CLASS II ONGOING Device recall · Reported 20 Mar 2024 · FDA Enforcement Report
CVS Health Waterproof Wound Tracking Dressing recalled
Medline Industries LP - Northfield is recalling CVS Health Waterproof Wound Tracking Dressing, distributed nationwide in the US. The recall was initiated on 23 Jan 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-1295-2024
- FDA event ID
- 94036
- Recalling firm
- Medline Industries LP - Northfield, Northfield, IL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 23 Jan 2024
- FDA classified
- 14 Mar 2024
- Reported
- 20 Mar 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 23 Jan 2024 | Recall initiated by company | |
| 14 Mar 2024 | Classified by FDA | +51 days |
| 20 Mar 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
Product failed sterility testing.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
CVS Health Waterproof Wound Tracking Dressing, REF CVS690330, immediate package contains 1 sterile dressing, 4 in. x 4 in., 4 dressings per box, 24 boxes per case.
Where it was distributed
US Nationwide distribution in the states of AL, CA, FL, IN, MI, MO, NJ, NY, PA, RI, SC, TN, TX. and VA. There was no foreign/government/military distribution.
Nationwide AlabamaCaliforniaFloridaIndianaMichiganMissouriNew JerseyNew YorkPennsylvaniaRhode IslandSouth CarolinaTennesseeTexasVirginia
Stores named: CVS
Questions about this recall
Why was it recalled?
Product failed sterility testing.
Which lots are affected?
Lot numbers 10322040003, 10322050003, 10322070006, and 10322100002; UDI-DI 0500428645208.
Where was it sold?
US Nationwide distribution in the states of AL, CA, FL, IN, MI, MO, NJ, NY, PA, RI, SC, TN, TX. and VA. There was no foreign/government/military 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.
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