MEDLINE convenience kits labeled as: 1) GYN LAPAROTOMY HARPER PACK-LF, REF DYNJ0160684F; 2) MAJOR LITHOTOMY PACK-LF
Summary
The FDA issued a Class II for MEDLINE convenience kits labeled as: 1) GYN LAPAROTOMY HARPER PACK-LF, REF DY by Medline Industries, LP. Reason: Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instru.
Details
Source
Device Recall
External ID
Z-0527-2026
Action Date
2025-11-26
Status
Ongoing
Category
device
Product 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.
Lot/Code Info: 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.
Quantity Affected: 570 kits
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.
Distribution
US Nationwide distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-09-30
Company
Northfield, IL
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 222 device recalls issued in the same week, part of 413 device-related FDA actions this month.
Medline Industries, LP has 442 FDA actions in our database, including 415 recalls and 27 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Medline Industries, LP) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Medline Industries, LP have FDA actions?
Medline Industries, LP has 442 FDA actions in our database, including 415 recalls and 27 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0527-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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