Browse Device Recalls
65 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 65 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.
Medical Device Recalls
Browse 65 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Nov 6, 2025 | BD InLay Optima Ureteral Stent Kit Size: 8 Fr. x 26 cm, Ureteral Stent Kit R... | Labeling discrepancy; Ureteral stent actual size may not match the actual product label. | Class II | C.R. Bard Inc |
| Nov 6, 2025 | BD InLay Optima Ureteral Stent Kit Size: 4.7 Fr. x 26 cm, Ureteral Stent Kit ... | Labeling discrepancy; Ureteral stent actual size may not match the actual product label. | Class II | C.R. Bard Inc |
| Nov 6, 2025 | Bard InLay Optima Size: 6 Fr. x 14 cm, Ureteral Stent Kit REF 787614 | Labeling discrepancy; Ureteral stent actual size may not match the actual product label. | Class II | C.R. Bard Inc |
| Nov 6, 2025 | BD InLay Optima Ureteral Stent Kit Size: 6 Fr. x 30 cm, Ureteral Stent Kit R... | Labeling discrepancy; Ureteral stent actual size may not match the actual product label. | Class II | C.R. Bard Inc |
| Jul 17, 2025 | SureStep Foley Tray System BARD¿ Lubri-Sil Foley Catheter Tray, REF: A942216 | Foley catheter trays have incorrect inserts, user may think:1)Silicone, when it's natural rubber ... | Class II | C.R. Bard Inc |
| Jul 17, 2025 | SureStep Foley Tray System Lubri-Sil I.C. Complete Care Infection Control Fol... | Foley catheter trays have incorrect inserts, user may think:1)Silicone, when it's natural rubber ... | Class II | C.R. Bard Inc |
| Jul 17, 2025 | SureStep Foley Tray System Bardex I.C. Complete Care Infection Control Foley ... | Foley catheter trays have incorrect inserts, user may think:1)Silicone, when it's natural rubber ... | Class II | C.R. Bard Inc |
| Jun 18, 2025 | Bardex Lubri-Sil I.C. 400-series Temperature Sensing Silver/Hydrogel Coated A... | Foley catheter may have an obstructed lumen, which may result in an inability to drain the bladde... | Class II | C.R. Bard Inc |
| Jun 3, 2025 | BD Heyman Follower Coude Tip for following sizes: 12Fr - REF:021312 14Fr... | Cather packaging may contain the incorrect French size. | Class II | C.R. Bard Inc |
| Jun 3, 2025 | BD Heyman Follower Straight Tip for following sizes: 10Fr - REF:21110, 1... | Cather packaging may contain the incorrect French size. | Class II | C.R. Bard Inc |
| Jun 3, 2025 | REF: 123400,Bard Urologist's Tray, For the Obstructed Urethra | Cather packaging may contain the incorrect French size. | Class II | C.R. Bard Inc |
| Apr 17, 2025 | Bard Blakemore Esophageal-Nasogastric Tube (Adult) REF: 0092100 | Due to customer complaints, there is a potential for users to be unable to or find it difficult t... | Class I | C.R. Bard Inc |
| Apr 17, 2025 | Bard Minnesota Four Lumen Esophagogastric Tamponade Tube, REF:0092220 18 Fr. ... | Due to customer complaints, there is a potential for users to be unable to or find it difficult t... | Class I | C.R. Bard Inc |
| Apr 17, 2025 | Bard¿ Blakemore Esophageal-Nasogastric Tube (Child) REF: 0092110 | Due to customer complaints, there is a potential for users to be unable to or find it difficult t... | Class I | C.R. Bard Inc |
| Apr 17, 2025 | Bard¿ Blakemore Esophageal-Nasogastric Tube (Intermediate)REF: 0092300 | Due to customer complaints, there is a potential for users to be unable to or find it difficult t... | Class I | C.R. Bard Inc |
| Apr 17, 2025 | Bard¿ Single Intragastric Linton Balloon Tube, REF: 0092740 | Due to customer complaints, there is a potential for users to be unable to or find it difficult t... | Class I | C.R. Bard Inc |
| May 9, 2024 | Bard Medical SureStep Foley Tray System, 16 Fr., Catalog #A319416AM; and Bard... | Some of the devices may function incorrectly resulting in no temperature display or erratic tempe... | Class II | C.R. Bard Inc |
| Dec 20, 2023 | Bard¿ Nasogastric Sump Tube with ENFit, 12Fr., 48in Long, REF EN0042120 | BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes wi... | Class II | C.R. Bard Inc |
| Dec 20, 2023 | Bard¿ Nasogastric Sump Tube with ENFit, 16Fr., 48in Long, REF EN0042160 | BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes wi... | Class II | C.R. Bard Inc |
| Dec 20, 2023 | Bard¿ Nasogastric Sump Tube and PreVent¿ Filter and Lopez Valve¿ with ENFit, ... | BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes wi... | Class II | C.R. Bard Inc |
| Dec 20, 2023 | Bard¿ Nasogastric Sump Tube and PreVent¿ Anti-Reflux Filter and Lopez Valve¿ ... | BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes wi... | Class II | C.R. Bard Inc |
| Dec 20, 2023 | Bard¿ Suction Connector with ENFit, REF EN0066000 | BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes wi... | Class II | C.R. Bard Inc |
| Dec 20, 2023 | Bard Nasogastric Sump Tube with ENFit, 10Fr., 36in Long, REF EN0042100 | BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes wi... | Class II | C.R. Bard Inc |
| Dec 20, 2023 | Bard¿ PreVent¿ Anti-Reflux Filter with ENFit, REF EN0046000 | BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes wi... | Class II | C.R. Bard Inc |
| Dec 20, 2023 | Bard¿ Nasogastric Sump Tube with PreVent¿ Anti-Reflux Filter with ENFit, 16Fr... | BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes wi... | Class II | C.R. Bard Inc |
| Dec 20, 2023 | Bard¿ Nasogastric Sump Tube and PreVent¿ Anti-Reflux Filter and Lopez Valve¿ ... | BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes wi... | Class II | C.R. Bard Inc |
| Dec 20, 2023 | Bard¿ Lopez Valve¿ with ENFit, REF EN0056000 | BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes wi... | Class II | C.R. Bard Inc |
| Dec 20, 2023 | Bard¿ Nasogastric Sump Tube with PreVent¿ Anti-Reflux Filter with ENFit, 10Fr... | BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes wi... | Class II | C.R. Bard Inc |
| Dec 20, 2023 | Bard¿ Nasogastric Sump Tube with PreVent¿ Anti-Reflux Filter with ENFit", 12F... | BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes wi... | Class II | C.R. Bard Inc |
| Dec 20, 2023 | Bard¿ Nasogastric Sump Tube and PreVent¿ Filter and Lopez Valve¿ with ENFit, ... | BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes wi... | Class II | C.R. Bard Inc |
| Dec 20, 2023 | Bard¿ Nasogastric Sump Tube with PreVent¿ Anti-Reflux Filter with ENFit, 14Fr... | BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes wi... | Class II | C.R. Bard Inc |
| Dec 20, 2023 | Bard¿ Nasogastric Sump Tube with ENFit, 18Fr., 48in Long, REF EN0042180 | BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes wi... | Class II | C.R. Bard Inc |
| Dec 20, 2023 | Bard¿ Nasogastric Sump Tube with PreVent¿ Anti-Reflux Filter with ENFit, 18Fr... | BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes wi... | Class II | C.R. Bard Inc |
| Dec 20, 2023 | Bard¿ Nasogastric Sump Tube with ENFit, 14Fr., 48in Long, REF EN0042140 | BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes wi... | Class II | C.R. Bard Inc |
| Nov 15, 2023 | Sensica Urine Output System, Catalog Number SCCS1002 | BD (C.R. Bard) has received user complaints reporting that when the device was connected to WiFi/... | Class II | C.R. Bard Inc |
| Apr 20, 2023 | Magic3 Go Intermittent Urinary Catheters, male Catalog Numbers: a) REF 50810G... | Some catheters had a manufacturing defect where the clear resealing label separating from the pro... | Class II | C.R. Bard Inc |
| Apr 20, 2023 | Magic3 Go Intermittent Urinary Catheters, pediatric Catalog Numbers: a) REF 5... | Some catheters had a manufacturing defect where the clear resealing label separating from the pro... | Class II | C.R. Bard Inc |
| Apr 20, 2023 | Magic3 Go Intermittent Urinary Catheters, Female Catalog Numbers: a) REF 5180... | Some catheters had a manufacturing defect where the clear resealing label separating from the pro... | Class II | C.R. Bard Inc |
| Apr 20, 2023 | HydroSil Go Intermittent Urinary Catheters, Catalog Numbers: a) REF 71808, b... | Some catheters had a manufacturing defect where the clear resealing label separating from the pro... | Class II | C.R. Bard Inc |
| May 19, 2022 | Sensica Urine Output System | Complaints relating to urine output measurement accuracy. | Class II | C.R. Bard Inc |
| Jan 27, 2022 | BARD SURESTEP INTERMITTENT CATHETER TRAY, 14Fr, REF INTS16C | There is a potential to leak from the catheter where it connects to the drain bag | Class II | C.R. Bard Inc |
| Jan 27, 2022 | BARD SURESTEP INTERMITTENT CATHETER TRAY, 14Fr, REF INTS14C | There is a potential to leak from the catheter where it connects to the drain bag | Class II | C.R. Bard Inc |
| Aug 5, 2021 | Catalog A902416, SureStep" Foley Tray, Silicone, Urine Meter, StatLock" Stabi... | There is potential for packaging defects that may impact the sterile barrier. | Class II | C.R. Bard Inc |
| Aug 5, 2021 | Catalog A300316A, SureStep" Foley Tray, Bardex" I.C., Complete Care", Drainag... | There is potential for packaging defects that may impact the sterile barrier. | Class II | C.R. Bard Inc |
| Aug 5, 2021 | Catalog A399400A, SureStep" Foley Tray, Add-a-Foley, Complete Care", Drainage... | There is potential for packaging defects that may impact the sterile barrier. | Class II | C.R. Bard Inc |
| Aug 5, 2021 | Catalog A319516AM, SureStep" Foley Tray, Lubri-Sil" I.C., Temperature Sensing... | There is potential for packaging defects that may impact the sterile barrier. | Class II | C.R. Bard Inc |
| Aug 5, 2021 | Catalog A303416A, SureStep" Foley Tray, Lubri-Sil" I.C., Temperature Sensing ... | There is potential for packaging defects that may impact the sterile barrier. | Class II | C.R. Bard Inc |
| Aug 5, 2021 | Catalog A902916, SureStep" Foley Tray, Lubricath", Urine Meter, StatLock" Sta... | There is potential for packaging defects that may impact the sterile barrier. | Class II | C.R. Bard Inc |
| Aug 5, 2021 | Catalog A300314A, SureStep" Foley Tray, Bardex" I.C., Complete Care", Drainag... | There is potential for packaging defects that may impact the sterile barrier. | Class II | C.R. Bard Inc |
| Aug 5, 2021 | Catalog A800365, SureStep" Foley Tray, Bard LubricathTM Foley Catheter Tray | There is potential for packaging defects that may impact the sterile barrier. | Class II | C.R. Bard Inc |
Frequently Asked Questions
When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.
All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.
Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.