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 |
|---|---|---|---|---|
| Jul 22, 2015 | Volcano Pioneer Plus Re-Entry Catheter; Product Code PPLUS20, Catheter for C... | Due to a manufacturing defect, there is the possibility that a small wire could extend through th... | Class II | Volcano Corporation |
| Jul 21, 2015 | Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affect... | Channel Error code is displayed on the PC unit with an audio and visual alarm, and on the syring... | Class I | CareFusion 303, Inc. |
| Jul 17, 2015 | MicroScan LabPro Information Manager System, Version 1.0 to Version 4.11, Cat... | The software incorrectly allows the operator to manually edit the carbohydrate substrates when ma... | Class II | Beckman Coulter Inc. |
| Jul 17, 2015 | Wall Chart for STERRAD 100NX System, P/N 10104. The STERRAD 100NX Steriliz... | Advanced Sterilization PRoducts (ASP) is recalling the Wall Chart for STERRAD 100NX System becaus... | Class II | Advanced Sterilization Products |
| Jul 17, 2015 | BD CD56 PE Cy 7: NCAM16.2 ASR Analyte Specific Reagent, Catalog number 33580... | Three lots of CD56 PE Cy 7, Catalog number 335809, contain a low amount of HLA-DR PE antibody whi... | Class II | Becton, Dickinson and Company, BD Biosciences |
| Jul 16, 2015 | Radiometer Fixation Kit N20 for the TCM CombiM monitoring system, REF 905-873... | When the fixation ring is taken off the paper liner there is a potential for fractions of the pap... | Class II | Radiometer America Inc |
| Jul 15, 2015 | iChemVELOCITY Automated Urine Chemistry Catalog No. 800-3049, 800-3050, 800-3... | Iris International is recalling the iChemVELOCITY systems because they do not maintain the on-boa... | Class II | Iris Diagnostics |
| Jul 15, 2015 | EnVeo R Loading System, Model No. LS-EnVeoR-23, LS-EnVeoR-2629, LS-EnVeoR-23-... | Medtronic is recalling the EnVeo R Loading Systems because of the presence of particulate. | Class I | Medtronic Cardiovascular Surgery-the Heart Valv... |
| Jul 9, 2015 | HardyCHROM MRSA Cat no: G307 Lot no: H15155 Expires: 2015-08-13 Container... | Hardy Diagnostics is recalling HardyCHROm MRSA due to a report of the potential for breakthrough ... | Class II | Hardy Diagnostics |
| Jul 2, 2015 | Silhouette Lift brochure Silhouette Sutures are for use in midface suspens... | Silhouette Lift is recalling the Silhouette Suture brochure because it does not include a comple... | Class II | Silhouette Lift, Inc. |
| Jul 1, 2015 | iovera 155 Smart Tip; Catalog numbers:STT0412-10 and STT0412-5 (10 and 5 c... | The expiration date on the outer box label and the pouch label for the iovera Smart Tip product i... | Class II | Myoscience Inc |
| Jun 29, 2015 | ACUSON S Family ultrasound systems utilizing the 18L6 HD and/or 6C1 HD biopsy... | When using the CIVCO biopsy attachments in combination with the ACUSON S Family on-screen guideli... | Class II | Siemens Medical Solutions USA, Inc. |
| Jun 26, 2015 | Hardy Diagnostics BEA Broth with Vancomycin container type: 13x100mm tube... | Hardy Diagnostics is recalling MacConkey Agar with Ciprofloxacin, Brain Heart Infusion Broth with... | Class II | Hardy Diagnostics |
| Jun 26, 2015 | Hardy Diagnostics MDR Acinetobacter container type: 15x100mm monoplate p... | Hardy Diagnostics is recalling MacConkey Agar with Ciprofloxacin, Brain Heart Infusion Broth with... | Class II | Hardy Diagnostics |
| Jun 26, 2015 | Hardy Diagnostics BEA Agar with Vancomycin container type: 15x100mm monop... | Hardy Diagnostics is recalling MacConkey Agar with Ciprofloxacin, Brain Heart Infusion Broth with... | Class II | Hardy Diagnostics |
| Jun 26, 2015 | Hardy Diagnostics MacConkey Agar with CiPRP, 1ug/ml Container type: 15x10... | Hardy Diagnostics is recalling MacConkey Agar with Ciprofloxacin, Brain Heart Infusion Broth with... | Class II | Hardy Diagnostics |
| Jun 26, 2015 | Hardy Diagnostics BHI with CIPRO, 1ug/ml container type: 16x100mm tube p... | Hardy Diagnostics is recalling MacConkey Agar with Ciprofloxacin, Brain Heart Infusion Broth with... | Class II | Hardy Diagnostics |
| Jun 26, 2015 | Hardy Diagnostics BEA Agar with VGA container type: 15x100mm monoplate p... | Hardy Diagnostics is recalling MacConkey Agar with Ciprofloxacin, Brain Heart Infusion Broth with... | Class II | Hardy Diagnostics |
| Jun 26, 2015 | Hardy Diagnostics VRE Broth, 5ml container type: 16x100mm tube packaged:... | Hardy Diagnostics is recalling MacConkey Agar with Ciprofloxacin, Brain Heart Infusion Broth with... | Class II | Hardy Diagnostics |
| Jun 25, 2015 | ACUSON S2000 and ACUSON S3000 ultrasound systems with the Virtual Touch IQ op... | Potential measurement error on ACUSON S Family ultrasound system. When repositioning the Virtual ... | Class II | Siemens Medical Solutions USA, Inc. |
| Jun 25, 2015 | ACUSON S 1000, ACUSON S 2000, or ACUSON S 3000 ultrasound systems with softw... | Potential measurement error on ACUSON S Family ultrasound system when using the Doppler manual t... | Class II | Siemens Medical Solutions USA, Inc. |
| Jun 24, 2015 | HardyCHROM VRE Agar-RSR Cat no: GA333 Lot no: H15055 Expires: 2015-07-04 ... | Hardy Diagnostics is recalling HardyCHROM VRE Agar due to lack of 510(k) clearance. | Class II | Hardy Diagnostics |
| Jun 22, 2015 | Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 an... | A software issue was discovered where an inaccurate FFR/iFR value could be calculated under certa... | Class II | Volcano Corporation |
| Jun 22, 2015 | Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 an... | A software issue was discovered where an inaccurate FFR/iFR value could be calculated under certa... | Class II | Volcano Corporation |
| Jun 22, 2015 | Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 an... | A software issue was discovered where an inaccurate FFR/iFR value could be calculated under certa... | Class II | Volcano Corporation |
| Jun 22, 2015 | Volcano s5/s5i/CORE Intravascular Ultrasound Systems with software versions 3... | A software issue was discovered where an inaccurate FFR/iFR value could be calculated under certa... | Class II | Volcano Corporation |
| Jun 22, 2015 | Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 an... | A software issue was discovered where an inaccurate FFR/iFR value could be calculated under certa... | Class II | Volcano Corporation |
| Jun 22, 2015 | Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 an... | A software issue was discovered where an inaccurate FFR/iFR value could be calculated under certa... | Class II | Volcano Corporation |
| Jun 22, 2015 | Abutment Retrieval Instrument Zirconia CC RP/WP, Article No. 37882 and Abutme... | One dimension of the affected instrument is incorrect. Therefore this instrument cannot be used t... | Class II | Nobel Biocare Usa Llc |
| Jun 19, 2015 | MiniMed NGP 640G 1.8ml (mmol/L), Model No. MMT-1511; NGP 640G 1.8ml (mg/dL), ... | Medtronic MiniMed is recalling the MiniMed 620G and 640G insulin pumps because there are certain ... | Class II | Medtronic MiniMed Inc. |
| Jun 18, 2015 | Natrelle CUI Series Tissue Expanders. Product Usage: Natrelle CUI Series ... | Allergan is recalling the NATRELLE 133 and CUI Series Tissue Expanders because the products shipp... | Class II | Allergan Inc |
| Jun 18, 2015 | Natrelle 133 Series Tissue Expanders Product Usage: Natrelle 133 Series T... | Allergan is recalling the NATRELLE 133 and CUI Series Tissue Expanders because the product shippe... | Class II | Allergan Inc |
| Jun 17, 2015 | Mission -Breath Alcohol Detector -15 tests - 0.08% BAC - Blow bags inc... | Acon Laboratories, Inc. is recalling Mission Breath Alcohol Detector due to a labeling amendment. | Class III | Acon Laboratories, Inc. |
| Jun 17, 2015 | Bond Elut OMS (Dried Matrix Spotting)' Product; Catalog model numbers: 50... | The product was marketed without 510(k) clearance. | Class II | Agilent Technologies, Inc. |
| 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... |
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.