CLASS II ONGOING Device recall · Reported 18 Feb 2026 · FDA Enforcement Report
Medline medical convenience kits packaged as recalled
Medline Industries is recalling Medline medical convenience kits packaged as: Sterile Resuture Pack, Kit, distributed nationwide in the US. The recall was initiated on 24 Dec 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1335-2026
- FDA event ID
- 98284
- Recalling firm
- Medline Industries, Northfield, IL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 24 Dec 2025
- FDA classified
- 9 Feb 2026
- Reported
- 18 Feb 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Packaging Defects
- Device type
- Surgical Instruments
Timeline
| 24 Dec 2025 | Recall initiated by company | |
| 9 Feb 2026 | Classified by FDA | +47 days |
| 18 Feb 2026 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may exhibit an open seal on the packaging of the applicators.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Medline medical convenience kits packaged as: STERILE RESUTURE PACK, Kit SKU DYNDL1980A
Where it was distributed
US Nationwide distribution.
Questions about this recall
Why was it recalled?
Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may exhibit an open seal on the packaging of the applicators.
Which lots are affected?
UDI/DI 10195327379292, Lot Number 25EBJ785
Where was it sold?
US Nationwide distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
10 other products · FDA event 98284This product is part of a recall event; the main page for the event is Medline medical convenience kits packaged as recalled.
More recalls from Medline Industries
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| Device | CLASS II | Rollator, Bariatric, Basic Steel, Burgundy recalled | Medline Industries | Foreign Material | Nationwide |
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| Device | CLASS II | Adaptable Beach Chair Beach Chair surgical patient positioner recalled | Quantum OPS | Device Malfunction | Nationwide |
| Device | CLASS II | Laparoscopic Prostatectomy kits recalled by Avid Medical | Avid Medical | Other | Nationwide |
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| Device | CLASS II | Gyn Laparoscopy/Laparotomy kits recalled by Avid Medical | Avid Medical | Other | Nationwide |
| Device | CLASS II | Gyn Laparoscopy Pack kits recalled by Avid Medical | Avid Medical | Other | Nationwide |