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Browse Device Recalls

18 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 18 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 18 FDA device recalls.

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DateProductReasonClassFirm
Jul 18, 2025 Brand Name: DJO SURGICAL Product Name: ALTIVATE REVERSE WEDGE GLENOID REAMER... Their is a potential that the reamer may kick or bind up during or immediately prior to use. Class II Encore Medical, LP
Jul 18, 2025 Brand Name: DJO SURGICAL Product Name: ALTIVATE REVERSE WEDGE GLENOID REAMER... Their is a potential that the reamer may kick or bind up during or immediately prior to use. Class II Encore Medical, LP
Jul 18, 2025 Brand Name: DJO SURGICAL Product Name: FA S Altivate Reverse Glenoid Tray M... Their is a potential that the reamer may kick or bind up during or immediately prior to use. Class II Encore Medical, LP
Jul 18, 2025 Brand Name: DJO SURGICAL Product Name: ALTIVATE REVERSE WEDGE GLENOID REAMER... Their is a potential that the reamer may kick or bind up during or immediately prior to use. Class II Encore Medical, LP
Nov 10, 2023 DJO surgical EMPOWR Porous Knee System Empowr 3D Femur-Porous Coated SIZE 8 L... Due to incorrect product/device within packaging. Class II Encore Medical, LP
Sep 6, 2023 RSP Glenoid Baseplate, 30mm P2 Porous Coated REF 508-32-204. DJO Surgical sho... Coating hex did not engage with the Straight Mod Hexdriver or with the Hex Head Screw Driver Class II Encore Medical, LP
Aug 4, 2023 DJO Surgical: Altivate Reverse, Humeral Stem, Small Shell, Size 6 x 108mm, RE... Orthopedic device components were not subjected to final sterilization before shipment, which if ... Class II Encore Medical, LP
Aug 4, 2023 DJO Surgical: Reverse Shoulder System (RSP) Semi Humeral Socket Insert, 32mm,... Orthopedic device components were not subjected to final sterilization before shipment, which if ... Class II Encore Medical, LP
Aug 4, 2023 DJO Surgical: CLP Hip, Stem, Polished Neck, Lateral Offset Implant, Size#3, R... Orthopedic device components were not subjected to final sterilization before shipment, which if ... Class II Encore Medical, LP
Aug 4, 2023 DJO Surgical: Delta Ceramic Femoral Head, 44 mm + 4.0 mm, REF: 400-03-443 Orthopedic device components were not subjected to final sterilization before shipment, which if ... Class II Encore Medical, LP
Aug 4, 2023 DJO Surgical: Empowr Knee, Universal Tibia Baseplate, 6R, REF: 352-02-106 Orthopedic device components were not subjected to final sterilization before shipment, which if ... Class II Encore Medical, LP
May 12, 2021 DJO Surgical EMPOWR 3D Knee Tibial Insert - e-plus, REF: 341-16-711 Left Sz. ... Packaging mixup; There is a potential that packaging identified as 12mm knee prosthesis contains ... Class II Encore Medical, LP
May 12, 2021 DJO Surgical EMPOWR 3D Knee Tibial Insert - e-plus, REF: 341-12-711, Left Sz.... Packaging mixup; There is a potential that packaging identified as 12mm knee prosthesis contains ... Class II Encore Medical, LP
Aug 31, 2020 AltiVate Reverse Small Socket Insert, 44mm Semi Constrained - E-Plus, Part Nu... Product mislabeled. Use may result in a delay in surgery, stopping of surgery, and revision surgery. Class II Encore Medical, LP
Sep 21, 2018 Exprt Precision System: Revision Hip, Proximal Body with Bolt, Lateral Offset... Complaints regarding loose proximal body bolts or bolts that were found through x-ray as sitting ... Class II Encore Medical, Lp
Apr 23, 2017 Linear Straight Broach Handle (Rasp Handle) (Greatbatch Part # 510397; DJO Su... Greatbatch Medical has voluntarily initiated a Recall for the Linear Straight Broach Handle (Rasp... Class II Greatbatch Medical
Feb 7, 2014 FMP X-alt Acetabular Liner This acetabular liner is intended for use with ... Packaging error -- two different types and sizes of acetabular liners used during hip replacement... Class II Djo Surgical
Jul 16, 2012 djo surgical Screw 6.5 mm, Sz 25mm, low profile. Product is intended for t... One lot of the 010-55-030, 6.5 mm Cancellous Bone Screw was recalled because a product complaint ... Class II Encore Medical, Lp

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.