CLASS II ONGOING Device recall · Reported 17 Jan 2024 · FDA Enforcement Report

Baxter Ostene Hemostasis Material, Product Codes: a) recalled

Baxter Healthcare is recalling Baxter Ostene Hemostasis Material, distributed nationwide in the US. The recall was initiated on 6 Dec 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll serial numbers, no UDI/DI

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-0658-2024
FDA event ID: 93503
Recalling firm: Baxter Healthcare, Deerfield, IL
Classification: Class II
Status: Ongoing
Recall initiated: 6 Dec 2023
FDA classified: 5 Jan 2024
Reported: 17 Jan 2024
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Labeling Errors
Device type: Other Medical Devices

Timeline

6 Dec 2023	Recall initiated by company
5 Jan 2024	Classified by FDA	+30 days
17 Jan 2024	Published in enforcement report	+12 days

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

Reason for recall

Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed below contains inaccurate content that does not align with some of the products Instructions for Use (IFU) or Prescribing Information (PI).

Product as listed by the FDA

Baxter Ostene Hemostasis Material, Product Codes: a) 1503831, 3.5 G; b) 1503832, 2.5 G; c) 1503833, 1.0 G

Where it was distributed

US Nationwide distribution.

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

All serial numbers, no UDI/DI

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

13 other products · FDA event 93503

This product is part of a recall event; the main page for the event is Baxter Flo-Thru Intraluminal Shunt, Product Codes: a) Product recalled.

Reported	Class	Recall	Company	Reason	Where
17 Jan 2024	CLASS II	Baxter Flo-Thru Intraluminal Shunt, Product Codes: a) Product recalled	Baxter Healthcare	Labeling Errors	Nationwide
17 Jan 2024	CLASS II	Baxter Floseal Hemostatic Matrix Fast Prep, Product Codes recalled	Baxter Healthcare	Labeling Errors	Nationwide
17 Jan 2024	CLASS II	Vascu-Guard Peripheral Vascular Patch (US), Product Codes recalled	Baxter Healthcare	Labeling Errors	Nationwide
17 Jan 2024	CLASS II	Baxter FloSeal Hemostatic Matrix NL, Product Codes: ADS201883 recalled	Baxter Healthcare	Labeling Errors	Nationwide
17 Jan 2024	CLASS II	Baxter Flo-Rester, Disposable internal vessel occluder recalled	Baxter Healthcare	Labeling Errors	Nationwide
17 Jan 2024	CLASS II	Peri-guard Supple, Product Codes: a) SPG1016: CM US, TS recalled	Baxter Healthcare	Labeling Errors	Nationwide
17 Jan 2024	CLASS II	Baxter Coseal Premix, Surgical Sealant, Product Codes: a) recalled	Baxter Healthcare	Labeling Errors	Nationwide
17 Jan 2024	CLASS II	Vascu-Guard Peripheral Vascular Patch (Global) recalled	Baxter Healthcare	Labeling Errors	Nationwide
17 Jan 2024	CLASS II	Baxter Preveleak Surgical Sealant, Product Codes: ADS201808 recalled	Baxter Healthcare	Labeling Errors	Nationwide
17 Jan 2024	CLASS II	Baxter Vascular Probe, Product Codes: a) recalled by Baxter Healthcare	Baxter Healthcare	Labeling Errors	Nationwide
17 Jan 2024	CLASS II	Peri-Guard Repair Patch, Product Codes: a) PG1016 : Cmus recalled	Baxter Healthcare	Labeling Errors	Nationwide
17 Jan 2024	CLASS II	Baxter FloSeal Hemostatic Matrix Recothrom, Product Codes recalled	Baxter Healthcare	Labeling Errors	Nationwide
17 Jan 2024	CLASS II	Peri-Guard Repair Patch, Product Codes: a) PC1016NBIO recalled	Baxter Healthcare	Labeling Errors	Nationwide

More recalls from Baxter Healthcare

All 565

Reported	Class	Recall	Company	Reason	Where
16 Sep 2026Drug	CLASS I	Dextrose Injection, USP, 70 % recalled by Baxter Healthcare	Baxter Healthcare	Particulate Matter	Nationwide
9 Sep 2026Drug	CLASS I	0.9% Sodium Chloride Injection USP, Viaflex recalledSodium Chloride	Baxter Healthcare	Particulate Matter	IL
9 Sep 2026Device	CLASS II	Baxter Novum IQ Syringe Pump, Loaner recalled by Baxter Healthcare	Baxter Healthcare	Device Malfunction	Nationwide
9 Sep 2026Device	CLASS II	Baxter Novum IQ Syringe Pump recalled by Baxter Healthcare	Baxter Healthcare	Device Malfunction	Nationwide
9 Sep 2026Drug	CLASS II	Clindamycin Phosphate in 0.9% Sodium Chloride Injection recalledClindamycin Phosphate	Baxter Healthcare	Manufacturing (CGMP) Deviations	Nationwide

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All 13,778

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16 Sep 2026Device	CLASS I	Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	AMS Convenience Kit: Dsaek Pack - RX recalled	Windstone Medical Packaging	Device Malfunction	Nationwide