Browse Device Recalls

3,029 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,029 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 3,029 FDA device recalls in 2016.

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DateProductReasonClassFirm
Jun 21, 2016 Ingenuity Flex, model # 728317; Intended to produce cross- sectional images ... Supplier design change contributed to a thinner plastic which was used as part of the cover on th... Class II Philips Medical Systems (Cleveland) 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 MODIFIED LINEAR STANDARD/LATERAL NECK TRIALS WITH SPRING SIDES REF S-200635 a... Reported failure of the instrument. The retaining ring component of a neck trial became disassem... Class II Encore Medical, Lp
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 lnvacare Precise Rx Pediatric Flowmeter Model Number: IRCPF16. Packed one per... The rear gradation scale was screen printed upside down on the flowmeter gauge. Class II Invacare Corporation
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 Ingenuity Core, model # 728326; Intended to produce cross- sectional images ... Supplier design change contributed to a thinner plastic which was used as part of the cover on th... Class II Philips Medical Systems (Cleveland) 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 Ingenuity Core 128, model #728323; Intended to produce cross- sectional imag... Supplier design change contributed to a thinner plastic which was used as part of the cover on th... Class II Philips Medical Systems (Cleveland) Inc
Jun 21, 2016 Invacare Precise Rx Pediatric Flowmeter Model Number: IRCPF16 AW. Packed one ... The rear gradation scale was screen printed upside down on the flowmeter gauge. Class II Invacare Corporation
Jun 21, 2016 Brilliance CT Big Bore Oncology, model #728243; Intended to produce cross- se... Supplier design change contributed to a thinner plastic which was used as part of the cover on th... Class II Philips Medical Systems (Cleveland) Inc
Jun 21, 2016 Brilliance iCT model #728306; Intended to produce cross- sectional images of... Supplier design change contributed to a thinner plastic which was used as part of the cover on th... Class II Philips Medical Systems (Cleveland) Inc
Jun 21, 2016 2 over 2 Elevating Monitor Suspension - Omega Medical Imaging, LLC Elevating... Elevating Monitor Suspension separated from the lifting column bracket Class II Omega Medical Imaging, 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.
Jun 20, 2016 Axiom REG implants Sterile The Axiom REG implants are used as artificial r... Following a FDA inspection showing that the firm failed to validate the design and process of its... Class II Anthogyr
Jun 20, 2016 Axiom 2.8 implants Sterile The Axiom REG implants are used as artificial ... Following a FDA inspection showing that the firm failed to validate the design and process of its... Class II Anthogyr
Jun 20, 2016 Image1 SPIES X-LINK Camera Control Unit (CCU), Product Model No. TC301, when ... Potential electrical interference issue when the Image1 SPIES X-LINK and Image1 SPIES D1 camera h... Class II Karl Storz Endoscopy
Jun 20, 2016 PoleStar system (N20 / N30) Warning Lamps Control Box, Warning Lamps Control ... Medtronic Navigation is recalling certain components of the PoleStar system (N20 / N30) because o... Class II Medtronic Navigation
Jun 17, 2016 Achillon Minimally Invasive Device for Achilles Tendon Rupture Treatment The... Data from internal studies suggests there may be a potential that the secondary package seal inte... Class II Integra LifeSciences Corp.
Jun 17, 2016 3T 16ch Flex SPEEDER Coil, Large, NeoCoil Part Number NC046200, Toshiba Medic... There is a potential for higher than specified surface temperatures involving the 3T 16ch Flex SP... Class II NeoCoil, LLC
Jun 17, 2016 Syva¿ EMIT¿ 2000 Theophylline - Catalog # 4P019UL /SMN#10445324 is a homogene... Siemens Healthcare Diagnostics has confirmed the Syva¿ EMIT¿ 2000 Theophylline reagent lot G3, wh... Class II Siemens Healthcare Diagnostics, Inc.
Jun 17, 2016 MOSAIQ Oncology Information System It is possible that that the selected Plan-of-the Day could be accidently changed by scrolling th... Class II Elekta, Inc.
Jun 17, 2016 ADVIA¿ Chemistry (Syva Onboard) Theophylline_2 (THEO_2) Reagent is for in vit... Siemens Healthcare Diagnostics has confirmed the Syva¿ EMIT¿ 2000 Theophylline reagent lot G3, wh... Class II Siemens Healthcare Diagnostics, Inc.
Jun 16, 2016 5.0mm Round Fluted Bur, Super Long Stryker Instruments initiated a voluntary recall of specific lots of Round Fluted Burs, due to ta... Class II Stryker Instruments Div. of Stryker Corporation
Jun 16, 2016 AB SCIEX Triple Quad 4500MD LC/MS/MS System. Mass Spectrometer for In-Vitro... MultiQuant MD software where under certain conditions a user can be presented with incorrect qua... Class II Ab Sciex
Jun 16, 2016 Medtronic, Temporary Pacing Lead System, Model 6416, Sterile EO. Product Cat... This Pacing Lead System does not comply with Section 8.5.2.3 of IEC 60601-1, and corresponding pr... Class II Medtronic Inc., Cardiac Rhythm and Heart Failure
Jun 16, 2016 AB SCIEX 3200MD QTRAP¿ LC/MS/MS System Mass Spectrometer for In-Vitro Diagn... MultiQuant MD software where under certain conditions a user can be presented with incorrect qua... Class II Ab Sciex
Jun 16, 2016 AB SCIEX QTRAP¿ 4500MD LC/MS/MS System Mass Spectrometer for In-Vitro Diagn... MultiQuant MD software where under certain conditions a user can be presented with incorrect qua... Class II Ab Sciex
Jun 16, 2016 AB Sciex API 3200MD" LC/MS/MS System. In-Vitro Diagnostic Instrument Part Nu... MultiQuant MD software where under certain conditions a user can be presented with incorrect qua... Class II Ab Sciex
Jun 16, 2016 Coolife Sinergy Radiofrequency Kit, SIK-17-75-4 (109971504); Kit used in conj... Mismatch between the length of the RF electrode (probe) and the cannula (introducer), Class II Halyard Health, Inc
Jun 16, 2016 6.0mm Round Fluted Bur, Super Long Stryker Instruments initiated a voluntary recall of specific lots of Round Fluted Burs, due to ta... Class II Stryker Instruments Div. of Stryker Corporation
Jun 15, 2016 EVA Floor Lifts, Model Numbers: 400, 450, 600 After feedback from customers and internal suspicion, Handicare has become aware that abnormal us... Class II Handicare AB
Jun 15, 2016 Pacemakers: Accolade MRI DR Model L311; Accolade MRI DR EL Model L331; and E... Five Accolate MRI and Essentio MRI DR pulse generators with an alternate MICS module configuratio... Class II Boston Scientific Corporation
Jun 15, 2016 Smith and Nephew TWINFIX QUICK-T Knot Pusher Suture Cutter; Part Number: 7209... The device could be subject to breaches of its sterile packaging. Class II Smith & Nephew, Inc.
Jun 15, 2016 A7 Anesthesia Delivery System, a device used to administer to a patient, cont... Potential for a leak to occur on the back-up O2 and air e-size cylinder yokes on the A7 Anesthesi... Class II Mindray DS USA, Inc. dba Mindray North America
Jun 15, 2016 Anspach G1 High Speed Electric Handpiece Air Cooled (eG1A) Use for cutting... The graphics at the attachment interface indicating locked and unlocked position are reversed. Class II The Anspach Effort, Inc.
Jun 14, 2016 T090-000V 90" 20 Drop IV Admin Set w/ Needlefree Y-Site. Packaged in a Tyvek ... WalkMed Infusion, LLC Announces a Voluntary Field Action of Multiple Triton Administration Sets D... Class II WalkMed Infusion, LLC

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.