Browse Device Recalls
3,013 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,013 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 3,013 FDA device recalls in 2018.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Feb 23, 2018 | REPAIR KIT, REF RPK-01, UDI 884908039856 Product Usage: The Medcomp Repai... | There is the potential for connection failures related to the female two-part luer to hemodialysi... | Class II | Medical Components, Inc dba MedComp |
| Feb 23, 2018 | 12F Tesio CATHETER SET (CUFF 22CM FROM TIP), REF MCTC1235SD, UDI 884908027242... | There is the potential for connection failures related to the female two-part luer to hemodialysi... | Class II | Medical Components, Inc dba MedComp |
| Feb 23, 2018 | IMRIS ORT200 Removable Operating Room Table, 50-60 Hz Version is intended for... | The rotational locking mechanisms on the ORT 200/300 tables fail to operate such that it cannot c... | Class II | Deerfield Imaging, Inc. |
| Feb 23, 2018 | IMRIS ORT200, Removable Operating Room Table, Part Numbers: (a) 113821-000 ... | The Operating Room Table may drift while in use, which could potentially result in unintended mov... | Class II | Deerfield Imaging, Inc. |
| Feb 23, 2018 | MINI INFANT < 3KG, RADIOTRANSLUCENT ELECTRODE, Physio-Control¿ Quik-Combo" Co... | Wire sets of certain devices were assembled with adhesive on the contact wires, which may impede ... | Class II | ConMed Corporation |
| Feb 23, 2018 | T4 Zipper Toga, Regular; Catalog number: 0400-830-000 Sterile personal prote... | Separation of material layers may occur, causing a potential risk of exposure to contaminants. | Class II | Stryker Instruments Div. of Stryker Corporation |
| Feb 23, 2018 | T4 Pullover Toga, L/XL; Catalog Number: 0400-720-000 Sterile personal prote... | Separation of material layers may occur, causing a potential risk of exposure to contaminants. | Class II | Stryker Instruments Div. of Stryker Corporation |
| Feb 23, 2018 | 12F X 60CM TESIO CATHETER SET WITH "Y" ADAPTOR, REF CMD757, UDI 884908005554 ... | There is the potential for connection failures related to the female two-part luer to hemodialysi... | Class II | Medical Components, Inc dba MedComp |
| Feb 23, 2018 | T5 Zipper Toga with Peel-Away Face Shield, (XL/T); Catalog number: 0400-850-1... | Separation of material layers may occur, causing a potential risk of exposure to contaminants. | Class II | Stryker Instruments Div. of Stryker Corporation |
| Feb 23, 2018 | ORTHOFIX, Connector System, SMALL SET SCREW, REF 79-2003 | Orthofix is conducting a voluntary recall of the Connector System Large Set Screw (PN: 79-2002) w... | Class II | Orthofix, Inc |
| Feb 23, 2018 | T4 Zipper Toga, X-Large; Catalog number: 0400-850-000 Sterile personal prote... | Separation of material layers may occur, causing a potential risk of exposure to contaminants. | Class II | Stryker Instruments Div. of Stryker Corporation |
| Feb 23, 2018 | 12F X 40CM TESIO CATHETER SET WITH "Y" ADAPTOR, REF CMD755, UDI 884908005530 ... | There is the potential for connection failures related to the female two-part luer to hemodialysi... | Class II | Medical Components, Inc dba MedComp |
| Feb 23, 2018 | 12F Tesio CATHETER SET (CUFF 32CM FROM TIP), REF MCTC1247SD, UDI 884908027266... | There is the potential for connection failures related to the female two-part luer to hemodialysi... | Class II | Medical Components, Inc dba MedComp |
| Feb 23, 2018 | CIVCO lnfiniti Needle Guide Bracket. used for performing needle-guided (or ca... | A cover failed leak testing during validation testing of new needle guides from a replacement tool. | Class II | Civco Medical Instruments Co. Inc. |
| Feb 23, 2018 | IMRIS ORT300, Removable Operating Room Table, Part Numbers: (a) 114093-000 ... | The Operating Room Table may drift while in use, which could potentially result in unintended mov... | Class II | Deerfield Imaging, Inc. |
| Feb 23, 2018 | T4 Zipper Toga (S/M); Catalog Number: 0400-810-000 Sterile personal protecti... | Separation of material layers may occur, causing a potential risk of exposure to contaminants. | Class II | Stryker Instruments Div. of Stryker Corporation |
| Feb 22, 2018 | Cobas b 221<4>Roche OMNI S4 system; Catalog numbers: 3337138001 and 333713869... | The software responsible for starting scheduled AutoQC measurements (scheduler) will not activate. | Class II | Roche Diagnostics Corporation |
| Feb 22, 2018 | cobas b 221<6>Roche OMNI S6 system; Catalog numbers: 3337154001 and 333715469... | The software responsible for starting scheduled AutoQC measurements (scheduler) will not activate. | Class II | Roche Diagnostics Corporation |
| Feb 22, 2018 | cobas b 221<2>Roche OMNI S2 system catalog numbers: 3337111001 and 3337111692... | The software responsible for starting scheduled AutoQC measurements (scheduler) will not activate. | Class II | Roche Diagnostics Corporation |
| Feb 22, 2018 | cobas b 221 AutoQC Module Complete; Catalog numbers: 3313522001 and 331352269... | The software responsible for starting scheduled AutoQC measurements (scheduler) will not activate. | Class II | Roche Diagnostics Corporation |
| Feb 21, 2018 | True 3D Viewer, Model: EP-00003 | With certain software versions, import of enhanced ultrasound formatted data/ultrasound images in... | Class II | Echopixel, Inc. |
| Feb 21, 2018 | Infinity Acute Care System (IACS) Monitoring Solution, Catalog Numbers: MS188... | The invasive pressure visual and audible alarms may not activate. | Class II | Draegar Medical Systems, Inc. |
| Feb 21, 2018 | 56% 1 Day Silicone Hydrogel (-2.50), 10 pack, UV Blocking, daily disposable ... | The secondary packaging is labeled with an incorrect expiration date. | Class III | CooperVision Inc. |
| Feb 21, 2018 | clariti 1 day/Fresh Day 90 pack (-1.00), UV Blocking, 90 silicon hydrogel, da... | The secondary packaging is labeled with an incorrect expiration date. | Class III | CooperVision Inc. |
| Feb 21, 2018 | 56% 1 Day Silicone Hydrogel (-4.50), 10 pack, UV Blocking, daily disposable ... | The secondary packaging is labeled with an incorrect expiration date. | Class III | CooperVision Inc. |
| Feb 21, 2018 | Biograph Horizon, PET/CT System using VJ10A, VJ10B, VJ20A scanners that provi... | Possibility that the Biograph Horizon systems performing CT retrospective cardiac gating or PET c... | Class II | Siemens Medical Solutions USA, Inc. |
| Feb 21, 2018 | Intra-Aortic Balloon Catheter Mega 8FR 50cc Product Usage: The intra-aortic... | The U.S. Instructions For Use for the Mega Intra-Aortic Balloon (IAB) Catheter was missing the Co... | Class II | Datascope Corporation |
| Feb 21, 2018 | ADVIA Centaur CA 125II Assay; Cat No. 09427226, SMN 10310443 (1-pack/100 test... | Upon dilution, some patient samples may exhibit over-recovery outside the representative data pro... | Class II | Siemens Healthcare Diagnostics, Inc |
| Feb 21, 2018 | Brilliance 64 with 4.1.7 XX026 software version model number 728231 Produc... | Surview scan with tube current lower than 30 mA is unable to be initialized. | Class II | Philips Medical Systems (Cleveland) Inc |
| Feb 21, 2018 | Intra-Aortic Balloon Catheter Mega 7.5FR 40cc Product Usage: The intra-ao... | The U.S. Instructions For Use for the Mega Intra-Aortic Balloon (IAB) Catheter was missing the Co... | Class II | Datascope Corporation |
| Feb 21, 2018 | F-T3SYSTEM, T3 (Trumpf Table Top) System The device is a surgical table ... | The recalling firm has become aware that the rail section clamps used to attach the leg support o... | Class II | Allen Medical Systems |
| Feb 21, 2018 | Intra-Aortic Balloon Catheter Mega 7.5FR 30cc Product Usage: The intra-ao... | The U.S. Instructions For Use for the Mega Intra-Aortic Balloon (IAB) Catheter was missing the Co... | Class II | Datascope Corporation |
| Feb 21, 2018 | clariti 1 day (-1.25) 90 pack, UV Blocking, 90 silicone hydrogel, daily dispo... | The secondary packaging is labeled with an incorrect expiration date. | Class III | CooperVision Inc. |
| Feb 21, 2018 | AUTOSTAT II IgM Rheumatoid Factor, IVD, Part: FGA 05 Product Usage: Rheum... | Reports of higher than anticipated positivity rate for patients tested using IgM Kit. Some negati... | Class II | Hycor Biomedical Inc |
| Feb 20, 2018 | IMRIS ORT100 Table, Part Number 110470-000 | The rotational locking mechanisms on the ORT 100/ T2X tables can become disengaged or unlocked wh... | Class II | Deerfield Imaging, Inc. |
| Feb 20, 2018 | Presource PBDS, Kit, No Spiro. Kit includes a exerciser volumetric 5000 ML d... | A defect in the seal of the Gatorade pouch contained in kits caused the pouch to leak within a li... | Class II | Cardinal Health 200, LLC |
| Feb 20, 2018 | Presource PBDS, Kit, Common Diabetes. Kit includes a exerciser volumetric 50... | A defect in the seal of the Gatorade pouch contained in kits caused the pouch to leak within a li... | Class II | Cardinal Health 200, LLC |
| Feb 20, 2018 | IMRIS T2X Table, Part Number 109682-600 | The rotational locking mechanisms on the ORT 100/ T2X tables can become disengaged or unlocked wh... | Class II | Deerfield Imaging, Inc. |
| Feb 20, 2018 | Syngo.plaza software Syngo.Plaza is a Picture Archiving and Communicati... | Software upgrade to correct format of study dates and issues with Legacy Presentation States (ann... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 20, 2018 | Presource PBDS, Kit, No Spiro Diabetes. Kit includes a exerciser volumetric ... | A defect in the seal of the Gatorade pouch contained in kits caused the pouch to leak within a li... | Class II | Cardinal Health 200, LLC |
| Feb 20, 2018 | Presource PBDS, Kit, Common. Kit includes a exerciser volumetric 5000 ML dev... | A defect in the seal of the Gatorade pouch contained in kits caused the pouch to leak within a li... | Class II | Cardinal Health 200, LLC |
| Feb 20, 2018 | Syngo.plaza software VB10A model numbers: 10863171, 10863172, 10863173 Syn... | Software upgrade to correct format of study dates and issues with Legacy Presentation States (ann... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 19, 2018 | SpF PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator SpF PLUS-M... | Lack of adequate validation and controls to ensure that product cleanliness parameters were consi... | Class I | Zimmer Biomet, Inc. |
| Feb 19, 2018 | EBI Osteogen Implantable Bone Growth Stimulator The OsteoGen Implantable... | Lack of adequate validation and controls to ensure that product cleanliness parameters were consi... | Class I | Zimmer Biomet, Inc. |
| Feb 16, 2018 | Doyen-Collin Mouth Gag 120MM/ General Instruments | The plastic sleeves of the Penis Clamp and Mouth Gag may stick together during or after reprocess... | Class III | Aesculap Implant Systems LLC |
| Feb 16, 2018 | Strauss Penis Clamp 130MM/General Instruments | The plastic sleeves of the Penis Clamp and Mouth Gag may stick together during or after reprocess... | Class III | Aesculap Implant Systems LLC |
| Feb 15, 2018 | SOMATOM Sensation 16 Intended to produce cross-sections images of the body... | to inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm ... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 15, 2018 | SOMATOM Sensation 10 Intended to produce cross-sections images of the body... | to inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm ... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 15, 2018 | Ingenuity TF PET/CT, Model No. 882442 Product Usage: The device is an int... | Following a period of inactivity, the mass storage device may cause the acquisition console to be... | Class II | Philips Medical Systems (Cleveland) Inc |
| Feb 15, 2018 | SOMATOM Emotion 6 Intended to produce cross-sections images of the body by... | To inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm ... | Class II | Siemens Medical Solutions USA, 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.