Browse Device Recalls

4,686 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 4,686 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 4,686 FDA device recalls in CA.

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DateProductReasonClassFirm
Dec 12, 2018 GelPOINT Path Transanal Procedural Pack with Epix Electrosurgical L-Hook with... Unintentional shifting of the tip insulation of the firm's electrosurgical probes. Class II Applied Medical Resources Corp
Dec 10, 2018 Aperio CS2 CE IVD scanner instrument, scanner part #23CS100CE. The incorrect sensor was used in the assembly of the camera in the scanner instrument which can p... Class II Leica Biosystems Imaging, Inc.
Dec 7, 2018 Spectranetics AngioSculpt PTCA Scoring Balloon Catheter, balloon outer diamet... The incorrect outer carton box was used for the product. Class II Spectranetics Corporation
Dec 6, 2018 VisuMax Software Version 2.10.13 with activated Software-Module ReLEx (SMILE)... VisuMax devices with software version 2.10.13 and activated SW-Module ReLEx (SMILE) option may ex... Class II Carl Zeiss Meditec, Inc.
Dec 5, 2018 The UniCel DxI 600 and 800 Access Immunoassay Systems, that are connected to ... When racks are front-loaded onto the sample presentation unit while samples from the automation l... Class II Beckman Coulter Inc.
Dec 5, 2018 UniCel DxC 660i, 680i, 860i, and 880i SYNCHRON Access Clinical Systems, that ... When racks are front-loaded onto the sample presentation unit while samples from the automation l... Class II Beckman Coulter Inc.
Dec 4, 2018 Da Vinci Xi/X EndoWrist Monopolar Curved scissors (MCS), model number 470179-... This recall is being initiated because lots of EndoWrist Monopolar Curved Scissor instruments ar... Class II Intuitive Surgical, Inc.
Dec 3, 2018 Pentax Medical C2 CryoBalloon Standard 90 degree Catheter, Model FG 1030, Ste... Incorrect default dose and dose increments may be transmitted to the controller if the catheter R... Class II PENTAX of America Inc
Dec 3, 2018 Pentax Medical C2 CryoBalloon Pear Focal Catheter, Model FG 1024, Sterile, RX... Incorrect default dose and dose increments may be transmitted to the controller if the catheter R... Class II PENTAX of America Inc
Dec 3, 2018 C2 CryoBalloon Controller, REF: FG-1017, with Controller Software v1.18.258 ... The Controller does not detect overpressure in the balloon during the application of non-dosing p... Class II PENTAX of America Inc
Dec 3, 2018 Pentax Medical C2 CryoBalloon Standard Focal Catheter, Model FG 1028, Sterile... Incorrect default dose and dose increments may be transmitted to the controller if the catheter R... Class II PENTAX of America Inc
Nov 28, 2018 ImplantDirect InterActive Precision IO Scan Adapter, Part #6534-09PT, Platfor... The peek part was loose on the titanium base of the device which could result in it falling into ... Class II Implant Direct Sybron Manufacturing, LLC
Nov 28, 2018 ImplantDirect InterActive Precision IO Scan Adapter, Part #6530-09PT, Platfor... The peek part was loose on the titanium base of the device which could result in it falling into ... Class II Implant Direct Sybron Manufacturing, LLC
Nov 27, 2018 ICU Medical, Transpac IV Monitoring Kit With Safeset Reservoir and Blood Samp... Reports of pressure tubing separation between the sampling port and the high pressure tubing on c... Class II ICU Medical, Inc.
Nov 27, 2018 ICU Medical, Transpac IV Monitoring Kit With Safeset Reservoir and Blood Samp... Reports of pressure tubing separation between the sampling port and the high pressure tubing on c... Class II ICU Medical, Inc.
Nov 27, 2018 ICU Medical, Transpac IV Monitoring Kit With Safeset Reservoir and Blood Samp... Reports of pressure tubing separation between the sampling port and the high pressure tubing on c... Class II ICU Medical, Inc.
Nov 21, 2018 da Vinci X Surgical System Due to a manufacturing variation in the arm that can result in a persistent recoverable fault err... Class II Intuitive Surgical, Inc.
Nov 21, 2018 da Vinci Xi Surgical System Due to a manufacturing variation in the arm that can result in a persistent recoverable fault err... Class II Intuitive Surgical, Inc.
Nov 19, 2018 St. Jude Medical Confirm Rx Insertable Cardiac Monitor, REF DM3500, Sterile. ... The device is unable to pair with the mobile app due to the device incorrectly determining the ce... Class II Abbott
Nov 13, 2018 Stryker Neurovascular, Merci 9F, 80cm, Balloon Guide Catheter, REF 90077, CE ... Labeling error; 8F Balloon Guide Catheters have been packaged within 9F Balloon Guide Catheter pa... Class II Stryker Neurovascular
Nov 13, 2018 Raindrop Near Vision Inlay, REF: RD1-1, Sterile, Rx Only, Manufacturer ReVisi... During a post approval study the firm found there was an increased risk of corneal haze following... Class I RVO 2.0, INC
Nov 9, 2018 AutoMate 1250, Sorter with Aliquot Module - UDI: 15099590364106; Model #ODL25... Beckman Coulter has identified a case where a customer using the microltiterplate kit option with... Class II Beckman Coulter Inc.
Nov 9, 2018 TEKIA Model 872 Single Piece Hydrophilic Acrylic Intraocular Lenses, Diopter ... A limited number of lenses may be mislabeled with the incorrect diopter power. Class II Tekia, Inc.
Nov 7, 2018 Philips Volcano FFR software used in the following systems connected to the M... Interoperability issue that affects certain systems that use the recalled software when it is con... Class II Volcano Corporation
Oct 30, 2018 Clinical Chemistry, ABX Pentra Lipase CP, ABX Pentra 400/Pentrac400, REF: A... Potential for chemical analyzer to report abnormal results due to an interference with triglyce... Class II Horiba Instruments Incorporated
Oct 26, 2018 Implant Direct, REF654311U, simply InterActive Implant, Surface: SBM, Qty 1, ... packaging error; An internal QA inspection revealed that a incorrect healing collar could have ... Class II Implant Direct Sybron Manufacturing, LLC
Oct 25, 2018 da Vinci SP Instrument Arm Drape. REF 430013-12 QTY 1 Pouch The instrument drape may tear while draping the Patient Side Cart presenting a breach in the ster... Class II Intuitive Surgical, Inc.
Oct 23, 2018 The da Vinci SP surgical system is made of three main components: the Surgeon... The firm became aware of a problem with the surgical system where the cannula mount button may be... Class II Intuitive Surgical, Inc.
Oct 18, 2018 iChem VELOCITY Urine Chemistry Strips, REF 800-7212, 100 test strips/vial. T... Falsely elevated (false positive) urobilinogen patient results due to an increase in the sensitiv... Class II Beckman Coulter Inc.
Oct 17, 2018 Visions PV .035 Digital IVUS Catheter, Catalog Number/Part Number 81234/400-0... Visions PV .035 Intravascular Ultrasound (IVUS) Catheters (catalog number 88901 adnd81234) due to... Class II Volcano Corporation
Oct 17, 2018 Visions PV .035 Digital IVUS Catheter, Catalog Number/Part Number 88901/400-0... Visions PV .035 Intravascular Ultrasound (IVUS) Catheters (catalog number 88901 adnd81234) due to... Class II Volcano Corporation
Oct 16, 2018 The PLEX Elite 9000, a Swept-Source OCT [SS-OCT] - Product Usage: The PLEX E... Under certain fault conditions, the existing design may expose the operator to a hazardous voltag... Class II Carl Zeiss Meditec, Inc.
Oct 16, 2018 Radrex-i X-Ray System (DRAD-3000E) TFP-4336W (Wireless FPD) Software version... software malfunction; It was found when a user performs radiography using the wireless flat pane... Class II Canon Medical System, USA, INC.
Oct 5, 2018 Iced Thermoset Closed-Loop Injectate Delivery System for cold Injectate. 1 u... Potential for leakage due to defect in the thermoset check valve component. Class II ICU Medical, Inc.
Oct 5, 2018 Thermoset Room Temperature Closed Loop Injectate Delivery System. 1 unit per... Potential for leakage due to defect in the thermoset check valve component. Class II ICU Medical, Inc.
Oct 5, 2018 Iced Thermoset Closed-Loop Injectate Delivery System for cold Injectate. 1 u... Potential for leakage due to defect in the thermoset check valve component. Class II ICU Medical, Inc.
Oct 3, 2018 Medtronic MiniMed 630G 6025805-003_C, Rx Only Medtronic MiniMed 670G 60258... Reports of occurrences in which insulin pumps with version 4.10 software have failed to make expe... Class II Medtronic Inc.
Sep 28, 2018 TriMed Wrist Hook Dorsal Impactor, REF IMPCT-WHD; and TriMed Wrist Hook Volar... The WHD/WHV impactors can rust over time due to an improper manufacturing process. Class II TriMed Inc.
Sep 28, 2018 TriMed Hex Driver 1.2, 55mm AO Cannulated, REF HXDRIVR-1.2C AO, nonsterile, R... The epoxy on Apex manufactured epoxy-coated instruments can pop off. Class II TriMed Inc.
Sep 28, 2018 TriMed Locking Drill Guide, 2.3mm, REF GUIDELCBS-2.3, nonsterile, Rx. The fi... The epoxy on Apex manufactured epoxy-coated instruments can pop off. Class II TriMed Inc.
Sep 28, 2018 TriMed Peg Guide Extender, REF PEG-XTNDR, nonsterile, Rx. The firm name on t... The spring on the PEG-Extender can rust due to the type of steel used to manufacture it. Class II TriMed Inc.
Sep 28, 2018 TriMed Countersink 1.7mm, HCS, REF HSINK-1.7, nonsterile, Rx. The firm name ... The epoxy on Apex manufactured epoxy-coated instruments can pop off. Class II TriMed Inc.
Sep 25, 2018 PRO-DEX Surgical Driver Battery Pack PDBP-001 Series PRO-DEX Battery Pack, S... Visual particulates within a battery Tyvek pouch. The battery is provided sterile for use with s... Class II Pro-Dex Inc
Sep 24, 2018 Disposable 25GA Vitrectomy Cutter, REF NGP0025, RX Only, Abbott Medical Optic... Packaging error, 20GA Vitrectomy Cutter may be found in a 25GA package. Use of a Vitrectomy cutt... Class II Johnson & Johnson Surgical Vision Inc
Sep 18, 2018 The Access Cortisol Reagent. REF (Catalog Number) 33600, Lot 831755. A param... Cross contamination may have occurred between wells for the reagent pack. As a result of this def... Class II Beckman Coulter Inc.
Sep 17, 2018 Kaluza C Flow Cytometry Software, RX Only in the U.S.A., Beckman Coulter, Inc... Compatibility issue between the software and Microsoft updates to Windows 7, 8, and 10. The comp... Class II Beckman Coulter Inc.
Sep 6, 2018 Implant Direct Scan Adapter Assembly Replant platform for the following part ... The action is being initiated due to incorrect assembly of the scan adapter . The result of the i... Class II Implant Direct Sybron Manufacturing, LLC
Aug 24, 2018 Beckman Coulter Uric Acid, REF OSR6098, OSR6198, and OSR6698. NAPQI, a metabolite of Acetominophen, causes negative interference with the recalled product assa... Class II Beckman Coulter Inc.
Aug 24, 2018 Beckman Coulter Lipase, REF OSR6130 and OSR6230. NAPQI, a metabolite of Acetaminophen, causes negative interference with the recalled product assa... Class II Beckman Coulter Inc.
Aug 24, 2018 TriMed Hex Cortical Screw 4.0, 40 mm, REF HEX4.0-40, non-Sterile, RX, a compo... The bone screw is shorter than the intended design specification. Class II TriMed 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.