Browse Device Recalls
17 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 17 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 17 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Dec 19, 2025 | TORNIER PERFORM REVERSED PERIP SCREW 5.0MMX18MM NON STERILE, catalog number D... | A specific lot of screws is incorrectly labeled. Screws are labeled as 5.0mmx18mm but actual scre... | Class II | Tornier, Inc |
| Mar 3, 2025 | stryker Latitude EV HUMERAL REVISION STEM TRIAL, L: 150mm, Size: LARGE, Side... | A specific lot of Latitude Humeral Trial Stems has the incorrect direct part marking. " Laser Ma... | Class II | Tornier, Inc |
| Aug 29, 2024 | Stryker Tornier Perform Humeral System, Reversed Insert, 45%, REF DWP2393, f... | Devices from one lot of Perform" Reversed Inserts may contain a locking ring that was assembled u... | Class II | Tornier, Inc |
| Aug 29, 2024 | stryker TORNIER PERFORM HUMERAL SYSTEM - STEMLESS US Anatomic Nucleus, REF DW... | One lot of Perform Humeral Nucleus may exceed the specification for bacterial endotoxin load (max... | Class II | Tornier, Inc |
| Jan 3, 2024 | Stryker Tornier Perform Reversed Glenoid Press-Fit Short Post Ti6AI4V, REF DW... | The incorrect device is contained in the labeled package. | Class II | Tornier, Inc |
| Sep 15, 2023 | stryker Tornier Perform Reversed Augmented Glenoid Lateralized Baseplate, 25m... | One lot of Tournier Perform Reversed Lateralized Baseplates were found to have been manufactured ... | Class II | Tornier, Inc |
| Jun 12, 2023 | AEQUALIS FLEX REVIVE Assembly Screw 0mm, Model Number ARS655101 | A comingle/swap resulted in the labeling and laser marking on the product to state it is a Aequal... | Class II | Tornier, Inc |
| Jun 12, 2023 | AEQUALIS FLEX REVIVE Assembly Screw 0mm Short, Model Number ARS655118 | A comingle/swap resulted in the labeling and laser marking on the product to state it is a Aequal... | Class II | Tornier, Inc |
| May 3, 2022 | Ratcheting Screwdriver Handle, provided in the Aequalis Perform Reversed kit | The device is unable to meet sterilization requirements when sterilized per instructions in an Ae... | Class II | Tornier, Inc |
| May 28, 2021 | Aequalis Ascend Flex Shoulder System Reversed Platform (Reversed Tray compone... | Two lots have been swapped thus have the incorrect product in the package. The component may be o... | Class II | Tornier, Inc |
| Oct 18, 2019 | Aequalis Ascend Flex Humeral Stem: Part Number UDI DWF601A 3700386944475 D... | During shipping, it is possible for the Aequalis Ascend Flex humeral stem to become unseated or o... | Class II | Tornier, Inc |
| Mar 26, 2018 | AEQUALIS HUMERAL NAIL DRILL BIT, REF 7020140 Product Usage: The Aequalis... | Drill bit tips without new BargerGard tip protector may puncture through sterile packaging. | Class II | Tornier, Inc |
| Feb 8, 2018 | Fornier Phantom Fiber(TM) Sutures: Item Number Description SMB000425 4.5 MM... | Data has shown that degradation of a raw material used in Phantom Fiber may occur more quickly th... | Class II | Tornier, Inc |
| Sep 19, 2016 | Aequalis Fx2 implant parts and instrument trays. Insert component : Part ... | Tornier is conducting a recall on Aequalis Fx2 ( implant parts and instrument trays) due to repo... | Class II | Tornier, Inc |
| Aug 6, 2015 | Salto Talaris Tibial Guide, Part # MJU333 ,Tray/Kit Code YKAL11, Non sterile... | Tornier has initiated a voluntary recall for the Salto Talaris Tibial Guide (part number MJU333) ... | Class II | Tornier, Inc |
| Jun 25, 2015 | Aequalis Humeral Nail Targeting Jig, Product Code: 9020060. Orthopedic man... | Recall for the Aequalis IM Nail instrumentation set (Tray Number 9020000) due to several reports ... | Class II | Tornier, Inc |
| Aug 13, 2013 | AEQUALIS Reversed II or AEQUALIS Reversed Fracture Impactor. These products ... | Following the identification of the disassociation of an impactor tip during surgery, Tornier is ... | Class II | Tornier, 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.