Browse Device Recalls
27 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 27 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 27 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Aug 8, 2022 | Stryker USB Converter, Polaris Spectra Camera, Catalog #201148, a component ... | Certain units have the potential to exhibit infant failures whereby units either arrive non-funct... | Class II | Mako Surgical Corporation |
| Oct 23, 2020 | Mako Integrated Cutting System (MICS) Handpiece, Catalog Number 209063, Softw... | Stryker has discovered a characterization issue associated with the Mako Integrated Cutting Syste... | Class II | Mako Surgical Corporation |
| Jul 9, 2020 | Mako Hip End Effector, Variable Angle Catalog Number: 206967 GTIN:008484860... | Characterization issue associated with the product. This issue may cause a discrepancy during bo... | Class II | Mako Surgical Corporation |
| Apr 25, 2019 | 2.7 Degree Straight Sagittal Saw attachment (Mako Total Knee Application and ... | The bearings of the saw attachments were ungreased. | Class II | Mako Surgical Corporation |
| Apr 25, 2019 | 2.7 Degree Angled Sagittal Saw attachment (Mako Total Knee Application Only) | The bearings of the saw attachments were ungreased. | Class II | Mako Surgical Corporation |
| Jul 24, 2018 | Stryker Mako Vizadisc Hip Procedure Tracking Kit | Specific lots of the Vizadisc Knee Procedure Tracking Kit and Vizadisc Hip Procedure Tracking Kit... | Class II | Mako Surgical Corporation |
| Jul 24, 2018 | Stryker Mako Vizadisc Knee Procedure Tracking Kit | Specific lots of the Vizadisc Knee Procedure Tracking Kit and Vizadisc Hip Procedure Tracking Kit... | Class II | Mako Surgical Corporation |
| May 10, 2018 | Rio System Irrigation Clip - Catalog # 111690 Product Usage: The RESTORIS... | Out of tolerance. | Class II | Mako Surgical Corporation |
| Jan 19, 2018 | Restoris MCK Onlay Insert Extractor. | Possible hinge pin disassociation from the Mako Onlay Insert Extractor. | Class II | Mako Surgical Corporation |
| Dec 27, 2017 | Makoplasty RIO Standard System; Ethernet to Fiber Optic Converter Catalog # 2... | Communication-connection error. | Class II | Mako Surgical Corporation |
| Dec 1, 2017 | RESTORIS MCK TIBIAL BASEPLATE-RM/LL used in unicompartmental knee arthroplast... | Incorrect product and/or label. Sizing is labeled incorrectly. | Class II | Mako Surgical Corporation |
| Aug 7, 2017 | Total Hip Application (THA) Product Usage: The Robotic Arm Interactive O... | Software discrepancy of not showing all the EE constants, when the screen is filled. | Class II | Mako Surgical Corporation |
| Aug 7, 2017 | Makoplasty Partial Knee Application (PKA) Product Usage: The Robotic Arm ... | Software discrepancy of not showing all the EE constants, when the screen is filled. | Class II | Mako Surgical Corporation |
| Jun 7, 2017 | MAKO RIO Standard System, internal cPCI Card CageP/N: 201337. Intended to ... | An intermittent electrical problem that could lead to a loss of system power due to a loose screw... | Class II | Mako Surgical Corporation |
| Dec 22, 2016 | MAKO RIO THA Application User Guides, for total hip arthroplasty, orthopedic ... | Five (5) AFMEA Risk Control Measures are missing from the MAKO RIO THA Application User Guides | Class II | Mako Surgical Corporation |
| Sep 29, 2016 | Stryker Restoris RIO Reamer Handle, Offset, Mako Rx only Product Usage: ... | Failure of the Offset Cup Reamer Handle not engaging its mating components. | Class II | Mako Surgical Corporation |
| Feb 23, 2016 | RESTORIS PST RIO Offset Shell Impactor For use by orthopedic surgeons spec... | Potential disassociation of the orientation pin. | Class II | Mako Surgical Corporation |
| Jan 15, 2016 | Restoris Multicompartmental Knee (MCK) System RESTORIS MCK is indicated fo... | Reports where the Mylar/Tyvek pouch for RESTORIS MCK Baseplate in the clamshell packaging configu... | Class II | Mako Surgical Corporation |
| Nov 25, 2015 | MAKOplasty Hip Array Kit Laminate 150230 | Stryker Orthpaedics became aware that there is the potential for the 210540 MAKOplasty Hip Array ... | Class II | Mako Surgical Corporation |
| Jul 16, 2015 | Robotic Arm Interactive Orthopedic (RIO) system component PN#205143 (locking ... | The locking pin on the RIO Base Array is damaged during assembly onto the RIO Base Array Connector. | Class II | Mako Surgical Corporation |
| Jan 22, 2015 | Restoris Partial Knee Application (PKA) RIO (TGS 2.0). For use with the Ro... | When using the MAKOplasty partial knee Arthroplasty application, the burr continues spinning outs... | Class II | Mako Surgical Corporation |
| Oct 7, 2014 | RESTORIS PST Acetabular Straight Shell Impactors An impactor is a reusable i... | MAKO has identified the potential that the shell impactors may be damaged intraoperatively. | Class II | Mako Surgical Corporation |
| Oct 7, 2014 | RESTORIS PST Acetabular Offset Shell Impactors An impactor is a reusable ins... | MAKO has identified the potential that the shell impactors may be damaged intraoperatively. | Class II | Mako Surgical Corporation |
| Oct 7, 2014 | RESTORIS PST Straight Shell Inserter An impactor is a reusable instrument de... | MAKO has identified the potential that the shell impactors may be damaged intraoperatively. | Class II | Mako Surgical Corporation |
| Apr 30, 2014 | Robotic Arm Interactive Orthopedic System (RIO) | Revision of the field manual | Class II | Mako Surgical Corporation |
| Jan 9, 2014 | Restoris Multicompartmental Knee (MCK) System is an implant system designed t... | The product may be mislabeled and could result in the incorrect implant being used. | Class II | Mako Surgical Corporation |
| Sep 12, 2012 | The RIO (TGS 2.), Model # MAKO TGS 2.0 (Part No. 204000). The RIO is inten... | MAKO Surgical Group recalled their RIO System software, version 2.4 and is implementing software ... | Class II | Mako Surgical Corporation |
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.