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Browse Device Recalls

3,133 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,133 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 3,133 FDA device recalls.

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DateProductReasonClassFirm
Jul 28, 2021 Corin Trinity-i, diameter 50mm Taper Size 3, Non-Occluded Ti Plasma Shell, RE... The packaging system on the devices have potential physical and water damage resulting in damage ... Class II Corin Ltd
Jul 28, 2021 Corin Unity Knee Augments, Size 5, 6 & 7 / 10mm Thick, Femoral Posterior Augm... The packaging system on the devices have potential physical and water damage resulting in damage ... Class II Corin Ltd
Jul 28, 2021 Corin Unity Knee Patella, Size 3 / 8.5mm, Centered Dome 3 PEG-UHMWPE, REF 112... The packaging system on the devices have potential physical and water damage resulting in damage ... Class II Corin Ltd
Jul 28, 2021 Corin TriFit TS, Size 8, Standard Tapered Stem, REF 694.0008, Sterile. The packaging system on the devices have potential physical and water damage resulting in damage ... Class II Corin Ltd
Jul 28, 2021 Corin MetaFix Hip Stem, Size 1, Short Neck, 135 degrees, Collared Hip Stem, R... The packaging system on the devices have potential physical and water damage resulting in damage ... Class II Corin Ltd
Jul 28, 2021 Corin BIOLOX Delta Mod Head, diameter 28mm Medium 0mm, 12/14 Taper, REF 104.2... The packaging system on the devices have potential physical and water damage resulting in damage ... Class II Corin Ltd
Jul 28, 2021 Corin Unity Knee CS Insert, Size 5 / 9.0mm, Fixed Condylar Stabilised - UHMWP... The packaging system on the devices have potential physical and water damage resulting in damage ... Class II Corin Ltd
Jun 23, 2021 TIN3018 Illinois Bone Marrow Aspiration/Intraosseous Infusion Needle 18G x 79... Due to complaints received regarding incomplete/open packaging seals potentially causing product ... Class II Bard Peripheral Vascular Inc
Jun 23, 2021 EJM4011 Jamshidi Evolve" Bone Marrow Biopsy/Aspiration Needle with Specimen C... Due to complaints received regarding incomplete/open packaging seals potentially causing product ... Class II Bard Peripheral Vascular Inc
Jun 23, 2021 TJM6008 Jamshidi" Crown Bone Marrow Biopsy/Aspiration Needle with Marrow Acqu... Due to complaints received regarding incomplete/open packaging seals potentially causing product ... Class II Bard Peripheral Vascular Inc
Jun 9, 2021 Avanti¿+ Catheter Sheath Introducer - Product Usage: Is indicated for use in ... The product in the packaging is larger (both inner and outer diameter) than the labeling indicates. Class II Cordis Corporation
Jun 1, 2021 CODMAN RANEY SCALP CLIPS-Disposable cylindrical clips designed to provide hem... Packaging-pouches with wrinkles across the Tyvek side may compromise the integrity of the pouch's... Class II Integra LifeSciences Corp.
May 12, 2021 DJO Surgical EMPOWR 3D Knee Tibial Insert - e-plus, REF: 341-16-711 Left Sz. ... Packaging mixup; There is a potential that packaging identified as 12mm knee prosthesis contains ... Class II Encore Medical, LP
May 12, 2021 DJO Surgical EMPOWR 3D Knee Tibial Insert - e-plus, REF: 341-12-711, Left Sz.... Packaging mixup; There is a potential that packaging identified as 12mm knee prosthesis contains ... Class II Encore Medical, LP
May 6, 2021 ACUVUE VITA soft (hydrophilic) contact lens (spherical) for daily wear. Base... Potential that a limited number of individual contact lens packages have an incomplete packaging ... Class II Johnson & Johnson Vision Care, Inc.
Apr 21, 2021 ELUVIA Drug-Eluting Vascular Stent System - Product Usage: indicated for impr... One batch of the ELUVIATM Drug Eluting Vascular Stent System incorrect placement of some 6x40mm E... Class II Boston Scientific Corporation
Apr 8, 2021 Angio Pack REF: AMS8050A, Sterile EO, Contents:2 Glove Dermassist 7.5 PF PR ... Angio tubing included within Custom Convenience kits may contain insufficient or incomplete weld Class II Windstone Medical Packaging, Inc.
Apr 8, 2021 Angio Pack REF: AMS6908C, Sterile EO, Contents:1 Blade Scalpel # 11 SS 1 Bo... Angio tubing included within Custom Convenience kits may contain insufficient or incomplete weld Class II Windstone Medical Packaging, Inc.
Apr 6, 2021 LeverEdge Contrast Injector: 35 cc syringe with ISO 594 female luer lock - Pr... The firm received a complaint regarding particulate found in the packaging foam that could contam... Class II LeMaitre Vascular, Inc.
Mar 23, 2021 Bioseal, Chest Tube Insertion Tray, containing ChloraPREP Applicator 3 mL, RE... Pre-op skin prep component ChloraPrep included within kits may allow the growth of Aspergillus pe... Class II Bioseal Corporation
Mar 23, 2021 Bioseal, Central Line Dressing Kit, containing ChloraPREP Applicator 3 mL, RE... Pre-op skin prep component ChloraPrep included within kits may allow the growth of Aspergillus pe... Class II Bioseal Corporation
Mar 23, 2021 Bioseal, Central Line Dressing Kit, containing ChloraPREP Applicator 3 mL, RE... Pre-op skin prep component ChloraPrep included within kits may allow the growth of Aspergillus pe... Class II Bioseal Corporation
Mar 16, 2021 Medtronic Abre Venous Self-expanding Sent System, Catalog number REF AB9U1608... Incorrect size printed on the device; packaging is labeled correctly. Class II Medtronic Inc.
Mar 5, 2021 MAMBA Microcatheter. Packaged with protective sleeve over catheter, sealed i... The firm initiated a removal of certain batches of MAMBA 135 and MAMBA Flex 135 Microcatheters du... Class II Boston Scientific Corporation
Mar 5, 2021 Prodisc C - prosthesis, intervertebral disc - Product Usage: indicated in ske... Centinel Spine learned through five customer complaints that the product was missing the "UP" etc... Class II Centinel Spine, Inc.
Mar 5, 2021 Trial Cutting Guide for Triathlon Total Knee System, Triathlon PKR System, Re... The posterior condyle of the Specialty Triathlon TS Trial Cutting Guide(s), sizes 1 through 8, (L... Class II Howmedica Osteonics Corp.
Mar 5, 2021 MAMBA Flex 135 Microcatheter. Packaged with protective sleeve over catheter,... The firm initiated a removal of certain batches of MAMBA 135 and MAMBA Flex 135 Microcatheters du... Class II Boston Scientific Corporation
Feb 26, 2021 Medtronic, REF: MMT-7008D, Enlite Glucose Sensor for the following packaging:... Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neop... Class II Medtronic Inc.
Feb 26, 2021 Medtronic REF: MMT-7020C1 Guardian Sensor (3) for the following packaging: ... Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neop... Class II Medtronic Inc.
Feb 26, 2021 Medtronic REF: MMT-7008B, Enlite Glucose Sensor for the following packaging: ... Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neop... Class II Medtronic Inc.
Feb 26, 2021 Medtronic, REF: MMT-7008A, Enlite Glucose Sensor for the following packaging:... Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neopla... Class II Medtronic Inc.
Feb 26, 2021 Medtronic REF: MMT-7020C2 Guardian Sensor (3) for the following packaging: ... Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neop... Class II Medtronic Inc.
Feb 26, 2021 Medtronic REF: MMT-7020C5 Guardian Sensor (3) for the following packaging: ... Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neop... Class II Medtronic Inc.
Feb 26, 2021 Medtronic REF: MMT-7020D5 Guardian Sensor (3) for the following packaging: ... Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neop... Class II Medtronic Inc.
Feb 26, 2021 Medtronic REF: MMT-7020LA, Guardian Sensor (3) for the following packaging: ... Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neop... Class II Medtronic Inc.
Feb 26, 2021 Medtronic REF: MMT-7020C4 Guardian Sensor (3) for the following packaging: ... Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neop... Class II Medtronic Inc.
Feb 26, 2021 Medtronic REF: MMT-7020LB, Guardian Sensor (3) for the following packaging: ... Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neop... Class II Medtronic Inc.
Feb 26, 2021 Medtronic REF: MMT-7020GA, Guardian Sensor (3) for the following packaging: ... Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neop... Class II Medtronic Inc.
Feb 26, 2021 Medtronic REF: MMT-7020D4 Guardian Sensor (3) for the following packaging: ... Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neop... Class II Medtronic Inc.
Feb 26, 2021 Medtronic, REF: MMT-7008C, Enlite Glucose Sensor for the following packaging:... Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neop... Class II Medtronic Inc.
Feb 26, 2021 Medtronic REF: MMT-7020D3 Guardian Sensor (3) for the following packaging: ... Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neop... Class II Medtronic Inc.
Feb 26, 2021 Medtronic REF: MMT-7020D1 Guardian Sensor (3) for the following packaging: ... Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neop... Class II Medtronic Inc.
Feb 26, 2021 Medtronic REF: MMT-7020A, Guardian Sensor (3) for the following packaging: ... Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neop... Class II Medtronic Inc.
Feb 26, 2021 Medtronic REF: MMT-7020C3 Guardian Sensor (3) for the following packaging: ... Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neop... Class II Medtronic Inc.
Feb 26, 2021 Medtronic REF: MMT-7020D2 Guardian Sensor (3) for the following packaging: ... Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neop... Class II Medtronic Inc.
Feb 26, 2021 Medtronic REF: MMT-7020B, Guardian Sensor (3) for the following packaging: ... Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neop... Class II Medtronic Inc.
Feb 26, 2021 Medtronic REF: MMT-7020C Guardian Sensor (3) kit for the following packaging:... Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neop... Class II Medtronic Inc.
Feb 22, 2021 EPIX Therapeutics DiamondTemp Unidirectional Large Curve Ablation Catheter,... It has been identified that the catheter size on the packaging labeling does not correspond to th... Class II EPIX THERAPEUTICS, INC
Feb 22, 2021 EPIX Therapeutics DiamondTemp Unidirectional Small Curve Ablation Catheter, ... It has been identified that the catheter size on the packaging labeling does not correspond to th... Class II EPIX THERAPEUTICS, INC
Feb 22, 2021 EPIX Therapeutics DiamondTemp Bidrectional Small Curve Ablation Catheter, 7.... It has been identified that the catheter size on the packaging labeling does not correspond to th... Class II EPIX THERAPEUTICS, 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.