Browse Device Recalls
20 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 20 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 20 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jun 14, 2018 | RT-5100 Refractor, a component of the Epic-5100 System. | The lens bonding was incomplete on the refractor. | Class III | Nidek Inc. |
| Dec 20, 2017 | AUTO REF/KERATOMETER ARK-1s | There is possibly a difference between the measured dioptric value of the subjective measurement ... | Class II | Nidek Inc. |
| Feb 1, 2017 | Final Fit Software Version 1.11 and 1.12; PC Based software installed outsi... | During treatment planning, the procedure was programmed with an unintended (wrong) correction. | Class II | Nidek Inc |
| Aug 8, 2016 | SPECULAR MICROSCOPE CEM-530; Software version 1.08 and 1.09. Opthalmic: Th... | Software version 1.08 and 1.09 for the Specular Microscope CEM 530 included a change of analysis ... | Class II | Nidek Inc |
| Jul 1, 2016 | OPTICAL BIOMETER AL-Scan: Software Version: 1.09 and earlier. Ophthalmic: ... | Nidek Inc. received information from our manufacturer NIDEK CO. Japan that the shown axial leng... | Class II | Nidek Inc |
| 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 |
| 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 |
| Mar 25, 2015 | Dual Delivery 4DD-1 of GYC-1000 Green Laser Photocoagulator system GYC4DD-1:... | Accessories to the GYC-1000 laser were missing Laser Aperture labels. | Class II | Nidek Inc |
| Mar 25, 2015 | Endophotocoagulation Delivery 4EP-1 of GYC-1000 Green Laser Photocoagulator S... | Accessories to the GYC-1000 laser were missing Laser Aperture labels. | Class II | Nidek Inc |
| Mar 24, 2015 | EC-5000 Excimer Laser Corneal Surgery System (EC-5000, EC 5000 CXIII, EC-5000... | Multi-stage treatment option for the EC-5000 Operator's Manual was not approved by the FDA. | Class II | Nidek Inc |
| Mar 6, 2015 | YC-1800 OPHTHALMIC YAG LASER SYSTEM; The YC-1800 allows the safe and blood... | Dear Doctor letter and Quick Reference Guide is being sent to users of the YC-1800 to reiterate i... | Class II | Nidek Inc |
| Jun 16, 2014 | Non-Mydriatic Auto Fundus Camera. Model AFC-330. An ophthalmic camera for us... | Image taken by AFC-330 has a white spot which may affect diagnosis or evaluation of image. | Class II | Nidek Inc |
| Jun 9, 2014 | MC-500 Multicolor Laser Photocoagulator; Distributed by NIDEK Inc. Manufact... | Laser aperture label was not affixed to device prior to shipment in the US. | Class II | Nidek Inc |
| Jun 9, 2014 | RT-5100 Refractor and RT-3100 Refractor; Distributed by MARCO Opthalmic: ... | Near Point Chart Arm of RT 5100 and RT-3100 Refractors may lower spontaneously with potential for... | Class II | Nidek Inc |
| May 16, 2014 | GYC-1000 Green Laser Photocoagulator system The Nidek Green Laser Photocoa... | Laser Aperture label was not applied to certain GYC-1000 Green Laser Photocoagulators devices in ... | Class II | Nidek Inc |
| Aug 1, 2013 | NAVIS-EX , Image Filing Software for NIDEK AFC Fundus camera, Ver 1.1.0 to 1.... | Under certain circumstances, the Left eye image may be saved as the Right eye image. | Class II | Nidek Inc |
| May 24, 2013 | MC-500 Multicolor Laser Photocoagulator using software version 2.20. Opthalm... | Retrospective review found that a Engineering Change Order initiated in May 2013 for a memory fun... | Class II | Nidek Inc |
| Oct 24, 2012 | Nidek MC-500 Multicolor Laser Photocoagulator using software version 2.20. O... | When the MC-500 is turned on and coagulation is performed without changing the laser color, the d... | Class II | Nidek Inc |
| Aug 6, 2012 | Nidek Excimer Laser Corneal Surgery System, model EC-5000 CXIII. Opthalmic D... | Contact failure in F1 and F4 fuse holders was detected on the EC-5000 CXIII Excimer Laser Corneal... | Class II | Nidek Inc |
| Mar 27, 2012 | MC-500 Multicolor Laser Photocoagulator; Indicated for use in retinal phot... | The spot size control of the scan delivery unit of the MC-500 Multicolor Laser Photocoagulator ma... | Class II | Nidek 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.