Bard
FDA adverse event reports naming Bard as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: BARD.
- Total reports
- 1,304
- Deaths
- 22
- Injuries
- 679
- Malfunctions
- 494
Reports per year
Source: FDA adverse event reports by year received, 2010–2024. Reporting paused twice in 2026 during FDA reporting-system changes and has since resumed.
Top device categories
- Port & Catheter, Implanted, Subcutaneous, IntravascularLJT205
- Mesh, Surgical, PolymericFTL174
- Catheter, UrologicalKOD171
- Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 DaysLJS123
- Filter, Intravascular, CardiovascularDTK109
- Catheter, Intravascular, DiagnosticDQO69
- Catheter, Retention Type, BalloonEZL32
- Set, Administration, IntravascularFPA29
- Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 DaysFOZ28
- Apparatus, Suction, Single Patient Use, Portable, NonpoweredGCY28
Recent recalls
- 2026-09-25Open, ClassifiedSoftware design
EnCor EnCompass Breast Biopsy and Tissue Removal System Console (model number: ENCPCONSOLE) and Driver (model number: ENCPDRIVER) with software
Breast biopsy and tissue removal system may experience the following errors: 1) Probe calibration and /or handheld driver failure (code HH01-00020009) , 2) Pressure sensor (code E01-0054000E), which prompts the user to restart and re-calibrate; errors may lead to interruption or prolongation of the biopsy procedure, or the need for additional tissue sampling or repeat biopsy.
- 2026-09-11Open, ClassifiedMaterial/Component Contamination
Power-Trialysis Short-Term Straight Dialysis Catheter, REF: 5605150; Power-Trialysis Short-Term Straight Dialysis Catheter, REF: 5605200; Power-Trialysis Short-Term Straight Dialysis Catheter, REF: 5605240; Power-Trialysis Short-Term Straight Dialysis Catheter, REF: 5605300; Power-Trialysis Short-Term Curved Extension Dialysis Catheter, REF: 5615120; Power-Trialysis Short-Term Curved Extension Dialysis Catheter, REF: 5615150; Power-Trialysis Short-Term Curved Extension Dialysis Catheter, REF: 5615200; Power-Trialysis Short-Term Curved Extension Dialysis Catheter, REF: 5615240; Power-Trialysis Short-Term Alphacurve Dialysis Catheter, REF: 5655120; Power-Trialysis Short-Term Alphacurve Dialysis Catheter, REF: 5655150; Power-Trialysis Short-Term Alphacurve Dialysis Catheter, REF: 5655200; Power-Trialysis Short-Term Alphacurve Dialysis Catheter, REF: 5655240; Power-Trialysis Short-Term Straight Dialysis Catheter Full Procedure Tray, REF: 5605200G; Power-Trialysis Slim-Cath Straight Short-Term Dialysis Catheter, REF: 5855200G; Power-Trialysis Slim-Cath Precurved Extension Short-Term Dialysis Catheter, REF: 5865150G; Power-Trialysis Slim-Cath Straight Short-Term Dialysis Catheter, REF: 5855150; Power-Trialysis Slim-Cath Straight Short-Term Dialysis Catheter, REF: 5855200; Power-Trialysis Slim-Cath Straight Short-Term Dialysis Catheter, REF: 5855240; Power-Trialysis Slim-Cath Straight Short-Term Dialysis Catheter, REF: 5855300; Power-Trialysis Slim-Cath Precurved Extension Short-Term Dialysis Catheter, REF: 5865120; Power-Trialysis Slim-Cath Precurved Extension Short-Term Dialysis Catheter, REF: 5865150; Power-Trialysis Slim-Cath Precurved Extension Short-Term Dialysis Catheter, REF: 5865200; Power-Trialysis Slim-Cath Precurved Extension Short-Term Dialysis Catheter, REF: 5865240
this is a downstream recall of class I recall RES 98777
- 2026-09-11Open, ClassifiedMaterial/Component Contamination
DuoGlide Short-Term Straight Dialysis Catheter, REF: 5625150; DuoGlide Short-Term Straight Dialysis Catheter, REF: 5625200; DuoGlide Short-Term Straight Dialysis Catheter, REF: 5625240; DuoGlide Short-Term Straight Dialysis Catheter, REF: 5625300; DuoGlide Short-Term Curved Extension Dialysis Catheter, REF: 5626120; DuoGlide Short-Term Curved Extension Dialysis Catheter, REF: 5626150; DuoGlide Short-Term Curved Extension Dialysis Catheter, REF: 5626200; DuoGlide Short-Term Curved Extension Dialysis Catheter, REF: 5626240; Niagara Dual-Lumen Short-Term Curved Extension Dialysis Catheter, REF: 5766200
this is a downstream recall of class I recall RES 98777
- 2026-09-04Open, ClassifiedUnder Investigation by firm
Products that contain the Pericare Wipes: Bardex Lubricath Foley Catheter Tray REF: 899914 899916 899918 UDI codes: 00801741024801 10801741024808 00801741024818 10801741024815 00801741024825 10801741024822 SureStep" Foley Tray System with Bardex Lubricath Temp Sensing Foley Catheter REF: A119416M UDI code: 00801741073700 10801741073707 SureStep" Foley Tray System Bard Lubricath Foley REF: A800361 UDI code: 00801741073939 10801741073936 SureStep" Foley Tray System Bard Lubricath Foley Catheter Tray REF: A899616 UDI code: 00801741104534 10801741104531 SureStep" Foley Tray System Bardex Lubricath Foley Catheter REF: A899914 UDI code: 00801741074004 10801741074001 SureStep" Foley Tray System Bardex Lubricath Foley Catheter REF: A899916 UDI code: 00801741074011 10801741074018 SureStep" Foley Tray System Bardex Lubricath Temperature Sensing Catheter REF: A900216 UDI code: 00801741120978 10801741120975 SureStep" Foley Tray System BardLubricath Foley Catheter REF: A902914 A902916 A902918 UDI code: 0080174107406610801741074063 00801741074073 10801741074070 0080174107408010801741074087 Bard Urine Meter Foley Catheter Tray With Bardex Lubricath Foley Catheter REF: 304916 UDI code: 00801741019736 01801741019739 Bard Urine Meter Foley Catheter Tray With Bardex Lubricath Foley Catheter REF: 902916 UDI codes: 00801741024863 10801741024860 (416A) SureStep Foley Tray System Bardex IC Complete Care (714A/716A/718A)SureStep Foley Tray System Bardex IC Complete REF: A304914 A304916 A304918 UDI codes: 00801741104350 10801741104357 00801741104367 10801741104364 00801741100499 10801741100496 SureStep" Foley Tray System Bard Lubricath Foley REF: A800365 UDI codes: 00801741073960 10801741073967 SureStep" Foley Tray System Bardex Lubricath Foley Catheter REF: A899918 UDI codes: 00801741074028 10801741074025 SureStep" Foley Tray System BardLubricath Foley Catheter REF: A902618 UDI codes: 00801741104640 10801741104647 SureStep" Foley Tray System BardLubricath Foley Catheter REF: A902616 UDI codes: 00801741104633 10801741104630 SureStep Intermittent Catheter Tray REF: INTL16C UDI codes: 00801741183195 10801741183192 For urological use only, Intended for use in the drainage and/or collection and/or measurement of urine.
Due to complaints received indicating presence of contamination on the surface of pericare wipes provided with various Foley and Intermittent Catheter Trays.
- 2026-09-04Open, ClassifiedUnder Investigation by firm
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 10801741024945 Lubri-Sil I.C. Complete Care All-Silicone Foley Catheter Tray REF: 300416A UDI code: 00801741024580 10801741024587 SureStep" Foley Tray System Lubri-Sil IC Complete Care REF: A300416A UDI code: 00801741073762 10801741073769 SureStep" Foley Tray System Lubri-Sil IC Complete Care REF: A303416A UDI code: 00801741073823 10801741073820 SureStep" Foley Tray System Lubri-Sil IC Complete Care REF: A307416A A307418A UDI codes: 00801741104381 10801741104388 00801741100505 10801741100502 SureStep" Foley Tray System Bard Silicone Foley Catheter Tray REF: A897516 UDI code: 00801741073984 10801741073981 SureStep" Foley Tray System Bardex All- Silicone Foley Catheter Tray REF: A902416 UDI code: 00801741074042 10801741074049 SureStep" Foley Tray System Bardex All- Silicone Foley Catheter Tray REF: A902418 UDI code: 00801741074059 10801741074056 SureStep" Foley Tray System Bard Lubri-Sil Foley Catheter REF: A907316 UDI code: 00801741104749 10801741104746 SureStep" Foley Tray System with Bard Lubri-Sil Catheter REF: A942210 UDI code: 00801741100567 10801741100564 SureStep" Foley Tray System with Bard Lubri-Sil Catheter REF: A942212 UDI code: 00801741100536 10801741100533 SureStep" Foley Tray System Bard Lubri-Sil Foley Catheter Tray REF: A942214 UDI code: 00801741074103 10801741074100 SureStep" Foley Tray System Bard Lubri-Sil Foley Catheter Tray REF: A942216 UDI code: 00801741074110 10801741074117 SureStep" Foley Tray System Bard Lubri-Sil Foley Catheter REF: A947316 UDI code: 00801741074141 10801741074148 SureStep" Foley Tray System with Bard Lubri-Sil Catheter REF: A942206 UDI code: 00801741100543 10801741100540 **** Lubri-Sil I.C. Complete Care Temp-Sensing Foley Catheter Tray and Urine Meter REF: 319516AM UDI code: 00801741024696 10801741024693 SureStep" Foley Tray System with Bard Lubri-Sil Temp Sensing Foley Catheter REF: A119214M UDI code: 00801741073670 10801741073677 REF: A119216M UDI code: 00801741073687 10801741073684 SureStep" Foley Tray Lubri-Sil I.C. Complete Care Temp Sensing Catheter REF: A300916A UDI code: 00801741120862 10801741120869 SureStep" Foley Tray System Lubri-Sil IC Complete Care REF: A319516A UDI code: 00801741100338 10801741100335 SureStep" Foley Tray System Lubri-Sil IC Complete Care REF: A319516AM UDI code: 00801741073892 10801741073899 SureStep" Foley Tray Lubri-Sil I.C. Complete Care Temp Sensing Catheter REF: A900916A UDI code: 00801741121029 10801741121026 SureStep" Foley Tray System Lubri-Sil Temperature Sensing Foley Catheter REF: A909216M UDI code: 00801741104763 10801741104760 ***** Bard Urine Meter Foley Catheter Tray With Bard Lubri-Sil Catheter REF 942208 UDI code: 00801741029370 10801741029377 Bard Urine Meter Foley Tray With Lubri-Sil All-Silicone Foley Catheter REF: 942216 UDI code: 00801741024979 10801741024976 Lubri-Sil I.C. Complete Care All-Silicone Foley Catheter Tray and Urine Meter REF: 303416A UDI code: 00801741024726 10801741024723 SureStep" Foley Tray System with Bard Lubri-Sil Temp Sensing Foley Catheter REF: A119218M UDI code: 00801741073694 10801741073691 SureStep" Foley Tray System Lubri-Sil IC Complete Care REF: A300418A UDI code: 00801741073779 10801741073776 SureStep" Foley Tray System Lubri-Sil IC Complete Care REF: A303418A UDI code: 00801741073830 10801741073837 SureStep" Foley Tray System Lubri-Sil IC Complete Care REF: A319514AM UDI code: 00801741073885 10801741073882 SureStep" Foley Tray System with Bard Lubri-Sil Catheter REF: A942208 UDI code: 00801741100550 10801741100557 SureStep" Foley Tray System Bard Lubri-Sil Foley Catheter Tray REF: A942218 UDI code: 00801741074127 10801741074124 SureStep" Foley Tray System Bard Lubri-Sil Foley
Due to complaints received indicating presence of contamination on the surface of pericare wipes provided with various Foley and Intermittent Catheter Trays.
- 2026-09-04Open, ClassifiedUnder Investigation by firm
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: 303314A 303316A 303318A UDI code: 00801741024252 10801741024259 00801741024269 10801741024266 00801741024276 10801741024273 *SureStep" Foley Tray System Bardex IC Complete Care REF: A300314A UDI codes: 00801741073724 10801741073721 REF: A300314AC (Canada Only) UDI-DI code: 00801741143243 *SureStep" Foley Tray System Bardex IC Complete Care REF: A300316A UDI code: 00801741073731 10801741073738 *SureStep" Foley Tray System Bardex IC Complete Care REF: A300318A UDI code: 00801741073748 10801741073745 *SureStep" Foley Tray System Bardex IC Complete Care REF: A303314A A303316A A303318A UDI code: 00801741073786 10801741073783 00801741073793 10801741073790 00801741073809 10801741073806 *SureStep" Foley Tray System Lubri-Sil IC Complete Care REF: A303414A UDI code: 00801741073816 10801741073813 *(416A)SureStep" Foley Tray System Bardex IC Complete Care (714A/716A/718A)SureStep" Foley Tray System Bardex IC Complete Care (914)SureStep" Foley Tray System REF: A304716A A304714A A304716A A304718A UDI code: 00801741104206 10801741104203 00801741104268 10801741104265 00801741104299 10801741104296 00801741100376 10801741100373 *SureStep" Foley Tray System Bardex IC Complete Care REF: A319416A UDI code: 00801741100307 10801741100304 *SureStep" Foley Tray System Bardex I.C. Complete Care Foley Catheter REF: A319416AM UDI code: 00801741073861 10801741073868 *SureStep" Foley Tray System Bardex IC Complete Care REF: A319418A UDI code: 00801741100314 10801741100311 SureStep" Foley Tray System Bardex IC Complete Care REF: A903316A UDI code: 00801741096600 10801741096607 ***** SureStep" Foley Tray System Lubri-Sil IC Complete Care REF: A300414A UDI code: 00801741073755 10801741073752 SureStep" Foley Tray System Bardex I.C. Complete Care Foley Catheter REF: A319414AM UDI code: 00801741073854 10801741073851 SureStep" Foley Tray System Bardex I.C. Complete Care Foley Catheter REF: A319418AM UDI code: 00801741073878 10801741073875 SureStep" Foley Tray System Bardex IC Complete Care REF: A903318A UDI code: 00801741104657 10801741104654 For urological use only, Intended for use in the drainage and/or collection and/or measurement of urine.
Due to complaints received indicating presence of contamination on the surface of pericare wipes provided with various Foley and Intermittent Catheter Trays.
- 2026-09-04Open, ClassifiedUnder Investigation by firm
Products that contain the Pericare Wipes: SureStep Intermittent Catheter Tray REF: INTP16 INTS14 INTS14C INTS16 INTS16C PEDINTS06 PEDINTS08 PEDINTS10 UDI code: 00801741183300 10801741183307 00801741183218 10801741183215 00801741183232 10801741183239 00801741183225 10801741183222 00801741183249 10801741183246 00801741183263 10801741183260 00801741183270 10801741183277 00801741183287 10801741183284 Preamendment REF: INTL14 INTL15 INTL16 INTP14 UDI code: 00801741183164 10801741183161 00801741183171 10801741183178 00801741183188 10801741183185 00801741183294 10801741183291 For urological use only, Intended for use in the drainage and/or collection and/or measurement of urine.
Due to complaints received indicating presence of contamination on the surface of pericare wipes provided with various Foley and Intermittent Catheter Trays.
- 2026-09-04Open, ClassifiedUnder Investigation by firm
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: A304400A UDI code: 00801741073847 10801741073844 SureStep" Foley Tray System Add-A-Foley Catheter REF: A399400 UDI code: 00801741100369 10801741100366 SureStep" Foley Tray System Complete Care Add-A-Foley Catheter REF: A399400A UDI code: 00801741073915 10801741073912 SureStep" Foley Tray System Complete Care Add-A-Foley Catheter REF: A904400A UDI code: 00801741074097 10801741074094 SureStep Intermittent Catheter Tray REF: INTAAI UDI code: 00801741183317 10801741183314 For urological use only, Intended for use in the drainage and/or collection and/or measurement of urine.
Due to complaints received indicating presence of contamination on the surface of pericare wipes provided with various Foley and Intermittent Catheter Trays.
- 2026-09-04Open, ClassifiedUnder Investigation by firm
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: A300316AC UDI-DI code: 00801741143250 SureStep" Foley Tray System Lubri-Sil IC Complete Care REF: A319516AMC UDI-DI code: 00801741143472 SureStep" Foley Tray System Bard Lubricath Foley REF: A800366C UDI-DI code: 00801741143571 SureStep" Foley Tray System Bard Silicone Foley Catheter Tray REF: A897514C UDI-DI code: 00801741074011 SureStep" Foley Tray System Bard Silicone Foley Catheter Tray REF: A897516C UDI-DI code: 00801741143595 SureStep" Foley Tray System Bard Silicone Foley Catheter Tray REF: A902114C UDI-DI code: 00801741144325 ***** SureStep" Foley Tray System Lubri-Sil IC Complete Care REF: A300416AC UDI code: 00801741143281 10801741143288 SureStep" Foley Tray System Bardex IC Complete Care REF: A303314AC UDI code: 00801741143304 10801741143301 SureStep" Foley Tray System Lubri-Sil IC Complete Care REF: A319514AMC UDI code: 00801741143465 10801741143462 SureStep" Foley Tray System Bard Lubricath Foley Catheter Tray REF: A800061C UDI code: 00801741144172 10801741144179 SureStep" Foley Tray System Bard Lubricath Foley Catheter Tray REF: A800065C UDI code: 00801741144202 10801741144209 SureStep" Foley Tray System Bard Lubricath Foley Catheter Tray REF: A800360C UDI code: 00801741143519 10801741143516 SureStep" Foley Tray System Bard Lubricath Foley Catheter Tray REF:A800361C UDI code: 00801741143526 10801741143523 SureStep" Foley Tray System Bard Lubricath Foley Catheter Tray REF: A800362C UDI code: 00801741143540 10801741143547 SureStep" Foley Tray System Bard Lubricath Foley REF: A800365C UDI code: 00801741143564 10801741143561 For urological use only, Intended for use in the drainage and/or collection and/or measurement of urine.
Due to complaints received indicating presence of contamination on the surface of pericare wipes provided with various Foley and Intermittent Catheter Trays.
- 2026-08-14Open, ClassifiedComponent change control
BD Needle Kit for Powered Driver 15mm x 15Ga, REF: D015151NK, BD Needle Kit for Powered Driver 25mm x 15Ga, REF: D015251NK, BD Needle Kit for Powered Driver 35mm x 15Ga, REF: D015351NK, BD Needle Kit for Powered Driver 45mm x 15Ga, REF: D015451NK, BD Needle Kit for Powered Driver 55mm x 15Ga, REF: D015551NK
After placement of intraosseous (IO) needle sets, used when intravenous access is difficult or impossible to obtain in emergent, urgent, or medically necessary cases, users may experience difficulty/inability to remove obturator, due to it locking to the needle hub, due to out-of-tolerance dimensions and IFU unclarity, which may result in new needle placement, which may result in delayed therapy
Monitor Bard automatically
DeviceWatch watches FDA adverse events and recalls for the products you care about, summarizes clinical narratives with AI and alerts you when a safety signal emerges.