Browse Device Recalls
244 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 244 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 244 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Dec 30, 2025 | da Vinci 5 Surgeon Console Viewer Display, ASSY, DV5 CONSOLE, IS5000, Part Nu... | Robotic-assisted surgical system has Viewer Display manufactured with outdated firmware, may resu... | Class II | Intuitive Surgical, Inc. |
| Dec 15, 2025 | da Vinci SP, SP Access Port Kit, Large Incision Reference Numbers:430073 ... | Access Port System tray may develop cracks potentially resulting in a sterility breach. | Class II | Intuitive Surgical, Inc. |
| Dec 4, 2025 | Brand Name: Ion Endoluminal System Product Name: Ion Vision Probe Bag Model... | Due to probe bags that may have a compromised or incomplete sterile pouch seal. | Class II | Intuitive Surgical, Inc. |
| Nov 17, 2025 | Da Vinci 5 ASSY, DV5 CONSOLE, IS5000 Model/Catalog Number: 380730 Used... | An error event following the release of a software version for the surgical system that can resul... | Class II | Intuitive Surgical, Inc. |
| Nov 7, 2025 | Brand Name: Da Vinci Product Name: da Vinci X, Xi Surgical System, & da Vin... | Due to a software implementation error that allowed instruments arms failing an important diagnos... | Class II | Intuitive Surgical, Inc. |
| Feb 26, 2025 | Brand Name: Da Vinci 5 Product Name: ASSY,DV5 CONSOLE,IS5000 Foot Tray Pedal... | Due to an increase in complaints concerning foot tray pedal spring failing resulting in the ped... | Class II | Intuitive Surgical, Inc. |
| Dec 19, 2024 | 8MM,FENESTRATED BIPOLAR FORCEPS,IS4000 REF 471205 | Due to increased complaints regarding frayed or broken grip cables on reusable instruments with j... | Class II | Intuitive Surgical, Inc. |
| Dec 19, 2024 | 8MM,LONG BIPOLAR GRASPER,IS4000 REF 471400 | Due to increased complaints regarding frayed or broken grip cables on reusable instruments with j... | Class II | Intuitive Surgical, Inc. |
| Dec 19, 2024 | 8MM,MEGA SUTURECUT ND,IS4000¿ REF 470309 | Due to increased complaints regarding frayed or broken grip cables on reusable instruments with j... | Class II | Intuitive Surgical, Inc. |
| Dec 19, 2024 | 8MM,TENACULUM FORCEPS,IS4000¿ REF 470207 | Due to increased complaints regarding frayed or broken grip cables on reusable instruments with j... | Class II | Intuitive Surgical, Inc. |
| Dec 19, 2024 | 8MM,CADIERE FORCEPS,IS4000 ¿ REF 470049 | Due to increased complaints regarding frayed or broken grip cables on reusable instruments with j... | Class II | Intuitive Surgical, Inc. |
| Dec 19, 2024 | 8MM,DUAL BLADE RETRACTOR,IS4000¿ REF 470249 | Due to increased complaints regarding frayed or broken grip cables on reusable instruments with j... | Class II | Intuitive Surgical, Inc. |
| Dec 19, 2024 | 8MM,TIP-UP FENESTRATED GRASPER,IS4000¿ REF 470347 | Due to increased complaints regarding frayed or broken grip cables on reusable instruments with j... | Class II | Intuitive Surgical, Inc. |
| Dec 19, 2024 | 8MM,SMALL GRASPING RETRACTOR,IS4000¿ REF 470318 | Due to increased complaints regarding frayed or broken grip cables on reusable instruments with j... | Class II | Intuitive Surgical, Inc. |
| Dec 19, 2024 | 8MM,COBRA GRASPER,IS4000 REF 471190 | Due to increased complaints regarding frayed or broken grip cables on reusable instruments with j... | Class II | Intuitive Surgical, Inc. |
| Dec 19, 2024 | 8MM,LARGE SUTURECUT NEEDLE DRIVER,IS4000¿ REF 470296 | Due to increased complaints regarding frayed or broken grip cables on reusable instruments with j... | Class II | Intuitive Surgical, Inc. |
| Dec 19, 2024 | 8MM,MICRO BIPOLAR FORCEPS,IS4000 ¿ REF 470171 | Due to increased complaints regarding frayed or broken grip cables on reusable instruments with j... | Class II | Intuitive Surgical, Inc. |
| Dec 19, 2024 | 8MM,MEDIUM-LARGE CLIP APPLIER,IS4000¿ REF 470327 | Due to increased complaints regarding frayed or broken grip cables on reusable instruments with j... | Class II | Intuitive Surgical, Inc. |
| Dec 19, 2024 | 8MM, POTTS SCISSORS, IS4000 REF 470001 | Due to increased complaints regarding frayed or broken grip cables on reusable instruments with j... | Class II | Intuitive Surgical, Inc. |
| Dec 19, 2024 | 8MM,LARGE HEM-O-LOK CLIP APPLIER,IS4000¿ REF 470230 | Due to increased complaints regarding frayed or broken grip cables on reusable instruments with j... | Class II | Intuitive Surgical, Inc. |
| Dec 19, 2024 | 8MM,CURVED BIPOLAR DISSECTOR,IS4000¿ REF 470344 | Due to increased complaints regarding frayed or broken grip cables on reusable instruments with j... | Class II | Intuitive Surgical, Inc. |
| Dec 19, 2024 | 8MM,FORCE BIPOLAR,IS4000 REF 470405 | Due to increased complaints regarding frayed or broken grip cables on reusable instruments with j... | Class II | Intuitive Surgical, Inc. |
| Dec 19, 2024 | 8MM, ROUND TIP SCISSORS, IS4000 ¿ REF 470007 | Due to increased complaints regarding frayed or broken grip cables on reusable instruments with j... | Class II | Intuitive Surgical, Inc. |
| Dec 19, 2024 | 8MM,MICRO BIPOLAR FORCEPS,IS4000 REF 471171 | Due to increased complaints regarding frayed or broken grip cables on reusable instruments with j... | Class II | Intuitive Surgical, Inc. |
| Dec 19, 2024 | 8MM,CURVED BIPOLAR DISSECTOR,IS4000 REF 471344 | Due to increased complaints regarding frayed or broken grip cables on reusable instruments with j... | Class II | Intuitive Surgical, Inc. |
| Dec 19, 2024 | 8MM,LARGE SUTURECUT NEEDLE DRIVER,IS4000 REF 471296 | Due to increased complaints regarding frayed or broken grip cables on reusable instruments with j... | Class II | Intuitive Surgical, Inc. |
| Dec 19, 2024 | 8MM, Tenaculum Forceps REF 470207 Instrument used with the da Vinci X/Xi S... | Due to an increase in complaints for pitch cable failures related to forceps and small Graptor in... | Class II | Intuitive Surgical, Inc. |
| Dec 19, 2024 | 8MM,FORCE BIPOLAR,IS4000 REF 471405 | Due to increased complaints regarding frayed or broken grip cables on reusable instruments with j... | Class II | Intuitive Surgical, Inc. |
| Dec 19, 2024 | 8MM, Small Graptor REF 470318 Is a grasping retractor Instrument used with... | Due to an increase in complaints for pitch cable failures related to forceps and small Graptor in... | Class II | Intuitive Surgical, Inc. |
| Dec 19, 2024 | 8MM,MARYLAND BIPOLAR FORCEPS,IS4000 REF 471172 | Due to increased complaints regarding frayed or broken grip cables on reusable instruments with j... | Class II | Intuitive Surgical, Inc. |
| Dec 19, 2024 | 8MM,DEBAKEY FORCEPS,IS4000 ¿ REF 470036 | Due to increased complaints regarding frayed or broken grip cables on reusable instruments with j... | Class II | Intuitive Surgical, Inc. |
| Dec 19, 2024 | 8MM,MARYLAND BIPOLAR FORCEPS,IS4000 ¿ REF 470172 | Due to increased complaints regarding frayed or broken grip cables on reusable instruments with j... | Class II | Intuitive Surgical, Inc. |
| Dec 19, 2024 | 8MM,PROGRASP FORCEPS,IS4000 ¿ REF 470093 | Due to increased complaints regarding frayed or broken grip cables on reusable instruments with j... | Class II | Intuitive Surgical, Inc. |
| Dec 19, 2024 | 8MM,CADIERE FORCEPS,IS4000 REF 471049 | Due to increased complaints regarding frayed or broken grip cables on reusable instruments with j... | Class II | Intuitive Surgical, Inc. |
| Dec 19, 2024 | 8MM,MEGA NEEDLE DRIVER,IS4000¿ REF 470194 | Due to increased complaints regarding frayed or broken grip cables on reusable instruments with j... | Class II | Intuitive Surgical, Inc. |
| Dec 19, 2024 | 8MM,RESANO FORCEPS,IS4000 ¿ REF 470181 | Due to increased complaints regarding frayed or broken grip cables on reusable instruments with j... | Class II | Intuitive Surgical, Inc. |
| Dec 19, 2024 | 8MM,BLACK DIAMOND MICRO FORCEPS,IS4000 ¿ REF 470033 | Due to increased complaints regarding frayed or broken grip cables on reusable instruments with j... | Class II | Intuitive Surgical, Inc. |
| Dec 19, 2024 | 8MM,LONG TIP FORCEPS,IS4000 REF 471048 | Due to increased complaints regarding frayed or broken grip cables on reusable instruments with j... | Class II | Intuitive Surgical, Inc. |
| Dec 19, 2024 | 8MM,FENESTRATED BIPOLAR FORCEPS,IS4000¿ REF 470205 | Due to increased complaints regarding frayed or broken grip cables on reusable instruments with j... | Class II | Intuitive Surgical, Inc. |
| Dec 19, 2024 | 8MM,ATRIAL RETRACTOR SHORT RIGHT,IS4000¿ REF 470246 | Due to increased complaints regarding frayed or broken grip cables on reusable instruments with j... | Class II | Intuitive Surgical, Inc. |
| Dec 19, 2024 | 8MM, MONOPOLAR CURVED SCISSORS, IS4000 REF 470179 | Due to increased complaints regarding frayed or broken grip cables on reusable instruments with j... | Class II | Intuitive Surgical, Inc. |
| Dec 19, 2024 | 8MM,PROGRASP FORCEPS,IS4000 REF 471093 | Due to increased complaints regarding frayed or broken grip cables on reusable instruments with j... | Class II | Intuitive Surgical, Inc. |
| Dec 19, 2024 | 8MM, LARGE NEEDLE DRIVER, IS4000 REF 470006 | Due to increased complaints regarding frayed or broken grip cables on reusable instruments with j... | Class II | Intuitive Surgical, Inc. |
| Dec 19, 2024 | 8MM,MEGA SUTURECUT ND,IS4000 REF 471309 | Due to increased complaints regarding frayed or broken grip cables on reusable instruments with j... | Class II | Intuitive Surgical, Inc. |
| Dec 19, 2024 | 8MM,HORIZON SMALL CLIP APPLIER,IS4000¿ REF 470401 | Due to increased complaints regarding frayed or broken grip cables on reusable instruments with j... | Class II | Intuitive Surgical, Inc. |
| Aug 21, 2024 | da Vinci 5, Surgeon Console Column Motor Connector; ASSY,DV5 CONSOLE,SSC,IS50... | Surgical system Error 23062 due to connector1) Partially damaged "Potential problem with ergonomi... | Class II | Intuitive Surgical, Inc. |
| Jul 12, 2024 | Ion Endoluminal System, REF: 380748-65 | There is a potential that the robotic system's instrument cart arm may contain screws that may ... | Class II | Intuitive Surgical, Inc. |
| Mar 13, 2024 | Patient Cart, Part: 380601, a component of the da Vinci SP Surgical System, M... | Surgical system may have inadequately welded top and/or bottom belts in the link 2 of the entry g... | Class II | Intuitive Surgical, Inc. |
| Oct 6, 2023 | Da Vinci Single-Site Wristed Needle Driver, REF: 478115, 5 mm | There is the potential for the needle drive to become dislodged and/or broken which could result ... | Class II | Intuitive Surgical, Inc. |
| Jun 12, 2023 | da Vinci Xi/X Tip-Up Fenestrated Grasper, REF: 470347, VER: 12 | Fenestrated Graspers have a manufacturing issue has the potential to cause breakage on both upper... | Class II | Intuitive Surgical, 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.