Browse Device Recalls
110 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 110 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 110 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Nov 2, 2022 | CareFusion V. Mueller TITANIUM BAYONET BIPOLAR FORCEPS, STRAIGHT, FINE 0.5MM ... | BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content t... | Class II | Carefusion 2200 Inc |
| Nov 2, 2022 | CareFusion V. Mueller ROUND HANDLE BAYONET BIPOLAR FORCEPS 1.0MM TIP OVERALL ... | BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content t... | Class II | Carefusion 2200 Inc |
| Nov 2, 2022 | Carefusion V. Mueller SCOVILLE-GREENWOOD BAYONET BIPOLAR FORCEPS 1.5MM TIPS, ... | BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content t... | Class II | Carefusion 2200 Inc |
| Nov 2, 2022 | CareFusion V. Mueller euro/Spine TITANIUM ROUND HANDLE BAYONET BIPOLAR FORCEP... | BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content t... | Class II | Carefusion 2200 Inc |
| Nov 2, 2022 | Carefusion V. Mueller ADSON BIPOLAR FORCEPS 1.0MM TIP OVERALL LENGTH 4-3/4" (... | BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content t... | Class II | Carefusion 2200 Inc |
| Nov 2, 2022 | Carefusion V. Mueller Neuro/Spine JEWELERS BIPOLAR FORCEPS 0.4MM TIP, CURVED,... | BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content t... | Class II | Carefusion 2200 Inc |
| Nov 2, 2022 | CareFusion V. Mueller TITANIUM BAYONET BIPOLAR FORCEPS, 1.0MM TIP, STRAIGHT M... | BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content t... | Class II | Carefusion 2200 Inc |
| Nov 2, 2022 | CareFusion V. Mueller TITANIUM BAYONET INSULATED IRRIGATING BIPOLAR FORCEPS 1... | BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content t... | Class II | Carefusion 2200 Inc |
| Nov 2, 2022 | CareFusion V. Mueller TITANIUM BAYONET BIPOLAR FORCEPS, 0.5MM TIP, ANGLED-UP ... | BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content t... | Class II | Carefusion 2200 Inc |
| Nov 2, 2022 | Carefusion V. Mueller" HARDY-STYLE BAYONET BIPOLAR FORCEPS, 0.5MM TIP, INSULA... | BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content t... | Class II | Carefusion 2200 Inc |
| Nov 2, 2022 | Carefusion V. Mueller"GERALD BIPOLAR FORCEPS INSULATED, 1.0MM TIP OVERALL LEN... | BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content t... | Class II | Carefusion 2200 Inc |
| Nov 2, 2022 | Carefusion V. Mueller" CUSHING BAYONET BIPOLAR FORCEPS, 2.0MM TIP, INSULATED ... | BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content t... | Class II | Carefusion 2200 Inc |
| Sep 26, 2022 | CareFusion V.Mueller GENESIS SMALL, SHALLOW CONT. 21 X 7" (53.3 X 17.8CM) 3" ... | Genesis STERRAD Reusable Rigid Sterilization Containers have not consistently met the requirement... | Class II | Carefusion 2200 Inc |
| Sep 26, 2022 | CareFusion V.Mueller GENESIS LARGE, SHALLOW CONT. 28 X 11" (71.1 X 27.9CM) 3"... | Genesis STERRAD Reusable Rigid Sterilization Containers have not consistently met the requirement... | Class II | Carefusion 2200 Inc |
| Sep 26, 2022 | CareFusion V.Mueller GENESIS FULL-LENGTH CONTAINER 23 X12" (58.4 X 30.5CM) 7"... | Genesis STERRAD Reusable Rigid Sterilization Containers have not consistently met the requirement... | Class II | Carefusion 2200 Inc |
| Sep 26, 2022 | CareFusion V.Mueller GENESIS FULL-LENGTH CONTAINER 23 X12" (58.4 X 30.5CM) 4"... | Genesis STERRAD Reusable Rigid Sterilization Containers have not consistently met the requirement... | Class II | Carefusion 2200 Inc |
| Sep 26, 2022 | CareFusion V.Mueller GENESIS HALF-LENGTH CONTAINER 11X12" (27.9 X 30.5CM) 5" ... | Genesis STERRAD Reusable Rigid Sterilization Containers have not consistently met the requirement... | Class II | Carefusion 2200 Inc |
| Sep 26, 2022 | CareFusion V.Mueller GENESIS LARGE, CONTAINER 28 X 11" (71.1 X 27.9CM) 6" (15... | Genesis STERRAD Reusable Rigid Sterilization Containers have not consistently met the requirement... | Class II | Carefusion 2200 Inc |
| Sep 26, 2022 | CareFusion V.Mueller GENESIS HALF-LENGTH CONTAINER 11X12" (27.9 X 30.5CM) 6" ... | Genesis STERRAD Reusable Rigid Sterilization Containers have not consistently met the requirement... | Class II | Carefusion 2200 Inc |
| Sep 26, 2022 | CareFusion V.Mueller GENESIS MID-LENGTH CONTAINER 19X12" (48.3 X 30.5CM) 5" (... | Genesis STERRAD Reusable Rigid Sterilization Containers have not consistently met the requirement... | Class II | Carefusion 2200 Inc |
| Sep 26, 2022 | CareFusion V.Mueller GENESIS MID-LENGTH CONTAINER 19X12" (48.3 X 30.5CM) 4" (... | Genesis STERRAD Reusable Rigid Sterilization Containers have not consistently met the requirement... | Class II | Carefusion 2200 Inc |
| Sep 26, 2022 | CareFusion V.Mueller GENESIS MINI CONTAINER 10-1/2 X 7-1/2" (26.7X19.0CM) 3" ... | Genesis STERRAD Reusable Rigid Sterilization Containers have not consistently met the requirement... | Class II | Carefusion 2200 Inc |
| Sep 26, 2022 | CareFusion V.Mueller GENESIS HALF-LENGTH CONTAINER 11X12" (27.9 X 30.5CM) 4" ... | Genesis STERRAD Reusable Rigid Sterilization Containers have not consistently met the requirement... | Class II | Carefusion 2200 Inc |
| Sep 26, 2022 | CareFusion V.Mueller GENESIS SMALL CONTAINER 21 X 7" (53.3 X 17.8CM) 5-1/2" (... | Genesis STERRAD Reusable Rigid Sterilization Containers have not consistently met the requirement... | Class II | Carefusion 2200 Inc |
| Sep 26, 2022 | CareFusion V.Mueller GENESIS QTR-LENGTH CONTAINER 12 X 8" (30.3X20.3CM) 4" (1... | Genesis STERRAD Reusable Rigid Sterilization Containers have not consistently met the requirement... | Class II | Carefusion 2200 Inc |
| Sep 26, 2022 | CareFusion V.Mueller GENESIS MID-LENGTH CONTAINER 19X12" (48.3 X 30.5CM) 6" (... | Genesis STERRAD Reusable Rigid Sterilization Containers have not consistently met the requirement... | Class II | Carefusion 2200 Inc |
| Sep 26, 2022 | CareFusion V.Mueller GENESIS FULL-LENGTH CONTAINER 23 X12" (58.4 X 30.5CM) 5"... | Genesis STERRAD Reusable Rigid Sterilization Containers have not consistently met the requirement... | Class II | Carefusion 2200 Inc |
| Sep 26, 2022 | CareFusion V.Mueller GENESIS MID-LENGTH CONTAINER 19X12" (48.3 X 30.5CM) 8" (... | Genesis STERRAD Reusable Rigid Sterilization Containers have not consistently met the requirement... | Class II | Carefusion 2200 Inc |
| Sep 26, 2022 | CareFusion V.Mueller GENESIS FULL-LENGTH CONTAINER 23 X12" (58.4 X 30.5CM) 6"... | Genesis STERRAD Reusable Rigid Sterilization Containers have not consistently met the requirement... | Class II | Carefusion 2200 Inc |
| Feb 23, 2022 | (a) CareFusion Snowden-Pencer Plastics, Endoplastic Endoscope 10 mm, 30 degre... | The finished device package did not contain the IFU. | Class II | Carefusion 2200 Inc |
| May 28, 2020 | Thora-Para 5 Fr Non-Valved Catheter Drainage Tray | The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the ... | Class II | Carefusion 2200 Inc |
| May 28, 2020 | Safe-T 8 Fr Thora-Para Tray With 8 Fr. Catheter and Sharps Injury Protection ... | The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the ... | Class II | Carefusion 2200 Inc |
| May 28, 2020 | Safe-T 5 Fr Thora-Para Tray With 5 Fr. Catheter and Sharps Injury Protection ... | The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the ... | Class II | Carefusion 2200 Inc |
| May 28, 2020 | Thora-Para 8 Fr Catheter Drainage Tray | The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the ... | Class II | Carefusion 2200 Inc |
| May 28, 2020 | Safe-T-Centesis 6 Fr Catheter Drainage Tray | The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the ... | Class II | Carefusion 2200 Inc |
| May 28, 2020 | Thora-Para 8 Fr Catheter Drainage Tray w/o Lidocaine | The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the ... | Class II | Carefusion 2200 Inc |
| May 28, 2020 | Safe-T-Centesis PLUS 6 Fr Catheter Drainage Tray | The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the ... | Class II | Carefusion 2200 Inc |
| May 28, 2020 | Safe-T PLUS Thora-Para 5 Fr Non-Valved Catheter Drainage Tray | The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the ... | Class II | Carefusion 2200 Inc |
| May 28, 2020 | Safe-T-Centesis 8 Fr Catheter Drainage Tray | The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the ... | Class II | Carefusion 2200 Inc |
| May 28, 2020 | Safe-T-Centesis 6 Fr Catheter Drainage Tray w/o Lidocaine | The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the ... | Class II | Carefusion 2200 Inc |
| May 28, 2020 | Thora-Para 5 Fr Catheter Drainage Tray | The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the ... | Class II | Carefusion 2200 Inc |
| May 28, 2020 | Safe-T PLUS Thora-Para 8 Fr Catheter Drainage Tray | The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the ... | Class II | Carefusion 2200 Inc |
| May 28, 2020 | Safe-T-Centesis PLUS 8 Fr Catheter Drainage Tray | The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the ... | Class II | Carefusion 2200 Inc |
| May 28, 2020 | Safe-T PLUS Thora-Para 5 Fr Catheter Drainage Tray | The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the ... | Class II | Carefusion 2200 Inc |
| May 18, 2020 | Mueller Knife Handle, Hexagonal - Product Usage: Intended to hold surgical bl... | Becton Dickinson and Company, is conducting a voluntary recall on the V. MuellerTM 3H Knife Handl... | Class II | Carefusion 2200 Inc |
| Feb 23, 2017 | Manometer, 550 ml three-Way Stopcock; STERILE; | The integrity of the sterile packaging is potentially compromised. | Class II | Carefusion 2200 Inc |
| Feb 23, 2017 | JAMSHIDI (TJ) NEEDLE BONE MARROW [a.) 13G x 3.5, b.) 8G x 4, c.) 11G x 4, d.)... | The integrity of the sterile packaging is potentially compromised. | Class II | Carefusion 2200 Inc |
| Feb 23, 2017 | ILLINOIS (TJ) NEEDLE ASPIRATION [15GA, 18GA]; STERILE; | The integrity of the sterile packaging is potentially compromised. | Class II | Carefusion 2200 Inc |
| Feb 23, 2017 | JAMSHIDI (TJ) NEEDLE BM ASP MAC [a.) 13G x 3.5, b.) 8G x 4, c.) 11G x 3.5, d.... | The integrity of the sterile packaging is potentially compromised. | Class II | Carefusion 2200 Inc |
| Feb 23, 2017 | Thoracentesis/ Paracentesis Kit 10/CS; STERILE; | The integrity of the sterile packaging is potentially compromised. | Class II | Carefusion 2200 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.