Browse Device Recalls

32 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 32 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 32 FDA device recalls.

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DateProductReasonClassFirm
Dec 19, 2025 Brand Name: MicroPort Product Name: HIPTURN FEM HEAD TRIAL 36MM REUSABLE Mo... Due to products not having FDA Premarket authorization to be distributed within the United States. Class II MicroPort Orthopedics Inc.
Oct 29, 2024 EVOLUTION MP FEMORAL COMPONENT CS/CR POROUS SIZE 5 RIGHT PRIMARY, REF: EFSRP5... Femoral implant porous size 5 right primary and femoral implant non-porous size 6 left primary ha... Class II MicroPort Orthopedics Inc.
May 3, 2024 EVOLUTION¿ MP Femoral CS/CR Non-Porous Non-porous MicroPort total knee rep... One confirmed incident has been received that EFSRN4PR, lot number MP1982170, Size 4 Evolution MP... Class II MicroPort Orthopedics Inc.
Oct 28, 2022 EVOLUTION MP Tibial Bases, Size 2+ LEFT, REF ETPKN2PL, knee tibial base One confirmed incident has been received that ETPKN2PL lot 1916559, size 2 Evolution MP Tibial Ba... Class II MicroPort Orthopedics Inc.
Oct 28, 2022 EVOLUTION MP Tibial Bases, Size 7 LEFT, REF ETPKN7SL, knee tibial base One confirmed incident has been received that ETPKN2PL lot 1916559, size 2 Evolution MP Tibial Ba... Class II MicroPort Orthopedics Inc.
May 4, 2022 PROFEMUR PLASMA Z CLASSIC STEM SIZE 7 STANDARD SHORT NECK One manufacturing lot is missing the plasma-spray coating in the proximal region of the stem body. Class II MicroPort Orthopedics Inc.
Jul 31, 2020 PROFEMUR Neck Extra Long Titanium, Catalog Numbers: PHA01206, PHA01236, PHA01... MicroPort Orthopedics Inc. states that there have been reports of fractures of the long and extra... Class I MicroPort Orthopedics Inc.
Jul 31, 2020 PROFEMUR Titanium and Cobalt Chrome modular necks, Item Numbers and descripti... MicroPort Orthopedics Inc. is voluntarily recalling any existing inventory of PROFEMUR¿ Titanium ... Class II MicroPort Orthopedics Inc.
Jul 31, 2020 PROFEMUR Neck Long Titanium, Catalog Numbers: PHA01204, PHA01214, PHA01224, ... MicroPort Orthopedics Inc. states that there have been reports of fractures of the long and extra... Class I MicroPort Orthopedics Inc.
Sep 18, 2017 MicroPort Orthopedics SCHANZ SCREW SELF DRILL, SIZE 4mm, REF 20070057, STERIL... The item is being recalled due to an inadequate pouch seal. This defect has the potential to lead... Class II MicroPort Orthopedics Inc.
Nov 17, 2016 PROFEMUR(R) R RASP HANDLE, REF PPW38078, 1 EACH, NON-STERILE, MicroPort Ortho... The recall is being initiated because all broach handles in the affected lot had the same non-con... Class II MicroPort Orthopedics Inc.
Jun 30, 2016 PROFEMUR(R) MODULAR NECK, HIP FEMORAL NECK MicroPort total hip systems intend... Profemur(R) neck, Item Number PHA01222 (Short AR VV2 Ti Neck) was labeled as Item Number PHA01212... Class II MicroPort Orthopedics Inc.
Jun 21, 2016 ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA... ADVANCE(R) HA Coated tibial bases are being recalled due to a higher than expected revision rate ... Class I MicroPort Orthopedics Inc.
Jun 21, 2016 Lineage Liners: REF 70102846, REF 70202852, REF 70202852, REF 70302858, REF ... Revision rate trends from within the MicroPort Orthopedics Inc. database evaluated for the modula... Class III MicroPort Orthopedics Inc.
Jun 21, 2016 ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA... ADVANCE(R) HA Coated tibial bases are being recalled due to a higher than expected revision rate ... Class I MicroPort Orthopedics Inc.
Jun 21, 2016 Lineage Shell: REF 36693646, REF 36693848, REF 36694050, REF 36694252, REF 36... Revision rate trends from within the MicroPort Orthopedics Inc. database evaluated for the modula... Class III MicroPort Orthopedics Inc.
Jun 21, 2016 ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA... ADVANCE(R) HA Coated tibial bases are being recalled due to a higher than expected revision rate ... Class I MicroPort Orthopedics Inc.
Jun 21, 2016 Conserve Shells: REF 38021146, REF 38021148, REF 38021150, REF 38021152, REF... Revision rate trends from within the MicroPort Orthopedics Inc. database evaluated for the modula... Class III MicroPort Orthopedics Inc.
Jun 21, 2016 ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA... ADVANCE(R) HA Coated tibial bases are being recalled due to a higher than expected revision rate ... Class I MicroPort Orthopedics Inc.
Jun 21, 2016 Conserve Cups: REF 38BF3642, REF 38BF3642SP, REF 38BF3844, REF 38BF3844SP, R... Revision rate trends from within the MicroPort Orthopedics Inc. database evaluated for the modula... Class III MicroPort Orthopedics Inc.
Jun 21, 2016 ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA... ADVANCE(R) HA Coated tibial bases are being recalled due to a higher than expected revision rate ... Class I MicroPort Orthopedics Inc.
Jun 21, 2016 ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA... ADVANCE(R) HA Coated tibial bases are being recalled due to a higher than expected revision rate ... Class I MicroPort Orthopedics Inc.
Jun 21, 2016 Procotyl (Rim- Lock) Liners: REF PHA04702, REF PHA04704, REF PHA04706, REF P... Revision rate trends from within the MicroPort Orthopedics Inc. database evaluated for the modula... Class III MicroPort Orthopedics Inc.
Jun 21, 2016 ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA... ADVANCE(R) HA Coated tibial bases are being recalled due to a higher than expected revision rate ... Class I MicroPort Orthopedics Inc.
Jun 21, 2016 Cobalt Chromium Heads Transcend: 26000017, 26000018, 26000019, 26000020, 26... Revision rate trends from within the MicroPort Orthopedics Inc. database evaluated for the modula... Class III MicroPort Orthopedics Inc.
Jun 21, 2016 Dynasty Liners: REF DLCOGA28, REF DLCOGB32, REF DLCOGC36, REF DLCOGD38, REF ... Revision rate trends from within the MicroPort Orthopedics Inc. database evaluated for the modula... Class III MicroPort Orthopedics Inc.
Jun 21, 2016 ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA... ADVANCE(R) HA Coated tibial bases are being recalled due to a higher than expected revision rate ... Class I MicroPort Orthopedics Inc.
Jun 21, 2016 ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA... ADVANCE(R) HA Coated tibial bases are being recalled due to a higher than expected revision rate ... Class I MicroPort Orthopedics Inc.
Jun 21, 2016 ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA... ADVANCE(R) HA Coated tibial bases are being recalled due to a higher than expected revision rate ... Class I MicroPort Orthopedics Inc.
Jun 21, 2016 ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA... ADVANCE(R) HA Coated tibial bases are being recalled due to a higher than expected revision rate ... Class I MicroPort Orthopedics Inc.
Feb 2, 2015 EVOLUTION MP TIBIAL BASE, REF ETPKN8SR, SIZE 8 RIGHT, TYPE PRIMARY, FIT CEMEN... Some units of the EVOLUTION Tibial Base was affected by a casting tool issue which caused varying... Class II Microport Orthopedics INC.
Apr 30, 2014 PATH(R) THREAD CUP ADAPTOR, REF 2007-0013, Wright Medical Technology, Inc. Or... Difficulty removing the cup adaptor from the impaction handle during surgery Class II Microport Orthopedics 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.