CLASS II ONGOING Device recall · Reported 3 May 2023 · FDA Enforcement Report

GEM Neurotube, Absorbable Woven Polyglycolic Acid Mesh Tube recalled

Baxter Healthcare is recalling GEM Neurotube, Absorbable Woven Polyglycolic Acid Mesh Tube, distributed nationwide in the US. The recall was initiated on 27 Mar 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesa) 5311-01240-010, Lot Number 19012112, exp. 12/31/2023; b) 5311-01240-012, Lot Number 19012112, exp. 12/31/2023

Quantity recalled169 units

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-1461-2023
FDA event ID: 91951
Recalling firm: Baxter Healthcare, Deerfield, IL
Classification: Class II
Status: Ongoing
Recall initiated: 27 Mar 2023
FDA classified: 25 Apr 2023
Reported: 3 May 2023
Type: Voluntary: Firm initiated
Customers notified by: N/A
Reason category: Packaging Defects
Device type: Other Medical Devices

Timeline

27 Mar 2023	Recall initiated by company
25 Apr 2023	Classified by FDA	+29 days
3 May 2023	Published in enforcement report	+8 days

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

Reason for recall

The product is brittle and potentially crumbling upon handling or when being removed from its package.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

GEM NEUROTUBE, Absorbable Woven Polyglycolic Acid Mesh Tube, Product Codes: a) 5311-01240-010, b) 5311-01240-012; for peripheral nerve repair

Where it was distributed

Worldwide distribution - US Nationwide and the countries of China, Germany, Sweden, Norway, Netherlands, Greece, Switzerland, France

Nationwide

Questions about this recall

Why was it recalled?

The product is brittle and potentially crumbling upon handling or when being removed from its package.

Which lots are affected?

a) 5311-01240-010, Lot Number 19012112, exp. 12/31/2023; b) 5311-01240-012, Lot Number 19012112, exp. 12/31/2023

Where was it sold?

Worldwide distribution - US Nationwide and the countries of China, Germany, Sweden, Norway, Netherlands, Greece, Switzerland, France

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.

More recalls from Baxter Healthcare

All 572

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

Other Other Medical Devices recalls

All 13,778

Reported	Class	Recall	Company	Reason	Where
16 Sep 2026Device	CLASS II	Citric Complete Dry Citric Acid Concentrate recalled	Nipro Renal Soultions USA	Other	Nationwide
16 Sep 2026Device	CLASS I	Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	Halyard IV Start Kit Non-Sterile recalled by Avid Medical	Avid Medical	Sterility	Nationwide
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