Medline Industries, LP recalls FORCEP
Reason for recall
The items may have weak packaging seals that may result in a breach of sterility if the seal fails and may lead to an increased risk of infection if product is utilized.
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
Affected products & lots
- FORCEP, STD STR, STERILE KELLY, 5.5 IN, Item NumberDYNJ04048UDI-DI 10193489195248Affected lot2023112290
What the firm is doing
An URGENT MEDICAL DEVICE RECALL notification letter dated 11/13/25 was sent to customers. REQUIRED ACTION: 1. Immediately check your stock for the affected item number(s) and the affected lot number(s) listed on the enclosed response form. Quarantine all affected product. Upon completion of the below actions, please destroy affected product. 2. Please complete and return the enclosed response form listing the quantity of affected product you have in inventory. Even if you do not have any affected product in inventory, please complete and return the response form. 3. Your account will receive credit once the response form is submitted, if applicable. 4. If you are a distributor, or have resold or transferred this product to another company or individual, you are required by FDA regulations to notify them of this recall communication. Please request that customers destroy any affected product. You should include your customers quantities on your response form. If you have any questions, contact the Recall Department at 866-359-1704 or recalls@medline.com.
DistributionShow detailsHide
US Nationwide distribution in the states CA, CO, IL, KS, and MI.
Use of the product may cause temporary or medically reversible adverse health consequences.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-0922-2026
- FDA device classification · LRWOfficial FDA classification for this device type
- CFR regulation · 21 CFR 878.4800The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find Medline Industries, LPSearch for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
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