🔍 RecallPedia

MEDLINE convenience kits labeled as: 1) GYN LAPAROTOMY HARPER PACK-LF, REF DYNJ0160684F; 2) MAJOR LITHOTOMY PACK-LF, REF DYNJ0425778O; 3) MINOR VAGINAL #76-RF, REF DYNJ27434R; 4) ABDOMINAL HYST PACK, REF DYNJ44848M; 5) DA VINCI HYSTERECTOMY, REF DYNJ44863Q; 6) VAGINAL HYSTERECTOMY PACK, REF DYNJ44900P; 7) URO GYN, REF DYNJ50047G; 8) ISS VAG HYST PACK, REF DYNJ50315F; 9) PK MAJOR GYN ST MICHAEL C, REF DYNJ60554B; 10) VAGINAL HYSTERECTOMY PACK, REF DYNJ67194B; 11) LAVH, REF DYNJ900298L; 12) LITHOTOMY-LF, REF DYNJ900721C; 13) GP-T A H PACK-LF, REF PHS396954006G; 14) GP-VAG HYSTERECTOMY PACK-LF, REF PHS396975006F.

Class I - Dangerous
🏥 Medical Devices Recalled: September 30, 2025 Medline Industries Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    1) REF DYNJ0160684F: UDI/DI 10195327304287 (each) 40195327304288 (case), Lot Numbers: 23DDC245, 23GDC219; 2) REF DYNJ0425778O: UDI/DI 10198459082290 (each) 40198459082291 (case), Lot Numbers: 24LMF192; 3) REF DYNJ27434R: UDI/DI 10195327107727 (each) 40195327107728 (case), Lot Numbers: 24BBR389, 24CBH709; 4) REF DYNJ44848M: UDI/DI 10195327415952 (each) 40195327415953 (case), Lot Numbers: 23EDB911, 23FDC315, 23HDA180; 5) REF DYNJ44863Q: UDI/DI 10195327298227 (each) 40195327298228 (case), Lot Numbers: 23FDB122, 23GDC100; 6) REF DYNJ44900P: UDI/DI 10195327298548 (each) 40195327298549 (case), Lot Numbers: 23DDB824, 23EDA215, 23FDB287; 7) REF DYNJ50047G: UDI/DI 10195327107734 (each) 40195327107735 (case), Lot Numbers: 24BBE163, 24DBO682; 8) REF DYNJ50315F: UDI/DI 10195327535353 (each) 40195327535354 (case), Lot Numbers: 23KMF190; 9) REF DYNJ60554B: UDI/DI 10195327361747 (each) 40195327361748 (case), Lot Numbers: 23EBD224, 23KBE886; 10) REF DYNJ67194B: UDI/DI 10195327299699 (each) 40195327299690 (case), Lot Numbers: 23HBN435; 11) REF DYNJ900298L: UDI/DI 10195327554170 (each) 40195327554171 (case), Lot Numbers: 23LBF269, 23LBT933, 24BBT248; 12) REF DYNJ900721C: UDI/DI 10193489951608 (each) 40193489951609 (case), Lot Numbers: 23HBW996; 13) REF PHS396954006G: UDI/DI 10195327454159 (each) 40195327454150 (case), Lot Numbers: 23HDB088; 14) REF PHS396975006F: UDI/DI 10195327454166 (each) 40195327454167 (case), Lot Numbers: 23JDB593.
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Medline Industries, LP
Reason for Recall:
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has expanded the scope of their recall of SafeAir Smoke Evacuation Pencils previously initiated in October 2024, adding an additional 47 lots to the scope of the recall. The initial recall was due to the potential for product to activate without manual input when plugged into a power source or remain active after buttons are released.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

MEDLINE convenience kits labeled as: 1) GYN LAPAROTOMY HARPER PACK-LF, REF DYNJ0160684F; 2) MAJOR LITHOTOMY PACK-LF, REF DYNJ0425778O; 3) MINOR VAGINAL #76-RF, REF DYNJ27434R; 4) ABDOMINAL HYST PACK, REF DYNJ44848M; 5) DA VINCI HYSTERECTOMY, REF DYNJ44863Q; 6) VAGINAL HYSTERECTOMY PACK, REF DYNJ44900P; 7) URO GYN, REF DYNJ50047G; 8) ISS VAG HYST PACK, REF DYNJ50315F; 9) PK MAJOR GYN ST MICHAEL C, REF DYNJ60554B; 10) VAGINAL HYSTERECTOMY PACK, REF DYNJ67194B; 11) LAVH, REF DYNJ900298L; 12) LITHOTOMY-LF, REF DYNJ900721C; 13) GP-T A H PACK-LF, REF PHS396954006G; 14) GP-VAG HYSTERECTOMY PACK-LF, REF PHS396975006F.

Product Codes/Lot Numbers:

1) REF DYNJ0160684F: UDI/DI 10195327304287 (each) 40195327304288 (case), Lot Numbers: 23DDC245, 23GDC219; 2) REF DYNJ0425778O: UDI/DI 10198459082290 (each) 40198459082291 (case), Lot Numbers: 24LMF192; 3) REF DYNJ27434R: UDI/DI 10195327107727 (each) 40195327107728 (case), Lot Numbers: 24BBR389, 24CBH709; 4) REF DYNJ44848M: UDI/DI 10195327415952 (each) 40195327415953 (case), Lot Numbers: 23EDB911, 23FDC315, 23HDA180; 5) REF DYNJ44863Q: UDI/DI 10195327298227 (each) 40195327298228 (case), Lot Numbers: 23FDB122, 23GDC100; 6) REF DYNJ44900P: UDI/DI 10195327298548 (each) 40195327298549 (case), Lot Numbers: 23DDB824, 23EDA215, 23FDB287; 7) REF DYNJ50047G: UDI/DI 10195327107734 (each) 40195327107735 (case), Lot Numbers: 24BBE163, 24DBO682; 8) REF DYNJ50315F: UDI/DI 10195327535353 (each) 40195327535354 (case), Lot Numbers: 23KMF190; 9) REF DYNJ60554B: UDI/DI 10195327361747 (each) 40195327361748 (case), Lot Numbers: 23EBD224, 23KBE886; 10) REF DYNJ67194B: UDI/DI 10195327299699 (each) 40195327299690 (case), Lot Numbers: 23HBN435; 11) REF DYNJ900298L: UDI/DI 10195327554170 (each) 40195327554171 (case), Lot Numbers: 23LBF269, 23LBT933, 24BBT248; 12) REF DYNJ900721C: UDI/DI 10193489951608 (each) 40193489951609 (case), Lot Numbers: 23HBW996; 13) REF PHS396954006G: UDI/DI 10195327454159 (each) 40195327454150 (case), Lot Numbers: 23HDB088; 14) REF PHS396975006F: UDI/DI 10195327454166 (each) 40195327454167 (case), Lot Numbers: 23JDB593.

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0527-2026

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