Browse Device Recalls
64 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 64 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 64 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Feb 11, 2026 | Embrace Drill Tower, Standard/Lateral (25mm); Item Number: 645-081/63; | The surgical technique for the Embrace Shoulder Instruments - Drill Tower has mixed-up article nu... | Class II | Waldemar Link GmbH & Co. KG (Mfg Site) |
| Feb 11, 2026 | Embrace Drill Tower, Wedged (25mm); Item Number: 645-081/62; | The surgical technique for the Embrace Shoulder Instruments - Drill Tower has mixed-up article nu... | Class II | Waldemar Link GmbH & Co. KG (Mfg Site) |
| Jan 12, 2026 | Endo-Model Replacement Plateau; Item Number: 15-0027/16; | The potential for an implant with a plateau screw where the bushing could detach from the screw s... | Class II | Waldemar Link GmbH & Co. KG (Mfg Site) |
| Jan 12, 2026 | Endo-Model Replacement Plateau; Item Number: 15-0027/12; | The potential for an implant with a plateau screw where the bushing could detach from the screw s... | Class II | Waldemar Link GmbH & Co. KG (Mfg Site) |
| Jan 12, 2026 | Endo-Model Replacement Plateau; Item Number: 15-8521/11; | The potential for an implant with a plateau screw where the bushing could detach from the screw s... | Class II | Waldemar Link GmbH & Co. KG (Mfg Site) |
| Jan 12, 2026 | Endo-Model Replacement Plateau; Item Number: 15-8521/09; | The potential for an implant with a plateau screw where the bushing could detach from the screw s... | Class II | Waldemar Link GmbH & Co. KG (Mfg Site) |
| Jan 12, 2026 | Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/02; | The potential for an implant with a plateau screw where the bushing could detach from the screw s... | Class II | Waldemar Link GmbH & Co. KG (Mfg Site) |
| Jan 12, 2026 | Endo-Model Replacement Plateau; Item Number: 15-2836/11; | The potential for an implant with a plateau screw where the bushing could detach from the screw s... | Class II | Waldemar Link GmbH & Co. KG (Mfg Site) |
| Jan 12, 2026 | Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/07; | The potential for an implant with a plateau screw where the bushing could detach from the screw s... | Class II | Waldemar Link GmbH & Co. KG (Mfg Site) |
| Jan 12, 2026 | Endo-Model Replacement Plateau; Item Number: 15-2835/12; | The potential for an implant with a plateau screw where the bushing could detach from the screw s... | Class II | Waldemar Link GmbH & Co. KG (Mfg Site) |
| Jan 12, 2026 | Endo-Model Replacement Plateau; Item Number: 15-0027/15; | The potential for an implant with a plateau screw where the bushing could detach from the screw s... | Class II | Waldemar Link GmbH & Co. KG (Mfg Site) |
| Jan 12, 2026 | Endo-Model Replacement Plateau; Item Number: 15-8521/15; | The potential for an implant with a plateau screw where the bushing could detach from the screw s... | Class II | Waldemar Link GmbH & Co. KG (Mfg Site) |
| Jan 12, 2026 | Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/05; | The potential for an implant with a plateau screw where the bushing could detach from the screw s... | Class II | Waldemar Link GmbH & Co. KG (Mfg Site) |
| Jan 12, 2026 | Endo-Model Replacement Plateau; Item Number: 15-8030/12; | The potential for an implant with a plateau screw where the bushing could detach from the screw s... | Class II | Waldemar Link GmbH & Co. KG (Mfg Site) |
| Jan 12, 2026 | Endo-Model Replacement Plateau; Item Number: 15-0027/11; | The potential for an implant with a plateau screw where the bushing could detach from the screw s... | Class II | Waldemar Link GmbH & Co. KG (Mfg Site) |
| Nov 10, 2025 | Endo Model Knee Fusion Nail SK, Knee Fusion Nail, Coupling Component, right,... | The device has been delivered with a preassembled locking screw that had been inserted from the w... | Class II | Waldemar Link GmbH & Co. KG (Mfg Site) |
| Jul 31, 2025 | LinkSymphoKnee System, Tibial Component, Modular, Symmetric, Sz. 5, CoCrMo/Ti... | Some modular LinkSymphoKnee TiNbN Tibial Components were manufactured with two uncoated security ... | Class II | Waldemar Link GmbH & Co. KG (Mfg Site) |
| Jul 15, 2025 | Plastic Trial Head Brown, 7 mm neck length. Item Number: 175-928/15. | Inconsistent size terminology and color coding used on labeling | Class II | Waldemar Link GmbH & Co. KG (Mfg Site) |
| Jul 15, 2025 | Prosthesis Head B, 28 mm, 7 mm neck length. Item Number: 198-828/04. | Inconsistent size terminology and color coding used on labeling | Class II | Waldemar Link GmbH & Co. KG (Mfg Site) |
| Apr 3, 2025 | L-Shaped Femoral Augment; Item Numbers: (1) 880-320/12 (Sz. 0 - cemented sm),... | The device was delivered with a preassembled Femoral Augment screw that was missing its thread. | Class II | Waldemar Link GmbH & Co. KG (Mfg Site) |
| Apr 3, 2025 | Distal Femoral Augment; Item Numbers: (1) 880-300/11 (Sz. 0 - cemented sm), (... | The device was delivered with a preassembled Femoral Augment screw that was missing its thread. | Class II | Waldemar Link GmbH & Co. KG (Mfg Site) |
| Apr 3, 2025 | Tibial Augment; Item Numbers: (1) 880-331/11 (Sz. 1-2 - cemented x-sm), (2) 8... | The device was delivered with a preassembled Femoral Augment screw that was missing its thread. | Class II | Waldemar Link GmbH & Co. KG (Mfg Site) |
| Apr 3, 2025 | Posterior Femoral Augment; Item Numbers: (1) 880-310/11 (Sz. 0 - cemented sm)... | The device was delivered with a preassembled Femoral Augment screw that was missing its thread. | Class II | Waldemar Link GmbH & Co. KG (Mfg Site) |
| Feb 14, 2025 | Modular Stem cylindrical, Tilastan¿, press-fit cementless, L= 80 mm, DIA = 12... | A problem was discovered during the scanning process of the outer carton label because of an inco... | Class II | Waldemar Link GmbH & Co. KG (Mfg Site) |
| Feb 14, 2025 | Modular Stem cylindrical, Tilastan¿, press-fit cementless, L= 80 mm, DIA = 13... | A problem was discovered during the scanning process of the outer carton label because of an inco... | Class II | Waldemar Link GmbH & Co. KG (Mfg Site) |
| Feb 14, 2025 | Modular Stem cylindrical, Tilastan¿, press-fit cementless, L= 80 mm, DIA = 1... | A problem was discovered during the scanning process of the outer carton label because of an inco... | Class II | Waldemar Link GmbH & Co. KG (Mfg Site) |
| Dec 5, 2024 | LINK MP Reconstruction System Neck Segment (with suture holes, standard, unc... | Error on the main label and the patient label. The labels indicate a size XXL, this is a standard... | Class II | Waldemar Link GmbH & Co. KG (Mfg Site) |
| May 22, 2024 | Endo Model M Tibial Components Modular Knee Prosthesis System. Product codes... | Blind screws of the modular tibial component cannot be loosened intraoperatively,prolongation sur... | Class II | Waldemar Link GmbH & Co. KG (Mfg Site) |
| May 22, 2024 | Endo Model SL Tibial Components 16-2817/02 Tibial Component... | Blind screws of the modular tibial component cannot be loosened intraoperatively,prolongation sur... | Class II | Waldemar Link GmbH & Co. KG (Mfg Site) |
| Feb 6, 2024 | SPII Model Lubinus, Hip Prosthesis Stem XL Neck, cemented | Due to two complaints, has come to our attention that additional guidance is required on the corr... | Class II | Waldemar Link GmbH & Co. KG (Mfg Site) |
| Feb 6, 2024 | SPII Model Lubinus, Hip Prosthesis Stem Standard Neck, cemented | Due to two complaints, has come to our attention that additional guidance is required on the corr... | Class II | Waldemar Link GmbH & Co. KG (Mfg Site) |
| Feb 6, 2024 | SPII Model Lubinus, Long Stem Prosthesis Standard Neck, cemented | Due to two complaints, has come to our attention that additional guidance is required on the corr... | Class II | Waldemar Link GmbH & Co. KG (Mfg Site) |
| Feb 6, 2024 | SPII Model Lubinus, Long Stem Prosthesis XL Neck, cemented | Due to two complaints, has come to our attention that additional guidance is required on the corr... | Class II | Waldemar Link GmbH & Co. KG (Mfg Site) |
| Jan 29, 2024 | Embrace Drill Tower, Standard/Lateral (25mm) | The surgical techniques for the Embrace Shoulder Instruments -Drill Tower (Article REF 645-081/62... | Class II | Waldemar Link GmbH & Co. KG (Mfg Site) |
| Jan 29, 2024 | Embrace Drill Tower, Wedged (25mm) | The surgical techniques for the Embrace Shoulder Instruments -Drill Tower (Article REF 645-081/62... | Class II | Waldemar Link GmbH & Co. KG (Mfg Site) |
| Jan 22, 2024 | LINK BiMobile Dual Mobility System E-Poly Liner for 28mm Head, 70mm Shell- In... | Mislabeled: Packaging incorrectly reflects a MobileLink Dual Mobility insert type F when it shoul... | Class II | Waldemar Link GmbH & Co. KG (Mfg Site) |
| Nov 30, 2023 | Link Patella Glide Resection Guide- For the implantation of the Endo-Model Kn... | Mislabeled: Angle and height of the device marked as L(large) corresponds to the small/medium dim... | Class II | Waldemar Link GmbH & Co. KG (Mfg Site) |
| Jul 26, 2023 | Link OptiStem Rasp Handle-Used with the OptiStem Rasp to prepare the femoral ... | A crack in the weld of the rasp handle may lead to a fracture of the frontal sleeve when the rasp... | Class II | Waldemar Link GmbH & Co. KG (Mfg Site) |
| Jul 14, 2023 | MobileLink Acetabular Cup System, Shell/Insert Adapter for Shell 74-80mm, Ins... | Product is labeled with incorrect offset. | Class II | Waldemar Link GmbH & Co. KG (Mfg Site) |
| Jul 3, 2023 | LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 23 - Indicated for p... | Increased force may be required to remove the LINK MP Monoblock trial hip stem (Sizes 14mm - 25mm... | Class II | Waldemar Link GmbH & Co. KG (Mfg Site) |
| Jul 3, 2023 | LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 20 - Indicated for p... | Increased force may be required to remove the LINK MP Monoblock trial hip stem (Sizes 14mm - 25mm... | Class II | Waldemar Link GmbH & Co. KG (Mfg Site) |
| Jul 3, 2023 | LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 24 - Indicated for p... | Increased force may be required to remove the LINK MP Monoblock trial hip stem (Sizes 14mm - 25mm... | Class II | Waldemar Link GmbH & Co. KG (Mfg Site) |
| Jul 3, 2023 | LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 18 - Indicated for p... | Increased force may be required to remove the LINK MP Monoblock trial hip stem (Sizes 14mm - 25mm... | Class II | Waldemar Link GmbH & Co. KG (Mfg Site) |
| Jul 3, 2023 | LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 21 - Indicated for p... | Increased force may be required to remove the LINK MP Monoblock trial hip stem (Sizes 14mm - 25mm... | Class II | Waldemar Link GmbH & Co. KG (Mfg Site) |
| Jul 3, 2023 | LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 19-Indicated for pat... | Increased force may be required to remove the LINK MP Monoblock trial hip stem (Sizes 14mm - 25mm... | Class II | Waldemar Link GmbH & Co. KG (Mfg Site) |
| Jul 3, 2023 | LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 16 - Indicated for p... | Increased force may be required to remove the LINK MP Monoblock trial hip stem (Sizes 14mm - 25mm... | Class II | Waldemar Link GmbH & Co. KG (Mfg Site) |
| Jul 3, 2023 | LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 15 - Indicated for p... | Increased force may be required to remove the LINK MP Monoblock trial hip stem (Sizes 14mm - 25mm... | Class II | Waldemar Link GmbH & Co. KG (Mfg Site) |
| Jul 3, 2023 | LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 22 - Indicated for p... | Increased force may be required to remove the LINK MP Monoblock trial hip stem (Sizes 14mm - 25mm... | Class II | Waldemar Link GmbH & Co. KG (Mfg Site) |
| Jul 3, 2023 | LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 14-Indicated for pat... | Increased force may be required to remove the LINK MP Monoblock trial hip stem (Sizes 14mm - 25mm... | Class II | Waldemar Link GmbH & Co. KG (Mfg Site) |
| Jul 3, 2023 | LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 25 - Indicated for p... | Increased force may be required to remove the LINK MP Monoblock trial hip stem (Sizes 14mm - 25mm... | Class II | Waldemar Link GmbH & Co. KG (Mfg Site) |
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.