Browse Device Recalls

2,115 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,115 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 2,115 FDA device recalls in N/A.

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DateProductReasonClassFirm
Sep 27, 2018 ORTHOFIX Catalogue Number: ref: 99-92503, PREFIX II DIAPHYSEAL COMPLETE KIT ... As a result of complaint investigations it was determined that batches of drill bits have a geome... Class II Orthofix Srl
Sep 27, 2018 ORTHOFIX Catalogue Number: ref: 99-93504, ELBOW STERILE KIT, UDI: (01)18054... As a result of complaint investigations it was determined that batches of drill bits have a geome... Class II Orthofix Srl
Sep 27, 2018 ORTHOFIX Catalogue Number: ref: 99-36501, RADIOLUCENT WRIST FIXATOR KIT COM... As a result of complaint investigations it was determined that batches of drill bits have a geome... Class II Orthofix Srl
Sep 27, 2018 ORTHOFIX Catalogue Number: ref 11007, drill bit diameter 4.8 MM LENGTH 280 MM... As a result of complaint investigations it was determined that batches of drill bits have a geome... Class II Orthofix Srl
Sep 27, 2018 ORTHOFIX Catalogue Number: ref: 99-92504, PREFIX II ANKLE COMPLETE KIT STERI... As a result of complaint investigations it was determined that batches of drill bits have a geome... Class II Orthofix Srl
Sep 27, 2018 ORTHOFIX Catalogue Number: ref: 99-93502, LOWER LIMB DIAPHYSEAL STERILE KIT... As a result of complaint investigations it was determined that batches of drill bits have a geome... Class II Orthofix Srl
Sep 27, 2018 ORTHOFIX Catalogue Number: ref: 99-93502US, TIBIA FEMUR DIAPHYSEAL STERILE KI... As a result of complaint investigations it was determined that batches of drill bits have a geome... Class II Orthofix Srl
Sep 27, 2018 ORTHOFIX Catalogue Number: ref: 99-91647UE, UE XCALIBER ANKLE COMPLETE KIT, R... As a result of complaint investigations it was determined that batches of drill bits have a geome... Class II Orthofix Srl
Sep 27, 2018 ORTHOFIX Catalogue Number: ref 1-1100201,DRILL BIT Diameter .4,8 MM L.240 MM ... As a result of complaint investigations it was determined that batches of drill bits have a geome... Class II Orthofix Srl
Sep 27, 2018 ORTHOFIX Catalogue Number: ref: 99-93503US, ANKLE TRANSFIX PIN STERILE KIT,... As a result of complaint investigations it was determined that batches of drill bits have a geome... Class II Orthofix Srl
Sep 27, 2018 ORTHOFIX Catalogue Number: ref 1-1100101,DRILL BIT Diameter 8 MM L.180 MM TIN... As a result of complaint investigations it was determined that batches of drill bits have a geome... Class II Orthofix Srl
Sep 27, 2018 ORTHOFIX Catalogue Number: ref 1100201, drill bit diameter 4.8 MM LENGTH 240 ... As a result of complaint investigations it was determined that batches of drill bits have a geome... Class II Orthofix Srl
Sep 27, 2018 ORTHOFIX Catalogue Number: ref: 99-93501JP, PELVIS STERILE KIT (STERILE GAMMA... As a result of complaint investigations it was determined that batches of drill bits have a geome... Class II Orthofix Srl
Sep 27, 2018 ORTHOFIX Catalogue Number: ref 1100301, drill bit diameter 3.2 MM LENGTH 200 ... As a result of complaint investigations it was determined that batches of drill bits have a geome... Class II Orthofix Srl
Sep 27, 2018 ORTHOFIX Catalogue Number: ref 1-1300301,DRILL BIT D.3,2 MM L.140 MM TIN COAT... As a result of complaint investigations it was determined that batches of drill bits have a geome... Class II Orthofix Srl
Sep 27, 2018 ORTHOFIX Catalogue Number: ref: 99-93501, PELVIS STERILE KIT, RX ONLY, UDI: ... As a result of complaint investigations it was determined that batches of drill bits have a geome... Class II Orthofix Srl
Sep 27, 2018 ORTHOFIX Catalogue Number: ref:99-93503 , ANKLE STERILE KIT, UDI: (01)1803... As a result of complaint investigations it was determined that batches of drill bits have a geome... Class II Orthofix Srl
Sep 27, 2018 ORTHOFIX Catalogue Number: ref: 99-93502JP, LOWER LIMB DIAPHYSEAL STERILE KIT... As a result of complaint investigations it was determined that batches of drill bits have a geome... Class II Orthofix Srl
Sep 27, 2018 ORTHOFIX Catalogue Number: ref: 99-92502, PREFIX II DIAPHYSEAL COMPLETE KIT... As a result of complaint investigations it was determined that batches of drill bits have a geome... Class II Orthofix Srl
Sep 27, 2018 ORTHOFIX Catalogue Number: ref 13550, drill bit diameter 2.7 MM LENGTH 127 MM... As a result of complaint investigations it was determined that batches of drill bits have a geome... Class II Orthofix Srl
Sep 27, 2018 ORTHOFIX Catalogue Number: ref 1-1355001, DRILL BIT D.2,7 MM L.127 MM TIN COA... As a result of complaint investigations it was determined that batches of drill bits have a geome... Class II Orthofix Srl
Sep 27, 2018 ORTHOFIX Catalogue Number: ref: 99-93601, GALAXY WRIST STERILE KIT, UDI: (01... As a result of complaint investigations it was determined that batches of drill bits have a geome... Class II Orthofix Srl
Sep 27, 2018 ORTHOFIX Catalogue Number: ref 1100101, drill bit diameter 4.8 MM LENGTH 180 ... As a result of complaint investigations it was determined that batches of drill bits have a geome... Class II Orthofix Srl
Sep 27, 2018 ORTHOFIX Catalogue Number: ref 1355001, drill bit diameter 2.7 MM LENGTH 127M... As a result of complaint investigations it was determined that batches of drill bits have a geome... Class II Orthofix Srl
Sep 27, 2018 ORTHOFIX Catalogue Number: ref: 99-91600UE, UE XCALIBER METADIAPHYSEAL COMPL... As a result of complaint investigations it was determined that batches of drill bits have a geome... Class II Orthofix Srl
Sep 27, 2018 ORTHOFIX Catalogue Number: ref: 99-92501, PREFIX II DIAPHYSEAL COMPLETE KIT S... As a result of complaint investigations it was determined that batches of drill bits have a geome... Class II Orthofix Srl
Sep 27, 2018 ORTHOFIX Catalogue Number: ref 1-1100701,DRILL BIT D.4,8 MM L.280 MM TIN COAT... As a result of complaint investigations it was determined that batches of drill bits have a geome... Class II Orthofix Srl
Sep 27, 2018 ORTHOFIX Catalogue Number: ref 1100701, drill bit diameter 4.8 MM LENGTH 280M... As a result of complaint investigations it was determined that batches of drill bits have a geome... Class II Orthofix Srl
Sep 24, 2018 PerkinElmer QSight 210 MD Mass Spectrometer Simplicity 3Q MD v1.0 with Hot Fi... Under certain conditions when using PerkinElmer QSight 210 MD mass spectrometer with Simplicity 3... Class II PerkinElmer Health Sciences Canada, Inc.
Sep 21, 2018 RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6 and RayStation 7, ... Robust optimization for plans using beam set + background dose is not supported in RayStation 4.5... Class II RAYSEARCH LABORATORIES AB
Sep 20, 2018 Single-Use Biopsy Forceps, JUMBO ALLIGATOR,3.2mm, REF Catalog No. NBF13-0113... Single-Use Biopsy Forceps box contains incorrect product, instead it contains some Grasping Force... Class II Micro-Tech (Nanjing) Co., Ltd.
Sep 19, 2018 Philips DigitalDiagnost software 4.1.x and 4.2.x, A Stationary X-ray System ... Stitching run on SkyPlate detector interrupted intermittently; Stitching with SkyPlate aborts af... Class II Philips Medical Systems Gmbh, DMC
Sep 17, 2018 NucliSENS¿ Magnetic Extraction Reagents Data loggers showed that one shipment to the United States experienced low temperatures that may ... Class II BioMerieux SA
Sep 7, 2018 V-Twin, Catalog # 6002-800, UDI: 03661540600180 - Product Usage: An in vitro ... The action is being initiated because the cooling indicator board was improperly installed. This... Class II Vital Scientific N.V.
Sep 6, 2018 Heating Profile PRISMAFLO II blood return warmer for Prismaflex Product ... PRISMAFLO II and PRISMAFLO II S Heating Profile only and not the Control Unit, damage may result ... Class II Stihler Electronic Gmbh
Sep 6, 2018 Heating Profile PRISMAFLO II S blood return warmer for Prismaflex Product C... PRISMAFLO II and PRISMAFLO II S Heating Profile only and not the Control Unit, damage may result ... Class II Stihler Electronic Gmbh
Sep 6, 2018 Heating Profile PRISMAFLO II S blood return warmer for Prismaflex Product... PRISMAFLO II and PRISMAFLO II S Heating Profile only and not the Control Unit, damage may result ... Class II Stihler Electronic Gmbh
Sep 5, 2018 Thoratec CentriMag Motor, Model: 102956, a component of the Thoratec CentriMa... Reports of circulatory support system motor stopping. Motor stop can be attributed to a break of ... Class II Thoratec Switzerland GMBH
Sep 4, 2018 Neuro Omega System, incorporating HaGuide software. For neurological and n... If cables are improperly connected, current may reach high charge density, causing tissue harm. Class I Alpha Omega Engineering
Aug 28, 2018 Hoffman LRF Hexapod Strut, Extra Short 89mm-109mm, Model Number 4935-0-010. P... The press fit connection of the Angular Sleeve and pin of the U-Joint and Click Lock did not meet... Class II Stryker GmbH
Aug 28, 2018 Hoffman LRF Hexapod Strut, Extra Short 131mm-191mm, Model Number 4935-0-030. ... The press fit connection of the Angular Sleeve and pin of the U-Joint and Click Lock did not meet... Class II Stryker GmbH
Aug 28, 2018 Hoffman LRF Hexapod Strut, Extra Short 105mm-139mm, Model Number 4935-0-020. ... The press fit connection of the Angular Sleeve and pin of the U-Joint and Click Lock did not meet... Class II Stryker GmbH
Aug 28, 2018 Hoffman LRF Hexapod Strut, Extra Short 183mm-295mm, Model Number 4935-0-040. ... The press fit connection of the Angular Sleeve and pin of the U-Joint and Click Lock did not meet... Class II Stryker GmbH
Aug 24, 2018 FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2) (same product... The firm has identified customer sites where there are modules on which the safety pacemaker labe... Class II Inpeco S.A.
Aug 24, 2018 Disposable Insulin Syringe 0.3mL in 3 different sizes 29Gx1/2, 30Gx5/16, and ... Defect consists of a small crack in the top end of the barrel near the needle. Class II ShinChang Medical Co., Ltd.
Aug 20, 2018 fMRI Hardware System VisualSystem allows video signals from the stimulus pr... Complaints of this version of the power supply unit (LPS) (1.0 and 1.1) being dragged into the ma... Class II NordicNeuroLab AS
Aug 15, 2018 Permobil powered wheelchairs, Model Numbers: (a) M300 PS, (b) C300 PS, (c) C... This correction decision has been made because of a potential failure of one or both backrest bar... Class II Permobil, Ab
Aug 14, 2018 TECOTHERM NEO, 100-130/200-240 VAC, 50-60 Hz/ max. 350VA, Class I, Schutzklas... The action is being initiated due to potential installation of faulty peltier-elements within the... Class II Tec Com Gmbh
Aug 9, 2018 Ambu Aura40 Standard, Reusable Laryngeal Mask Catalog Number: 340300000 Ambu Aura40 Standard, Reusable Laryngeal Mask packaged in a pouch marked AuraStraight Silicone, ... Class II Besmed Health Business Corporation
Aug 1, 2018 sterEOS workstation 3D projections may be incorrect when the pair of images used is a secondary capture generated fr... Class II EOS Imaging

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.