Browse Device Recalls
3,264 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,264 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 3,264 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Aug 20, 2021 | DuoDERM Control Gel Formula Border Dressings 15x15cm (1x5pk) | Primary packaging labeling may be incorrect. | Class II | ConvaTec, Inc |
| Aug 19, 2021 | Monoject 0.9% Sodium Chloride, Flush Prefilled Syringe, 10 mL, REF: 888157012... | Monoject 0.9% Sodium Chloride Flush Syringe Manufactured by Cardinal Health and placed into kits.... | Class I | Windstone Medical Packaging, Inc. |
| Aug 6, 2021 | TECNIS Eyhance IOLs are permanent intraocular implants intended for implantat... | Nonconforming product was distributed in error. Product was nonconforming due endotoxin levels h... | Class II | Johnson & Johnson Surgical Vision Inc |
| Aug 5, 2021 | Catalog A902416, SureStep" Foley Tray, Silicone, Urine Meter, StatLock" Stabi... | There is potential for packaging defects that may impact the sterile barrier. | Class II | C.R. Bard Inc |
| Aug 5, 2021 | Catalog A300316A, SureStep" Foley Tray, Bardex" I.C., Complete Care", Drainag... | There is potential for packaging defects that may impact the sterile barrier. | Class II | C.R. Bard Inc |
| Aug 5, 2021 | Catalog A399400A, SureStep" Foley Tray, Add-a-Foley, Complete Care", Drainage... | There is potential for packaging defects that may impact the sterile barrier. | Class II | C.R. Bard Inc |
| Aug 5, 2021 | Catalog A319516AM, SureStep" Foley Tray, Lubri-Sil" I.C., Temperature Sensing... | There is potential for packaging defects that may impact the sterile barrier. | Class II | C.R. Bard Inc |
| Aug 5, 2021 | Catalog A303416A, SureStep" Foley Tray, Lubri-Sil" I.C., Temperature Sensing ... | There is potential for packaging defects that may impact the sterile barrier. | Class II | C.R. Bard Inc |
| Aug 5, 2021 | Catalog A902916, SureStep" Foley Tray, Lubricath", Urine Meter, StatLock" Sta... | There is potential for packaging defects that may impact the sterile barrier. | Class II | C.R. Bard Inc |
| Aug 5, 2021 | Catalog A300314A, SureStep" Foley Tray, Bardex" I.C., Complete Care", Drainag... | There is potential for packaging defects that may impact the sterile barrier. | Class II | C.R. Bard Inc |
| Aug 5, 2021 | Catalog A800365, SureStep" Foley Tray, Bard LubricathTM Foley Catheter Tray | There is potential for packaging defects that may impact the sterile barrier. | Class II | C.R. Bard Inc |
| Aug 5, 2021 | Catalog A800361, SureStep" Foley Tray, Bard LubricathTM Foley Catheter Tray | There is potential for packaging defects that may impact the sterile barrier. | Class II | C.R. Bard Inc |
| Aug 5, 2021 | Catalog A943216, SureStep" Foley Tray, Lubricath", Urine Meter, StatLock" Sta... | There is potential for packaging defects that may impact the sterile barrier. | Class II | C.R. Bard Inc |
| Aug 5, 2021 | Catalog A303316A, SureStep" Foley Tray, Bardex" I.C., Complete Care", Urine M... | There is potential for packaging defects that may impact the sterile barrier. | Class II | C.R. Bard Inc |
| Aug 5, 2021 | Catalog A300318A, SureStep" Foley Tray, Bardex" I.C., Complete Care", Drainag... | There is potential for packaging defects that may impact the sterile barrier. | Class II | C.R. Bard Inc |
| Aug 5, 2021 | Catalog A303318A, SureStep" Foley Tray, Bardex" I.C., Complete Care", Urine M... | There is potential for packaging defects that may impact the sterile barrier. | Class II | C.R. Bard Inc |
| Aug 5, 2021 | Catalog A119216M, SureStep" Foley Tray, Lubri-Sil", Urine Meter, Temperature ... | There is potential for packaging defects that may impact the sterile barrier. | Class II | C.R. Bard Inc |
| Aug 5, 2021 | Catalog A800061, SureStep" Foley Tray, Bard LubricathTM Foley Catheter Tray | There is potential for packaging defects that may impact the sterile barrier. | Class II | C.R. Bard Inc |
| Aug 5, 2021 | Catalog A902616, SureStep" Foley Tray, Bardex" I.C., Lubricath", Urine Meter | There is potential for packaging defects that may impact the sterile barrier. | Class II | C.R. Bard Inc |
| Aug 5, 2021 | Catalog A897514, SureStep" Foley Tray, Silicone, Drainage Bag, StatLock" Stab... | There is potential for packaging defects that may impact the sterile barrier. | Class II | C.R. Bard Inc |
| Aug 5, 2021 | Catalog A942216, SureStep" Foley Tray, Bard LubricathTM, Urine Meter, StatLoc... | There is potential for packaging defects that may impact the sterile barrier. | Class II | C.R. Bard Inc |
| Aug 5, 2021 | Catalog A899916, SureStep" Foley Tray, Lubricath", Drainage Bag, StatLock" St... | There is potential for packaging defects that may impact the sterile barrier. | Class II | C.R. Bard Inc |
| Aug 5, 2021 | Catalog A800360, SureStep" Foley Tray, Bard LubricathTM Foley Catheter Tray | There is potential for packaging defects that may impact the sterile barrier. | Class II | C.R. Bard Inc |
| Aug 5, 2021 | Catalog A319416AM, SureStep" Foley Tray, Bardex" I.C., Complete Care", Urine ... | There is potential for packaging defects that may impact the sterile barrier. | Class II | C.R. Bard Inc |
| Aug 3, 2021 | Arc Endocuff Vision as follows: ARV110 ENDOCUFF-V M BLUE PK8, Part Number:... | Packaging seal defect may allow a breach of the package sterile barrier and result in patient inf... | Class II | Olympus Corporation of the Americas |
| Jul 29, 2021 | ECHELON Oval MRI System | There was no label on the pad packaging or notification in the user manual that the table pads c... | Class II | Hitachi Healthcare Americas Corporation |
| Jul 29, 2021 | ECHELON MRI System | There was no label on the pad packaging or notification in the user manual that the table pads c... | Class II | Hitachi Healthcare Americas Corporation |
| Jul 29, 2021 | OASIS MRI System | There was no label on the pad packaging or notification in the user manual that the table pads c... | Class II | Hitachi Healthcare Americas Corporation |
| 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 |
| 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. |
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.