Browse Device Recalls
16 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 16 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 16 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Feb 22, 2019 | Paltop 1.25 Hex Drivers, Long Part Number: 60-70101 | Paltop Surgical Kits contain 1.25mm Hex Driver(s) which may have a slightly oversized hex driving... | Class II | Keystone Dental Inc |
| Feb 22, 2019 | Paltop 1.25 Hex Drivers, Short Part Number: 60-70102 | Paltop Surgical Kits contain 1.25mm Hex Driver(s) which may have a slightly oversized hex driving... | Class II | Keystone Dental Inc |
| Feb 22, 2019 | Paltop Fully Guided Surgical Kit- containing the 1.25mm Hex Driver For surgi... | Paltop Surgical Kits contain 1.25mm Hex Driver(s) which may have a slightly oversized hex driving... | Class II | Keystone Dental Inc |
| Feb 22, 2019 | Paltop Premium Surgical Kit-containing the 1.25mm Hex Driver For surgical an... | Paltop Surgical Kits contain 1.25mm Hex Driver(s) which may have a slightly oversized hex driving... | Class II | Keystone Dental Inc |
| May 1, 2018 | Prima Plus ¿4.1 x 11.5mm Implant, Catalog Number 15737K Keystone Dental im... | The implants are mislabeled. | Class II | Keystone Dental Inc |
| Mar 13, 2018 | Genesis Surgical Cassette Tapered Implants are intended for placement fo... | The surgical cassette contained extra-large white grommets making the 3.8 mm and 6.5mm dental bur... | Class II | Keystone Dental Inc |
| Jan 24, 2018 | Stage-1 Tissue Punch, Disposable, 4.5mm; catalog number: ISS141K. Intended... | The cutting edge of tissue punches may be potentially damaged with small dents and nicks. | Class II | Keystone Dental Inc |
| Oct 16, 2017 | STAGE-1¿ RDS COC Abutment Plastic Sleeve, Non-Lock, Multi-Unit; Catalog Numbe... | A locking plastic abutment sleeve, used by dental technicians in dental laboratories to aid in th... | Class III | Keystone Dental Inc |
| Aug 25, 2017 | Stage-1¿ RDS Indexed Abutment for RDS Stage-1¿ Single Stage Implants ... | The recalled units are mislabeled with an incorrect expiration date. The expiration date printed ... | Class II | Keystone Dental Inc |
| Jun 20, 2017 | Multi-Unit Abutment Angled, 17¿, 4mm Cuff 4.1/4.5mm TiLobe¿ Implants, Catalog... | Abutments are unable to accept the final abutment screw | Class II | Keystone Dental Inc |
| Jun 16, 2017 | Max Implant System - Bone Tap for use with 7.0mm diameter Max Implant, Catalo... | An 8mm diameter bone tap was laser marked as 7mm diameter and was packed with a 7mm label. | Class II | Keystone Dental Inc |
| Mar 9, 2017 | Keystone Dental Inc. PrimaConnex Straight Implant TC, WD Internal Connection ... | Straight PrimaConnex Implants contained Tapered PrimaConnex Implants | Class II | Keystone Dental Inc |
| Sep 15, 2016 | Keystone Dental PrimaConnex¿ Straight Implant TC, RD Internal Connection 4.0 ... | Small diameter (SD) cover screw was packaged with the regular diameter implant and do not match t... | Class II | Keystone Dental Inc |
| Mar 11, 2013 | PrimaConnex Tapered Implant TC, SD Internal Connection 3.5 x 10mm Catalog N... | Mislabeled: Cover screw that was in the package was a WD cover screw and not a SD cover screw as ... | Class II | Keystone Dental Inc |
| Jul 5, 2011 | Genesis Straight Esthetic 4.0 mm 1mm Cuff Abutment Part Number: G71200 Ge... | Mislabeled: Genesis Straight Esthetic 5.0mm Contour ,3mm cuff labeled as Genesis Straight Estheti... | Class II | Keystone Dental Inc |
| Jul 5, 2011 | Genesis Straight Esthetic 5.0 mm 3. mm Cuff Abutment Part Number: G71205 ... | Mislabeled: Genesis Straight Esthetic 4.0mm Contour ,1mm cuff labeled as Genesis Straight Estheti... | Class II | Keystone Dental 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.