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 |
|---|---|---|---|---|
| Feb 3, 2015 | IntellaTip MiFi Open-Irrigated radiofrequency Ablation Catheters: Material n... | Reports of formation of char adherent to the proximal part of the distal tip electrodes | Class I | Boston Scientific Corp |
| Jan 23, 2015 | MAX-TL 9.0 x 7.0 mm Implant, Catalog No. 15711K; Z-MAX Implant 9.0 x 7 mm Len... | Z-MAX Implant, 9mm diameter, 7mm length labeled package, catalog number Z-MAX9-7, contained a MAX... | Class II | Southern Implants, Inc |
| Jan 22, 2015 | GemLock Long Hex Driver, Catalog RHL2.5; Also distributed within the Tapered ... | The Gemlock Long Hex Driver may not fit into the Fixture Mount Transfer (FMT) or the internal hex... | Class II | Zimmer Dental Inc |
| Jan 21, 2015 | HARMONIC ACE Curved Shears Instructions for Use, 5MM, IS1200; for use with th... | Internal labeling review found that the IFU for the Harmonic Ace incorrectly instructs the user o... | Class II | Intuitive Surgical, Inc. |
| Jan 21, 2015 | Aquarius iNtuition Client Viewer. Findings Workflow module, RECIST 1.1: Pict... | Software anomaly related to RECIST1.1 target lesion evaluation criteria in Findings Workflow Modu... | Class II | TeraRecon, Inc. |
| Jan 21, 2015 | HARMONIC ACE Curved Shears Instructions for Use, 8MM, IS2000/IS3000; for use ... | Internal labeling review found that the IFU for the Harmonic Ace incorrectly instructs the user o... | Class II | Intuitive Surgical, Inc. |
| Jan 15, 2015 | da Vinci Si Surgical System, IS3000; - Wall chart for EndoWrist Stapler 45 Sy... | The Wall chart has been updated because it was noted that Wall Chart (PN 551524-03 Rev A) was inc... | Class II | Intuitive Surgical, Inc. |
| Jan 13, 2015 | SmartSite Low Sorbing Infusion Set, Model No. 10015862 The SmartSite Infusio... | CareFusion is recalling the SmartSite Low Sorbing Infusion set due to disconnection and leakage i... | Class II | CareFusion 303, Inc. |
| Jan 12, 2015 | ACUSON S2000 Automated Breast Volume Scanner (ABVS), model number 10434730. ... | There is a low probability the scanner arm will become completely detached from the scanner column. | Class II | Siemens Medical Solutions USA, Inc. |
| Jan 12, 2015 | ACUSON SC2000 Ultrasound System, Model 10433816, component 10040596 - UILK2. ... | The bolt holding the control panel of the ACUSON SC2000 in a fixed position may fail and the Cont... | Class II | Siemens Medical Solutions USA, Inc. |
| Jan 9, 2015 | Alive ECG App 2.1.2 ( a medical device application for the Apple iOS operatin... | Alive ECG App version 2.1.2 (intended to be used with the AliveCor Heart Monitor) crashed upon us... | Class III | Alivecor SFO |
| Dec 24, 2014 | Tyvek Pouch/Roll with STERRAD Chemical Indicator, P/N 12425 | Advanced Sterilization Products (ASP) is recalling the Tyvek Rolls with STERRAD Chemical Indicato... | Class II | Advanced Sterilization Products |
| Dec 22, 2014 | SpermMar Test 0.7ml Beads Particles Label on bottle: SpermMar Test IgA ... | The firm is recalling three batches (FP14A09, FP14A10, FP14A11) of SpermMAR IgA test due to new f... | Class II | Vitrolife Inc |
| Dec 19, 2014 | Anti-Lambda APC-H7, Catalog Number 656157. Product Usage: Intended for ... | Two lots of the Anti-Lambda APC-H7 antibody are contaminated with CD38 antibody. | Class II | BD Biosciences, Systems & Reagents |
| Dec 19, 2014 | CD8 (Leu-2a) PE (In vitro diagnostic), Catalog number 340046. Hematology: ... | One lot of CD8 PE is contaminated with CD4 FITC and may cause an unexpected staining pattern and ... | Class II | BD Biosciences, Systems & Reagents |
| Dec 19, 2014 | Zippie Zone Pediatric Rigid Wheelchair Model EIRZ1. | There is the potential for the height adjustable handle to dislodge due to failing locking mechan... | Class II | Sunrise Medical (US) LLC |
| Dec 19, 2014 | Quickie Q7 Adult Rigid Wheelchair Model EIR4. | There is the potential for the height adjustable handle to dislodge due to failing locking mechan... | Class II | Sunrise Medical (US) LLC |
| Dec 18, 2014 | Merlin@home RF Remote Monitoring Transmitter, Model EX1150, with software ver... | Transmitter may initiate a software reset resulting in backup operation in some implanted St. Jud... | Class II | St Jude Medical Cardiac Rhythm Management Division |
| Dec 18, 2014 | Ti-Bond Marketing Literature/Labeling, Catalog No. LT10000, MP-14000 This de... | Spinal Elements is recalling the Ti-Bond related brochures that includes LT-10000 and MP-14000 (a... | Class II | Spinal Elements, Inc |
| Dec 15, 2014 | Beckman Coulter, Lipase Assay, Catalog No. OSR6X30 | N-Acetyl Cysteine (NAC), when administered in therapeutic concentrations for the treatment of ace... | Class II | Beckman Coulter Inc. |
| Dec 15, 2014 | Beckman Coulter, Lactate Assay, Catalog No. OSR6X93 | N-Acetyl Cysteine (NAC), when administered in therapeutic concentrations for the treatment of ace... | Class II | Beckman Coulter Inc. |
| Dec 15, 2014 | Beckman Coulter, Uric Acid Assay, Catalog No. OSR6X98 | N-Acetyl Cysteine (NAC), when administered in therapeutic concentrations for the treatment of ace... | Class II | Beckman Coulter Inc. |
| Dec 15, 2014 | Beckman Coulter, Cholesterol Assay, Catalog No. OSR6X16 | N-Acetyl Cysteine (NAC), when administered in therapeutic concentrations for the treatment of ace... | Class II | Beckman Coulter Inc. |
| Dec 12, 2014 | MUM-1 (Multiple myeloma oncogene-1), catalog number PRM352 AA; Product U... | Three lots of MUM-1 may not meet their labeled shelf life, as a drop in staining intensity over t... | Class II | Biocare Medical Llc |
| Dec 8, 2014 | iChem 10 SG Urine Chemistry Strips, PN 800-7005. Intended for the in vitro... | Iris International is recalling the iChem 10 SG Urine Chemistry Strip because of false positive l... | Class II | Beckman Coulter Inc. |
| Dec 5, 2014 | INRatio Monitors - 0100004 Alere INRatio PT/INR System Professional - 01000... | In certain cases, an INRatio PT/INR Monitor system may provide an INR result that is significantl... | Class I | Alere San Diego, Inc. |
| Dec 5, 2014 | INRatio 2 Monitors - 0200431 Alere INRatio 2 PT/INR Professional Testing Sys... | In certain cases, an INRatio PT/INR Monitor system may provide an INR result that is significantl... | Class I | Alere San Diego, Inc. |
| Dec 5, 2014 | Alere INRatio PT/INR Test Strips, Alere INRatio PT/INR System Professional ... | In certain cases, an INRatio PT/INR Monitor system may provide an INR result that is significantl... | Class I | Alere San Diego, Inc. |
| Dec 5, 2014 | IS3000 Vision Side Cart (VSC) used in conjunction with the da Vinci Si Surgic... | Intuitive Surgical is initiating a voluntary correction related to da Vinci Si System (IS3000) Vi... | Class II | Intuitive Surgical, Inc. |
| Dec 4, 2014 | Sensei X Robotic Catheter System, model numbers 02057 and 08257. - Set up joi... | The Set Up Joint subassembly of the Sensei X Robotic Catheter System may become loose relative to... | Class II | Hansen Medical Inc |
| Dec 3, 2014 | RTH8 Rotor, P/N X01-005847-001. RTH8 used in the StatSpin Express 4 Horizont... | Iris International is recalling the RTH8 Rotor used in the StatSpin Express 4 Horizontal Centrifu... | Class II | Iris Diagnostics |
| Nov 21, 2014 | Fluorescence Imaging Procedure Kit, designed for use with Firefly Fluorescen... | The storage conditions for indocyanine green (ICG) are not on the individual Fluorescence Imaging... | Class II | Intuitive Surgical, Inc. |
| Nov 21, 2014 | Fluorescence Imaging Procedure Kit, designed for use with Firefly Fluorescen... | The storage conditions for indocyanine green (ICG) are not on the individual Fluorescence Imaging... | Class II | Intuitive Surgical, Inc. |
| Nov 20, 2014 | IntellaMap Orion High Resolution Mapping Catheter; Material number: M004RC64... | Some IntellaMap Orion High Resolution Mapping Catheters are exhibiting a failure mode in which a ... | Class II | Boston Scientific Corp |
| Nov 19, 2014 | Lotus TAVR 27mm, Transcatheter Aortic Valve Prosthesis Premounted on Delive... | Lotus valve became unlocked during release from the delivery system. This may lead to percutaneo... | Class I | Boston Scientific Corporation |
| Nov 19, 2014 | Lite DM (Lite Data Manager) Software Version(s): Versions 2.0.0.19 and lower... | HORIBA Medical is informing all HORIBA Medical Lite DM customers using software version 2.0.0.19 ... | Class II | Horiba Instruments Inc |
| Nov 19, 2014 | Lotus TAVR 25mm, Transcatheter Aortic Valve Prosthesis Premounted on Delive... | Lotus valve became unlocked during release from the delivery system. This may lead to percutaneo... | Class I | Boston Scientific Corporation |
| Nov 19, 2014 | Lotus TAVR 23mm, Transcatheter Aortic Valve Prosthesis Premounted on Delive... | Lotus valve became unlocked during release from the delivery system. This may lead to percutaneo... | Class I | Boston Scientific Corporation |
| Nov 17, 2014 | PKG, PENNINGTON FORCEPS, P/N 0250080242. Laparoscopic Manual Instruments ar... | The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401... | Class II | Stryker Endoscopy |
| Nov 17, 2014 | PKG, 5MM PEEK HANDLE, 45CM, P/N 0250181164 Laparoscopic Manual Instruments a... | The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401... | Class II | Stryker Endoscopy |
| Nov 17, 2014 | PKG, 5MM X 33CM INSERT, JOHANN FORCEPS, P/N 0Laparoscopic Manual Instruments ... | The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401... | Class II | Stryker Endoscopy |
| Nov 17, 2014 | PKG, ROTATING HANDLE, RATCHET, INSULATED SHAFT, P/N 0250080231. Laparoscopi... | The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401... | Class II | Stryker Endoscopy |
| Nov 17, 2014 | PKG, MARYLAND FORCEPS, CURVED, P/N 0250080009. Laparoscopic Manual Instrume... | The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401... | Class II | Stryker Endoscopy |
| Nov 17, 2014 | PKG, 5MM X 45CM INSERT, ALLIS FORCEPS, DOUBLE ROW TEETH, P/N 0250080754 Lapa... | The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401... | Class II | Stryker Endoscopy |
| Nov 17, 2014 | PKG, 3MM INSERT, NEEDLE NOSE FORCEPS, 29CM, P/N 0250282052 Laparoscopic Manu... | The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401... | Class II | Stryker Endoscopy |
| Nov 17, 2014 | PKG, 5MM INSERT, PADDLE BABCOCK, 33CM, P/N 0250080700 Laparoscopic Manual In... | The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401... | Class II | Stryker Endoscopy |
| Nov 17, 2014 | PKG, MICRO SCISSORS, STRAIGHT, P/N 0250080029. Laparoscopic Manual Instrume... | The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401... | Class II | Stryker Endoscopy |
| Nov 17, 2014 | PKG, BULLET FORCEPS, TAPERED, SERRATED, SPOON, P/N 0250080281. Laparoscopic... | The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401... | Class II | Stryker Endoscopy |
| Nov 17, 2014 | PKG, ASSY, 3.5MM PYRAMIDAL TROCAR, LONG P/N 0250080730 Laparoscopic Manual ... | The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401... | Class II | Stryker Endoscopy |
| Nov 17, 2014 | PKG, AXIAL HANDLE, W/RATCHET, INSULATED SHAFT, P/N 0250080235. Laparoscopic... | The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401... | Class II | Stryker Endoscopy |
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.