Home › Device types › MLT
Pelvic Exam Kit
FDA product code MLT · Class 2 · Obstetrics/Gynecology
372
Registered devices
1
Adverse events
10
Recalls
1
510(k) clearances
Devices with this code
Centurion — CENTURION MEDICAL PRODUCTS CORPORATIONCenturion — CENTURION MEDICAL PRODUCTS CORPORATIONCARDINAL HEALTH — Cardinal Health 200, LLCMedline Industries, Inc. — MEDLINE INDUSTRIES, INC.Medline Industries, Inc. — MEDLINE INDUSTRIES, INC.CARDINAL HEALTH — Cardinal Health 200, LLCCenturion — CENTURION MEDICAL PRODUCTS CORPORATIONCenturion — CENTURION MEDICAL PRODUCTS CORPORATIONCenturion — CENTURION MEDICAL PRODUCTS CORPORATIONMEDLINE — MEDLINE INDUSTRIES, INC.Centurion — CENTURION MEDICAL PRODUCTS CORPORATIONCenturion — CENTURION MEDICAL PRODUCTS CORPORATIONCenturion — CENTURION MEDICAL PRODUCTS CORPORATIONCenturion — CENTURION MEDICAL PRODUCTS CORPORATIONCenturion — CENTURION MEDICAL PRODUCTS CORPORATIONCenturion — CENTURION MEDICAL PRODUCTS CORPORATIONCenturion — CENTURION MEDICAL PRODUCTS CORPORATIONMEDLINE INDUSTRIES, INC. — MEDLINE INDUSTRIES, INC.Medline Industries, Inc. — MEDLINE INDUSTRIES, INC.CARDINAL HEALTH — Cardinal Health 200, LLCCenturion — CENTURION MEDICAL PRODUCTS CORPORATIONCenturion — CENTURION MEDICAL PRODUCTS CORPORATIONMEDLINE INDUSTRIES, INC. — MEDLINE INDUSTRIES, INC.DeRoyal — DEROYAL INDUSTRIES, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-05-04 | Medline Industries, LP | During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularitie |
| 2026-04-27 | Medline Industries, LP | Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for applicat |
| 2025-03-03 | MEDLINE INDUSTRIES, LP - Northfield | There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits. |
| 2024-10-09 | MEDLINE INDUSTRIES, LP - Northfield | Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker. |
| 2024-04-08 | MEDLINE INDUSTRIES, LP - Northfield | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have bee |
| 2023-05-30 | DeRoyal Industries Inc | The outer package seal could be open, or compromised which affects the sterility of the procedure pack inside. |
| 2022-11-17 | MEDLINE INDUSTRIES, LP - Northfield | Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging. |
| 2019-12-11 | Centurion Medical Products Corporation | Incomplete seals on the sterile package may compromise the sterility |
| 2019-12-11 | Centurion Medical Products Corporation | Incomplete seals on the sterile package may compromise the sterility |
| 2019-12-11 | Centurion Medical Products Corporation | Incomplete seals on the sterile package may compromise the sterility |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsSourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.