Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

MEDLINE convenience kits labeled as: 1) GENERAL LAPAROSCOPY Recalled by Medline Industries, LP Due to Medline Industries, LP is issuing a recall for...

Date: September 30, 2025
Company: Medline Industries, LP
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Medline Industries, LP directly.

Affected Products

MEDLINE convenience kits labeled as: 1) GENERAL LAPAROSCOPY, REF CDS930027W; 2) GENERAL MAJOR CDS, REF CDS980245X; 3) BASIC GENERAL CDS, REF CDS980566F; 4) TOTAL KNEE CDS, REF CDS982823R; 5) BASIC CDS, REF CDS982936U; 6) UPPER EXTREMITY CDS, REF CDS983907M; 7) MAJOR ABDOMINAL CDS, REF CDS983908Q; 8) LOWER EXTREMITY CDS, REF CDS983909Q; 9) GENERAL SURGERY CDS, REF CDS983914M; 10) GENERAL ORTHO CDS, REF CDS983915N; 11) GENERAL LAP, REF CDS984251O; 12) ROBOTIC, REF CDS984262O; 13) HYPOSPADIUS PACK, REF DYNJ00282Q; 14) MINOR HARPER PACK-LF, REF DYNJ0161694F; 15) THROMBECTOMY HARPER PACK-LF, REF DYNJ0161832F; 16) MAJOR COMPONENT HARPER PACK-LF, REF DYNJ0161949C; 17) MINOR PACK-LF, REF DYNJ0259893T; 18) TOTAL KNEE PACK LF, REF DYNJ0368519AA; 19) TOTAL KNEE PACK LF, REF DYNJ0368519Y; 20) PEDIATRIC BASIC PACK-LF, REF DYNJ0406353N; 21) DONOR FREE FLAP PACK-LF, REF DYNJ0426069O; 22) DONOR FREE FLAP PACK-LF, REF DYNJ0426069P; 23) VASCULAR PACK-LF, REF DYNJ0429345R; 24) GENERAL PACK-LF, REF DYNJ0506906S; 25) BASIC PACK-LF, REF DYNJ0519294K; 26) TOTAL HIP PACK-LF, REF DYNJ0537284AC; 27) TOTAL HIP PACK-LF, REF DYNJ0537284AD; 28) BASIC MAJOR PACK-LF, REF DYNJ0537337AA; 29) BASIC MAJOR PACK-LF, REF DYNJ0537337Y; 30) BASIC GENERAL PACK-LF, REF DYNJ14004N; 31) MVFF/FIBU #54-RF, REF DYNJ21927S; 32) AUGMENTATION #87-RF, REF DYNJ27319W; 33) BASIC SET-UP, REF DYNJ34979B; 34) BASIC PACK, REF DYNJ35834D; 35) MINOR SINGLE BASIN PACK, REF DYNJ37698M; 36) ISSAQUAH PEDIATRIC PACK, REF DYNJ39001F; 37) TOTAL JOINT PACK, REF DYNJ40982F; 38) BASIC PACK, REF DYNJ42791F; 39) TOTAL JOINT PACK, REF DYNJ42793F; 40) RRP PACK, REF DYNJ44109F; 41) CENTRACARE BASIC PACK, REF DYNJ44858J; 42) DONOR PACK, REF DYNJ44865G; 43) UROLOGY RECONSTRUCTION PACK, REF DYNJ44866P; 44) UROLOGY PACK, REF DYNJ44899R; 45) ENDOCRINE PACK-RF, REF DYNJ47131F; 46) ENDOCRINE PACK-RF, REF DYNJ47131G; 47) ORTHO MAJOR, REF DYNJ48131K; 48) ENDO BLADDER PACK, REF DYNJ49672M; 49) ORTHO SPINE SUPPLEMENT PACK-LF, REF DYNJ51445B; 50) MINOR GENERAL PACK, REF DYNJ53036J; 51) ACL PACK, REF DYNJ54634I; 52) READY SET CLOSE PACK, REF DYNJ57214C; 53) KIDNEY TRANSPLANT, REF DYNJ57455C; 54) TOTAL HIP PACK, REF DYNJ58563F; 55) TOTAL HIP PACK, REF DYNJ58563G; 56) TOTAL KNEE PACK, REF DYNJ58564F; 57) TRANSPLANT PACK, REF DYNJ59201D; 58) PACK RECTAL, REF DYNJ60156C; 59) C-SECTION PK CABRINI, REF DYNJ60577B; 60) MINI KIT PACK CABRINI, REF DYNJ60579B; 61) MAJOR GENERAL CHRISTUS, REF DYNJ61184D; 62) PK CUST BASIC PK CHRISTUS, REF DYNJ61647B; 63) THORACIC PACK, REF DYNJ62015B; 64) MAJOR GENERAL PACK, REF DYNJ62397B; 65) VASCULAR PACK, REF DYNJ62683D; 66) GENDER AFFIRMING SURGERY, REF DYNJ66252C; 67) GENDER AFFIRMING SURGERY, REF

Quantity: 20941 kits

Why Was This Recalled?

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.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Medline Industries, LP

Medline Industries, LP has 182 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report