Browse Device Recalls
4,602 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 4,602 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 4,602 FDA device recalls in CA.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| May 24, 2016 | TriFoillmaging Triumph/Triumph II Research CT scanners. | The Firm has determined that several Triumph/Triumph II Research CT scanners produced by Northrid... | Class II | Northridge Tri-Modality Imaging, |
| May 24, 2016 | QuickSlide MGS-80, Automated Mutli-Slide Gram Stainer/GramPRO-80. Systemat... | Discrepant culture and gram stain results, which could potentially lead to misdiagnosis or improp... | Class II | Hardy Diagnostics |
| May 20, 2016 | Sharpoint Polypropylene Blue Monofilament 6"/15cm 9-0 USP, Product No. J2558N | Surgical Specialties is recalling Sharpoint Polyproplyene Blue Monofilament 6"/15cm 9-0 USP becau... | Class II | SSC- Surgical Specialties Corporation |
| May 19, 2016 | Toshiba Ultimax DREX-ULT80 X-ray generator | It was discovered that the generator of the system could possibly terminate the exposure prematur... | Class II | Toshiba American Medical Systems Inc |
| May 19, 2016 | Toshiba Kalare DREX-KL80 X-ray generator | It was discovered that the generator of the system could possibly terminate the exposure prematur... | Class II | Toshiba American Medical Systems Inc |
| May 19, 2016 | 6534-08N InterActive¿ Implant Open-Tray Transfer Narrow Part Number: 6534-08... | The incorrect sized product, InterActive Implant Open-Tray Transfer Wide, 6534-08W, was packaged ... | Class II | Implant Direct Sybron Manufacturing, LLC |
| May 17, 2016 | AVEA Comprehensive ventilator-refurbished, R17310-xx (xx = 0-14) A continuo... | CareFusion has identified a potential risk associated with AVEA Ventilator caused by an incorrect... | Class I | Carefusion 211 Inc dba Carefusion |
| May 17, 2016 | AVEA Comprehensive ventilator, 17310-xx (xx = 0 - 14) A continuous ventila... | CareFusion has identified a potential risk associated with AVEA Ventilator caused by an incorrect... | Class I | Carefusion 211 Inc dba Carefusion |
| May 17, 2016 | AVEA Standard ventilator-refurbished, R17311-xx (xx = 0-14) A continuous ven... | CareFusion has identified a potential risk associated with AVEA Ventilator caused by an incorrect... | Class I | Carefusion 211 Inc dba Carefusion |
| May 17, 2016 | AVEA GDE upgrade kit, 12284-PMN A continuous ventilator intended to mechanic... | CareFusion has identified a potential risk associated with AVEA Ventilator caused by an incorrect... | Class I | Carefusion 211 Inc dba Carefusion |
| May 17, 2016 | AVEA Standard with Compressor ventilator, 17312-xx (xx = 0 - 14) A continuo... | 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)-1st Generation, 16222-001-99 A continuous ventilat... | CareFusion has identified a potential risk associated with AVEA Ventilator caused by an incorrect... | Class I | Carefusion 211 Inc dba Carefusion |
| May 17, 2016 | AVEA GDE/UIM upgrade kit, 12283-PMN A continuous ventilator intended to mech... | CareFusion has identified a potential risk associated with AVEA Ventilator caused by an incorrect... | Class I | Carefusion 211 Inc dba Carefusion |
| May 17, 2016 | AVEA Standard ventilator, 17311-xx (xx = 0 - 14) A continuous ventilator in... | CareFusion has identified a potential risk associated with AVEA Ventilator caused by an incorrect... | Class I | Carefusion 211 Inc dba Carefusion |
| May 17, 2016 | Access 2 Immunoassay System, Remanufactured, Catalog No. 386220 is an invitro... | Due to the lack of updated thermal components, these instruments may be more susceptible to the i... | Class II | Beckman Coulter Inc. |
| May 17, 2016 | AVEA Standard with Compressor ventilator-refurbished, R17312-xx (xx = 0-14) ... | CareFusion has identified a potential risk associated with AVEA Ventilator caused by an incorrect... | Class I | Carefusion 211 Inc dba Carefusion |
| 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 |
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.