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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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.