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 |
|---|---|---|---|---|
| Mar 1, 2018 | Fabius MRI, anesthesia machine, catalog no. 8607300 Product Usage: The pr... | The automatic ventilation may fail if the position detection of the motor is disturbed. If the ve... | Class I | Draeger Medical, Inc. |
| Mar 1, 2018 | 38 cm (15") Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, Micro... | ICU Medical is expanding the scope of their previously initiated recall to include additional I.V... | Class II | ICU Medical de Mexico, S.A. de C.V. |
| Feb 28, 2018 | PICC Kit, Product Code: AMS-7063-1 Convenience kit for the insertion of PI... | Potential friction holes may affect the sterility of the product. | Class II | Vygon U.S.A. |
| Feb 28, 2018 | Neonatal PICC Tray, Product Code: AMS-8010CP-1 Convenience kit for the ins... | Potential friction holes may affect the sterility of the product. | Class II | Vygon U.S.A. |
| Feb 28, 2018 | PICC Insertion Tray, Product Code: AMS-7192CS-3 Convenience kit for the in... | Potential friction holes may affect the sterility of the product. | Class II | Vygon U.S.A. |
| Feb 28, 2018 | Maximum Barrier Tray, Product Code: MCITX-1 Convenience kit for the insert... | Potential friction holes may affect the sterility of the product. | Class II | Vygon U.S.A. |
| Feb 28, 2018 | Maximum Barrier Tray, Product Code: AMS-9018CP Convenience kit for the ins... | Potential friction holes may affect the sterility of the product. | Class II | Vygon U.S.A. |
| Feb 28, 2018 | Zimmer Biomet Comprehensive Segmental Revision System (SRS). Orthopedic impla... | During assembly, an SRS Humeral Distal Body implant failed to engage correctly at the point of re... | Class II | Biomet, Inc. |
| Feb 28, 2018 | Maximum Barrier Insertion Tray, Product Code: AMS-9152CP Convenience kit f... | Potential friction holes may affect the sterility of the product. | Class II | Vygon U.S.A. |
| Feb 28, 2018 | Avenir Muller Stem; Item Number: 01.06010.003, Lot Number: 2904368, UDI: (01)... | A potential commingle that could result in the product in the package not matching the product o... | Class II | Zimmer GmbH |
| Feb 28, 2018 | PICC Insertion Tray, Product Code: AMS-7192CS-4 Convenience kit for the in... | Potential friction holes may affect the sterility of the product. | Class II | Vygon U.S.A. |
| Feb 28, 2018 | PICC Tray, Product Code: AMS-9093CP Convenience kit for the insertion of ... | Potential friction holes may affect the sterility of the product. | Class II | Vygon U.S.A. |
| Feb 28, 2018 | Avenir Muller Stem; Item Number: 01.06010.104, Lot Number: 2905496, UDI: (01)... | A potential commingle that could result in the product in the package not matching the product o... | Class II | Zimmer GmbH |
| Feb 27, 2018 | Iridex TruFocus LIO Premiere" Laser Indirect Ophthalmoscope ( LIO ) The... | It was discovered that the laser energy was not going where intended to put it, resulting in foca... | Class II | Iridex Corporation |
| Feb 27, 2018 | Bard(R) Premature Infant Feeding Tube, ENFit(TM), REF EN0036400 Product U... | BMD has identified that the product code/lot number combination identified above may have ineffec... | Class II | C.R. Bard, Inc. |
| Feb 27, 2018 | FlareHawk Interbody Fusion System (previously XCage Interbody Fusion System) ... | Recently Integrity Implants uncovered a discrepancy in the cleaning parameters in several of thei... | Class II | Integrity Implants Inc. |
| Feb 27, 2018 | Bard(R) Infant Feeding Tube, ENFit(TM), REF EN0036410 Product Usage: BAR... | BMD has identified that the product code/lot number combination identified above may have ineffec... | Class II | C.R. Bard, Inc. |
| Feb 27, 2018 | SPIFE Alkaline Hemoglobin Kit, Cat. No. 3415, for use in the separation a... | Lots of gel kits contained a newer revision of the Customer Procedures instructions than intended... | Class III | Helena Laboratories, Corp. |
| Feb 27, 2018 | Bard(R) Adult/Pediatric Feeding Tube, ENFit(TM), REF EN0036420 Product Us... | BMD has identified that the product code/lot number combination identified above may have ineffec... | Class II | C.R. Bard, Inc. |
| Feb 27, 2018 | AQURE, Software version 2.3.0 and 2.3.1 Product Usage: The AQURE system i... | There is a potential problem relating to the AQURE System, versions 2.3.0 and 2.3.1, that may res... | Class II | Radiometer Medical ApS |
| Feb 27, 2018 | Bard(R) Premature Infant Feeding tube, ENFit(TM), REF EN0036430 Product U... | BMD has identified that the product code/lot number combination identified above may have ineffec... | Class II | C.R. Bard, Inc. |
| Feb 26, 2018 | MindFrame Capture LP Revascularization Devices: Product Numbers: (a) REF 3... | There is a potential issue for all MindFrame Capture devices to partially detach or separate from... | Class I | Micro Therapeutics Inc, Dba Ev3 Neurovascular |
| Feb 26, 2018 | Sternal Valve Retractors With Atrial and Aortic Rakes; Models SRCL-1, SRCL-AR... | Failure in a retractor blade due to corrosion. In the area of the blade where the bearing/button ... | Class II | Genesee BioMedical, Inc. |
| Feb 26, 2018 | Atellica Solution and Atellica Sample Handler Prime for in vitro diagnostic t... | When more than one immunoassay analyzer is connected to a single solution system, reporting and c... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Feb 26, 2018 | Cold Storage Solution, 2L, labeled as Waters IGL Cold Storage Solution, Catal... | Bags of solution may have a small leak at the base of the injection port where the port is welded... | Class II | Preservation Solutions, Inc. |
| Feb 26, 2018 | Atelia IM 1300 Analyzer for in vitro diagnostic testing of clinical specimens. | When more than one immunoassay analyzer is connected to a single solution system, reporting and c... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Feb 26, 2018 | WET-FIELD OSHER THERMODOT MARKER, 25GA FINE TIP, CURVED; Part number 221270. ... | Incorrect tip was used during manufacturing of the Osher Thermodot Marker. The markers have a nee... | Class II | Beaver-Visitec International Inc. |
| Feb 26, 2018 | Analyzer and Atellica IM 1600 Analyzer system for in vitro diagnostic testing... | When more than one immunoassay analyzer is connected to a single solution system, reporting and c... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Feb 26, 2018 | Wet-Field Hemostatic Eraser Bipolar 25G, fine tip, straight, 5/SP; Part Numbe... | Products were packaged with incorrect labeling, | Class II | Beaver-Visitec International Inc. |
| Feb 23, 2018 | MINI INFANT < 3KG, RADIOTRANSLUCENT ELECTRODE, Philips Plug Style Connector, ... | Wire sets of certain devices were assembled with adhesive on the contact wires, which may impede ... | Class II | ConMed Corporation |
| Feb 23, 2018 | T5 Zipper Toga with Peel-Away Face Shield, (L/XL); Catalog number: 0400-820-1... | 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 | T4 Pullover Toga, Large; Catalog Number: 0400-760-000 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 MODIFIED Tesio CATHETER SET, REF MCTC1235SM, UDI 884908027259 Product ... | 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 | ORTHOFIX, Connector System, LARGE SET SCREW, REF 79-2002 | Orthofix is conducting a voluntary recall of the Connector System Large Set Screw (PN: 79-2002) w... | Class II | Orthofix, Inc |
| Feb 23, 2018 | REPAIR KIT, REF ARA101, UDI 884908083637 Product Usage: The Medcomp Repair ... | 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 | T4 Pullover Toga, Regular ; Catalog Number: 0400-750-000 Sterile personal pr... | 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 | CATHETER REPAIR KIT, REF AAC52001, UDI 884908001891 Product Usage: The M... | 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 ORT300 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 | T4 Pullover Toga, (S/M); Catalog Number: 0400-710-000 Sterile personal prot... | 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 | IMRIS ORT100 Table, Part Numbers: (a) 110470-000 (b) 110470-600 | 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, ZOLL¿ Connector, REF/Catalog N... | Wire sets of certain devices were assembled with adhesive on the contact wires, which may impede ... | Class II | ConMed Corporation |
| Feb 23, 2018 | GE Healthcare Centricity PACS-IW, Model Numbers: (a) 2052831-00X (b) 204958... | A database handling error could occur during the image acquisition process affecting the complete... | Class II | GE Healthcare |
| Feb 23, 2018 | MINI INFANT < 3KG, RADIOTRANSLUCENT ELECTRODE, Philips Plug Style Connector, ... | Wire sets of certain devices were assembled with adhesive on the contact wires, which may impede ... | Class II | ConMed Corporation |
| Feb 23, 2018 | IMRIS T2X Table, Part Numbers: (a) 108000-000 (b) 108000-600 (c) 109682-00... | 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, Universal/Anderson Connector, ... | Wire sets of certain devices were assembled with adhesive on the contact wires, which may impede ... | Class II | ConMed Corporation |
| Feb 23, 2018 | Versatex Monofilament Mesh 50 x 50cm, Product No. VTX5050M The device is m... | There have been patient reports of abdominal hernia recurrence following hernia repair. The recal... | Class II | Sofradim Production |
| Feb 23, 2018 | T4 Pullover Toga, X-Large; Catalog Number: 0400-770-000 Sterile personal pro... | 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 | TWO PART ADAPTER, REF MCTLA2000, UDI 884908027310 Product Usage: The Medc... | 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 | T4 Zipper Toga, (L/XL); Catalog Number: 0400-820-000 Sterile personal protec... | 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 | CATHETER REPAIR KIT, REF RMS52001, UDI 884908039658 Product Usage: The Me... | There is the potential for connection failures related to the female two-part luer to hemodialysi... | Class II | Medical Components, Inc dba MedComp |
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.