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.

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DateProductReasonClassFirm
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.