CLASS II ONGOING Device recall · Reported 14 Jun 2023 · FDA Enforcement Report

HydroSil Go Intermittent Urinary Catheters recalled by C.R. Bard

C.R. Bard is recalling HydroSil Go Intermittent Urinary Catheters. The recall was initiated on 20 Apr 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesa) REF 71808, Lot Numbers: JUGU9026; b) REF 71810, Lot Numbers: JUGT9154, JUGU9053, JUGV9130, JUGV9133; c) REF 71812, Lot Numbers: JUGT0236, JUGT1689, JUGT2702, JUGU1955, JUGU1968, JUGV9158; d) REF 71814, Lot Numbers: JUGT3326; e) REF 71816, Lot Numbers: JUGU9023; f) REF 71818, Lot Numbers: JUGT0288, JUGU9022

Quantity recalled308520 devices

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-1701-2023
FDA event ID: 92082
Recalling firm: C.R. Bard, Covington, GA
Classification: Class II
Status: Ongoing
Recall initiated: 20 Apr 2023
FDA classified: 8 Jun 2023
Reported: 14 Jun 2023
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Sterility
Device type: Heart & Vascular Devices

Timeline

20 Apr 2023	Recall initiated by company
8 Jun 2023	Classified by FDA	+49 days
14 Jun 2023	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

Some catheters had a manufacturing defect where the clear resealing label separating from the product foil pouch, resulting in a possible opening into the product packaging that could impact product sterility.

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

HydroSil Go Intermittent Urinary Catheters, Catalog Numbers: a) REF 71808, b) REF 71810, c) REF 71812, d) REF 71814, e) REF 71816, f) REF 71818

Where it was distributed

Worldwide

Questions about this recall

Is HydroSil Go Intermittent Urinary Catheters recalled?

Yes. C.R. Bard recalled HydroSil Go Intermittent Urinary Catheters on 20 Apr 2023. The recall is Class II and its status is Ongoing. Recall number Z-1701-2023.

Why was it recalled?

Which lots are affected?

a) REF 71808, Lot Numbers: JUGU9026; b) REF 71810, Lot Numbers: JUGT9154, JUGU9053, JUGV9130, JUGV9133; c) REF 71812, Lot Numbers: JUGT0236, JUGT1689, JUGT2702, JUGU1955, JUGU1968, JUGV9158; d) REF 71814, Lot Numbers: JUGT3326; e) REF 71816, Lot Numbers: JUGU9023; f) REF 71818, Lot Numbers: JUGT0288, JUGU9022

Where was it sold?

Worldwide

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 21 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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16 Sep 2026Device	CLASS II	Products that contain the Pericare Wipes recalled by C.R. Bard	C.R. Bard	Other	Nationwide
16 Sep 2026Device	CLASS II	Products that contain the Pericare Wipes recalled by C.R. Bard	C.R. Bard	Other	Nationwide
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Reported	Class	Recall	Company	Reason	Where
16 Sep 2026Device	CLASS II	Getinge PVC Thoracic Catheter, Soft PVC Right Angle recalled	Atrium Medical	Potency & Assay	Nationwide
16 Sep 2026Device	CLASS II	Products that contain the Pericare Wipes: *Bardex¿ I.C recalled	C.R. Bard	Other	Nationwide
16 Sep 2026Device	CLASS II	Products that contain the Pericare Wipes recalled by C.R. Bard	C.R. Bard	Other	Nationwide
16 Sep 2026Device	CLASS II	Products that contain the Pericare Wipes recalled by C.R. Bard	C.R. Bard	Other	Nationwide
16 Sep 2026Device	CLASS II	Getinge PVC Thoracic Catheter, Firm PVC Straight recalled	Atrium Medical	Potency & Assay	Nationwide