FDA (Devices) recall action 97846
The FDA (Devices) publishes a recall like this one as 20 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 20 pages.
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.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Medline is recalling 12 Port Insertion Pack convenience kits containing SafeAir Smoke Evacuation Pencils, after Stryker expanded its recall of the pencils by 47 lots.
Medline is recalling 20,941 general surgery, laparoscopy and total knee convenience kits containing SafeAir Smoke Evacuation Pencils, after Stryker expanded its recall by 47 lots.
Medline is recalling 12 Cath Lab Pacemaker Pack convenience kits containing SafeAir Smoke Evacuation Pencils, after Stryker expanded its recall of the pencils by 47 lots.
Medline is recalling 120 Circumcision Pack convenience kits containing SafeAir Smoke Evacuation Pencils, after Stryker expanded its recall of the pencils by 47 lots.
Medline is recalling 570 gynecology laparotomy, lithotomy and hysterectomy convenience kits containing SafeAir Smoke Evacuation Pencils, after Stryker expanded its recall by 47 lots.
Medline is recalling 4,214 breast, abdominoplasty and plastics convenience kits containing SafeAir Smoke Evacuation Pencils, after Stryker expanded its recall by 47 lots.
Medline is recalling 48 LOCAL BASIC convenience kits containing SafeAir Smoke Evacuation Pencils, after Stryker expanded its recall of the pencils by 47 lots.
Medline is recalling 28,679 laparotomy convenience kits containing SafeAir Smoke Evacuation Pencils, after Stryker expanded its recall of the pencils by 47 lots.
Medline is recalling 40,151 neurosurgery, back and joint convenience kits containing SafeAir Smoke Evacuation Pencils, after Stryker expanded its recall of the pencils by 47 lots.
Medline is recalling 1,315 neurosurgery convenience kits containing SafeAir Smoke Evacuation Pencils, after Stryker expanded its recall of the pencils by 47 lots.
Medline is recalling 3,078 head and neck, ENT and thoracotomy convenience kits containing SafeAir Smoke Evacuation Pencils, after Stryker expanded its recall by 47 lots.
Medline is recalling 11,032 C-section convenience kits containing SafeAir Smoke Evacuation Pencils, after Stryker expanded its recall of the pencils by 47 lots.
Medline is recalling 301 breast biopsy and mastectomy convenience packs containing SafeAir Smoke Evacuation Pencils, after Stryker expanded its recall of the pencils by 47 lots.
Medline is recalling 345 Minor Eye Tray #81 convenience kits containing SafeAir Smoke Evacuation Pencils, after Stryker expanded its recall of the pencils by 47 lots.
Medline is recalling 1,921 basin convenience packs containing SafeAir Smoke Evacuation Pencils, after Stryker expanded its recall of the pencils by 47 lots.
Medline is recalling 424 major vaginal surgery convenience packs containing SafeAir Smoke Evacuation Pencils, after Stryker expanded its recall of the pencils by 47 lots.
Medline is recalling 5,133 vascular, carotid and open heart convenience kits containing SafeAir Smoke Evacuation Pencils, after Stryker expanded its recall by 47 lots.
Medline is recalling 142 central line and free flap convenience packs containing SafeAir Smoke Evacuation Pencils, after Stryker expanded its recall of the pencils by 47 lots.
Medline is recalling 18 GP-LEEP convenience packs containing SafeAir Smoke Evacuation Pencils, after Stryker expanded its recall of the pencils by 47 lots.
Medline is recalling 2,844 gynecology laparoscopy and robotic convenience kits containing SafeAir Smoke Evacuation Pencils, after Stryker expanded its recall of the pencils by 47 lots.