CLASS II ONGOING Device recall · Reported 11 Dec 2024 · FDA Enforcement Report
Medline convenience kits labeled as: Colon Wound Closure Pack recalled
Medline Industries LP - Northfield is recalling Medline convenience kits labeled as: Colon Wound Closure Pack, distributed nationwide in the US. The recall was initiated on 9 Oct 2024 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-0636-2025
- FDA event ID
- 95621
- Recalling firm
- Medline Industries LP - Northfield, Northfield, IL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 9 Oct 2024
- FDA classified
- 5 Dec 2024
- Reported
- 11 Dec 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 9 Oct 2024 | Recall initiated by company | |
| 5 Dec 2024 | Classified by FDA | +57 days |
| 11 Dec 2024 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.
Product as listed by the FDA
MEDLINE convenience kits labeled as: COLON WOUND CLOSURE PACK, REF DYNJ52141B
Where it was distributed
US Nationwide distribution.
Questions about this recall
Why was it recalled?
Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.
Which lots are affected?
REF DYNJ52141B, UDI/DI 10195327028459 (each) 40195327028450 (case), Lot Numbers: 23FMA347, 23JBS200
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
26 other products · FDA event 95621This product is part of a recall event; the main page for the event is Medline convenience kits labeled as: Port Insertion Pack recalled.
More recalls from Medline Industries LP - Northfield
All 792| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | Medline medical convenience kits labeled as recalled | Medline Industries LP - Northfield | Device Malfunction | 6 states |
| Device | CLASS I | Medline medical convenience kits labeled as recalled | Medline Industries LP - Northfield | Device Malfunction | 6 states |
| Device | CLASS I | Medline ReNewal Reprocessed St. Jude Medical Response recalled | Medline Industries LP - Northfield | Particulate Matter | Nationwide |
| Device | CLASS II | The Medline General Surgery Tray is customized to meet recalled | Medline Industries LP - Northfield | Sterility | Nationwide |
| Device | CLASS II | Medline Kits containing BD SureStep Foley Tray Systems recalled | Medline Industries LP - Northfield | Labeling Errors | FL, IL |
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