FDA Medical devices recall ·
MEDLINE Medical Procedure Kits labeled as CLOVIS HYSTEROSCOPY… recall
- Recall number
- Z-2505-2026
- Date
- (initiated May 4, 2026)
- Company / brand
- Medline Industries, LP
3 Lakes Dr, Northfield, IL, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 37324 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
MEDLINE Medical Procedure Kits labeled as CLOVIS HYSTEROSCOPY, CSC-N PELVISCOPY, D AND C PACK, D&C HYSTER PACK, FLWR GYN PACK, FS LAP TUBAL LIGATION, HILLSDALE D&C / HYSTEROSCOPY, LAVH NEW BRAUNFELS,TVH PACK, etc (see recall documents for a full list of affected products)
Why was it recalled?
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Medline Kit Number/SKU DYNJ61063A: UDI/DI 10193489640458 (each), 40193489640459 (case), Lot Number 21KBV571; Medline Kit Number/SKU DYNJ61063B: UDI/DI 10195327193478 (each), 40195327193479 (case), Lot Number 23EBU351; Medline Kit Number/SKU DYNJ61063B: UDI/DI 10195327193478 (each), 40195327193479 (case), Lot Number 23DBQ190; Medline Kit Number/SKU DYNJ61063B: UDI/DI 10195327193478 (each), 40195327193479 (case), Lot Number 23BBE364; Medline Kit Number/SKU DYNJ61063B: UDI/DI 10195327193478 (each), 40195327193479 (case), Lot Number 22IBW094; Medline Kit Number/SKU DYNJ61063C: UDI/DI 10195327451684 (each), 40195327451685 (case), Lot Number 26CMK666; Medline Kit Number/SKU DYNJ61063C: UDI/DI 10195327451684 (each), 40195327451685 (case), Lot Number 26BMG709; Medline Kit Number/SKU DYNJ61063C: UDI/DI 10195327451684 (each), 40195327451685 (case), Lot Number 26AMI644; Medline Kit Number/SKU DYNJ61063C: UDI/DI 10195327451684 (each), 40195327451685 (case), Lot Number 25KMD133; Medline Kit Number/SKU DYNJ61063C: UDI/DI 10195327451684 (each), 40195327451685 (case), Lot Number 25JMA568; Medline Kit Number/SKU DYNJ61063C: UDI/DI 10195327451684 (each), 40195327451685 (case), Lot Number 25IMF717; Medline Kit Number/SKU DYNJ61063C: UDI/DI 10195327451684 (each), 40195327451685 (case), Lot Number 25HMJ595; Medline Kit Number/SKU DYNJ61063C: UDI/DI 10195327451684 (each), 40195327451685 (case), Lot Number 25FMH149; Medline Kit Number/SKU DYNJ61063C: UDI/DI 10195327451684 (each), 40195327451685 (ca
Distribution
Worldwide distribution - US Nationwide and the countries of AE, BB, BM, BS, CA, CY, GU, NL, PA, QA, SA, VI.
States: California Pennsylvania
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2505-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.