Browse Device Recalls
352 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 352 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 352 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 |
| Aug 1, 2022 | BD MaxGuard Extension Set, REF: ME1069 | Administration set, and extension set product labels list expiration year 2027 but the labels sho... | Class II | CAREFUSION |
| Aug 1, 2022 | BD MaxGuard Extension Set with 4-way stopcock, REF: M4058 | Administration set, and extension set product labels list expiration year 2027 but the labels sho... | Class II | CAREFUSION |
| Aug 1, 2022 | BD MaxGuard Extension Set with 2 Needleless Y-Site, REF: MX9059 | Administration set, and extension set product labels list expiration year 2027 but the labels sho... | Class II | CAREFUSION |
| Aug 1, 2022 | BD MaxGuard Extension Set with 0.2 Micron Filter and Needleless Y-Site, REF: ... | Administration set, and extension set product labels list expiration year 2027 but the labels sho... | Class II | CAREFUSION |
| Aug 1, 2022 | BD MaxGuard Flow Controller Extension Set with Needleless Y-Site, REF: MFS106 | Administration set, and extension set product labels list expiration year 2027 but the labels sho... | Class II | CAREFUSION |
| Aug 1, 2022 | BD MaxGuard Flow Controller Extension Set with Needleless Y-Site, REF: MFS141 | Administration set, and extension set product labels list expiration year 2027 but the labels sho... | Class II | CAREFUSION |
| Aug 1, 2022 | BD MaxGuard Extension Set with 1.2 Micron Filter and Needleless Y-Site, REF: ... | Administration set, and extension set product labels list expiration year 2027 but the labels sho... | Class II | CAREFUSION |
| Aug 1, 2022 | BD MaxGuard 15 Drop Administration Set with 4 Needleless Y-Sites, REF: MX9433 | Administration set, and extension set product labels list expiration year 2027 but the labels sho... | Class II | CAREFUSION |
| Aug 1, 2022 | BD MaxGuard Drop Administration set with 3 Needleless Y-Sites Removable 3-por... | Administration set, and extension set product labels list expiration year 2027 but the labels sho... | Class II | CAREFUSION |
| May 24, 2022 | BD Pyxis MedBank Cabinet Software v2.1.2.9 Legacy MedBank Cabinets with ... | The automated dispensing cabinet software update included a .dll file that is not compatible with... | Class II | CareFusion 303, 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 |
| Aug 24, 2021 | Catalog # BEK3411, Ecomomy Jamshidi Bone Marrow Biopsy Tray, 11 G X 4"Biopsy/... | Due to misbranded products shipped to customers. | Class II | Bard Peripheral Vascular Inc |
| Aug 24, 2021 | Catalog # BEK4511, Qty: 10, Ecomomy Jamshidi Bone Marrow Biopsy and Aspiratio... | Due to misbranded products shipped to customers. | Class II | Bard Peripheral Vascular Inc |
| Aug 2, 2021 | BD ADD-ON Burette Set V/NV Needle-Free Valve, REF: 82113E-0006 | Needle-free connector valves, either standalone or attached to extension sets, may have issues in... | Class II | CAREFUSION |
| Aug 2, 2021 | BD Extension Set SMALLBORE Tubing SmartSite VALVE, REF: 10010511; BD SmartSi... | Needle-free connector valves, either standalone or attached to extension sets, may have issues in... | Class II | CAREFUSION |
| Aug 2, 2021 | BD Alaris Pump Infusion Buerette Set Smallbore Tubing Smartsite Port (Burette... | Needle-free connector valves, either standalone or attached to extension sets, may have issues in... | Class II | CAREFUSION |
| Aug 2, 2021 | BD SmartSite Bag Access Device Needle-Free Valve, REF: 2300E; BD Bag access D... | Needle-free connector valves, either standalone or attached to extension sets, may have issues in... | Class II | CAREFUSION |
| Aug 2, 2021 | BD Gravity Burette Set 60 DP 3 SmartSite VALVES BALL VALVE DRIP CHAMBER, REF:... | Needle-free connector valves, either standalone or attached to extension sets, may have issues in... | Class II | CAREFUSION |
| Aug 2, 2021 | BD Syringe Set 20 DP MIC TBG 0.2MF CKV Anti-Siphon SmartSite VLV Sensing Disc... | Needle-free connector valves, either standalone or attached to extension sets, may have issues in... | Class II | CAREFUSION |
| Aug 2, 2021 | BD SmartSite, REF: 2000E CHINA; BD SmartSite Connector, REF: 2000E-04; BD Sma... | Needle-free connector valves, either standalone or attached to extension sets, may have issues in... | Class II | CAREFUSION |
| Aug 2, 2021 | BD BURETTE GRAVITY SET 60 DROP 2 Smartsite VALVES VENTED/NONVENTED, REF: 42163E | Needle-free connector valves, either standalone or attached to extension sets, may have issues in... | Class II | CAREFUSION |
| Aug 2, 2021 | BD SmartSite 'Y' Extension Set 2 Needle-Free Valves, REF: 20019E7D | Needle-free connector valves, either standalone or attached to extension sets, may have issues in... | Class II | CAREFUSION |
| Aug 2, 2021 | BD SmartSite Bag Access Device, REF: 2300E-0500; BD BAG ACCESS DEVICE CHECK V... | Needle-free connector valves, either standalone or attached to extension sets, may have issues in... | Class II | CAREFUSION |
| Aug 2, 2021 | BD Extension Set SMALLBORE Tubing with 2 SmartSite VALVES, REF: 20019E | Needle-free connector valves, either standalone or attached to extension sets, may have issues in... | Class II | CAREFUSION |
| Aug 2, 2021 | BD Alaris Pump Infusion Buerette Set 0.2 Micron Filter Smallbore Tubing Smart... | Needle-free connector valves, either standalone or attached to extension sets, may have issues in... | Class II | CAREFUSION |
| Aug 2, 2021 | BD SE Burette Set 20 Drops 2 Injection Ports Vented/NonVented, REF: 72103E-0006 | Needle-free connector valves, either standalone or attached to extension sets, may have issues in... | Class II | CAREFUSION |
| Aug 2, 2021 | BD Gravity IV Set 3-port Closed Manifold Back Check Valve 3 Needle-Free Y-sit... | Needle-free connector valves, either standalone or attached to extension sets, may have issues in... | Class II | CAREFUSION |
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.