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Browse Device Recalls

70 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 70 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 70 FDA device recalls.

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DateProductReasonClassFirm
Mar 6, 2024 stryker Infinity Resection Adjustment Block, REF 33600030, ankle arthroplasty Stryker has identified an issue that impacts specific lots of Infinity" Resection Guide Adjustmen... Class II Wright Medical Technology, Inc.
Jun 13, 2023 Stryker Infinity Alignment Frame Distal Sub-Assembly, Catalog #33600020, non-... The devices were manufactured with the pin sleeve holes too narrow, which does not allow the pin... Class II Wright Medical Technology, Inc.
Apr 10, 2023 stryker ORTHOLOC 3Di Fusion Plate MTP Right, REF 58A220RT, bone stabilization... Two lots of Ortholoc 3Di Fusion plates contain incorrect dorsiflexion descriptions laser marked o... Class II Wright Medical Technology, Inc.
Apr 10, 2023 stryker ORTHOLOC 3Di Fusion Plate MTP Right, REF 58A221RT, bone stabilization... Two lots of Ortholoc 3Di Fusion plates contain incorrect dorsiflexion descriptions laser marked o... Class II Wright Medical Technology, Inc.
Feb 2, 2023 ORTHOLOC 3DSi CLAW II 4 HOLE Plate, Size 25MM, REF 402S0425, Bone fixation de... Stryker has identified an issue that impacts two specific lots of CLAW" II plates. The plates wit... Class II Wright Medical Technology, Inc.
Feb 2, 2023 ORTHOLOC 3DSi CLAW II 4 HOLE Plate, Size 25MM, REF 40241425, Bone fixation de... Stryker has identified an issue that impacts two specific lots of CLAW" II plates. The plates wit... Class II Wright Medical Technology, Inc.
Sep 30, 2022 Stryker INBONE Tibial Tray, Left Plasma Spray Ti6Al4V, CPti, Use w/ 18mm Stem... The tibial tray lock detail is oversized (larger than specification). Class II Wright Medical Technology, Inc.
Sep 30, 2022 Stryker INBONE Tibial Tray, Left Plasma Spray Ti6Al4V, CPti, Use w/ 16mm Stem... The tibial tray lock detail is oversized (larger than specification). Class II Wright Medical Technology, Inc.
Aug 3, 2022 stryker EVOLVE, Proline Stem, CoCr, Size: +2, O: 705mm, REF 496S275, Wright ... The outer label does not match the device inside the package. The affected lot of EVOLVE Proline ... Class II Wright Medical Technology, Inc.
Aug 3, 2022 stryker EVOLVE, Proline Stem, CoCr, Size: +4, OD: 9.5mm, REF 496S275, Wrigh... The outer label does not match the device inside the package. The affected lot of EVOLVE Proline ... Class II Wright Medical Technology, Inc.
Jul 27, 2022 Stryker SWANSON Flexspan Finger Joint Implant W/O Grommets Silicone, Size: 00... An incorrect sizing label was applied to the carton packaging. Class II Wright Medical Technology, Inc.
Jun 14, 2022 Wright EVOLVE TRIAD Plate Cutter, REF 49510120 The plate cutter is unable to meet sterilization requirements when it is sterilized in a double-w... Class II Wright Medical Technology, Inc.
Jun 2, 2022 Stryker INFINITY Resect Guide for INBONE Talus, Size 4, Model #33620254, non-... The instrument is incorrectly color coded. Class II Wright Medical Technology, Inc.
Mar 10, 2022 EasyFuse Dynamic Compression System Instrument Pack The drill and adjustable drill guide can jam/bind intraoperatively resulting in the drill guide b... Class II Wright Medical Technology, Inc.
Feb 15, 2022 Wright Medical Technology, Inc. ORTHOLOC Non-Locking Screw 2mm x 8mm, REF 520... An incorrect screw is packaged in the product, which contains a locking screw instead of a non-lo... Class II Wright Medical Technology, Inc.
Feb 9, 2022 The DARCO¿ Locking Bone Plate System is designed with rhombus (parallelogram... Product was labelled with the incorrect manufacturing and distribution dates. Class II Wright Medical Technology, Inc.
Dec 3, 2021 Wright Medical Technology Inc. CHARLOTTE MTP Hex Screw, Model #41122718, 2.7m... Incorrect product is contained in the packaging. Class II Wright Medical Technology, Inc.
Jul 28, 2020 Hardware removal kit, Part Number 1985KIT1 - Product Usage: The Wright Medica... Hardware removal kit does not include drivers to remove Dart-Fire 2.5 and 3.0mm Headless screws. Class II Wright Medical Technology, Inc.
Jul 28, 2020 Screw Removal Case Assembly, Part Number 1985BASE - Product Usage: The Wright... Hardware removal kit does not include drivers to remove Dart-Fire 2.5 and 3.0mm Headless screws. Class II Wright Medical Technology, Inc.
Dec 27, 2019 WRIGHT EVOLVE Proline Head, Size: +2, OD: 22mm, REF 496H222 Two lots of EVOLVE Modular Radial Head could have the wrong size product in the package. Both th... Class II Wright Medical Technology, Inc.
Dec 27, 2019 WRIGHT EVOLVE Proline Head, Size: +2, OD: 20mm, REF 496H220 Two lots of EVOLVE Modular Radial Head could have the wrong size product in the package. Both th... Class II Wright Medical Technology, Inc.
Mar 14, 2018 WRIGHT, Wright Medical Technology, VALOR(R) Nail, Right, Small, OD: 11.5mm, L... Tow lot of VALOR(TM) Nail could potentially be missing the assembled compression screw. Class II Wright Medical Technology, Inc.
Mar 14, 2018 WRIGHT, Wright Medical Technology, VALOR(R) Nail, Right, Medium, OD: 10mm, L:... Tow lot of VALOR(TM) Nail could potentially be missing the assembled compression screw. Class II Wright Medical Technology, Inc.
Nov 8, 2016 SWANSON FINGER JOINT #2, Part Number 4700002 The firm discovered a lack of adequate documentation confirming sterility on certain products. Class II Wright Medical Technology, Inc.
Nov 8, 2016 ORTHOLOC 3DI PLT SYS STERILE, LOCKING SCREW, 3.5 x 38mm Sterile, Part Number ... The firm discovered a lack of adequate documentation confirming sterility on certain products. Class II Wright Medical Technology, Inc.
Nov 8, 2016 Dart Fire HEADED SCREW 4.0X 32MM, Part Number D1S40032S The firm discovered a lack of adequate documentation confirming sterility on certain products. Class II Wright Medical Technology, Inc.
Nov 8, 2016 VALOR SCREW 5.0MM X 45MM LEN, Part Number 4151150045 The firm discovered a lack of adequate documentation confirming sterility on certain products. Class II Wright Medical Technology, Inc.
Nov 8, 2016 SWANSON GREAT TOE, TITANIUM SZ 4, Part Number 4833104 The firm discovered a lack of adequate documentation confirming sterility on certain products. Class II Wright Medical Technology, Inc.
Nov 8, 2016 SWANSON TRAPEZIUM IMPLANT, Part Number 4520002 The firm discovered a lack of adequate documentation confirming sterility on certain products. Class II Wright Medical Technology, Inc.
Nov 8, 2016 EVANS OPENING WEDGE PLATE 10MM, Part Number 58S30010 The firm discovered a lack of adequate documentation confirming sterility on certain products. Class II Wright Medical Technology, Inc.
Nov 8, 2016 CPS CALCANEAL PLATE SML 54MM, Part Number DCS2805001 The firm discovered a lack of adequate documentation confirming sterility on certain products. Class II Wright Medical Technology, Inc.
Nov 8, 2016 INBONE STEM, TIBIAL, TOP, Part Number 200011901 The firm discovered a lack of adequate documentation confirming sterility on certain products. Class II Wright Medical Technology, Inc.
Nov 8, 2016 SWANSON FINGER JOINT #1, Part Number 4700001 The firm discovered a lack of adequate documentation confirming sterility on certain products. Class II Wright Medical Technology, Inc.
Nov 8, 2016 Darco STERILE HEADED DRILL BIT 4.4MM , Part Number 777S06514 The firm discovered a lack of adequate documentation confirming sterility on certain products. Class II Wright Medical Technology, Inc.
Nov 8, 2016 PRO-STIM 10cc INJECTABLE, Part Number 86SR0410 The firm discovered a lack of adequate documentation confirming sterility on certain products. Class II Wright Medical Technology, Inc.
Jul 21, 2015 CrossCHECK Locking Screw in the following sizes: 3.0 x 8 mm, REF CCP-L3008;... These screws have a potential of passing through the plate in the case when torque is applied in ... Class II Wright Medical Technology, Inc.
Jul 21, 2015 CrossCHECK Non-Locking Screw in the following sizes: 3.0 x 8 mm, REF CCP-N300... These screws have a potential of passing through the plate in the case when torque is applied in ... Class II Wright Medical Technology, Inc.
Apr 16, 2015 PHALINX (TM) HAMMERTOE HANDLE, SIZE: SMALL, STYLE: ANGLED, REF 45304012, CONT... The term DORSAL was laser etched on the incorrect side on some of the angled handles. Class II Wright Medical Technology, Inc.
Apr 16, 2015 PHALINX (TM) HAMMERTOE HANDLE, SIZE: X-SMALL, STYLE: ANGLED, REF 45304011, CO... The term DORSAL was laser etched on the incorrect side on some of the angled handles. Class II Wright Medical Technology, Inc.
Apr 16, 2015 PHALINX (TM) HAMMERTOE HANDLE, SIZE: MEDIUM, STYLE: ANGLED, REF 45304013, CON... The term DORSAL was laser etched on the incorrect side on some of the angled handles. Class II Wright Medical Technology, Inc.
Apr 16, 2015 PHALINX (TM) HAMMERTOE HANDLE, SIZE: LARGE, STYLE: ANGLED, REF 45304014, CONT... The term DORSAL was laser etched on the incorrect side on some of the angled handles. Class II Wright Medical Technology, Inc.
Mar 6, 2015 CROSSCHECK(R) Plating system, Utility Plate, 3-Hole, REF CCP-UTN3. Orthope... The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specific... Class II Wright Medical Technology, Inc.
Mar 6, 2015 CROSSCHECK(R) Plating system, Utility Plate, 7-Hole, REF CCP-UTN7. Orthope... The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specific... Class II Wright Medical Technology, Inc.
Mar 6, 2015 CROSSCHECK(R) Plating system, Utility Plate, 2-Hole, REF CCP-UTN2. Orthope... The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specific... Class II Wright Medical Technology, Inc.
Mar 6, 2015 CROSSCHECK(R) Plating system, LAPIDUS CX plate, 2mm Step, Right, REF CCP-LPX2... The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specific... Class II Wright Medical Technology, Inc.
Mar 6, 2015 CROSSCHECK(R) Plating system, HOCKEY STICK CX Plate, Left, REF CCP-HSX1L. ... The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specific... Class II Wright Medical Technology, Inc.
Mar 6, 2015 CROSSCHECK(R) Plating system, LAPIDUS CX Plate, NEUTRAL, Left, REF CCP-LPX0L.... The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specific... Class II Wright Medical Technology, Inc.
Mar 6, 2015 CROSSCHECK(R) Plating system, LAPIDUS CX Plate, 1mm Step, Right, REF CCP-LPX1... The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specific... Class II Wright Medical Technology, Inc.
Mar 6, 2015 CROSSCHECK(R) Plating system, MTP CX Plate, Left, REF CCP-MPX1L. Orthopedi... The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specific... Class II Wright Medical Technology, Inc.
Mar 6, 2015 CROSSCHECK(R) Plating system, LAPIDUS CX Plate, 2mm Step, Left, REF CCP-LPX2L... The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specific... Class II Wright Medical Technology, 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.