Browse Device Recalls
360 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 360 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 360 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jul 31, 2019 | C2 Nerve Monitor, 8 Channel, 5140-508-280, UDI 07613327277319 Product Usag... | Stryker C2 NerveMonitor's design and instructions may not optimally address usability issues rela... | Class II | Stryker Instruments Div. of Stryker Corporation |
| Jul 19, 2019 | Stryker, Omega 4.75 mm,. PEEK Knotless Anchor System, Double-Double, REF 3910... | Complaints have been received regarding difficulty in removing the driver from the screw. High d... | Class II | Stryker Corporation |
| Jul 19, 2019 | Stryker, Omega 4.75 mm,. PEEK Knotless Anchor System, Single, REF 3910-500-47... | Complaints have been received regarding difficulty in removing the driver from the screw. High d... | Class II | Stryker Corporation |
| Apr 23, 2019 | Stryker Connected OR Cart,120 V Ref Cat. #240-099-155, Qty 1, Rx Only, Manufa... | There is a potential problem with firm s Connected OR Cart, 120V resulting in cart monitor not at... | Class II | Stryker Corporation |
| Mar 19, 2019 | Performance Series Sagittal Blade, Catalog Number 6125-127-100 Product Usa... | During manufacture, packaging materials for a small portion of the lot may not have been properly... | Class II | Stryker Instruments Div. of Stryker Corporation |
| Mar 7, 2019 | Stryker Heated Tube Set with Real-Time Pressure Sensing (RTP), REF 0620-040-6... | The heated tube sets were consistently leaking and detaching from the cassette. | Class II | Stryker Corporation |
| Mar 7, 2019 | Stryker High Flow Tube Set with Real-Time Pressure Sensing (RTP), REF 0620-04... | The heated tube sets were consistently leaking and detaching from the cassette. | Class II | Stryker Corporation |
| Mar 7, 2019 | Stryker High Flow II Tube Set, REF 0620-040-660, an accessory to the PNEUMO ... | The heated tube sets were consistently leaking and detaching from the cassette. | Class II | Stryker Corporation |
| Dec 4, 2018 | Triton Sponge System (Software), GAUS-3, Software Versions 4.6.5, 4.8.7, 4.9.6 | Gauss Surgical is updating the Instructions for Use (IFU) for our Triton Sponge System in order t... | Class III | Stryker Instruments Div. of Stryker Corporation |
| Nov 20, 2018 | Power-LOAD Cot Fastening System, Model #6390, Catalog #6390-000-000 | The power load floor plates which hold the ambulance cot anchors in place during patient transpor... | Class II | Stryker Medical Division of Stryker Corporation |
| Oct 10, 2018 | Naera Hospital Bassinet, Model No. 4402 | It was identified that the volume of air inside the mattress may expand in regions of high altitu... | Class II | Stryker Medical Division of Stryker Corporation |
| Oct 8, 2018 | The Spirit Select Bed, Model 5700 Spirit Plus /with high rail siderail option | The beds with the high rail side rail option may not be complaint with IEC 60601-2-52/C1:2010. T... | Class II | Stryker Medical Division of Stryker Corporation |
| Oct 8, 2018 | The Spirit Plus Bed, Model 5600 Spirit Plus /with high rail siderail option | The beds with the high rail side rail option may not be complaint with IEC 60601-2-52/C1:2010. T... | Class II | Stryker Medical Division of Stryker Corporation |
| Sep 6, 2018 | Altrix¿ Precision Temperature Management System Model: 8001Product Usage: T... | Users may experience alarm fatigue due to frequent alarming relating to patient temperature devia... | Class II | Stryker Medical Division of Stryker Corporation |
| Aug 13, 2018 | IsoFlex LAL Support Surface, Model Number 2860 Product Usage: : The Is... | Certain 2860 IsoFlex LAL support surfaces were assembled with a non-conforming fire barrier. | Class II | Stryker Medical Division of Stryker Corporation |
| Mar 12, 2018 | Power-LOAD Cot Fastening System, Model #6390, Catalog #6390-000-000, UDI: 076... | The power load floor plates which hold the ambulance cot anchors in place during patient transpor... | Class II | Stryker Medical Division of Stryker Corporation |
| Mar 9, 2018 | 6376 M-1 Cot Fastener, catalog no. 6376000000 | The Operations Manual and Maintenance Manual are missing various warnings and contain incorrect i... | Class II | Stryker Medical Division of Stryker Corporation |
| Mar 9, 2018 | 6381 M-1 Cot Fastener, catalog no. 6381000000 | The Operations Manual and Maintenance Manual are missing various warnings and contain incorrect i... | Class II | Stryker Medical Division of Stryker Corporation |
| Feb 23, 2018 | T5 Zipper Toga with Peel-Away Face Shield, (L/XL); Catalog number: 0400-820-1... | Separation of material layers may occur, causing a potential risk of exposure to contaminants. | Class II | Stryker Instruments Div. of Stryker Corporation |
| Feb 23, 2018 | T4 Pullover Toga, Large; Catalog Number: 0400-760-000 Sterile personal prote... | Separation of material layers may occur, causing a potential risk of exposure to contaminants. | Class II | Stryker Instruments Div. of Stryker Corporation |
| Feb 23, 2018 | T4 Pullover Toga, Regular ; Catalog Number: 0400-750-000 Sterile personal pr... | Separation of material layers may occur, causing a potential risk of exposure to contaminants. | Class II | Stryker Instruments Div. of Stryker Corporation |
| Feb 23, 2018 | T4 Pullover Toga, (S/M); Catalog Number: 0400-710-000 Sterile personal prot... | Separation of material layers may occur, causing a potential risk of exposure to contaminants. | Class II | Stryker Instruments Div. of Stryker Corporation |
| Feb 23, 2018 | T4 Pullover Toga, X-Large; Catalog Number: 0400-770-000 Sterile personal pro... | Separation of material layers may occur, causing a potential risk of exposure to contaminants. | Class II | Stryker Instruments Div. of Stryker Corporation |
| Feb 23, 2018 | T4 Zipper Toga, (L/XL); Catalog Number: 0400-820-000 Sterile personal protec... | Separation of material layers may occur, causing a potential risk of exposure to contaminants. | Class II | Stryker Instruments Div. of Stryker Corporation |
| Feb 23, 2018 | T4 Zipper Toga, Regular; Catalog number: 0400-830-000 Sterile personal prote... | Separation of material layers may occur, causing a potential risk of exposure to contaminants. | Class II | Stryker Instruments Div. of Stryker Corporation |
| Feb 23, 2018 | T4 Pullover Toga, L/XL; Catalog Number: 0400-720-000 Sterile personal prote... | Separation of material layers may occur, causing a potential risk of exposure to contaminants. | Class II | Stryker Instruments Div. of Stryker Corporation |
| Feb 23, 2018 | T5 Zipper Toga with Peel-Away Face Shield, (XL/T); Catalog number: 0400-850-1... | Separation of material layers may occur, causing a potential risk of exposure to contaminants. | Class II | Stryker Instruments Div. of Stryker Corporation |
| Feb 23, 2018 | T4 Zipper Toga, X-Large; Catalog number: 0400-850-000 Sterile personal prote... | Separation of material layers may occur, causing a potential risk of exposure to contaminants. | Class II | Stryker Instruments Div. of Stryker Corporation |
| Feb 23, 2018 | T4 Zipper Toga (S/M); Catalog Number: 0400-810-000 Sterile personal protecti... | Separation of material layers may occur, causing a potential risk of exposure to contaminants. | Class II | Stryker Instruments Div. of Stryker Corporation |
| Jan 25, 2018 | CMI (Collagen Meniscus Implant) device, Ivy Sports Medicine s collagen-based ... | The recalled products were shipped without the required temperature control packaging, therefore ... | Class II | Stryker Corporation |
| Dec 21, 2017 | 3910-090-800 ASSY, PKG, 8.0MM X 90MM DRI-LOK THREADED CANNULA, 5 units per bo... | Inadvertent shipment of expired units. | Class II | Stryker Corporation |
| Nov 17, 2017 | StrykeFlow 2 System, labeled sterile. Includes the following: a. STRYKER ... | Routine bioburden testing of certain lots were found to have levels higher than internal acceptab... | Class II | Stryker Corporation |
| Nov 17, 2017 | ACL DISPOSABLE PACK BONE-TENDON-BONE, Model 0234020280, labeled sterile. | Routine bioburden testing of certain lots were found to have levels higher than internal acceptab... | Class II | Stryker Corporation |
| Nov 17, 2017 | STRYKER CASSETTE PUMP, AHTO Tube Set, labeled sterile. Includes the followin... | Routine bioburden testing of certain lots were found to have levels higher than internal acceptab... | Class II | Stryker Corporation |
| Nov 17, 2017 | STRYKER WEDGE INTERFERENCE SCREW SYSTEM, ACL Interface Screw, 9MM X 25MM, Mod... | Routine bioburden testing of certain lots were found to have levels higher than internal acceptab... | Class II | Stryker Corporation |
| Nov 9, 2017 | 180-Gram Cement Cartridge with Breakaway Femoral Nozzle, Product Number: 0206... | Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable ... | Class II | Stryker Instruments Div. of Stryker Corporation |
| Nov 9, 2017 | 1. InterPulse Handpiece with coaxial bone cleaning tip, Product Number: 0210-... | Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable ... | Class II | Stryker Instruments Div. of Stryker Corporation |
| Nov 9, 2017 | Revolution 90 Degree Tibial Nozzle, Product Number: 0606-516-000, UDI: (01)45... | Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable ... | Class II | Stryker Instruments Div. of Stryker Corporation |
| Nov 9, 2017 | 1. AutoPlex System, Product Number: 0605-887-000, UDI: (01)4546540593108; 2. ... | Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable ... | Class II | Stryker Instruments Div. of Stryker Corporation |
| Nov 9, 2017 | Break-Away Femoral Nozzle, Product Number: 0206-512-000, UDI: (01)45465400394... | Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable ... | Class II | Stryker Instruments Div. of Stryker Corporation |
| Nov 9, 2017 | 1. Femoral Canal Pressurizer without Hub, Medium, Blue, Product Number: 0206-... | Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable ... | Class II | Stryker Instruments Div. of Stryker Corporation |
| Nov 9, 2017 | Advanced Cement Mixing (ACM) Kit w/ Femoral Breakaway Nozzle & Prox. Med. Pre... | Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable ... | Class II | Stryker Instruments Div. of Stryker Corporation |
| Nov 9, 2017 | 1. 11g/10mm iVAS System Kit, Product Number: 0705-310-000, UDI: (01)761325250... | Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable ... | Class II | Stryker Instruments Div. of Stryker Corporation |
| Nov 9, 2017 | 10g/15mm (15/2) iVAS System Kit, Product Number: 0705-115-000, UDI: (01)76132... | Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable ... | Class II | Stryker Instruments Div. of Stryker Corporation |
| Nov 9, 2017 | 11g Verteport Cement Cannula (18/pkg), Product Number: 0306-511-000, UDI: (01... | Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable ... | Class II | Stryker Instruments Div. of Stryker Corporation |
| Nov 9, 2017 | PCD Kit: Long 90, 13g Match-Ground w/ Bevel, Product Number: 0506-485-000, UD... | Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable ... | Class II | Stryker Instruments Div. of Stryker Corporation |
| Nov 9, 2017 | Intramedullary Brush Standard O.D. 14 mm, Product Number: 6198-001-514, UDI: ... | Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable ... | Class II | Stryker Instruments Div. of Stryker Corporation |
| Nov 9, 2017 | Revolution CMS w/ Femoral Breakaway Nozzle & Med. Press., Product Number: 060... | Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable ... | Class II | Stryker Instruments Div. of Stryker Corporation |
| Nov 7, 2017 | T/Pump temperature therapy pump, Models TP700 and TP700C | The T/Pump Operations Manual and Maintenance Manual were incorrectly revised to add the sentence,... | Class III | Stryker Medical Division of Stryker Corporation |
| Oct 16, 2017 | The Stryker Thoracic Pedicle Feeler 6002-350-000 is a smart instrument for re... | Stryker Instruments and Stryker Leibinger GmbH & Co. KG are voluntarily recalling certain serial... | Class II | Stryker Instruments Div. of Stryker 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.