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
May 17, 2016 TCA Board, 16542A A continuous ventilator intended to mechanically control o... CareFusion has identified a potential risk associated with AVEA Ventilator caused by an incorrect... Class I Carefusion 211 Inc dba Carefusion
May 17, 2016 Gas Delivery Engine (GDE)-refurbished, R16650A A continuous ventilator inten... CareFusion has identified a potential risk associated with AVEA Ventilator caused by an incorrect... Class I Carefusion 211 Inc dba Carefusion
May 17, 2016 Gas Delivery Engine (GDE), 16650A A continuous ventilator intended to mechan... CareFusion has identified a potential risk associated with AVEA Ventilator caused by an incorrect... Class I Carefusion 211 Inc dba Carefusion
May 12, 2016 COSEAL Surgical Sealant Kit, 2 mL, Product Code: 934070; For use in vascular ... Potential for incomplete dissolution of the polyethylene glycol (PEG) component during the recons... Class II Baxter Healthcare Corp
May 12, 2016 Alaris System PC Unit Model 8015 with software versions 9.17 and 9.19; Centr... A patient weight can be populated incorrectly under certain conditions when using the RESTORE fea... Class II CareFusion 303, Inc.
May 12, 2016 COSEAL Surgical Sealant Kit, 8 mL, Product Code: 934072; For use in vascular... Potential for incomplete dissolution of the polyethylene glycol (PEG) component during the recons... Class II Baxter Healthcare Corp
May 12, 2016 COSEAL Surgical Sealant Kit, 4 mL, Product Code: 934071; For use in vascular... Potential for incomplete dissolution of the polyethylene glycol (PEG) component during the recons... Class II Baxter Healthcare Corp
May 10, 2016 SIOOA I (EP I84) Rabbit Monoclonal Antibody; Catalogue numbers 408R-14, 408R... Cell Marque became aware of some lots of SIOOA I (EP I84) Rabbit Monoclonal Antibody, catalogue n... Class II Cell Marque Corporation
May 9, 2016 SEAL,IS4000 PORTS,5MM-8MM,BOX of 10; Model numbers: 470361-03, 470361-04, 470... Potential for particulates in insufflation stopcocks on the da Vinci Xi Surgical System cannula s... Class II Intuitive Surgical, Inc.
May 9, 2016 SEAL,IS4000 PORTS,12MM&STAPLER,BOX of 10; Model numbers: 470380-04, 470380-05... Potential for particulates in insufflation stopcocks on the da Vinci Xi Surgical System cannula s... Class II Intuitive Surgical, Inc.
May 4, 2016 ReShape Integrated Dual Balloon System, Gen 1, Catalog No. RSM110, Model No. ... Due to a suspected misalignment of the connection between the proximal balloon cap of the implant... Class II Reshape Medical Inc
May 4, 2016 Stryker FlowPort II Adapter: Model number: 00CAT00778 The FlowPort II Adapt... Complaints were received for the Stryker FlowPort II Adapter, and investigation found that the sc... Class II Stryker Corporation
May 2, 2016 STAAR AQ Cartridge-FP, guide and delivery system for Intraocular lenses. The STAAR AQ Cartridge-FP may malfunction and may crack during loading or delivery of the IOL (In... Class II Staar Surgical Co.
Apr 25, 2016 Toshiba America Medical Systems, Inc . Celesteion PCA-9000A/2 CT Scanner It has been found that if the scan range extends beyond the maximum Field of View (FOV), a recons... Class II Toshiba American Medical Systems Inc
Apr 25, 2016 Toshiba America Medical Systems, Inc . Aquilion LB TSX-201A/2, 3 CT Scanner It has been found that if the scan range extends beyond the maximum Field of View (FOV), a recons... Class II Toshiba American Medical Systems Inc
Apr 25, 2016 Toshiba America Medical Systems, Inc Aquilion Lightning TSX-035A CT Scanner. It has been found that if the scan range extends beyond the maximum Field of View (FOV), a recons... Class II Toshiba American Medical Systems Inc
Apr 25, 2016 Volcano s5, s5i, CORE and CORE Mobile systems with software version 3.4 and v... Volcano has become aware of an incompatibility issue between Impacted Systems and hospital networ... Class II Volcano Corporation
Apr 25, 2016 Toshiba America Medical Systems, Inc . Aquilion RXL TSX-101 A/R, U CT Scann... It has been found that if the scan range extends beyond the maximum Field of View (FOV), a recons... Class II Toshiba American Medical Systems Inc
Apr 24, 2016 Toshiba American Medical Systems Celesteion, Item Code: PCA-9000A/2, 9000A/3B... Potential degradation of detector performance. Class II Toshiba American Medical Systems Inc
Apr 22, 2016 Accriva- APTT Cuvette for use on the Hemochron Jr. test system, catalog #J103... Clot activating reagent mis-positioned or visibly absent in the cuvette's test channel causing AP... Class II Accriva Diagnostics Inc., dba ITC, dba Accumetrics
Apr 14, 2016 MEXL-3010/A5- Vantage Titan 3T Magnetic Resonance Imaging System Product U... A potential problem associated to the gradient coil (ASGC) in the Titan 3T MRI System. Class II Toshiba American Medical Systems Inc
Apr 14, 2016 Pentaray NAV High-Density Mapping ECO Catheter, Catalog No. D128207, D128208,... Biosense Webster is recalling the Pentaray Catheters to clarify the contraindication language in ... Class II Biosense Webster, Inc.
Apr 14, 2016 Pentaray NAV High-Density Mapping Catheter, Catalog No. D128201, D128202, D12... Biosense Webster is recalling the Pentaray Catheters to clarify the contraindication language in ... Class II Biosense Webster, Inc.
Apr 13, 2016 Uric Acid, Catalog No. OSR6x98 Product Usage:Uric acid OSR6x98 is intended... Beckman Coulter has identified that Dipyrone (Metamizole) may cause erroneous, false low results ... Class II Beckman Coulter Inc.
Apr 13, 2016 Triglyceride, Catalog No. OSR6x118 Product Usage:Triglyceride OSR6x118 is ... Beckman Coulter has identified that Dipyrone (Metamizole) may cause erroneous, false low results ... Class II Beckman Coulter Inc.
Apr 13, 2016 Lipase, Catalog No. OSR6x30 Product Usage: Lipase OSR6x30 is intended as ... Beckman Coulter has identified that Dipyrone (Metamizole) may cause erroneous, false low results ... Class II Beckman Coulter Inc.
Apr 13, 2016 Cholesterol, Catalog No. OSR6x16 Product Usage:Cholesterol OSR6x16 is inte... Beckman Coulter has identified that Dipyrone (Metamizole) may cause erroneous, false low results ... Class II Beckman Coulter Inc.
Apr 13, 2016 Lactate, Catalog No. OSR6x93 Product Usage: Lactate OSR6x93 is intended a... Beckman Coulter has identified that Dipyrone (Metamizole) may cause erroneous, false low results ... Class II Beckman Coulter Inc.
Apr 12, 2016 Aquilion Lightning CT System iStation cover, SID: 70000246, Item Code: TSX-03... Toshiba American Medical Systems, Inc. is recalling the TSX-035A because of a potential problem w... Class II Toshiba American Medical Systems Inc
Apr 12, 2016 CinchLock Flex Knotless Anchor with Inserter; Model number CAT02643; Orth... Stryker Endoscopy is recalling the CinchLock SS Knotless Anchor with Inserter and the CinchLock F... Class II Stryker Corporation
Apr 12, 2016 CinchLock SS Knotless Anchor with Inserter; Model number CAT02462; Ortho... Stryker Endoscopy is recalling the CinchLock SS Knotless Anchor with Inserter and the CinchLock F... Class II Stryker Corporation
Apr 11, 2016 TRUE 3D VIEWER SYSTEM Model Number EP-00001-XX Software versions 1.0, 1.25... Imaging system data may be displayed with an incorrect orientation (sidedness) where the patient ... Class II Echopixel, Inc.
Apr 8, 2016 ACUSON SC2000 Ultrasound imaging system with software version VB10C and using... While imaging with a transesophageal (TEE) transducer (Z6Ms, V5Ms, or V7M), user may lose the abi... Class II Siemens Medical Solutions USA, Inc.
Apr 1, 2016 Direct Drive Clip Applier CA090, indicated for ligation of tubular structures... Increased customer complaints indicating inconsistent clip application; may lead to unoccluded ve... Class II Applied Medical Resources Corp
Mar 31, 2016 X-Ray Diagnostic Table, Model No. YSF-300 Use in combination with an X-ray h... Report of unintentional movement of table to reverse tilting. Class II Shimadzu Medical Systems
Mar 31, 2016 CF InPlex ASR Card; Catalog Number: 95-0501. Complaints of false positive HET mutations and leaking cards; could lead to unnecessary invasive ... Class II Hologic, Inc
Mar 31, 2016 Mach 4 Mouse Probe vial within the Mach 4 Universal HRP-Polymer Kit; Catalog... Biocare Medical has identified a single lot (082715) of its Mach 4 HRP Polymer kit in which some ... Class III Biocare Medical, LLC
Mar 31, 2016 BD Trucount Absolute Counting Tubes: Model number: 340334 IVD; BD Trucou... One lot of lot of BD Trucount tubes may contain tubes from another lot. There is a 3.3% differenc... Class II Becton, Dickinson and Company, BD Biosciences
Mar 31, 2016 Hologic InPlex CF Molecular Test (IVD); Catalog Number: 95-432. Complaints of false positive HET mutations and leaking cards; could lead to unnecessary invasive ... Class II Hologic, Inc
Mar 31, 2016 Ellipse ICD (Implantable Cardioverter Defibrillator) Model CD2411-36Q, CD2411... St. Jude Medical is recalling the Ellipse ICD (Implantable Cardioverter Defibrillator) due to the... Class II St Jude Medical Inc.
Mar 28, 2016 PneumoSure XL High Flow Insufflator and PneumoSure High Flow Insufflator; H... When operating the device in high flow mode (40L/min, 15 mmHg) and connecting to a house gas inle... Class II Stryker Endoscopy
Mar 25, 2016 EndoWrist Stapler 45 and Stapler 30 instruments used on the da Vinci Xi syst... Potential for unexpected motion of the Xi Stapler jaws on the da Vinci Xi System with p5 software... Class II Intuitive Surgical, Inc.
Mar 25, 2016 Magellan Robotic Catheter Accessory Kits, Model number MACC 50 and MACC80. ... Firm's quarterly dose audit testing showed that one batch was radiated below the augmented dose a... Class II Hansen Medical Inc
Mar 24, 2016 Alaris PC unit, Model 8015 The Alaris PC unit is the central programming, ... The Alaris PC units model 8015 may display a system error code 133.6080 due to failure with the s... Class II CareFusion 303, Inc.
Mar 24, 2016 CELL-DYN Emerald Cleaner, product number 09H46-02. 960mL. IVD; Hematolo... Three lots of CELL-DYN Emerald Cleaner may have occurrences where the analyzer generates Quality ... Class II Abbott Laboratories
Mar 21, 2016 Hardy Diagnostics GBS Detect Cat no. A300. Used for the isolation and det... Performance failure; poor hemolytic reaction of non or weakly hemolytic group B streptococcus (GB... Class II Hardy Diagnostics
Mar 21, 2016 GDC-18 360 11MM X 30CM Detachable Coil Sterile; Model number: M0033471020SR... The incorrect DFU was packaged with two lots of GDC 360 degree Detachable Coils. Class II Stryker Neurovascular
Mar 21, 2016 GDC-10 360 SOFT 10MM X 20CM SR Detachable Coil Sterile; Model number: M0033... The incorrect DFU was packaged with two lots of GDC 360 degree Detachable Coils. Class II Stryker Neurovascular
Mar 18, 2016 BD-Retic-Count Reticulocyte Reagent System; Hematology: Used for in vitro ... The carton label for one lot of BD Retic-Count Reticulocyte Reagent System had the incorrect stor... Class III Becton, Dickinson and Company, BD Biosciences
Mar 16, 2016 da Vinci S Surgical System (IS1200/IS2000/IS3000) user manual, instrument & a... Intuitive Surgical has found that the use of instruments other than the Cardiac Probe Grasper (e.... Class II Intuitive Surgical, 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.