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 |
|---|---|---|---|---|
| Jun 16, 2015 | INSTRUMENT ARM DRAPE, IS4000, 20 PACK; used on the da Vinci Xi Surgical Syste... | Field Safety Notification to advise of an issue that may occur involving the combination of the d... | Class II | Intuitive Surgical, Inc. |
| Jun 15, 2015 | BD Flow Cytometers; used on all BD FACSCount, BD FACSCalibur, BD FACSCanto, B... | Instruments installed between June 2007 and September 2011 do not contain labeling pursuant to th... | Class III | BD Biosciences, Systems & Reagents |
| Jun 15, 2015 | OPD-Scan III Refractive Power/Corneal Analyzer Opthalmic Software versions 1... | Software bug was found where there was no difference in Total and Corneal high-order aberrations,... | Class II | Nidek Inc |
| Jun 8, 2015 | Natrelle Re-sterilizable Breast Implant Sizer, Size: 410 cc, Style No. MSZFX4... | Allergan is recalling the NATRELLE 410cc Re-Sterilizable Breast Implant Sizer because the expired... | Class II | Allergan Inc |
| Jun 4, 2015 | Volcano PV .035 Catheter: Part number: 88901; Product Usage: The Volcano... | During a relabeling procedure at the manufacturing facility, the products were labeled with a she... | Class II | Volcano Corporation |
| Jun 4, 2015 | Prestige Plus 185cm J-Tip: Part number: 9185J; Product Usage: The Presti... | During a relabeling procedure at the manufacturing facility, the products were labeled with a she... | Class II | Volcano Corporation |
| Jun 3, 2015 | SERFAS 90 degree Energy Probe, Part Number 279-350-101; SERFAS Energy Prob... | Stryker Endoscopy is recalling all non expired SERFAS 90 degree Energy Probes due to reports of f... | Class II | Stryker Endoscopy |
| Jun 1, 2015 | Sechrist Low Profile Wheeled Stretcher, Model No. 21762-110-33H, 21762-110-36... | Sechrist Industries is recalling the Sechrist Low Profile Wheeled Stretcher because it may experi... | Class II | Sechrist Industries Inc |
| May 29, 2015 | InjectionPlasty 1.0 Bone Void Filler; an injectable and biocompatible calciu... | Reports of venous uptake, DVT, pulmonary embolism in patients who were implanted with Injection P... | Class II | Skeletal Kinetics, Llc |
| May 29, 2015 | ACUSON SC2000 Ultrasound Systems between software versions VA16A and VA30A an... | When performing a 2D Stress Echo study, some following keystrokes result in a potential loss of d... | Class II | Siemens Medical Solutions USA, Inc. |
| May 28, 2015 | Stripper, 0.2mm Disposable EndoStat Fiber, The Fiber Stripper is a tool p... | validation data related to cleaning instructions and sterilization methods and the methods define... | Class II | American Medical Systems Innovation Center - Si... |
| May 28, 2015 | Sureflex 150 Lithotripsy Fiber, 5x, Blue; Sure F!ex laser fibers are inten... | validation data related to cleaning instructions and sterilization methods and the methods define... | Class II | American Medical Systems Innovation Center - Si... |
| May 28, 2015 | Sureflex 365 Lithotripsy Fiber, 5x, Blue; Sure F!ex laser fibers are inten... | validation data related to cleaning instructions and sterilization methods and the methods define... | Class II | American Medical Systems Innovation Center - Si... |
| May 28, 2015 | Sureflex 200 Lithotripsy Fiber, 5x, Blue; Sure F!ex laser fibers are inten... | validation data related to cleaning instructions and sterilization methods and the methods define... | Class II | American Medical Systems Innovation Center - Si... |
| May 28, 2015 | Fiber Stripper, 200¿m, Autoclavable; The Fiber Stripper is a tool provided... | validation data related to cleaning instructions and sterilization methods and the methods define... | Class II | American Medical Systems Innovation Center - Si... |
| May 28, 2015 | Tool, StripperW/BLD, 10S, Nonautoclavable; The Fiber Stripper is a tool p... | validation data related to cleaning instructions and sterilization methods and the methods define... | Class II | American Medical Systems Innovation Center - Si... |
| May 28, 2015 | Fiber Stripper, 910¿m, Autoclavable; The Fiber Stripper is a tool provided... | validation data related to cleaning instructions and sterilization methods and the methods define... | Class II | American Medical Systems Innovation Center - Si... |
| May 28, 2015 | Tool, Stripper W/BLD, 28S, Nonautoclavable; The Fiber Stripper is a tool p... | validation data related to cleaning instructions and sterilization methods and the methods define... | Class II | American Medical Systems Innovation Center - Si... |
| May 28, 2015 | Fiber Stripper, 273¿m, Autoclavable; The Fiber Stripper is a tool provided... | validation data related to cleaning instructions and sterilization methods and the methods define... | Class II | American Medical Systems Innovation Center - Si... |
| May 28, 2015 | Stripper, 0.3mm Disposable EndoStat Fiber, The Fiber Stripper is a tool p... | validation data related to cleaning instructions and sterilization methods and the methods define... | Class II | American Medical Systems Innovation Center - Si... |
| May 28, 2015 | Stripper, 0.6mm Disposable EndoStat Fiber, The Fiber Stripper is a tool p... | validation data related to cleaning instructions and sterilization methods and the methods define... | Class II | American Medical Systems Innovation Center - Si... |
| May 28, 2015 | Tool, Stripper W/BLD, 18S, Autoclavable; The Fiber Stripper is a tool prov... | validation data related to cleaning instructions and sterilization methods and the methods define... | Class II | American Medical Systems Innovation Center - Si... |
| May 28, 2015 | Tool, Stripper W/BLD, 12S, Nonautoclavable; The Fiber Stripper is a tool p... | validation data related to cleaning instructions and sterilization methods and the methods define... | Class II | American Medical Systems Innovation Center - Si... |
| May 28, 2015 | Sureflex 550 Lithotripsy Fiber, 5x, Blue; Sure F!ex laser fibers are inten... | validation data related to cleaning instructions and sterilization methods and the methods define... | Class II | American Medical Systems Innovation Center - Si... |
| May 28, 2015 | Tool, Stripper W/BLD, 14S, Autoclavable; The Fiber Stripper is a tool prov... | validation data related to cleaning instructions and sterilization methods and the methods define... | Class II | American Medical Systems Innovation Center - Si... |
| May 28, 2015 | Sureflex 910 Lithotripsy Fiber, 5x, Blue; Sure F!ex laser fibers are inten... | validation data related to cleaning instructions and sterilization methods and the methods define... | Class II | American Medical Systems Innovation Center - Si... |
| May 28, 2015 | 1X1 Cleaving Tiles; The Fiber Cleaver is a reusable and sterilizable to... | validation data related to cleaning instructions and sterilization methods and the methods define... | Class II | American Medical Systems Innovation Center - Si... |
| May 28, 2015 | Fiber Stripper, 365¿m, Autoclavable; The Fiber Stripper is a tool provided... | validation data related to cleaning instructions and sterilization methods and the methods define... | Class II | American Medical Systems Innovation Center - Si... |
| May 28, 2015 | 365¿M Lithotripsy Fiber- Reusable; Sure F!ex laser fibers are intended for... | validation data related to cleaning instructions and sterilization methods and the methods define... | Class II | American Medical Systems Innovation Center - Si... |
| May 28, 2015 | Sureflex 273 Lithotripsy Fiber, 5x, Blue; Sure F!ex laser fibers are inten... | validation data related to cleaning instructions and sterilization methods and the methods define... | Class II | American Medical Systems Innovation Center - Si... |
| May 28, 2015 | 200¿M Lithotripsy Fiber- Reusable; Sure F!ex laser fibers are intended for... | validation data related to cleaning instructions and sterilization methods and the methods define... | Class II | American Medical Systems Innovation Center - Si... |
| May 28, 2015 | Tool, Stripper W/BLD, 14S, Nonautoclavable; The Fiber Stripper is a tool p... | validation data related to cleaning instructions and sterilization methods and the methods define... | Class II | American Medical Systems Innovation Center - Si... |
| May 28, 2015 | Tool, Stripper W/BLD, 28S, Autoclavable; The Fiber Stripper is a tool prov... | validation data related to cleaning instructions and sterilization methods and the methods define... | Class II | American Medical Systems Innovation Center - Si... |
| May 28, 2015 | Tool, Stripper W/BLD, 44S, Nonautoclavable; The Fiber Stripper is a tool p... | validation data related to cleaning instructions and sterilization methods and the methods define... | Class II | American Medical Systems Innovation Center - Si... |
| May 28, 2015 | Tool, Stripper W/BLD, 12S, Autoclavable; The Fiber Stripper is a tool prov... | validation data related to cleaning instructions and sterilization methods and the methods define... | Class II | American Medical Systems Innovation Center - Si... |
| May 28, 2015 | Fiber Stripper, 550¿m, Autoclavable; The Fiber Stripper is a tool provided... | validation data related to cleaning instructions and sterilization methods and the methods define... | Class II | American Medical Systems Innovation Center - Si... |
| May 28, 2015 | Tool, StripperW/BLD, 10S, Autoclavable; The Fiber Stripper is a tool prov... | validation data related to cleaning instructions and sterilization methods and the methods define... | Class II | American Medical Systems Innovation Center - Si... |
| May 28, 2015 | Fiber Stripper, 150¿m, Autoclavable; The Fiber Stripper is a tool provided... | validation data related to cleaning instructions and sterilization methods and the methods define... | Class II | American Medical Systems Innovation Center - Si... |
| May 28, 2015 | Stripper, 0.4mm Disposable EndoStat Fiber, The Fiber Stripper is a tool p... | validation data related to cleaning instructions and sterilization methods and the methods define... | Class II | American Medical Systems Innovation Center - Si... |
| May 28, 2015 | Tool, Stripper W/BLD, 44S, Autoclavable; The Fiber Stripper is a tool prov... | validation data related to cleaning instructions and sterilization methods and the methods define... | Class II | American Medical Systems Innovation Center - Si... |
| May 28, 2015 | Fiber Cleaver; Fiber Cleaver is also used to score the outer jacket on Endo... | validation data related to cleaning instructions and sterilization methods and the methods define... | Class II | American Medical Systems Innovation Center - Si... |
| May 28, 2015 | Tool, Stripper W/BLD, 18S, Nonautoclavable; The Fiber Stripper is a tool p... | validation data related to cleaning instructions and sterilization methods and the methods define... | Class II | American Medical Systems Innovation Center - Si... |
| May 21, 2015 | Thoracic Grasper, 5 MM, for use with da Vinci S (IS2000) and SI (IS3000) Surg... | The coating of the 5 mm Thoracic Grasper main tube may experience damage with the possibility of ... | Class II | Intuitive Surgical, Inc. |
| May 18, 2015 | ClearSight, Model No. EVHRS Heart Reference Sensor. The EV1000 Clinical Plat... | Edward Lifesciences is recalling the ClearSight System because the finger component of the Heart ... | Class II | Edwards Lifesciences, LLC |
| May 18, 2015 | ActCel advanced bleeding control Topical Hemostatic Dressing 2in X 2in (5... | Coreva Health Science, LLC. is recalling ActCel Hemostatic Dressing due to customer literature an... | Class II | Coreva Health Science LLC |
| May 13, 2015 | StoneLight 30 Laser System (NS3000). For use in surgical procedures using ... | During internal testing a situation was discovered where when changing the settings, a new settin... | Class II | New Star Lasers, Inc. |
| May 13, 2015 | Alaris PC unit model 8015, Infusion pump. software version 9.17 Product Us... | An issue with the cancel functionality used during atypical infusion programming to cancel user i... | Class II | CareFusion 303, Inc. |
| May 11, 2015 | EVOTECH Endoscope Cleaner and Reprocessing System 208V, P/N 50004. The ASP... | Advanced Sterilization Products (ASP) is recalling the EVOTECH Endoscope Cleaner and Reprocessor ... | Class II | Advanced Sterilization Products |
| May 11, 2015 | EVOTECH Endoscope Cleaner and Reprocessing System 220-230V, P/N 50004-002. ... | Advanced Sterilization Products (ASP) is recalling the EVOTECH Endoscope Cleaner and Reprocessor ... | Class II | Advanced Sterilization Products |
| May 8, 2015 | Toshiba Aquilion CT System TSX-301B | If two specific operations are performed in multi-phase helical scanning, the acquired raw data m... | Class II | Toshiba American Medical Systems 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.