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 16, 2016 | da Vinci S Surgical System (IS4000) user manual English and OUS. Product U... | Intuitive Surgical has found that the use of instruments other than the Cardiac Probe Grasper (e.... | Class II | Intuitive Surgical, Inc. |
| Mar 16, 2016 | iVue and iVue 500 (now called iScan) OCT systems with software version 2016.0... | A software anomaly was detected that affects Optovue iVue and iVue 500 with Normative Database th... | Class II | Optovue, Inc. |
| Mar 8, 2016 | Diana Automated Compounding System, Diana V1.3, Item No. CH5300, CH5300R The... | ICU Medical Inc. has received a report of compounded volumes not meeting the accuracy specificati... | Class II | ICU Medical, Inc. |
| Mar 8, 2016 | Diana Automated Compounding System, Diana Onco 3xx, Item No. ASN303 The Dian... | ICU Medical Inc. has received a report of compounded volumes not meeting the accuracy specificati... | Class II | ICU Medical, Inc. |
| Mar 8, 2016 | Diana Automated Compounding System, Diana Onco Plus 1.2, Item No. ASN222, ASN... | ICU Medical Inc. has received a report of compounded volumes not meeting the accuracy specificati... | Class II | ICU Medical, Inc. |
| Mar 8, 2016 | Diana Automated Compounding System, Diana Onco Plus 1.3, Item No. ASN223 The... | ICU Medical Inc. has received a report of compounded volumes not meeting the accuracy specificati... | Class II | ICU Medical, Inc. |
| Mar 8, 2016 | Diana Automated Compounding System, Final Assembly, Diana Onco Plus, Item No.... | ICU Medical Inc. has received a report of compounded volumes not meeting the accuracy specificati... | Class II | ICU Medical, Inc. |
| Mar 8, 2016 | Diana Automated Compounding System, Diana Onco Plus, Item No. ASN220 The Dia... | ICU Medical Inc. has received a report of compounded volumes not meeting the accuracy specificati... | Class II | ICU Medical, Inc. |
| Mar 4, 2016 | The Spectra-System Dental Implant 2008 system is comprised of dental implant ... | Implant Direct Sybron Manufacturing, LLC is recalling GoDirect Implants because some consignees d... | Class II | Implant Direct Sybron Manufacturing, LLC |
| Feb 29, 2016 | RT-5100 (Epic 5100) Refractor and RT 3100 Refractor: Product Usage: Instr... | There has been a reoccurrence of an issue on the RT 5100 and RT 3100 Refractor of the Near Point ... | Class II | Nidek Inc |
| Feb 25, 2016 | 30" (76 cm) Appx 6.3 ml, 20 Drop Admin Set w/ Integrated ChemoLock Port Drip ... | ICU Medical has identified an issue with a connection in an isolated number of I.V. infusion admi... | Class II | ICU Medical, Inc. |
| Feb 25, 2016 | 30" (76 cm) Appx 3.6 ml, 20 Drop Admin Set w/ Integrated ChemoLock Port Drip ... | ICU Medical has identified an issue with a connection in an isolated number of I.V. infusion admi... | Class II | ICU Medical, Inc. |
| Feb 25, 2016 | 74" (188cm) approximately 9.0ml, 20 Drop Admin Set w/ Integrated ChemoLock P... | ICU Medical has identified an issue with a connection in an isolated number of I.V. infusion admi... | Class II | ICU Medical, Inc. |
| Feb 25, 2016 | 110" (279 cm) Appx 13.8 ml, 20 Drop Admin Set w/ Integrated ChemoLock Port Dr... | ICU Medical has identified an issue with a connection in an isolated number of I.V. infusion admi... | Class II | ICU Medical, Inc. |
| Feb 25, 2016 | 31" (79 cm) Appx. 3.4 ml, 20 Drop Admin Set w/ Integrated ChemoLock Port Drip... | ICU Medical has identified an issue with a connection in an isolated number of I.V. infusion admi... | Class II | ICU Medical, Inc. |
| Feb 25, 2016 | 30" (76 cm) Appx. 3.3 ml, Admin Set w/ 20 Drop Admin Set w/ Integrated ChemoL... | ICU Medical has identified an issue with a connection in an isolated number of I.V. infusion admi... | Class II | ICU Medical, Inc. |
| Feb 25, 2016 | 30" (76 cm) Appx. 6.3 ml, 20 Drop Admin Set w/ Integrated ChemoLock Port Drip... | ICU Medical has identified an issue with a connection in an isolated number of I.V. infusion admi... | Class II | ICU Medical, Inc. |
| Feb 25, 2016 | 30" (76 cm) Appx. 3.3 ml, Admin Set w/ 20 Drop Integrated ChemoLock Drip Cham... | ICU Medical has identified an issue with a connection in an isolated number of I.V. infusion admi... | Class II | ICU Medical, Inc. |
| Feb 24, 2016 | Toshiba America Medical Systems Angio WorkStation: XIDF-AWS801v6.00, v6.01, a... | During a procedure the Peak Skin Dose (PSD) value was displayed on the DTS larger than the DTS ex... | Class II | Toshiba American Medical Systems Inc |
| Feb 24, 2016 | PureWick External Catheter for Women-Wick Product Usage: A flexible, con... | PureWick is recalling external catheter for women Wicks because the labeling did not contain the ... | Class II | Purewick Corporation |
| Feb 23, 2016 | Dexcom G4 PLATINUM Receiver with Share Receiver Part Number: MT22495 Receive... | Customers may not receive an intended audible alarm or alert if relying on hearing the alarm or a... | Class I | Dexcom Inc |
| Feb 23, 2016 | Dexcom G4 PLATINUM (Pediatric) Receiver with Share Receiver Part Number: MT2... | Customers may not receive an intended audible alarm or alert if relying on hearing the alarm or a... | Class I | Dexcom Inc |
| Feb 23, 2016 | Dexcom G5 Mobile Receiver Receiver Part Number: MT22719 Receiver (mg/dL), Bl... | Customers may not receive an intended audible alarm or alert if relying on hearing the alarm or a... | Class I | Dexcom Inc |
| Feb 23, 2016 | Dexcom G4 PLATINUM Receiver Receiver Part Number: MT20649 Receiver (mg/dL), ... | Customers may not receive an intended audible alarm or alert if relying on hearing the alarm or a... | Class I | Dexcom Inc |
| Feb 23, 2016 | Dexcom G4 PLATINUM (Pediatric) Receiver Receiver Part Number: MT22430 Receiv... | Customers may not receive an intended audible alarm or alert if relying on hearing the alarm or a... | Class I | Dexcom Inc |
| Feb 23, 2016 | Dexcom G4 PLATINUM (Professional) Receiver Receiver Part Number: MT20649 Rec... | Customers may not receive an intended audible alarm or alert if relying on hearing the alarm or a... | Class I | Dexcom Inc |
| Feb 22, 2016 | Molteno3 Glaucoma Implants G-Series: GS-Single Plate 175mm2 (IOP reorder#:... | Innovative Ophthalmic Products (IOP) is recalling the Molteno 3 G-Series Glaucoma Implant the pac... | Class II | Innovative Ophthalmic Products, Inc |
| Feb 19, 2016 | ABX Pentra 400 (version 5.0.8 or lower) The ABX PENTRA 400 and 400C are di... | Horiba Instruments, Inc. is recalling ABX Pentra 400( version 5.0.8 or lower) and Pentra C400 (ve... | Class II | Horiba Instruments Inc |
| Feb 19, 2016 | Pentra C400 (version 1.1.2 or lower) The ABX PENTRA 400 and 400C are discr... | Horiba Instruments, Inc. is recalling ABX Pentra 400( version 5.0.8 or lower) and Pentra C400 (ve... | Class II | Horiba Instruments Inc |
| Feb 19, 2016 | CareLink iPro2 Reports, Model No. MMT-7340 is software intended to retrospec... | Medtronic MiniMed is recalling 19 CareLink iPro Therapy Management reports because the CareLink i... | Class II | Medtronic MiniMed Inc. |
| Feb 16, 2016 | da Vinci Si (IS3000) and da Vinci Xi (IS4000) Surgeon Side Console (SSC)Touch... | Class II | Intuitive Surgical, Inc. | |
| Feb 15, 2016 | Alaris Pump VersaSafe Infusion Set, Model No. 2122-0007 | CareFusion is recalling the Alaris VersaSafe Infusion Set because of separation and/or leakages a... | Class II | CareFusion 303, Inc. |
| Feb 12, 2016 | Alaris PC Unit, Infusion Pump Model 8000, Part No. TC10005092 | CareFusion is recalling the Alaris PC unit because a component on the PC unit power supply may ca... | Class II | CareFusion 303, Inc. |
| Feb 11, 2016 | MicroScan LabPro Information Manager System, Software Versions 1.0 to 4.41 ... | Beckman Coulter is recalling the MicroScan LabPro Information Manager System because the software... | Class II | Beckman Coulter Inc. |
| Feb 11, 2016 | KAMRA Inlay, ACI 7000 Corneal Inlay, Part No. 76195-01 and 76195-10 (OUS) ... | AcuFocus is recalling KAMRA ACI 7000 Corneal Inlays due to concerns with the labeled shelf life. | Class II | AcuFocus, Inc. |
| Feb 10, 2016 | Simplexa Flu A/B & RSV Direct (MOL2650) with Direct Amplification Disc (MOL14... | Focus Diagnostics is recalling the Direct Amplification Discs (DAD) supplied with the Simplexa HS... | Class II | Focus Diagnostics Inc |
| Feb 10, 2016 | Simplexa HSV 1&2 Direct (MOL2150) with Direct Amplification Disc (MOL1451, MO... | Focus Diagnostics is recalling the Direct Amplification Discs (DAD) supplied with the Simplexa HS... | Class I | Focus Diagnostics Inc |
| Feb 10, 2016 | Simplexa Group A Strep Direct (MOL2850) with Direct Amplification Disc (MOL14... | Focus Diagnostics is recalling the Direct Amplification Discs (DAD) supplied with the Simplexa HS... | Class I | Focus Diagnostics Inc |
| Feb 8, 2016 | TF Adaptive Gutta Percha Point Size SM3 50pk, Part No. 815-1541 Intended t... | Ormco Corporation is recalling the TF Adaptive Gutta Percha Point Size SM3-50pk because the inner... | Class II | Ormco/Sybronendo |
| Feb 5, 2016 | Allegra X-5 rotor yoke, Catalog No. (Instruments) B30589 and B30590 (Rotor) B... | A defective rotor yoke on Allegra X-5 allows improper rotor seating on the hub resulting in possi... | Class II | Beckman Coulter Inc. |
| Feb 5, 2016 | Volcano SpinVision Sterile Equip cover II; Sterile; General Hospital: Thes... | Volcano Corporation has identified that certain lot numbers of Volcano R-100 Sterile Equipment Co... | Class II | Volcano Corporation |
| Feb 5, 2016 | Volcano R100 Sterile Equipment Cover; Sterile; General Hospital: These Ste... | Volcano Corporation has identified that certain lot numbers of Volcano R-100 Sterile Equipment Co... | Class II | Volcano Corporation |
| Feb 4, 2016 | MitraClip Clip Delivery System, product number MSK0101. The MitraClip System ... | Abbott Vascular has recently received reports of cases on Clip Delivery System devices that conta... | Class I | Abbott Vascular |
| Jan 27, 2016 | Karma Flexx Wheelchair Manual Wheelchair. | Karman Healthcare, Inc. is recalling Karma Flexx Wheelchair because incorrect size screws and cor... | Class II | Karman Healthcare Inc |
| Jan 25, 2016 | BD FMC7 FITC: Model 430918. FMC7 is intended for in vitro diagnostic use in ... | Becton, Dickinson and Company (BD) has determined that the FMC7 FITC (ASR) has an incorrect expi... | Class III | Becton, Dickinson and Company, BD Biosciences |
| Jan 22, 2016 | CyberKnife Robotic; Catalog/part number 032000 and 033000 Cosmetic cover pack... | The gun box mounting bracket may fail to support the weight of the gun box when in vertical (inve... | Class II | Accuray Incorporated |
| Jan 18, 2016 | CEA / CD66e Ab-2, Product code RB-368-R7, RB-368-R1; 7 ml each. Descript... | Certain lots of CEA/CD66e Ab2 were produced with a dilution factor of 1:100 instead of the recomm... | Class III | Lab Vision Corporation |
| Jan 15, 2016 | Jadak Barcode Scanner, Part No. 350587-32, 350587-41, 351377-32. Product... | Customers reported issues when scanning medications with the scanners. When a user scans a medic... | Class II | CareFusion 303, Inc. |
| Jan 14, 2016 | Toshiba DRAD-3000E FPD Wireless System Product Usage The DRAD-3000¿ is i... | When a user performed radiography using the wireless FPD, a message window appeared on the monit... | Class II | Toshiba American Medical Systems Inc |
| Jan 13, 2016 | iChem VELOCITY Automated Urine Chemistry, Catalog No. 800-3049, 800-3050, 800... | Iris International noted loose or missing analyte pads found in several locations (strip vial, s... | Class II | Beckman Coulter 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.