaging can expose surgical instruments to bacteria and other environmental contaminants. Using non-sterile instruments during an eye procedure significantly increases the risk of serious infection or other complications for the patient.

What You Should Do

  1. This recall affects MEDLINE STERILE BASIC EYE PACK 16 kits with reference (REF) numbers DYNJ37743D (Lot 25EMI333) and DYNJ37743F (Lot 25GMD927).
  2. Stop using the recalled eye procedure kits immediately to avoid the risk of patient infection.
  3. Contact Medline Industries, LP or your medical supply distributor to arrange for the return, replacement, or correction of any remaining affected stock.
  4. Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) for additional information 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 STERILE BASIC EYE PACK 16 (REF DYNJ37743D)
Model / REF:
DYNJ37743D
Lot Numbers:
25EMI333
UDI:
10193489600124
40193489600125

UDI/DI 10193489600124 is for individual units; 40193489600125 is for cases.

Product: MEDLINE STERILE BASIC EYE PACK 16 (REF DYNJ37743F)
Model / REF:
DYNJ37743F
Lot Numbers:
25GMD927
UDI:
10198459390685
40198459390686

UDI/DI 10198459390685 is for individual units; 40198459390686 is for cases.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97815
Status: Active
Manufacturer: Medline Industries, LP
Sold By: Medical supply distributors
Manufactured In: United States
Units Affected: 1024 units
Distributed To: Missouri

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.