Medline Industries, LP recalls Convenience kits CATARACT PACK DYNJ59881A
Reason for recall
Kits may exhibit open seals in sterile pouch packaging. Open seal may compromise product sterility. If not detected prior to use, issue may lead to contamination of sterile field or patient infection if product is used.
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
- Convenience kits CATARACT PACKDYNJ59881AUDI-DI 10198459020612Affected lot25GBP246
What the firm is doing
Firm began notifying customers on July 31, 2026 via email and first-class mail. Customers were instructed to discard any affected sterile convenience kits.
DistributionShow detailsHide
US Nationwide distribution in states of Arkansas, Florida, North Carolina, Maryland, and Texas.
Use of the product may cause temporary or medically reversible adverse health consequences.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-3210-2026
- FDA device classification · OJKOfficial FDA classification for this device type
- CFR regulation · 21 CFR 886.4790The 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.
More Class II recalls
PI CARDIA LTD recalls Pi-Cardia Inc. ShortCut REF: Z-A-20.003-US
Transfemoral catheter, positing arm may detached due to weld issue.
- Percutaneous Catheter For Cutting Or Splitting Heart Valve Leaflets Concomitant To Transcatheter Valve Procedures
- Process control
ICU Medical, Inc. recalls CADD Yellow Medication Cassette Reservoir with NRFit connector US Product Codes: 21-…
Reservoirs may exhibit medication leakage at the joint between luer connector and tubing. Issue could result in delay or interruption of therapy, under delivery of medication, exposure to infectious or toxic agents, or a…
- I.V. Fluid Transfer Set
- Process control
F & A Foundation recalls Reign Medical Clench Staple System (Compression)
Bone fixation staple requires a new 510(k); the performance characteristics of this device have not been adequately established.
- Bone Fixation Staple
- No Marketing Application