Covington, GA, United States
C.R. Bard Inc recalls
23 recalls recorded since 2018, most recently on 25 June 2026. 14 are listed as ongoing. Status and classification are as published by the FDA.
Recalls23
Ongoing (FDA)14
Terminated or completed9
Class I (FDA)1
Ongoing Class II Medical devices
- Recall started
- 25 June 2026
- Reason
- Due to complaints received indicating presence of contamination on the surface of pericare wipes provided with various Foley and Intermittent Catheter Trays.
- Distribution
- Worldwide - U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI and WY. The countries of Bahrain, Canada, Cos
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-3118-2026, Z-3115-2026, Z-3114-2026, Z-3119-2026, Z-3117-2026, Z-3116-2026
- Products that contain the Pericare Wipes: SureStep" Foley Tray System Add-A-Foley Catheter REF: A153200 UDI code: 00801741121067¿ 10801741121064 SureStep" Foley Tray System Complete Care¿ Add-A-Foley Catheter REF: A304
- Products that contain the Pericare Wipes: Bard¿ Foley Tray With Lubri-Sil¿ All-Silicone Foley Catheter REF: 947314 947316 947318 UDI codes: 00801741024924¿ 10801741024921 00801741024931¿ 10801741024938 00801741024948¿ 1
- Products that contain the Pericare Wipes: Bardex Lubricath Foley Catheter Tray REF: 899914 899916 899918 UDI codes: 00801741024801¿ 10801741024808 00801741024818¿ 10801741024815 00801741024825¿ 10801741024822
- Products that contain the Pericare Wipes: (Canada Only) SureStep" Foley Tray System Bardex¿ IC Complete Care¿ REF: A300314AC UDI-DI code: 00801741143243 SureStep" Foley Tray System Bardex¿ IC Complete Care¿ REF: A300316
- Products that contain the Pericare Wipes: SureStep Intermittent Catheter Tray REF: INTP16 INTS14 INTS14C INTS16 INTS16C PEDINTS06 PEDINTS08 PEDINTS10 UDI code: 00801741183300¿ 10801741183307 00801741183218¿ 108017411832
- Products that contain the Pericare Wipes: *Bardex¿ I.C. Complete Care¿ Foley Catheter Tray REF: 300316A UDI codes: 00801741024344¿ 10801741024341 *Bardex¿ I.C. Complete Care¿ Foley Catheter Tray and Urine Meter REF: 30
Ongoing Class II Medical devices
- Recall started
- 23 April 2026
- Reason
- Due to stain present on the surface of affected foley catheters.
- Distribution
- U.S.: AK, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, and WI O.U.S.: Canada
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2226-2026
- Silastic Foley Catheters Silastic Brand Foley Catheter 30cc REF: 33416 33418 33420 33422 33424 Silastic Brand Foley Catheter 5cc REF: 33614 33616 33618 33620 33622 33624
Ongoing Class II Medical devices
- Recall started
- 6 November 2025
- Reason
- Labeling discrepancy; Ureteral stent actual size may not match the actual product label.
- Distribution
- Worldwide - US Nationwide distribution in the states of AZ, CA, CO, FL, GA, IA, IN, KY, LA, MA, MD, MI, MO, ND, NJ, NY, OH, PA, SD, VA, WA, WI and the countries of Canada, EMEA (Belgium, Denmark, Slovakia, Spain, Turkey, United Kingdom, MENA (Jordan), S Africa), Greater Asia (China).
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0907-2026, Z-0905-2026, Z-0906-2026, Z-0908-2026
- BD InLay Optima Ureteral Stent Kit Size: 6 Fr. x 30 cm, Ureteral Stent Kit REF 788630
- Bard InLay Optima Size: 6 Fr. x 14 cm, Ureteral Stent Kit REF 787614
- BD InLay Optima Ureteral Stent Kit Size: 4.7 Fr. x 26 cm, Ureteral Stent Kit REF 788426
- BD InLay Optima Ureteral Stent Kit Size: 8 Fr. x 26 cm, Ureteral Stent Kit REF 78826
Ongoing Class II Medical devices
- Recall started
- 17 July 2025
- Reason
- Foley catheter trays have incorrect inserts, user may think:1)Silicone, when it's natural rubber latex, or 2)Natural rubber latex with infection control coating, when it's silicone hydrogel with antimicrobial coating, or 3)Natural latex with infection control, when it's silicone hydrogel coated without antimicrobial coating, which may cause infection and/or local and/or systemic allergic reaction
- Distribution
- US Nationwide distribution including in the states of NC, FL, NY, MA, MN, TX, CA, OH, MI, WA, NJ, IL, ID, SC, IN, OK, OR, AL, VA, HI, MO, MS, MD, AZ, KY, GA, IA, CO, NM, PA, ME, UT, NE.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2589-2025, Z-2590-2025, Z-2591-2025
- SureStep Foley Tray System Bardex I.C. Complete Care Infection Control Foley Catheter Tray, REF: A303316A
- SureStep Foley Tray System Lubri-Sil I.C. Complete Care Infection Control Foley Catheter Tray, REF: A303414A
- SureStep Foley Tray System BARD¿ Lubri-Sil Foley Catheter Tray, REF: A942216
Ongoing Class II Medical devices
- Recall started
- 18 June 2025
- Reason
- Foley catheter may have an obstructed lumen, which may result in an inability to drain the bladder, of urine and may include pelvic or abdominal pain, flank pain, bladder dysfunction, obstructive uropathy, acute kidney injury and/or hydronephrosis.
- Distribution
- Worldwide - US Nationwide distribution in the states of IA, PA, AR, OR, MN, IN, WV, OK, AL, MD, HI, GA, AZ, MA, FL, CA and the countries of Japan.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2462-2025
- Bardex Lubri-Sil I.C. 400-series Temperature Sensing Silver/Hydrogel Coated All-Silicone Foley Catheter 5cc Balloon, REF: 119314; SureStep Foley Tray System Lubri-Sil I.C. Complete Care, REF: A319514A; Bard Silver Lub
Ongoing Class II Medical devices
- Recall started
- 3 June 2025
- Reason
- Cather packaging may contain the incorrect French size.
- Distribution
- Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, FL, GA, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WI, WV and the country of Canada.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2076-2025, Z-2074-2025, Z-2075-2025
- REF: 123400,Bard Urologist's Tray, For the Obstructed Urethra
- BD Heyman Follower Straight Tip for following sizes: 10Fr - REF:21110, 12Fr - REF:21112, 14Fr - REF: 21114, 20Fr - REF: 21120
- BD Heyman Follower Coude Tip for following sizes: 12Fr - REF:021312 14Fr - REF:021314, 16Fr - REF: 021316
Ongoing Class I Medical devices
- Recall started
- 17 April 2025
- Reason
- Due to customer complaints, there is a potential for users to be unable to or find it difficult to remove the plastic plugs in order to inflate the gastric and/or esophageal balloons.
- Distribution
- US: AK AL AR AZ CA CO CT DC DE FL GA HI IA ID IL IN KS KY LA MA MD ME MI MN MO MS MT NC ND NE NH NJ NM NV NY OH OK OR PA RI SC SD TN TX UT VA VT WA WI WV WY, Puerto Rico OUS: Singapore, Canada, Belgium, Ireland, Netherlands, South Africa, Sweden, U
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1759-2025, Z-1758-2025, Z-1757-2025, Z-1755-2025, Z-1756-2025
- Bard¿ Single Intragastric Linton Balloon Tube, REF: 0092740
- Bard¿ Blakemore Esophageal-Nasogastric Tube (Intermediate)REF: 0092300
- Bard¿ Blakemore Esophageal-Nasogastric Tube (Child) REF: 0092110
- Bard Minnesota Four Lumen Esophagogastric Tamponade Tube, REF:0092220 18 Fr. (6mm, 7/32"), 41" Length (104cm) with 8" (20.3cm) Balloon X-Ray Opaque Rubber
- Bard Blakemore Esophageal-Nasogastric Tube (Adult) REF: 0092100
Ongoing Class II Medical devices
- Recall started
- 9 May 2024
- Reason
- Some of the devices may function incorrectly resulting in no temperature display or erratic temperatures being displayed on the temperature monitoring devices.
- Distribution
- Distribution was nationwide. There was no government/military/foreign distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2154-2024
- Bard Medical SureStep Foley Tray System, 16 Fr., Catalog #A319416AM; and Bard Medical Bardex IC Complete Care Infection Control Temperature-Sensing Foley Catheter Tray with Bard Hydrogel and Bacti-Guard Silver Alloy Coat
Ongoing Class II Medical devices
- Recall started
- 20 December 2023
- Reason
- BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occurred.
- Distribution
- US
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0792-2024, Z-0800-2024, Z-0794-2024, Z-0798-2024, Z-0803-2024, Z-0797-2024, Z-0796-2024, Z-0801-2024, Z-0805-2024, Z-0799-2024, Z-0795-2024, Z-0790-2024 and 5 more
- Bard¿ Nasogastric Sump Tube with ENFit, 14Fr., 48in Long, REF EN0042140
- Bard¿ Nasogastric Sump Tube with PreVent¿ Anti-Reflux Filter with ENFit, 18Fr., 48in Long, REF EN0046180
- Bard¿ Nasogastric Sump Tube with ENFit, 18Fr., 48in Long, REF EN0042180
- Bard¿ Nasogastric Sump Tube with PreVent¿ Anti-Reflux Filter with ENFit, 14Fr., 48in Long, REF EN0046140
- Bard¿ Nasogastric Sump Tube and PreVent¿ Filter and Lopez Valve¿ with ENFit, 14Fr., 48in Long, REF EN0056140
- Bard¿ Nasogastric Sump Tube with PreVent¿ Anti-Reflux Filter with ENFit", 12Fr., 48in Long, REF EN0046120
- Bard¿ Nasogastric Sump Tube with PreVent¿ Anti-Reflux Filter with ENFit, 10Fr., 36in Long, REF EN0046100
- Bard¿ Lopez Valve¿ with ENFit, REF EN0056000
- and 9 more product lines
Ongoing Class II Medical devices
- Recall started
- 15 November 2023
- Reason
- BD (C.R. Bard) has received user complaints reporting that when the device was connected to WiFi/Internet, the time displayed on the Sensica device changed during a patient monitoring session which resulted in 1) incorrect time displayed on the monitoring screen, 2) incorrect hour block timestamps on the monitoring screen, 3) incorrect hour timestamps on data screens, and 4) incorrect catheter use time.
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0554-2024
- Sensica Urine Output System, Catalog Number SCCS1002
Ongoing Class II Medical devices
- Recall started
- 20 April 2023
- Reason
- 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.
- Distribution
- Worldwide
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1701-2023, Z-1698-2023, Z-1700-2023, Z-1699-2023
- 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
- Magic3 Go Intermittent Urinary Catheters, Female Catalog Numbers: a) REF 51808, b) REF 51810, c) REF 51812, d) REF 51814, e) REF 51816, f) REF 51818
- Magic3 Go Intermittent Urinary Catheters, pediatric Catalog Numbers: a) REF 52810G
- Magic3 Go Intermittent Urinary Catheters, male Catalog Numbers: a) REF 50810G, b) REF 50812G, c) REF 50814G, d) REF 50816G, e) REF 50818G, f) REF 53810G, g) REF 53812G, h) REF 53814G, i) REF 53816G, j) REF 53818G, k) REF
Ongoing Class II Medical devices
- Recall started
- 19 May 2022
- Reason
- Complaints relating to urine output measurement accuracy.
- Distribution
- US Nationwide.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1293-2022
- Sensica Urine Output System
Terminated Class II Medical devices
- Recall started
- 27 January 2022
- Terminated
- 10 July 2026
- Reason
- There is a potential to leak from the catheter where it connects to the drain bag
- Distribution
- US Nationwide distribution in the states of GA, ME, NJ, WI, MN, SD, CO, ND, ID, IL, FL, LA, MD, PA, OH, NE.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0666-2022, Z-0667-2022
- BARD SURESTEP INTERMITTENT CATHETER TRAY, 14Fr, REF INTS14C
- BARD SURESTEP INTERMITTENT CATHETER TRAY, 14Fr, REF INTS16C
Ongoing Class II Medical devices
- Recall started
- 5 August 2021
- Reason
- There is potential for packaging defects that may impact the sterile barrier.
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2527-2021, Z-2530-2021, Z-2534-2021, Z-2541-2021, Z-2533-2021, Z-2535-2021, Z-2529-2021, Z-2521-2021, Z-2526-2021, Z-2524-2021, Z-2525-2021, Z-2537-2021 and 9 more
- Catalog A319416AM, SureStep" Foley Tray, Bardex" I.C., Complete Care", Urine Meter, Temperature Sensing, StatLock" Stabilization Device
- Catalog A800360, SureStep" Foley Tray, Bard LubricathTM Foley Catheter Tray
- Catalog A899916, SureStep" Foley Tray, Lubricath", Drainage Bag, StatLock" Stabilization Device
- Catalog A942216, SureStep" Foley Tray, Bard LubricathTM, Urine Meter, StatLock" Stabilization Device
- Catalog A897514, SureStep" Foley Tray, Silicone, Drainage Bag, StatLock" Stabilization Device
- Catalog A902616, SureStep" Foley Tray, Bardex" I.C., Lubricath", Urine Meter
- Catalog A800061, SureStep" Foley Tray, Bard LubricathTM Foley Catheter Tray
- Catalog A119216M, SureStep" Foley Tray, Lubri-Sil", Urine Meter, Temperature Sensing Dual, StatLock" Stabilization Device
- and 13 more product lines
Terminated Class II Medical devices
- Recall started
- 11 January 2021
- Terminated
- 2 February 2023
- Reason
- The device catheter tip was cut off (no tip) and the product packaging was not fully sealed.
- Distribution
- Worldwide distribution - US Nationwide distribution and the countries of Australia, Canada.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1431-2021
- Bard Clean-Cath Intermittent Catheter, 12 French female length (catheter, urological) - Product Usage: for urological use only.
Terminated Class II Medical devices
- Recall started
- 15 April 2020
- Terminated
- 20 May 2021
- Reason
- There is potential for a white paper-type residue attached to the catheter.
- Distribution
- US Nationwide distribution including in the states of AZ, CA, FL, GA, IA, IL, IN, KS, KY, MA, MD, MI, MO, NC, NE, NJ, NY, RI, SD, TN, TX, UT, VA, WV.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1970-2020
- SureStep Foley Tray System - Product Usage: Intended for use in the drainage and/or collection and/or measurement of urine. Generally, drainage is accomplished by inserting the catheter through the urethra and into the b
Terminated Class II Medical devices
- Recall started
- 13 January 2020
- Terminated
- 12 April 2021
- Reason
- Leaks or disconnect near the sampling port of the Intra Abdominal Pressure Monitoring Device which could lead to the potential of inaccurate readings. The measurement should be confirmed with other means, such as a new IAP system of the same kind or by choosing other diagnostic means such as but not limited to alternative systems, such as open IAP measurement options or exchanging the tubing system, which does not require invasive maneuvers.
- Distribution
- Distributed Nationwide including Washington DC and Guaynabo PR; Distributed OUS to Belgium and Japan.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1219-2020
- The Bard Intra-abdominal Pressure Monitoring Device is composed of a tubing set used for infusing fluid into the urinary bladder through the Foley catheter sampling port. It utilizes a clamping device to occlude the urin
Terminated Class II Medical devices
- Recall started
- 27 February 2018
- Terminated
- 11 July 2019
- Reason
- BMD has identified that the product code/lot number combination identified above may have ineffectively fused tubing and ENFit(TM) connector.
- Distribution
- US Nationwide Distribution
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1357-2018, Z-1356-2018, Z-1355-2018, Z-1354-2018
- Bard(R) Premature Infant Feeding tube, ENFit(TM), REF EN0036430 Product Usage: BARD(R) Nasogastric Sump Tubes with ENFit(TM) connector are intended to be used for: Decompression of stomach by suction or aspiration
- Bard(R) Adult/Pediatric Feeding Tube, ENFit(TM), REF EN0036420 Product Usage: BARD(R) Nasogastric Sump Tubes with ENFit(TM) connector are intended to be used for: Decompression of stomach by suction or aspiration
- Bard(R) Infant Feeding Tube, ENFit(TM), REF EN0036410 Product Usage: BARD(R) Nasogastric Sump Tubes with ENFit(TM) connector are intended to be used for: Decompression of stomach by suction or aspiration of gastri
- Bard(R) Premature Infant Feeding Tube, ENFit(TM), REF EN0036400 Product Usage: BARD(R) Nasogastric Sump Tubes with ENFit(TM) connector are intended to be used for: Decompression of stomach by suction or aspiration
Terminated Class II Medical devices
- Recall started
- 13 December 2017
- Terminated
- 14 December 2020
- Reason
- Foley Catheter with Incorrect Retainer Cap Print
- Distribution
- FL, NY, MN and TX Canada, Japan and Taiwan
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2064-2018
- Bardex Lubricath 3-Way 75cc Continuous Irrigation Foley Catheter (Creevy), 22Fr. Rx (01267522)
Ongoing Class II Medical devices
- Recall started
- 10 November 2017
- Reason
- Issues identified with the monitor including urine output measurement errors, temperature measurement errors and undesired alarms.
- Distribution
- AR, AZ, CA, FL, GA, HI, IN, JP, KS, LA, MD, MN, MO, MS, NC, NJ, OH, OK, TN, TX, VA, WA, WI, and WY
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2243-2018
- CritiCore Automated Urine Output and Temperature Monitor
Terminated Class II Medical devices
- Recall started
- 10 November 2017
- Terminated
- 22 September 2021
- Reason
- 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
- Initiated
- Voluntary: Firm initiated
- Recall number
- 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.
Terminated Class II Medical devices
- Recall started
- 29 September 2017
- Terminated
- 7 July 2021
- Reason
- The possibility exists that use of the Uros Automated Urine Output and Temperature Monitor may lead to the loss of urine output measurement data and/or urine output measurement inaccuracies resulting in an impact on clinical treatment decisions.
- Distribution
- US Distribution to the state of: FL
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0488-2018
- BARD UROS AUTOMATED URINE OUPTUT AND TEMPERATURE MONITOR, MODEL BK10001M The Uros(TM) Automated Urine Output and Temperature Monitor is indicated to monitor urine output and core bladder temperature.
Terminated Class II Medical devices
- Recall started
- 14 September 2017
- Terminated
- 5 November 2019
- Reason
- Several instances of a catheter caught in the sterile barrier seal and in some instances cut catheters were observed.
- Distribution
- US Nationwide in the states of AK, AL, AR, AZ, CA, FL, GA, HI, IA, ID, KS, KY, MD, ME, MI, MN, MO, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, including Puerto Rico
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1307-2018, Z-1309-2018, Z-1308-2018
- HydroSil Gripper Intermittent Catheters- 10" lengths - 30 catheters per box, each catheter is packaged in an individual pouch. MGC3 Product Usage Intermittent catheters are intended for urinary bladder drainage in pa
- Personal Intermittent Catheters- 16" and 10" lengths - 30 catheters per box, each catheter is packaged in an individual pouch, Item Numbers: 50612, 50614, 50616, 50618, 52306, 52308, 52310, 52606, 52606G, 52608, 52608G,
- Magic 3 Intermittent Catheters- 12 Male - 30 catheters per box, each catheter is packaged in an individual pouch. Urinary catheter.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.