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 |
|---|---|---|---|---|
| Mar 14, 2019 | Drill Tapered RP 4.3x11.5 mm Single-Pat - Product Usage: The Guided Drills (T... | Due to a problem in the packaging sealing process at the supplier of the affected devices, it can... | Class II | Nobel Biocare Usa Llc |
| Mar 14, 2019 | Drill Tapered NP 3.5x11.5 mm Single-Pat - Product Usage: The Guided Drills (T... | Due to a problem in the packaging sealing process at the supplier of the affected devices, it can... | Class II | Nobel Biocare Usa Llc |
| Mar 14, 2019 | Guided Start Drills/Counterbore NobRpl NP - Product Usage: The Guided Drills ... | Due to a problem in the packaging sealing process at the supplier of the affected devices, it can... | Class II | Nobel Biocare Usa Llc |
| Mar 7, 2019 | Stryker Heated Tube Set with Real-Time Pressure Sensing (RTP), REF 0620-040-6... | The heated tube sets were consistently leaking and detaching from the cassette. | Class II | Stryker Corporation |
| Mar 7, 2019 | Stryker High Flow Tube Set with Real-Time Pressure Sensing (RTP), REF 0620-04... | The heated tube sets were consistently leaking and detaching from the cassette. | Class II | Stryker Corporation |
| Mar 7, 2019 | Stryker High Flow II Tube Set, REF 0620-040-660, an accessory to the PNEUMO ... | The heated tube sets were consistently leaking and detaching from the cassette. | Class II | Stryker Corporation |
| Mar 6, 2019 | TruDi NAV Suction, TDNS000Z, 0 Degree Tip Angle, (01)10705031245877 | The firm became aware that three (3) lots of the NAV Suction Instruments contain calibration iss... | Class II | Acclarent, Inc. |
| Mar 6, 2019 | AquaBeam Handpiece, Sterile EO, Rx Only, REF: 310301, and 320301, a component... | Certain lots may develop an internal leak due to a micro-crack in a specific weld joint within th... | Class II | PROCEPT BIOROBOTICS CORPORATION |
| Mar 6, 2019 | TruDi NAV Suction, TDNS090Z, 90 Degree Tip Angle, (01) 10705031245891 | The firm became aware that three (3) lots of the NAV Suction Instruments contain calibration iss... | Class II | Acclarent, Inc. |
| Mar 6, 2019 | TruDi NAV Suction, TDNS070Z, 70 Degree Tip Angle (01) 10705031245884 | The firm became aware that three (3) lots of the NAV Suction Instruments contain calibration iss... | Class II | Acclarent, Inc. |
| Mar 3, 2019 | MRIdian Linac Radiation Therapy System Model 10000 and 20000 | Issue with transferring treatment regiment from one system to another. Adequate instructions for... | Class II | Viewray, Inc. |
| Mar 1, 2019 | Thoratec HeartMate 3 Coring Tool, Sterile EO, Rx Only, REF 10005872, an opti... | Small black plastic particle was observed in the left ventricle during implant procedure. | Class II | Thoratec Corp. |
| Feb 25, 2019 | NIDEK Specular Microscope, Model CEM-530 - Product Usage: The device provides... | The electromagnetic noise exceeded the upper limit of the Electromagnetic Compatibility Standard ... | Class III | Nidek, Inc. |
| Feb 21, 2019 | icumedical Oncology Kit w/12" Ext Set w/Spiros w/Red Cap, Clamp, Graduated Ad... | There is a potential for certain lots of ChemoLock and ChemoClave Vial Spikes to have plastic bur... | Class I | ICU Medical, Inc. |
| Feb 21, 2019 | icumedical ChemoLock, 20mm, (a) REF CL-80S (b) REF CL-80S-10 (10 units). ... | There is a potential for certain lots of ChemoLock and ChemoClave Vial Spikes to have plastic bur... | Class I | ICU Medical, Inc. |
| Feb 21, 2019 | icumedical Oncology Kit w/12" (30cm) Ext Set w/Spiros w/Red Cap, Clamp, Gradu... | There is a potential for certain lots of ChemoLock and ChemoClave Vial Spikes to have plastic bur... | Class I | ICU Medical, Inc. |
| Feb 21, 2019 | icumedical ChemoClave Vented Vial Spike, 20 mm, REF CH-70S . Used in IV admin... | There is a potential for certain lots of ChemoLock and ChemoClave Vial Spikes to have plastic bur... | Class I | ICU Medical, Inc. |
| Feb 21, 2019 | icumedical ChemoClave Vented Vial Spike, 20 mm, REF CH-80S. Used in IV admini... | There is a potential for certain lots of ChemoLock and ChemoClave Vial Spikes to have plastic bur... | Class I | ICU Medical, Inc. |
| Feb 21, 2019 | SetSource ChemoClave Vented Vial Spike, 20mm, REF Z7148. Used in IV administr... | There is a potential for certain lots of ChemoLock and ChemoClave Vial Spikes to have plastic bur... | Class I | ICU Medical, Inc. |
| Feb 21, 2019 | icumedical ChemoLock Closed Vial Spike w/Skirt, (a) REF CL-80S-4 (4 units) ... | There is a potential for certain lots of ChemoLock and ChemoClave Vial Spikes to have plastic bur... | Class I | ICU Medical, Inc. |
| Feb 20, 2019 | FLEXIBLE NEURO-FIBERSCOPE, 3.7MM X 34CM, Model # 11282BN1 | The action is being initiated due to Flexible Neuroscopes manufactured with the incorrect channe... | Class II | Karl Storz Endoscopy |
| Feb 20, 2019 | CELL-DYN Emerald analyzer, REF 09H39-01. The CELL-DYN Emerald is an autom... | There is a potential for the device to generate Quality Control (QC) low or out-of-range low for ... | Class II | Abbott Laboratories |
| Feb 15, 2019 | QuickTox 5 Panel Drug Screen DipCard | Mixed Products containing QuickTox 5 Panel Drugs Screen Dipcard (P/N QT11, LOT #188787) and Alere... | Class III | Ameditech Inc |
| Feb 15, 2019 | Alere Cholestech LDX Analyzer, model # 14-874 containing power supplies with ... | The polarity of the output of power supply was reversed. Due to polarity of the output of power... | Class II | Alere San Diego, Inc. |
| Feb 8, 2019 | Infinix DP- i(Infinix-8000F) CAT-870B Catheterization Table (Titling) - Produ... | Table tilts without operator involvement as a result of liquid spilling into tilt console trigger... | Class II | Canon Medical System, USA, INC. |
| Feb 6, 2019 | Na¿da CL Q30 Sound Processor, Sand Beige, Model Cl-5260-120; Silver Gray, Mod... | The sound processors were loaded with the incorrect firmware. | Class II | Advanced Bionics, LLC |
| Feb 6, 2019 | Na¿da CI Q90 Sound Processor, Silver Gray, Model Cl-5280-140. | The sound processors were loaded with the incorrect firmware. | Class II | Advanced Bionics, LLC |
| Feb 6, 2019 | Na¿da CI Q70 Sound Processor, Sand Beige, Model Cl-5245-120; Silver Gray, Mod... | The sound processors were loaded with the incorrect firmware. | Class II | Advanced Bionics, LLC |
| Jan 28, 2019 | Kii Fios First Entry, 5 X 75 mm, RX only, REF CFF05 Qty: 6, Sterile R, Lot: ... | The product may not have met sterility requirements . Use of a non-sterile device on a patient m... | Class II | Applied Medical Resources Corp |
| Jan 28, 2019 | ACUSON NX2 Diagnostic Ultrasound System, Model # 11284381, RX Only, Siemens M... | The action is being initiated due to internal testing which identified a possibility for transduc... | Class II | Siemens Medical Solutions USA, Inc. |
| Jan 28, 2019 | ACUSON NX3 Elite Diagnostic Ultrasound System, Model # 11235411, RX Only, Si... | The action is being initiated due to internal testing which identified a possibility for transduc... | Class II | Siemens Medical Solutions USA, Inc. |
| Jan 28, 2019 | ACUSON NX3 Diagnostic Ultrasound System, Model # 11235612, RX Only, Siemens ... | The action is being initiated due to internal testing which identified a possibility for transduc... | Class II | Siemens Medical Solutions USA, Inc. |
| Jan 28, 2019 | ACUSON NX2 Elite Diagnostic Ultrasound System, Model # 11284500, RX Only, Sie... | The action is being initiated due to internal testing which identified a possibility for transduc... | Class II | Siemens Medical Solutions USA, Inc. |
| Jan 17, 2019 | Aircast REF 3011 - PL RX only VF-PL Sterile Cuff Pkg., Lot# 418003, Expirati... | The product may not meet sterility requirements. Product labeled as sterile, however all units do... | Class II | DJO, LLC |
| Jan 16, 2019 | daVinci Harmonic ACE Curved Shears | During an internal inspection, Intuitive found that the sterile packaging of the da Vinci S/Si Ha... | Class II | Intuitive Surgical, Inc. |
| Jan 16, 2019 | Edwards Lifesciences(R) IntraClude(TM) Intra-Aortic Occlusion Device is a... | Edwards Lifesciences has received a limited number of customer reports regarding an inter-lumen l... | Class II | Edwards Lifesciences, LLC |
| Jan 14, 2019 | SHIMADZU MobileDaRt Evolution (MX8 Version), Mobile X-Ray System Product U... | In these units, the brake is usually released by gripping the drive handle and applied by letting... | Class II | Shimadzu Medical Systems Usa Com |
| Jan 14, 2019 | TRINIAS for diagnostic imaging and interventional procedures in cardiac angio... | Two issues: Event 1: Normal operation of the device is to power up the device in the morning, ... | Class II | Shimadzu Medical Systems Usa Com |
| Jan 14, 2019 | BRANSIST safire Product Usage: DIGITAL ANGIOGRAPHY SYSTEM This system is ... | Normal operation of the device is to power up the device in the morning, register the first patie... | Class II | Shimadzu Medical Systems Usa Com |
| Jan 11, 2019 | Ethyl Alcohol Enzymatic Assay, (a) REF 0220 (small test kit), (b) REF 0221 (l... | Shelf life of the product may be reduced due to degradation of the assay. | Class III | Lin-Zhi International Inc |
| Jan 9, 2019 | SwishPlus Implant 5.7mmD x 8mmL, SBM 6.5mmD Platform, Part Number 925708 | Due to a complaint received and internal investigation it was determined that implant vials were ... | Class II | Implant Direct Sybron Manufacturing LLC |
| Jan 9, 2019 | Insufflation tubing to be used with varies insufflator units. REF 031200-10; ... | The sterile single-use tubing may contain higher ethylene oxide (EO) residues than the acceptable... | Class III | Karl Storz Endoscopy |
| Jan 3, 2019 | icumedical ChemoLock Vial Spike, 20mm, REF CL-80S The ChemoLock Closed Sy... | There is a potential for one lot of ChemoLock Vial Spike to contain burr particulate | Class I | ICU Medical, Inc. |
| Jan 2, 2019 | BD FACSLyric 3L 10C with FACSuite Clinical Software v1.1.1, catalog number 66... | A customer site was identified to have three FACSLyric IVD systems with FACSuite clinical v1.1.1 ... | Class III | Becton, Dickinson and Company, BD Biosciences |
| Dec 26, 2018 | Eclipse(TM) Treatment Planning System with Proton Convolution Superposition a... | There is an anomaly with the Eclipse(TM) Treatment Planning System [TPS] Proton Convolution Super... | Class II | Varian Medical Systems, Inc. |
| Dec 21, 2018 | Edwards Lifesciences Swan Ganz Thermodilution Catheter, REF 131VF7P Produc... | These Swan Ganz catheters have incorrect lumen assembly, which causes reversal of the lumens. If ... | Class I | Edwards Lifesciences, LLC |
| Dec 21, 2018 | Edwards Lifesciences Swan Ganz Thermodilution Catheter, REF131F 7J Product... | These Swan Ganz catheters have incorrect lumen assembly, which causes reversal of the lumens. If ... | Class I | Edwards Lifesciences, LLC |
| Dec 21, 2018 | Edwards Lifesciences Swan Ganz Thermodilution Catheter, REF 151F7 Product ... | These Swan Ganz catheters have incorrect lumen assembly, which causes reversal of the lumens. If ... | Class I | Edwards Lifesciences, LLC |
| Dec 21, 2018 | Edwards Lifesciences Swan Ganz Thermodilution Catheter, REF 131F7P (5 pack of... | These Swan Ganz catheters have incorrect lumen assembly, which causes reversal of the lumens. If ... | Class I | Edwards Lifesciences, LLC |
| Dec 12, 2018 | Epix Electrosurgical Probes with Smoke Evacuation, Angled L-Hook Tip, 5mm x 4... | Unintentional shifting of the tip insulation of the firm's electrosurgical probes. | 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.