CLASS II ONGOING Device recall · Reported 11 Dec 2024 · FDA Enforcement Report

Hollister CalciCare Calcium Alginate Dressing recalled

Advanced Medical Solutions is recalling Hollister CalciCare Calcium Alginate Dressing, distributed nationwide in the US. The recall was initiated on 1 Oct 2024 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel Number: 529937R UDI-DI code: 0060075029530 Lot Number: W00070134

Quantity recalled3900 boxes

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-0617-2025
FDA event ID: 95613
Recalling firm: Advanced Medical Solutions, Winsford
Classification: Class II
Status: Ongoing
Recall initiated: 1 Oct 2024
FDA classified: 4 Dec 2024
Reported: 11 Dec 2024
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Surgical Instruments

Timeline

1 Oct 2024	Recall initiated by company
4 Dec 2024	Classified by FDA	+64 days
11 Dec 2024	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Due to defects on primary packaging pouch that compromise the device's ability to maintain a sterile barrier.

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

Hollister CalciCare Calcium Alginate Dressing REF 529937R calcium alginate dressings are indicated for moderate to heavily exuding chronic and acute wounds such as: ¿ pressure ulcers ¿ leg ulcers ¿ cavity wounds ¿ lacerations ¿ post-operative surgical wounds

Where it was distributed

U.S. Nationwide distribution in the states of IL, TX, and VA.

Nationwide Illinois Texas Virginia

Questions about this recall

Why was it recalled?

Due to defects on primary packaging pouch that compromise the device's ability to maintain a sterile barrier.

Which lots are affected?

Model Number: 529937R UDI-DI code: 0060075029530 Lot Number: W00070134

Where was it sold?

U.S. Nationwide distribution in the states of IL, TX, and VA.

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

2 other products · FDA event 95613

This product is part of a recall event; the main page for the event is Medline Maxorb Extra Alginate Wound Dressing Square recalled.

Reported	Class	Recall	Company	Reason	Where
11 Dec 2024	CLASS II	Medline Maxorb Extra Alginate Wound Dressing Square recalled	Advanced Medical Solutions	Sterility	Nationwide
11 Dec 2024	CLASS II	McKesson Calcium Alginate Dressing MFR# 3562 Wound dressing recalled	Advanced Medical Solutions	Sterility	Nationwide

Reported	Class	Recall	Company	Reason	Where
11 Dec 2024Device	CLASS II	McKesson Calcium Alginate Dressing MFR# 3562 Wound dressing recalled	Advanced Medical Solutions	Sterility	Nationwide
11 Dec 2024Device	CLASS II	Medline Maxorb Extra Alginate Wound Dressing Square recalled	Advanced Medical Solutions	Sterility	Nationwide
14 Sep 2016Device	CLASS II	ReliaMed¿ Alginate/CMC recalled by Advanced Medical Solutions	Advanced Medical Solutions	Packaging Defects	OH
14 Sep 2016Device	CLASS II	ReliaMed¿ Silver Alginate/CMC recalled by Advanced Medical Solutions	Advanced Medical Solutions	Packaging Defects	OH

Other Surgical Instruments recalls

All 3,891

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14 Oct 2026Device	CLASS II	Gyn Laparoscopy/Laparotomy kits recalled by Avid Medical	Avid Medical	Other	Nationwide
14 Oct 2026Device	CLASS II	Gyn Laparoscopy Pack kits recalled by Avid Medical	Avid Medical	Other	Nationwide