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Browse Device Recalls

97 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 97 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 97 FDA device recalls.

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DateProductReasonClassFirm
Jan 15, 2026 Brand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS, 7L 16MM, VE Mo... Knee and Humeral socket implants contain incorrect labeling. Class II Encore Medical, LP
Jan 15, 2026 Brand Name: Reverse Shoulder Prosthesis (RSP) Product Name: RSP STANDARD HUM... Knee and Humeral socket implants contain incorrect labeling. Class II Encore Medical, LP
Jan 15, 2026 Brand Name: Reverse Shoulder Prosthesis (RSP) Product Name: RSP HUMERAL SOCK... Knee and Humeral socket implants contain incorrect labeling. Class II Encore Medical, LP
Jan 5, 2026 EMPOWR Acetabular System: Liner, 10 degree Hooded, HXe+, 36H, REF: 942-01-36H... 942-01-40G acetabular system package was found to contain 942-01-36H acetabular system; and sever... Class II Encore Medical, LP
Jan 5, 2026 EMPOWR 3D Knee Tibial Insert 5R 14MM, VE, REF: 342-14-705 942-01-40G acetabular system package was found to contain 942-01-36H acetabular system; and sever... 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: 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
Jul 9, 2025 Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNE... Knee implants contain incorrect labeling (size and/or side incorrect) Class II Encore Medical, LP
Jul 9, 2025 Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNE... Knee implants contain incorrect labeling (size and/or side incorrect) Class II Encore Medical, LP
Jun 12, 2025 Brand Name: EMPOWR Dual Mobility" Product Name: EMPOWR Acetabular, Dual Mobi... Due to packaging discrepancy with the incorrect tibial inserts/implants being packaged. Issued di... Class II Encore Medical, LP
Jun 12, 2025 Brand Name: EMPOWR Dual Mobility" Product Name: EMPOWR Acetabular, Dual Mobi... Due to packaging discrepancy with the incorrect tibial inserts/implants being packaged. Issued di... Class II Encore Medical, LP
Jun 2, 2025 Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KN... Due to packaging discrepancy with the incorrect tibial inserts/implants being packaged. The use ... Class II Encore Medical, LP
Jun 2, 2025 Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KN... Due to packaging discrepancy with the incorrect tibial inserts/implants being packaged. The use ... Class II Encore Medical, LP
May 28, 2025 Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL ... Package labeling for Altivate Reverse Torx Peripheral screw contains a different size then actua... Class II Encore Medical, LP
May 28, 2025 Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL ... Package labeling for Altivate Reverse Torx Peripheral screw contains a different size then actua... Class II Encore Medical, LP
May 28, 2025 Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL ... Package labeling for Altivate Reverse Torx Peripheral screw contains a different size then actua... Class II Encore Medical, LP
May 28, 2025 Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL ... Package labeling for Altivate Reverse Torx Peripheral screw contains a different size then actua... Class II Encore Medical, LP
Dec 18, 2024 EMPOWR 3D Knee Tibial Insert, 5R 16MM, VE, REF: 342-16-705; EMPOWR 3D Knee T... 5R 16MM knee tibial insert package may contain knee tibial insert 3R 14MM and vice versa, which m... Class II Encore Medical, LP
Dec 10, 2024 EMPOWR 3D Knee Tibial Insert, 6R 10MM, VE, REF: 342-10-706 Knee insert package may contain an acetabular system, which may cause surgical delay to get a new... 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
Oct 5, 2023 REF 130-03-738, All-Poly e + Patella, Domed Tri-Peg, 9x38mm, STERILE H2O2 Mislabeling Class II Encore Medical, LP
Oct 5, 2023 Reverse Shoulder System e+, REF 509-01-032, RSP Humeral Socket Insert, Sz. 32... Mislabeling Class II Encore Medical, LP
Sep 29, 2023 DJO EMPOWR Knee Punch Handle, REF: 801-05-040 Knee punch handle tip is breaking during surgery due to the lack of heat treatment, which may lea... Class II Encore Medical, LP
Sep 25, 2023 RSP Humeral Small Socket Insert Size 32 mm Semi-Constrained +4, e-plus, REF: ... Two different humeral socket Insert devices were swapped during packaging, which could result in ... Class II Encore Medical, LP
Sep 25, 2023 RSP Humeral Socket Insert Size 36mm Semi-Constrained +4 mm, REF: 509-01-436, ... Two different humeral socket Insert devices were swapped during packaging, which could result in ... 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 22, 2023 EMPOWR 3D Knee Tibial Insert, 5R, 10MM, VE, REF: 342-10-705 Knee insert and acetabular system parts were swapped within inner pack prior to the product being... Class II Encore Medical, LP
Aug 22, 2023 EMPOWR Acetabular System, Liner, 10¿ Hooded, HXe+, 40H, REF: 942-01-40H Knee insert and acetabular system parts were swapped within inner pack prior to the product being... Class II Encore Medical, LP
Aug 22, 2023 REVERSE PROSTHESIS SHOULDER SYSTEM, SCREW, LOCKING BONE, RSP, 5mmX30mm long, ... Reverse shoulder prosthesis package that should contain 5mmx30 screws could contain incorrect 3.5... 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
Feb 28, 2023 EMPOWR Porous Knee Patella Over Drill, REF: 802-05-104; EMPOWR Knee Patella D... Patella drills are marked with incorrect diameter size of 5.6mm, when they should be 5.4mm. Porou... Class II Encore Medical, LP
Dec 22, 2022 EMPOWR VVC KNEE TIBIAL INSERT, SIZE 6, 22MM, REF: 346-22-706; EMPOWR VVC KNEE... Tibial insert implant large boxes were labeled small and the small boxes were labeled large. If t... Class II Encore Medical, LP
Aug 12, 2022 EMPOWER 3D Knee Tibial Insert, REF: 341-14-708. Orthopedic implant component. Hip liner implant boxes may contain knee inserts and knee insert boxes may contain hip liner impl... Class II Encore Medical, LP
Aug 12, 2022 EMPOWR Acetabular System, Liner, 10 deg Hooded, HXe+ 40H, REF: 942-01-40H. Or... Hip liner implant boxes may contain knee inserts and knee insert boxes may contain hip liner impl... Class II Encore Medical, LP
May 5, 2022 DJO EMPOWR 3D Knee (Right) 10mm Tibial Insert, REF: 342-10-708 A right, size 8, knee tibial insert package may include a mispackaged, left ,size 4, knee tibial ... Class II Encore Medical, LP
Jun 28, 2021 AltiVate Anatomic Shoulder System for the following Part Numbers: 1. Part ... Complaints have been received concerning the humeral stem failing to mate with the broach handles... 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
Feb 5, 2021 DJO EMPOWR KNEE Femoral Sizer Incorrect assembly of a subcomponent by a vendor and as a result, the windows provided to show th... Class II Encore Medical, LP
Sep 9, 2020 EMPOWR Acetabular System *** EMPOWR Acetabular Cup, Cluster Hole, 54G *** Si... Due to incomplete machining a small peg remnant on the top of the dome that protrudes above the s... 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
Aug 7, 2020 RSP Standard HUMERAL SOCKET INSERT, 40 MM plus 4MM, HXe-Plus, Part No. 509-00... Product may be mislabeled with the size etched onto products differing from the size information ... Class II Encore Medical, LP
Aug 7, 2020 RSP Standard HUMERAL SOCKET INSERT, 44MM, HXe-Plus, Part No. 509-00-044 Product may be mislabeled with the size etched onto products differing from the size information ... Class II Encore Medical, LP
Aug 3, 2020 DJO EMPOWR Tibial Knee Punch Handle Part No. 801-05-040 and 801-05-018 contai... There is a potential for the retaining pin of the tibial punch handle to become loose and fall ou... 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.