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Browse Device Recalls

140 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 140 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 140 FDA device recalls.

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DateProductReasonClassFirm
Jun 11, 2024 Various Merit Medical convenience kits that contain recalled Jiangsu Shenli M... Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... Class II Merit Medical Systems, Inc.
Jun 11, 2024 Various Merit Medical convenience kits that contain recalled Jiangsu Shenli M... Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... Class II Merit Medical Systems, Inc.
Jun 11, 2024 Various Merit Medical convenience kits that contain recalled Jiangsu Shenli M... Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... Class II Merit Medical Systems, Inc.
Jun 11, 2024 Various Merit Medical convenience kits that contain recalled Jiangsu Shenli M... Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... Class II Merit Medical Systems, Inc.
Jun 11, 2024 Various Merit Medical convenience kits that contain recalled Jiangsu Shenli M... Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... Class II Merit Medical Systems, Inc.
Jun 11, 2024 Various Merit Medical convenience kits that contain recalled Jiangsu Shenli M... Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... Class II Merit Medical Systems, Inc.
Jun 11, 2024 Various Merit Medical convenience kits that contain recalled Jiangsu Shenli M... Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... Class II Merit Medical Systems, Inc.
Jun 11, 2024 Various Merit Medical convenience kits that contain recalled Jiangsu Shenli M... Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... Class II Merit Medical Systems, Inc.
Jun 11, 2024 Various Merit Medical convenience kits that contain recalled Jiangsu Shenli M... Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... Class II Merit Medical Systems, Inc.
Jun 11, 2024 Various Merit Medical convenience kits that contain recalled Jiangsu Shenli M... Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... Class II Merit Medical Systems, Inc.
Jun 11, 2024 Various Merit Medical convenience kits that contain recalled Jiangsu Shenli M... Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... Class II Merit Medical Systems, Inc.
Jun 11, 2024 Various Merit Medical convenience kits that contain recalled Jiangsu Shenli M... Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... Class II Merit Medical Systems, Inc.
May 22, 2024 Prelude Roadster Guide Sheath REF: -PG4F45S -PG4F90S -PG5F45MP -PG5F45R ... Due to older version of Instruction for Use (IFU) instructing to ensure that the value and the sh... Class II Merit Medical Systems, Inc.
Mar 14, 2024 Prelude Guide Sheath Roadster, REF PG6F45S018, 6F 0.087" (2.2 mm), 45 cm, STE... Their is a potential that sheaths labeled with .018 dilators may contain a .038 dilator. Class II Merit Medical Systems, Inc.
Mar 14, 2024 Prelude Guide Sheath Roadster, REF PG5F45S018, 5F 0.076 (1.9 mm), 45 cm, STER... Their is a potential that sheaths labeled with .018 dilators may contain a .038 dilator. Class II Merit Medical Systems, Inc.
Nov 6, 2023 Fountain, REF: IS4-135-30 and IS4-90-10, CE2797, STERILEEO, Rx ONLY The sterility of microcatheter and infusion system devices cannot be guaranteed. Class II Merit Medical Systems, Inc.
Nov 6, 2023 Merit Pursue Microcatheter, REF: 28HC17130SN, 28HC17150ST/A, 29HC2015045/A, 2... The sterility of microcatheter and infusion system devices cannot be guaranteed. Class II Merit Medical Systems, Inc.
Nov 6, 2023 Merit Maestro Microcatheter, Reference Numbers: 28MC2111045/B, 28MC21110ST/... The sterility of microcatheter and infusion system devices cannot be guaranteed. Class II Merit Medical Systems, Inc.
Apr 22, 2023 Aspira Peritoneal Drainage Catheter Insertion Tray 15.5F, REF 4992209 Version... There is a potential that valve assemblies will not open. preventing fluid from draining. Class II Merit Medical Systems, Inc.
Apr 22, 2023 Aspira Valve Repair Kit, REF: 4992306 Version A, Sterile EO, Rx Only There is a potential that valve assemblies will not open. preventing fluid from draining. Class II Merit Medical Systems, Inc.
Apr 22, 2023 Aspira Drainage Catheter Insertion Tray 15.5F, REF: ASP-11-5, STERILE EO, Rx ... There is a potential that valve assemblies will not open. preventing fluid from draining. Class II Merit Medical Systems, Inc.
Apr 22, 2023 Aspira Peritoneal Drainage Catheter Insertion Tray 15.5F, REF 4992206 Version... There is a potential that valve assemblies will not open. preventing fluid from draining. Class II Merit Medical Systems, Inc.
Apr 22, 2023 Aspira Peritoneal Drainage Catheter Insertion Tray 15.5F, REF 4992207 Version... There is a potential that valve assemblies will not open. preventing fluid from draining. Class II Merit Medical Systems, Inc.
Apr 22, 2023 Aspira Pleural Drainage Catheter Insertion Tray 15.5F, REF 4992508, Version A... There is a potential that valve assemblies will not open. preventing fluid from draining. Class II Merit Medical Systems, Inc.
Apr 22, 2023 Aspira Pleural Drainage Catheter Insertion Tray 15.5F, REF 4992507, Version A... There is a potential that valve assemblies will not open. preventing fluid from draining. Class II Merit Medical Systems, Inc.
Apr 22, 2023 Aspira Peritoneal Drainage Catheter Insertion Tray 15.5F, REF 4992208 Version... There is a potential that valve assemblies will not open. preventing fluid from draining. Class II Merit Medical Systems, Inc.
Apr 22, 2023 Aspira Drainage Catheter Insertion Tray 15.5F, REF: ASP-15-5, STERILE EO, Rx ... There is a potential that valve assemblies will not open. preventing fluid from draining. Class II Merit Medical Systems, Inc.
Apr 22, 2023 Aspira Pleural Drainage Catheter Insertion Tray 15.5F, REF 4992506, Version A... There is a potential that valve assemblies will not open. preventing fluid from draining. Class II Merit Medical Systems, Inc.
Apr 22, 2023 Aspira Drainage Catheter Insertion Tray 15.5F, REF: ASP-15, STERILE EO, Rx On... There is a potential that valve assemblies will not open. preventing fluid from draining. Class II Merit Medical Systems, Inc.
Apr 22, 2023 Aspira Drainage Catheter Insertion Tray 15.5F, REF: ASP-11, STERILE EO, Rx On... There is a potential that valve assemblies will not open. preventing fluid from draining. Class II Merit Medical Systems, Inc.
Apr 22, 2023 Aspira Pleural Drainage Catheter Insertion Tray 15.5F, REF: 4992509, Version ... There is a potential that valve assemblies will not open. preventing fluid from draining. Class II Merit Medical Systems, Inc.
Mar 21, 2023 COBRA-OS, custom Sheath Introducer Kit, 4 French, REF: E01P2, Sterile EO, Sin... Custom sheath Introducer contains incorrect needle size Class II Merit Medical Systems, Inc.
Feb 15, 2023 Flex-Neck Catheter External Repair Kit REF CE-1400 LOT CE-1400/A Product that was built for design verification testing was inadvertently distributed to customers. Class II Merit Medical Systems, Inc.
Aug 3, 2022 CorVocet Biopsy System, Catalog Code: CORA1410/B, CORA1410S/B, CORA1415/B, CO... Biopsy Systems have components that are misaligned due to an issue with the manufacturing assembl... Class II Merit Medical Systems, Inc.
Aug 3, 2022 CorVocet Biopsy System/Catalog Code: CORA1610/B, CORA1610S/B, CORA1615/B, COR... Biopsy Systems have components that are misaligned due to an issue with the manufacturing assembl... Class II Merit Medical Systems, Inc.
Mar 1, 2022 Access-9 Large Bore Hemostasis Valves, Catalog Code: 580775001, IN8112/C, K05... A design change made to a hemostasis valve to improve manufacturability caused an internal gap be... Class II Merit Medical Systems, Inc.
Mar 1, 2022 AccessPLUS Large Bore Hemostasis Valves, Catalog Code: 580758001, 580774001, ... A design change made to a hemostasis valve to improve manufacturability caused an internal gap be... Class II Merit Medical Systems, Inc.
Jul 21, 2021 MERITMEDICAL Prelude Short Sheath Introducer, REF: PSS-6F-4-018MT, 21G 6F(2.0... There is a potential that a package sheath contains an incorrect dilator. Class II Merit Medical Systems, Inc.
Jun 30, 2021 Prelude SNAP Splittable Sheath Introducer, REF: PLS-1007, size 7F, Standard L... There is a potential that 7F sheaths are packaged as 10F sheaths. Class II Merit Medical Systems, Inc.
Jun 30, 2021 Prelude SNAP Splittable Sheath Introducer, REF: PLSX -1010, size 10F, Standar... There is a potential that 7F sheaths are packaged as 10F sheaths. Class II Merit Medical Systems, Inc.
Jun 10, 2021 basixALPHA Inflation Device 30 atm/bar 20 mL - Product Usage: Used to inflate... Due to a design issue, inflation syringe handle separating from the inflation device when handle ... Class II Merit Medical Systems, Inc.
Jan 19, 2021 HeartSpan Transseptal Needles Catalog No. FND-019-01, Lot No. E1913644 consis... The labeled needle tip curvature of specific lots of transseptal needles may not match the actual... Class II Merit Medical Systems, Inc.
Jan 19, 2021 Heartspan Transseptal Needles, Catalog No. FND-019-02, Lot No. E1913645 consi... The labeled needle tip curvature of specific lots of transseptal needles may not match the actual... Class II Merit Medical Systems, Inc.
Nov 10, 2020 Product Code: K12T-02871, Revision A, Custom Procedure Kit, Embolization Kit ... Angiography/Angioplasty custom kits contain header bags which may not be fully sealed, resulting ... Class II Merit Medical Systems, Inc.
Nov 10, 2020 Custom Procedure Kit, Cardiac Cath Pack, Product Code: K12T-10996 Rev. B, Ste... Angiography/Angioplasty custom kits contain header bags which may not be fully sealed, resulting ... Class II Merit Medical Systems, Inc.
Nov 10, 2020 Product Code: K05T-02533, Custom Inflation Kit, Custom K05 Sterile EO, Rx Onl... Angiography/Angioplasty custom kits contain header bags which may not be fully sealed, resulting ... Class II Merit Medical Systems, Inc.
Sep 16, 2020 Merit Medical Cultura Collection and Transport System, 3 mL Viral Transport M... The flocked tip of the 100mm swab may break off in the nasophyaryngeal cavity during sample colle... Class II Merit Medical Systems, Inc.
Sep 16, 2020 Merit Medical Cultura Collection and Transport System, Ref CFTS100, Single Us... The flocked tip of the 100mm swab may break off in the nasophyaryngeal cavity during sample colle... Class II Merit Medical Systems, Inc.
Sep 16, 2020 MeritMedical Cultura Flex Swab, Sterile Flocked Collection Device, Ref C100F,... The flocked tip of the 100mm swab may break off in the nasophyaryngeal cavity during sample colle... Class II Merit Medical Systems, Inc.
Mar 11, 2020 PreludeSYNC DISTAL Radial Compression Devices, SDRB-REG-LT, SDRB-REG-RT During the sterilization of radial compression devices, some of the inflatable balloons may break... Class II Merit Medical Systems, 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.