Go Backs
HomeCategoriesStatesCheck Your Home
Go Backs

Track product recalls and safety alerts from CPSC, FDA, NHTSA, and USDA. Stay informed and keep your family safe.

Browse

  • Categories
  • States
  • Check Your Home
  • Risk Levels

Agencies

  • CPSC
  • FDA Food
  • FDA Drug
  • FDA Device
  • FDA Veterinary
  • NHTSA
  • USDA

Company

  • About
  • FAQ
  • Contact
  • Terms of Service
  • Privacy Policy
Buy Me a Coffee

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.

ยฉ 2026 Go Backs. All rights reserved.

Medium RiskFDA Device
Medical Devices/Surgical Equipment

Medline Surgical Instruments Recalled for Compromised Sterility Risk

Agency Publication Date: December 23, 2024
Share:
Sign in to monitor this recall

Summary

Medline Industries has recalled various sterile surgical instruments, including hemostats, scissors, needleholders, forceps, curettes, IUD hooks, and rummell instruments. Verbatim reports indicate that approximately 21,440 units are affected by this recall. The tools were recalled because weak seals on their packaging could result in a breach of sterility, potentially leading to patient infections. No injuries or incidents have been reported to date.

Risk

The weak seals on the product packaging may allow outside contaminants to enter, causing the surgical instruments to lose their sterile status. If used during a medical procedure, these contaminated tools could cause a serious infection in a patient. The breach in sterility might not be visible to the user before the instrument is used.

What You Should Do

  1. This recall affects various sterile surgical instruments sold under the Medline brand, including Kelly Hemostats, O.R. Scissors, Mayo Hegar Needleholders, Magill Forceps, Bruns Curettes, IUD Removal Hooks, and Rummell instruments.
  2. Check the Medline Item Number and Lot Number on your instrument packaging to see if your product is affected. Affected items include Item Numbers 66695, DYND04000, 67870, 66790, 67600K, I68785, and ST006ST. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled product immediately.
  4. Contact Medline Industries or your medical distributor to arrange for the return, replacement, or correction of the instruments.
  5. Call the FDA Consumer Complaint hotline at 1-888-463-6332 (1-888-INFO-FDA) for additional questions.

Your Remedy Options

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

Affected Products

Product: STERILE STRT KELLY HEMOSTAT (SK8039S)
Model / REF:
66695
SK8039S
Lot Numbers:
2023011990
UDI:
00653160024869
60653160024861

Recall #: Z-0754-2025

Product: O.R. SCISSORS, S/B, 5.5 STERILE
Variants: S/B, 5.5 inch
Model / REF:
DYND04000
Lot Numbers:
2023052490
UDI:
10193489191349
20193489191346

Recall #: Z-0755-2025

Product: ST OR MAYO HEGAR NEEDLEHOLDER 6"(OR2500)
Variants: 6 inch
Model / REF:
67870
OR2500
Lot Numbers:
2023091290
UDI:
00653160196894
30653160196895

Recall #: Z-0756-2025

Product: STERILE MAGILL FORCEP (MAGF9)
Model / REF:
66790
MAGF9
Lot Numbers:
2023012390
UDI:
00653160007671
50653160007676

Recall #: Z-0757-2025

Product: ST REPROCESSED BRUNS CURETTE #00 (BC00)
Variants: #00
Model / REF:
67600K
BC00
Lot Numbers:
2023012490
UDI:
10653160382140
00653160382143

Recall #: Z-0758-2025

Product: ST IUD REMOVAL HOOK 10" (504090)
Variants: 10 inch
Model / REF:
I68785
504090
Lot Numbers:
2023021390
UDI:
10653160327141
00653160327144

Recall #: Z-0759-2025

Product: RUMMELL
Model / REF:
ST006ST
Lot Numbers:
2023111490
UDI:
10653160251224
00653160251227

Recall #: Z-0760-2025

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95843
Status: Active
Manufacturer: MEDLINE INDUSTRIES, LP - Northfield
Sold By: Medline Industries; Medical distributors; Hospitals; Surgical centers
Manufactured In: United States
Units Affected: 7 products (21,440 total)
Distributed To: Nationwide

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.