Browse Device Recalls
136 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 136 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 136 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Oct 1, 2019 | 1. Vaccess CT Power-Injectable Implantable Port with Suture Plugs, Ref: 74960... | Firm has identified that the product may be at risk of incorrectly containing a tunneler with a b... | Class II | Bard Peripheral Vascular Inc |
| Oct 1, 2019 | 1.PowerPort Implantable Port With Attachable 9.6 F Open-Ended Single-Lumen Ve... | Firm has identified that the product may be at risk of incorrectly containing a tunneler with a b... | Class II | Bard Peripheral Vascular Inc |
| Oct 1, 2019 | 1. Power Port isp M.R.I. Implantable Port with Attachable 9.6 F Open-Ended Si... | Firm has identified that the product may be at risk of incorrectly containing a tunneler with a b... | Class II | Bard Peripheral Vascular Inc |
| Oct 1, 2019 | BardPort Titanium Implantable Port with Attachable 9.6 F Open-Ended Single-Lu... | Firm has identified that the product may be at risk of incorrectly containing a tunneler with a b... | Class II | Bard Peripheral Vascular Inc |
| Oct 1, 2019 | BardPort M.R.I. Implantable Port with Attachale 9.6 F Open-Ended Single-Lumen... | Firm has identified that the product may be at risk of incorrectly containing a tunneler with a b... | Class II | Bard Peripheral Vascular Inc |
| Oct 1, 2019 | PowerFlow Implatable Apheresis IV Port with attachable 9.6 F ChronoFl x Open... | Firm has identified that the product may be at risk of incorrectly containing a tunneler with a b... | Class II | Bard Peripheral Vascular Inc |
| Oct 1, 2019 | 1. X-Port isp M.R.I Implantable Port, with Pre-Attached 9.6 F Open-Ended Sing... | Firm has identified that the product may be at risk of incorrectly containing a tunneler with a b... | Class II | Bard Peripheral Vascular Inc |
| Oct 1, 2019 | BardPort M.R.I. Hard Base Implantable Port with Attachable 9.6 F Open-Ended S... | Firm has identified that the product may be at risk of incorrectly containing a tunneler with a b... | Class II | Bard Peripheral Vascular Inc |
| Aug 14, 2019 | Bard Conquest 40 PTA Dilation Catheter, 8mm X 20mm x 75cm (CQF7582), 8mm x 40... | The catheter packaging incorrectly listed the balloon size as 8mm X 20mm instead of the intended ... | Class II | Bard Peripheral Vascular Inc |
| Jun 14, 2019 | EQUISTREAM¿ XK Long-Term Hemodialysis Catheter. REF/UDI:5913230/:(01)00801741... | Incorrect Peel-Apart Introducer Sheath in Kit. | Class II | Bard Peripheral Vascular Inc |
| Jun 14, 2019 | EQUISTREAM¿ XK Long-Term Hemodialysis Catheter. REF/UDI:5913190/(01)008017410... | Incorrect Peel-Apart Introducer Sheath in Kit. | Class II | Bard Peripheral Vascular Inc |
| May 31, 2019 | GlidePath Long-Term Hemodialysis Catheter with Preloaded Stylet, REF/Product ... | The action is being initiated due to complaints received concerning the molded tip of the tunnel... | Class II | Bard Peripheral Vascular Inc |
| May 31, 2019 | EQUISTREAM LONG-TERM HEMODIALYSIS CATHETER, REF/Product code:5905280, 14.5 Fr... | The action is being initiated due to complaints received concerning the molded tip of the tunnel... | Class II | Bard Peripheral Vascular Inc |
| May 31, 2019 | EQUISTREAM XK Long-Term Hemodialysis Catheter with Preloaded Stylet, REF/Pro... | The action is being initiated due to complaints received concerning the molded tip of the tunnel... | Class II | Bard Peripheral Vascular Inc |
| May 31, 2019 | EQUISTREAM Long-Term Hemodialysis Catheter with Preloaded Styet, REF/Product ... | The action is being initiated due to complaints received concerning the molded tip of the tunnel... | Class II | Bard Peripheral Vascular Inc |
| May 31, 2019 | EQUISTREAM Long-Term Hemodialysis Catheter with Preloaded Styet, REF/Product ... | The action is being initiated due to complaints received concerning the molded tip of the tunnel... | Class II | Bard Peripheral Vascular Inc |
| May 31, 2019 | EQUISTREAM XK Long-Term Hemodialysis Catheter with Preloaded Stylet, REF/Pro... | The action is being initiated due to complaints received concerning the molded tip of the tunnel... | Class II | Bard Peripheral Vascular Inc |
| May 31, 2019 | EQUISTREAM XK Long-Term Hemodialysis Catheter with Preloaded Stylet, REF/Pro... | The action is being initiated due to complaints received concerning the molded tip of the tunnel... | Class II | Bard Peripheral Vascular Inc |
| May 31, 2019 | GlidePath Long-Term Hemodialysis Catheter with Preloaded Stylet, REF/Product ... | The action is being initiated due to complaints received concerning the molded tip of the tunnel... | Class II | Bard Peripheral Vascular Inc |
| May 31, 2019 | EQUISTREAM Long-Term Hemodialysis Catheter with Preloaded Styet, REF/Product ... | The action is being initiated due to complaints received concerning the molded tip of the tunnel... | Class II | Bard Peripheral Vascular Inc |
| May 31, 2019 | EQUISTREAM XK Long-Term Hemodialysis Catheter with Preloaded Stylet, REF/Pro... | The action is being initiated due to complaints received concerning the molded tip of the tunnel... | Class II | Bard Peripheral Vascular Inc |
| May 31, 2019 | EQUISTREAM LONG-TERM HEMODIALYSIS CATHETER, REF/Product code:5905240, 14.5 Fr... | The action is being initiated due to complaints received concerning the molded tip of the tunnel... | Class II | Bard Peripheral Vascular Inc |
| May 31, 2019 | GlidePath Long-Term Hemodialysis Catheter, REF/Product code:5396240, 14.5F, A... | The action is being initiated due to complaints received concerning the molded tip of the tunnel... | Class II | Bard Peripheral Vascular Inc |
| May 31, 2019 | EQUISTREAM XK Long-Term Hemodialysis Catheter with Preloaded Stylet, REF/Pro... | The action is being initiated due to complaints received concerning the molded tip of the tunnel... | Class II | Bard Peripheral Vascular Inc |
| May 31, 2019 | GlidePath Long-Term Hemodialysis Catheter with Preloaded stylet, REF/Product ... | The action is being initiated due to complaints received concerning the molded tip of the tunnel... | Class II | Bard Peripheral Vascular Inc |
| May 31, 2019 | EQUISTREAM LONG-TERM HEMODIALYSIS CATHETER, REF/Product Code:5905190, 14.5 Fr... | The action is being initiated due to complaints received concerning the molded tip of the tunnel... | Class II | Bard Peripheral Vascular Inc |
| May 31, 2019 | GlidePath Long-Term Hemodialysis Catheter with Preloaded stylet, REF/Product ... | The action is being initiated due to complaints received concerning the molded tip of the tunnel... | Class II | Bard Peripheral Vascular Inc |
| May 31, 2019 | EQUISTREAM Long-Term Hemodialysis Catheter with Preloaded Styet, REF/Product ... | The action is being initiated due to complaints received concerning the molded tip of the tunnel... | Class II | Bard Peripheral Vascular Inc |
| May 31, 2019 | GlidePath Long-Term Hemodialysis Catheter, REF/Product code:5396280, 14.5F, A... | The action is being initiated due to complaints received concerning the molded tip of the tunnel... | Class II | Bard Peripheral Vascular Inc |
| May 31, 2019 | GlidePath Long-Term Hemodialysis Catheter with Preloaded stylet, REF/Product ... | The action is being initiated due to complaints received concerning the molded tip of the tunnel... | Class II | Bard Peripheral Vascular Inc |
| May 31, 2019 | GlidePath Long-Term Hemodialysis Catheter with Preloaded Stylet, REF/Product ... | The action is being initiated due to complaints received concerning the molded tip of the tunnel... | Class II | Bard Peripheral Vascular Inc |
| May 31, 2019 | GlidePath Long-Term Hemodialysis Catheter, REF/Product code:5396190, 14.5F, A... | The action is being initiated due to complaints received concerning the molded tip of the tunnel... | Class II | Bard Peripheral Vascular Inc |
| May 31, 2019 | EQUISTREAM XK Alphacurve Long-Term Hemodialysis Catheter REF/Product code:591... | The action is being initiated due to complaints received concerning the molded tip of the tunnel... | Class II | Bard Peripheral Vascular Inc |
| May 31, 2019 | GlidePath Long-Term Hemodialysis Catheter with Preloaded stylet, REF/Product ... | The action is being initiated due to complaints received concerning the molded tip of the tunnel... | Class II | Bard Peripheral Vascular Inc |
| May 31, 2019 | EQUISTREAM XK Long-Term Hemodialysis Catheter with Preloaded Stylet, REF/Pro... | The action is being initiated due to complaints received concerning the molded tip of the tunnel... | Class II | Bard Peripheral Vascular Inc |
| May 31, 2019 | GlidePath Long-Term Hemodialysis Catheter with Preloaded Stylet, REF/Product ... | The action is being initiated due to complaints received concerning the molded tip of the tunnel... | Class II | Bard Peripheral Vascular Inc |
| May 31, 2019 | GlidePath Long-Term Hemodialysis Catheter with Preloaded stylet, REF/Product ... | The action is being initiated due to complaints received concerning the molded tip of the tunnel... | Class II | Bard Peripheral Vascular Inc |
| May 31, 2019 | EQUISTREAM Long-Term Hemodialysis Catheter with Preloaded Styet, REF/Product ... | The action is being initiated due to complaints received concerning the molded tip of the tunnel... | Class II | Bard Peripheral Vascular Inc |
| May 31, 2019 | GlidePath Long-Term Hemodialysis Catheter with Preloaded stylet, REF/Product ... | The action is being initiated due to complaints received concerning the molded tip of the tunnel... | Class II | Bard Peripheral Vascular Inc |
| May 2, 2019 | EnCor Breast Biopsy Probes, packaged individually in sterile pouches, 5 pouch... | There has been an increase in complaints related to leaks, suction issues, and failure to obtain ... | Class II | Bard Peripheral Vascular Inc |
| May 2, 2019 | EnCor Breast Biopsy Probes, packaged individually in sterile pouches, 5 pouch... | There has been an increase in complaints related to leaks, suction issues, and failure to obtain ... | Class II | Bard Peripheral Vascular Inc |
| May 2, 2019 | EnCor Breast Biopsy Probes, packaged individually in sterile pouches, 5 pouch... | There has been an increase in complaints related to leaks, suction issues, and failure to obtain ... | Class II | Bard Peripheral Vascular Inc |
| May 2, 2019 | EnCor Breast Biopsy Probes, packaged individually in sterile pouches, 5 pouch... | There has been an increase in complaints related to leaks, suction issues, and failure to obtain ... | Class II | Bard Peripheral Vascular Inc |
| May 2, 2019 | EnCor Breast Biopsy Probes, packaged individually in sterile pouches, 5 pouch... | There has been an increase in complaints related to leaks, suction issues, and failure to obtain ... | Class II | Bard Peripheral Vascular Inc |
| May 2, 2019 | EnCor Breast Biopsy Probes, packaged individually in sterile pouches, 5 pouch... | There has been an increase in complaints related to leaks, suction issues, and failure to obtain ... | Class II | Bard Peripheral Vascular Inc |
| Apr 12, 2019 | BD WAVELINQ 4F EndoAVF System, Arterial Catheter 50 cm, Venous Catheter 43 cm... | The firm has become aware of a potential problem with their venous and arterial magnetic catheter... | Class II | Bard Peripheral Vascular Inc |
| Feb 18, 2019 | LIFESTREAM Balloon Expandable Vascular Covered Stent . BARD PERIPHERAL VASCUL... | Certain product code/lot number combinations may experience introducer sheath compatibility issu... | Class II | Bard Peripheral Vascular Inc |
| Feb 14, 2019 | PowerPort isp M.R.I. Implantable Port with Attachable 8F Polyurethane Open-En... | Complaints received that products packaged with the incorrect introducer sheath size. | Class II | Bard Peripheral Vascular Inc |
| Jun 25, 2018 | POWERPORT CLEARVUE isp, 6F CHRONOFLEX Catheter, Intermediate NAUTILUS DELTA ... | Certain NAUTILUS DELTA Port Kit product code / lot number combinations may be at risk of experien... | Class II | Bard Peripheral Vascular Inc |
| Apr 16, 2018 | BARD PERIPHERAL VASCULAR SEEKER(R) Crossing Support Catheter, 0.014", 150 cm,... | Device is at risk of having detectable levels of bacterial endotoxin present on the packaging hoo... | Class II | Bard Peripheral Vascular 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.