Browse Device Recalls
68 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 68 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 68 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| May 28, 2025 | Long Nail, RIGHT Gamma4 10x320mm x 125, component of the Gamma4 System. Catal... | Investigation confirmed that the GAMMA4 Right Long Nail was manufactured with the geometry of a l... | Class II | Stryker GmbH |
| May 22, 2025 | Femoral Nail, RIGHT T2 GTN 8x300 mm. Catalog Number: 1851-0830S. | Investigation determined that one lot of the T2 Greater Trochanter Nail (GTN) was labeled as left... | Class II | Stryker GmbH |
| May 22, 2025 | Femoral Nail, LEFT T2 GTN 8x300 mm. Catalog Number: 1850-0830S. | Investigation determined that one lot of the T2 Greater Trochanter Nail (GTN) was labeled as left... | Class II | Stryker GmbH |
| Mar 28, 2025 | Guide Wire with Ruler Tube 3x1000 mm DIA; Catalog number/REF: 2351-3100S; | The metal ring at the end of the Guide Wire with Ruler Tube may detach from the main body of the ... | Class II | Stryker GmbH |
| Mar 28, 2025 | Guide Wire with Ruler Tube 3x800 mm DIA; Catalog number/REF: 2351-3080S; | The metal ring at the end of the Guide Wire with Ruler Tube may detach from the main body of the ... | Class II | Stryker GmbH |
| May 9, 2024 | Stryker Hoffman LRF Wire Tensioner REF 4933-9-100, a component of the Hoffman... | The adjustment ring on the device may become loose resulting in the wire tension not being able t... | Class II | Stryker GmbH |
| Feb 7, 2023 | stryker Hoffmann LRF, Transport Strut, Model Number 4933-0-400; Orthopedic ex... | Stryker has identified a nonconformance in specific lots of Hoffmann LRF Bone Transport Struts. S... | Class II | Stryker GmbH |
| Mar 28, 2022 | Smart Toe II Intramedullary Arthrodesis Implant | The nickel-sensitivity statement on the outer carton may be partially covered by a label resultin... | Class II | Stryker GmbH |
| May 27, 2021 | Nail Insertion Sleeve, elastic T2 Tibia SPI ¿8-11 (SPI Elast. Sleeve 8-11), C... | The devices have a different inner diameter than the diameter specified on the outer box label. | Class II | Stryker GmbH |
| May 27, 2021 | Nail Insertion Sleeve, elastic T2 Tibia SPI ¿8-13 (SPI Elast. Sleeve 8-13), C... | The devices have a different inner diameter than the diameter specified on the outer box label. | Class II | Stryker GmbH |
| Sep 25, 2020 | Osteosynthesis Compression Staple EasyClip | The device has the potential to release nickel above the acceptable margin of safety in pediatric... | Class II | Stryker GmbH |
| May 7, 2020 | Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x45 mm Catalog Number: 1896... | Seal integrity of the blister pack may be compromised and sterility cannot be assured | Class II | Stryker GmbH |
| May 7, 2020 | Stryker End Cap, Standard T2 Humerus ¿6 mm Catalog Number: 18300003S - Pro... | Seal integrity of the blister pack may be compromised and sterility cannot be assured | Class II | Stryker GmbH |
| May 7, 2020 | Stryker Locking Screw, Fully Threaded S2 05x35 mm Catalog Number: 17965035S ... | Seal integrity of the blister pack may be compromised and sterility cannot be assured | Class II | Stryker GmbH |
| May 7, 2020 | Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x35 mm Catalog Number: 1896... | Seal integrity of the blister pack may be compromised and sterility cannot be assured | Class II | Stryker GmbH |
| May 7, 2020 | Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x50 mm Catalog Number: 1896... | Seal integrity of the blister pack may be compromised and sterility cannot be assured | Class II | Stryker GmbH |
| May 7, 2020 | Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x30 mm Catalog Number: 18... | Seal integrity of the blister pack may be compromised and sterility cannot be assured | Class II | Stryker GmbH |
| May 7, 2020 | Stryker End Cap T2 Humerus ¿6mm, 15mm height Catalog Number: 18300015S - P... | Seal integrity of the blister pack may be compromised and sterility cannot be assured | Class II | Stryker GmbH |
| May 7, 2020 | Stryker 1 End Cap T2 Humerus ¿6mm, 5mm height Catalog Number: 18300005S - ... | Seal integrity of the blister pack may be compromised and sterility cannot be assured | Class II | Stryker GmbH |
| May 7, 2020 | Stryker Locking Screw, Partially Threaded T2 Tibia ¿5x55 mm Catalog Number: ... | Seal integrity of the blister pack may be compromised and sterility cannot be assured | Class II | Stryker GmbH |
| May 7, 2020 | Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x40 mm Catalog Number: 1896... | Seal integrity of the blister pack may be compromised and sterility cannot be assured | Class II | Stryker GmbH |
| May 7, 2020 | Stryker End Cap, Std, Ti Gamma3 Catalog Number: 30051100S - Product Usage: ... | Seal integrity of the blister pack may be compromised and sterility cannot be assured | Class II | Stryker GmbH |
| May 7, 2020 | Stryker End Cap T2 Tibia +10 mm Catalog Number: 18220010S - Product Usage:... | Seal integrity of the blister pack may be compromised and sterility cannot be assured | Class II | Stryker GmbH |
| May 7, 2020 | Stryker Locking Screw, Fully Threaded T2 Humerus ¿4x32 mm Catalog Number: 18... | Seal integrity of the blister pack may be compromised and sterility cannot be assured | Class II | Stryker GmbH |
| May 7, 2020 | Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x37,5 mm Catalog Number: 18... | Seal integrity of the blister pack may be compromised and sterility cannot be assured | Class II | Stryker GmbH |
| May 7, 2020 | Stryker Compression Screw, Advanced T2 Tibia Catalog Number: 18220001S - Pr... | Seal integrity of the blister pack may be compromised and sterility cannot be assured | Class II | Stryker GmbH |
| Dec 5, 2019 | Stryker T2 Alpha Delta Strike Plate IMN Instruments - part of the IMN Instrum... | Instrument can break at the level of the thread when being exposed to high forces during nail imp... | Class II | Stryker GmbH |
| Nov 21, 2019 | Stryker Pin To Rod Coupling External Fixation System Hoffmann II Compact - P... | Pin To Rod Coupling could not clamp the pin and rod as intended | Class II | Stryker GmbH |
| Jul 25, 2019 | Endotrac ECTR Triangle Blade, Angled, Catalog Number 2054A-1 The EPF syst... | The seal integrity of the sterile bag containing the kits may be compromised. | Class II | Stryker GmbH |
| Jul 25, 2019 | Endotrac ECTR Hook Blade, Angled, Catalog Number 2055A-1 The EPF system i... | The seal integrity of the sterile bag containing the kits may be compromised. | Class II | Stryker GmbH |
| Jul 25, 2019 | Endotrac EPF/EGR Triangle Blade, Angled, Catalog Number 3054A-1 The EPF s... | The seal integrity of the sterile bag containing the kits may be compromised. | Class II | Stryker GmbH |
| Jul 25, 2019 | Endotrac ECTR Hook Blade, Catalog Number 2055-1 The EPF system is designe... | The seal integrity of the sterile bag containing the kits may be compromised. | Class II | Stryker GmbH |
| Jul 25, 2019 | Endotrac ECTR Triangle Blade, Catalog Number 2054-1 The EPF system is des... | The seal integrity of the sterile bag containing the kits may be compromised. | Class II | Stryker GmbH |
| Jul 25, 2019 | Endotrac ECTR Push Blade, Catalog Number 2053-1 The EPF system is designe... | The seal integrity of the sterile bag containing the kits may be compromised. | Class II | Stryker GmbH |
| Jul 25, 2019 | Endintrak¿ 2 Hook Blade, Angled, Catalog Number 4058A-1 The EPF system is... | The seal integrity of the sterile bag containing the kits may be compromised. | Class II | Stryker GmbH |
| Jul 25, 2019 | Endotrac EPF/EGR Hook Blade, Angled, Catalog Number 3055A-1 The EPF syste... | The seal integrity of the sterile bag containing the kits may be compromised. | Class II | Stryker GmbH |
| Jul 25, 2019 | Endotrac EPF/EGR Triangle Blade, Catalog Number 3054-1 The EPF system is ... | The seal integrity of the sterile bag containing the kits may be compromised. | Class II | Stryker GmbH |
| Jul 25, 2019 | Endintrak 2 Hook Blade, Catalog Number 4058-1 The EPF system is designed ... | The seal integrity of the sterile bag containing the kits may be compromised. | Class II | Stryker GmbH |
| Jul 25, 2019 | Endotrac EPF/EGR Push Blade, Catalog Number 3053-1 The EPF system is desi... | The seal integrity of the sterile bag containing the kits may be compromised. | Class II | Stryker GmbH |
| Jul 25, 2019 | Endotrac EPF/EGR Hook Blade, Catalog Number 3055-1 The EPF system is desi... | The seal integrity of the sterile bag containing the kits may be compromised. | Class II | Stryker GmbH |
| Jul 25, 2019 | Endotrig ETF Hook Blade, Catalog Number 1052-1 The EPF system is designed ... | The seal integrity of the sterile bag containing the kits may be compromised. | Class II | Stryker GmbH |
| Apr 30, 2019 | Endotrac ECTR Hook/Triangle Blade Kit, Catalogue Number 2056-1 | The seal integrity of the sterile bag containing the kits may be compromised. | Class II | Stryker GmbH |
| Apr 30, 2019 | Endotrac EPF/EGR Hook/Triangle Blade Kit, Catalogue Number 3056-1 | The seal integrity of the sterile bag containing the kits may be compromised. | Class II | Stryker GmbH |
| Jan 21, 2019 | Instrument Tray, Basic T2 Femur Long Catalog #: 1806-9900 Product Usage... | The faceplates may incorrectly identify the T2 Basic Long Instrument Set as T2 Basic Short Instr... | Class II | Stryker GmbH |
| Aug 28, 2018 | Hoffman LRF Hexapod Strut, Extra Short 89mm-109mm, Model Number 4935-0-010. P... | The press fit connection of the Angular Sleeve and pin of the U-Joint and Click Lock did not meet... | Class II | Stryker GmbH |
| Aug 28, 2018 | Hoffman LRF Hexapod Strut, Extra Short 131mm-191mm, Model Number 4935-0-030. ... | The press fit connection of the Angular Sleeve and pin of the U-Joint and Click Lock did not meet... | Class II | Stryker GmbH |
| Aug 28, 2018 | Hoffman LRF Hexapod Strut, Extra Short 105mm-139mm, Model Number 4935-0-020. ... | The press fit connection of the Angular Sleeve and pin of the U-Joint and Click Lock did not meet... | Class II | Stryker GmbH |
| Aug 28, 2018 | Hoffman LRF Hexapod Strut, Extra Short 183mm-295mm, Model Number 4935-0-040. ... | The press fit connection of the Angular Sleeve and pin of the U-Joint and Click Lock did not meet... | Class II | Stryker GmbH |
| Jul 26, 2018 | Hoffmann LRF Hexapod Software Catalog #: 983031 Software Version #: H... | When creating a correction plan with the Correct Axial First button selected and the No. of cor... | Class II | Stryker GmbH |
| Jun 27, 2018 | Stryker T2 ANKLE ARTHRODESIS NAIL RIGHT 10MMX200MM Item Number: 1819-1020S T... | Incomplete seal on the Tyvek lid may compromise the sterility of the device | Class II | Stryker GmbH |
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.