Device recall: BARD(R) CRITICORE(R) MONITOR, Model: 000002N Series The CritiCore(R) Automated Urine Output and Temperature Monitor is i

FDA enforcement event 78622 · Class II · initiated 10 Nov 2017 · status Terminated · terminated 22 Sep 2021

DeviceVoluntary: Firm initiated1 product recordCovington, GA

C.R. Bard, Inc. (Covington, GA) initiated this device recall on 10 Nov 2017; FDA lists 1 product record under event 78622, classified Class II.

FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 93% of the 1,091 device enforcement events initiated in 2017 carry the same class.

Status: Terminated, terminated 22 Sep 2021. Initiation: voluntary: firm initiated. C.R. Bard, Inc. has 49 enforcement events on this register, with a median of 1 product record per event.

Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.

Recalling firm

C.R. Bard, Inc., Covington, GA.

Reason for recall

"BMD has identified that some lots of CritiCore(R) monitors may experience failures involving urine output volume measurement fluctuations, core bladder temperature measurement fluctuations and alarm errors."

Distribution

"US Distribution and Internationally to Japan"

Product records

Recall number	Product	Quantity	Class	Status	Report date
Z-0565-2018	BARD(R) CRITICORE(R) MONITOR, Model: 000002N Series The CritiCore(R) Automated Urine Output and Temperature Monitor is indicated to monitor urine output and core bladder temperature.	343 units	Class II	Terminated	21 Feb 2018

Context

93%of 2017 device events are Class II1,091 events that year

1product record in this eventfirm median: 1

49events on this register for the firm

Other enforcement events for C.R. Bard, Inc.

Initiated	Product (first record)	Type	Class	Records
25 Jun 2026	Products that contain the Pericare Wipes: Bardex Lubricath Foley Catheter Tray REF: 899914 899916 899918 UDI codes: 0080	Device	Class II	6
23 Apr 2026	Silastic Foley Catheters Silastic Brand Foley Catheter 30cc REF: 33416 33418 33420 33422 33424 Silastic Brand Foley Cath	Device	Class II	1
6 Nov 2025	Bard InLay Optima Size: 6 Fr. x 14 cm, Ureteral Stent Kit REF 787614	Device	Class II	4
17 Jul 2025	SureStep Foley Tray System Bardex I.C. Complete Care Infection Control Foley Catheter Tray, REF: A303316A	Device	Class II	3
18 Jun 2025	Bardex Lubri-Sil I.C. 400-series Temperature Sensing Silver/Hydrogel Coated All-Silicone Foley Catheter 5cc Balloon, REF	Device	Class II	1
3 Jun 2025	BD Heyman Follower Straight Tip for following sizes: 10Fr - REF:21110, 12Fr - REF:21112, 14Fr - REF: 21114, 20Fr - REF:	Device	Class II	3
17 Apr 2025	Bard Minnesota Four Lumen Esophagogastric Tamponade Tube, REF:0092220 18 Fr. (6mm, 7/32"), 41" Length (104cm) with 8" (2	Device	Class I	5
9 May 2024	Bard Medical SureStep Foley Tray System, 16 Fr., Catalog #A319416AM; and Bard Medical Bardex IC Complete Care Infection	Device	Class II	1
20 Dec 2023	Bard Nasogastric Sump Tube with ENFit, 10Fr., 36in Long, REF EN0042100	Device	Class II	17
15 Nov 2023	Sensica Urine Output System, Catalog Number SCCS1002	Device	Class II	1

All 49 events for C.R. Bard, Inc.

Questions and answers

Why was this device recalled?

FDA's record gives the reason for recall as: "BMD has identified that some lots of CritiCore(R) monitors may experience failures involving urine output volume measurement fluctuations, core bladder temperature measurement fluctuations and alarm errors."

What does Class II mean?

FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

Where was the product distributed?

FDA's distribution pattern field reads: "US Distribution and Internationally to Japan"

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 22 Sep 2021. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

Where does this data come from?

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.

Provenance

Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.