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Browse Device Recalls

3,037 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,037 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 3,037 FDA device recalls.

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DateProductReasonClassFirm
Dec 22, 2021 JAGTOME RX 39-20-450-025 Material Number: M00573090 Sterility of device is compromised due to a sterile barrier breach Class II Boston Scientific Corporation
Dec 22, 2021 JAGTOME RX 39-30-260-025 Material Number: M00573100 Sterility of device is compromised due to a sterile barrier breach Class II Boston Scientific Corporation
Dec 22, 2021 DREAMTOME 44-30MM/260CM Material Number: M00584050 Sterility of device is compromised due to a sterile barrier breach Class II Boston Scientific Corporation
Dec 22, 2021 HYDRATOME RX 49-20MM/260CM Material Number: M00583000 Sterility of device is compromised due to a sterile barrier breach Class II Boston Scientific Corporation
Dec 22, 2021 JAGTOME RX 44-20-260-035 Material Number: M00573040 Sterility of device is compromised due to a sterile barrier breach Class II Boston Scientific Corporation
Dec 22, 2021 HYDRATOME RX 44-20MM/450CM Material Number: M00583060 Sterility of device is compromised due to a sterile barrier breach Class II Boston Scientific Corporation
Dec 13, 2021 RESODURA matrix onlay 10.0 cm x 12.5 cm - indicated as dural substitutes for ... Outer packaging (outer pouch) is not sealed compromising sterility and result in potential risk o... Class II Collagen Matrix, Inc.
Dec 13, 2021 DuraMatrix-Onlay Collagen Dura Substitute Membrane 4 inches x 5 inches (10.0... Outer packaging (outer pouch) is not sealed compromising sterility and result in potential risk o... Class II Collagen Matrix, Inc.
Nov 17, 2021 Malosa Core Suface Treatment Pack -Medical Corneal Kit intended to be used to... Kit packaging may have small holes compromising product sterility Class II Beaver Visitec International, Inc.
Nov 17, 2021 Malosa Core Phaco Pack 2- Medical Refractive Kit intended to be used to aid i... Kit packaging may have small holes compromising product sterility Class II Beaver Visitec International, Inc.
Nov 17, 2021 Malosa Core Phaco Pack 1-Medical Cataract Kit intended to be used to aid in c... Kit packaging may have small holes compromising product sterility Class II Beaver Visitec International, Inc.
Nov 17, 2021 Malosa Core LASIK Pack 2-Medical Refractive Kit- intended to be used to aid i... Kit packaging may have small holes compromising product sterility Class II Beaver Visitec International, Inc.
Nov 17, 2021 Malosa Core SMILE Pack 2-Beaver-Visitec- A Medical Refractive Kit intended to... Kit packaging may have small holes compromising product sterility Class II Beaver Visitec International, Inc.
Nov 17, 2021 Malosa Core SMILE Pack 1-Medical Refractive Kit intended to be used to aid in... Kit packaging may have small holes compromising product sterility Class II Beaver Visitec International, Inc.
Nov 2, 2021 RoyalSilk Non-Reinforced Surgical Gowns XXX-large, X-long SKU: 95998 Potential for open packaging seals compromising the sterility of the surgical gowns Class II Cardinal Health
Nov 2, 2021 Cardinal Health Poly-Reinforced Surgical Gowns X-large SKU: 9040 Potential for open packaging seals compromising the sterility of the surgical gowns Class II Cardinal Health
Nov 2, 2021 SmartGown Breathable Surgical Gowns with raglan sleeves X-large, X-long, A-li... Potential for open packaging seals compromising the sterility of the surgical gowns Class II Cardinal Health
Nov 2, 2021 Cardinal Health Poly-Reinforced Surgical Gowns XX-large SKU: 9070 Potential for open packaging seals compromising the sterility of the surgical gowns Class II Cardinal Health
Nov 2, 2021 RoyalSilk Non-Reinforced Surgical Gowns XX-large SKU: 9578 Potential for open packaging seals compromising the sterility of the surgical gowns Class II Cardinal Health
Nov 2, 2021 SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns-Large SKU: 9011 Potential for open packaging seals compromising the sterility of the surgical gowns Class II Cardinal Health
Nov 2, 2021 Cardinal Health Poly-Reinforced Surgical Gowns Large SKU: 9010 Potential for open packaging seals compromising the sterility of the surgical gowns Class II Cardinal Health
Nov 2, 2021 SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns-X-Large SKU: 9041 Potential for open packaging seals compromising the sterility of the surgical gowns Class II Cardinal Health
Nov 2, 2021 SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns X-large, X-long ... Potential for open packaging seals compromising the sterility of the surgical gowns Class II Cardinal Health
Nov 2, 2021 RoyalSilk Non-Reinforced Surgical Gowns Large SKU: 9518 Potential for open packaging seals compromising the sterility of the surgical gowns Class II Cardinal Health
Nov 2, 2021 RoyalSilk Non-Reinforced Surgical Gowns X-large SKU: 9548 Potential for open packaging seals compromising the sterility of the surgical gowns Class II Cardinal Health
Sep 27, 2021 BD Syringe Tip Cap Bulk Sterile Convenience Pak-1000 units/shelf carton. Used... Holes in product packaging impacts package integrity and may compromise sterility. Class II Becton Dickinson & Company
Sep 10, 2021 FIVE S 3.5x65, Flexible Intubation Videoscope, REF: 091361-01 (1 Unit), and 0... During a regular requalification review, affected flexible intubation video endoscopes did not ac... Class II Karl Storz Endoscopy
Aug 9, 2021 DuoDERM CGF Dressing 10x10CM (1x5PK) (ICC 187660) DuoDERM Extra Thin Dressin... There is a potential for open seals which can compromise sterility. Class II ConvaTec, Inc
Aug 5, 2021 Bone Marrow Transplantation biopsy needle Sterility assurance may be compromised. Class II M.D.L. S.r.l.
Aug 5, 2021 Aspirated Cyto-Histological Biopsy needle Sterility assurance may be compromised. Class II M.D.L. S.r.l.
Aug 5, 2021 General Manual surgical instrument Sterility assurance may be compromised. Class II M.D.L. S.r.l.
Aug 5, 2021 Mammary Nodules Localization Sterility assurance may be compromised. Class II M.D.L. S.r.l.
Aug 5, 2021 Soft Tissue Biopsy Needles Sterility assurance may be compromised. Class II M.D.L. S.r.l.
Jul 28, 2021 Corin Trinity Screw, diameter 6.5mm 35mm Length, Cancellous Bone Screw, REF 3... The packaging system on the devices have potential physical and water damage resulting in damage ... Class II Corin Ltd
Jul 28, 2021 Corin Trinity Dual Mobility, Size 4, Dual Mobility CoCr Liner, REF 321.04.540... The packaging system on the devices have potential physical and water damage resulting in damage ... Class II Corin Ltd
Jul 28, 2021 Corin Trinity Liner ECIMA, diameter 40mm Neutral Offset, Taper Size 4, REF 3... The packaging system on the devices have potential physical and water damage resulting in damage ... Class II Corin Ltd
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
Jul 23, 2021 MIVI Super 90 Guide Catheters, MIVI Mi-Axus 8F Catheters, REF MIA-9080S (80 c... There is potential for nonsterility of product due to a possible defect in the pouch seal. Class II Mivi Neuroscience Inc
Jul 23, 2021 MIVI Super 90 8F Guide Catheter, 95 cm, REF MIA-9095S-IDE, For Investigationa... There is potential for nonsterility of product due to a possible defect in the pouch seal. Class II Mivi Neuroscience Inc
Jul 9, 2021 COPAN FLOQSwabs, STERILE.EO, for drawing clinical samples. CE0123, for the ... A sterility assurance level of 10-6 cannot be guaranteed due to intentional fraud and data integr... Class II Copan Italia
Jun 21, 2021 DELTAVEN Y, Safety I.V. Catheter in Pur with closed system a) REF 3832072 b... Problems related to the sterilization of the medical devices; possible missing sterility of the m... Class II Delta Med SpA
Jun 21, 2021 NEO DELTA SELFSAFE PUR 1, I.V. Catheter, REF 3718122 Problems related to the sterilization of the medical devices; possible missing sterility of the m... Class II Delta Med SpA
Jun 21, 2021 DELTAVEN FASTFLASH, Safety I.V. Catheter in Pur with closed system: a) REF 3... Problems related to the sterilization of the medical devices; possible missing sterility of the m... Class II Delta Med SpA
Jun 21, 2021 DELTAVEN Safety I.V. Catheter in Pur with closed system: a) REF 3836272 b) ... Problems related to the sterilization of the medical devices; possible missing sterility of the m... Class II Delta Med SpA

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.