CLASS II ONGOING Device recall · Reported 28 Aug 2024 · FDA Enforcement Report
Med-soft Liner W/ 6mmx3m Tub recalled by MEDLINE INDUSTRIES, LP
Medline Industries LP - Northfield is recalling Med-soft Liner W/ 6mmx3m Tub, distributed nationwide in the US. The recall was initiated on 22 Mar 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-2698-2024
- FDA event ID
- 94356
- Recalling firm
- Medline Industries LP - Northfield, Northfield, IL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 22 Mar 2024
- FDA classified
- 22 Aug 2024
- Reported
- 28 Aug 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
| 22 Mar 2024 | Recall initiated by company | |
| 22 Aug 2024 | Classified by FDA | +153 days |
| 28 Aug 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
A slight dimensional variation which has the potential for increased difficulty fitting into outer canister.
Product as listed by the FDA
1,5L MED-SOFT LINER W/ 6MMX3M TUB. & ADULT VC, REF OR53929
Where it was distributed
Worldwide - US Nationwide and the countries of Panama, Mexico, Canada, Qatar, El Salvador, Oman, Colombia, Singapore.
Questions about this recall
Why was it recalled?
A slight dimensional variation which has the potential for increased difficulty fitting into outer canister.
Which lots are affected?
UDI/DI 40888277422286 (package), 0888277DC265NSKX (unit), Lot Numbers: 670220505, 670220609, 670220621, 670220720, 670220804, 670220926, 670220928, 670221024, 670221115, 670221227, 670230109, 670230210, 670230424
Where was it sold?
Worldwide - US Nationwide and the countries of Panama, Mexico, Canada, Qatar, El Salvador, Oman, Colombia, Singapore.
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
20 other products · FDA event 94356This product is part of a recall event; the main page for the event is Liner, Soft, Suction Canister, 1500cc recalled by MEDLINE INDUSTRIES, LP.
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