Browse Device Recalls

2,609 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,609 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 2,609 FDA device recalls in 2023.

Clear
DateProductReasonClassFirm
Mar 6, 2023 VASOVIEW HEMOPRO, OUS, Endoscopic Vessel Harvesting System, Model Number C-VH... Some batches of product were not sterilized to their minimum sterilization specification. Class II Maquet Cardiovascular, LLC
Mar 6, 2023 VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System, Model Number C-VH-4000 Some batches of product were not sterilized to their minimum sterilization specification. Class II Maquet Cardiovascular, LLC
Mar 3, 2023 CombiDiagnost R90 R1.1 Philips has identified a compliance issue where ProxiDiagnost N90 R.1.0, CombiDiagnost R90 R.1.0 ... Class II Philips North America
Mar 3, 2023 HydroPICC 4Fr Single Lumen Catheter, Maximal Barrier Kit, Model Number 80001004 The catheter packaged with specific lots of the HydroPICC Kits and HydroMID Kits have a shorter e... Class II Access Vascular, Inc
Mar 3, 2023 CombiDiagnost R90 R.1.0 Philips has identified a compliance issue where ProxiDiagnost N90 R.1.0, CombiDiagnost R90 R.1.0 ... Class II Philips North America
Mar 3, 2023 ProxiDiagnost N90 R.1.0 Philips has identified a compliance issue where ProxiDiagnost N90 R.1.0, CombiDiagnost R90 R.1.0 ... Class II Philips North America
Mar 2, 2023 NanoKnife 5-Probe Procedure Pack 15 cm - Activation. Indicated for the surgic... Not programmed in accordance with specification. The programming affects the RFID function and do... Class II Angiodynamics, Inc.
Mar 2, 2023 Cirq Arm System 2.0 Risk of mechanical instability due to potential manufacturing error of the device Class II Brainlab AG
Mar 2, 2023 SafeLight Fiber Optic Cable: Clear, 5MM X 10FT 3.05M, REF: 0233-050-100; Gray... Fiber optic cables assembled with not enough epoxy on the proximal end, creating light output iss... Class II Stryker Corporation
Mar 2, 2023 Centurion CirClamp with 1.3cm Bell & Insert Reprocessed, Reorder #CR230K, Ste... The CirClamp subassembly found in the kit was the incorrect size. Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 1, 2023 Atrium Pneumostat Chest Drain Valve, Part Number 16100 The Instructions for Use (IFU) for the Pneumostat Chest Drain Valve and the Express Mini 500 Dry ... Class II Atrium Medical Corporation
Mar 1, 2023 Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 18X4,1BLA,... Not able to achieve desired pressure and not holding pressure result from two different causes wh... Class II Stryker Corporation
Mar 1, 2023 Titan NB Infra Zero Ang 16cm, Catalog Number EN88162400; inflatable penile Pr... A decrease in wall thickness has the potential for a premature pump failure, compared to a pump w... Class II Coloplast Manufacturing US, LLC
Mar 1, 2023 Titan Touch Pump, Catalog Numbers 5177502400; inflatable penile Prosthesis A decrease in wall thickness has the potential for a premature pump failure, compared to a pump w... Class II Coloplast Manufacturing US, LLC
Mar 1, 2023 Titan 0-Deg Scrotal 18 Cm, Catalog Number ES89182400; inflatable penile Prost... A decrease in wall thickness has the potential for a premature pump failure, compared to a pump w... Class II Coloplast Manufacturing US, LLC
Mar 1, 2023 Titan Touch NB Infr Zero 18cm, Catalog Number EN28182400; inflatable penile P... A decrease in wall thickness has the potential for a premature pump failure, compared to a pump w... Class II Coloplast Manufacturing US, LLC
Mar 1, 2023 Mild Chromic Gut Absorbable Sutures, CH GUT 5-0 12 UD SS-14 SS-14 (G-1766-K),... Medtronic was made aware of a supplier calibration issue during the contract sterilization proces... Class II Covidien, LP
Mar 1, 2023 Titan 0-Deg Scrotal 22 Cm, Catalog Number ES89222400; inflatable penile Prost... A decrease in wall thickness has the potential for a premature pump failure, compared to a pump w... Class II Coloplast Manufacturing US, LLC
Mar 1, 2023 Trilogy Evo O2 and LifeVentEVO2 Portable Electric Ventilator, Model Numbers D... The accuracy of delivered oxygen may deviate below the required tolerance of 5% from setpoint whe... Class I Philips Respironics, Inc.
Mar 1, 2023 Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 34X4,1BLA,... Not able to achieve desired pressure and not holding pressure result from two different causes wh... Class II Stryker Corporation
Mar 1, 2023 Titan Touch Infr Zero Ang 22cm, Catalog Number ES28222400; inflatable penile ... A decrease in wall thickness has the potential for a premature pump failure, compared to a pump w... Class II Coloplast Manufacturing US, LLC
Mar 1, 2023 Plain Gut Absorbable Sutures, PLAIN GUT 5/0 18 P-13 X12 (SG-5686), PLAIN GUT ... Medtronic was made aware of a supplier calibration issue during the contract sterilization proces... Class II Covidien, LP
Mar 1, 2023 Titan 0-Deg Infrapubic 20 Cm, Catalog Number ES88202400; inflatable penile Pr... A decrease in wall thickness has the potential for a premature pump failure, compared to a pump w... Class II Coloplast Manufacturing US, LLC
Mar 1, 2023 Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 34X4,1BLA,... Not able to achieve desired pressure and not holding pressure result from two different causes wh... Class II Stryker Corporation
Mar 1, 2023 Titan Touch NB Infr Zero 16cm, Catalog Number EN28162400; inflatable penile P... A decrease in wall thickness has the potential for a premature pump failure, compared to a pump w... Class II Coloplast Manufacturing US, LLC
Mar 1, 2023 Trilogy Evo Universal Portable Electric Ventilator, Model Number DS2000X11B The accuracy of delivered oxygen may deviate below the required tolerance of 5% from setpoint whe... Class I Philips Respironics, Inc.
Mar 1, 2023 Trilogy EV300 Portable Electric Ventilator, Model Numbers DS2200X11B, IN2200X... The accuracy of delivered oxygen may deviate below the required tolerance of 5% from setpoint whe... Class I Philips Respironics, Inc.
Mar 1, 2023 Chromic Gut Absorbable Sutures, SURGIGUT* 0 CHR GS-25 90CM X36 (CG-904), SURG... Medtronic was made aware of a supplier calibration issue during the contract sterilization proces... Class II Covidien, LP
Mar 1, 2023 Titan 0-Deg Scrotal 20 Cm, Catalog Number ES89202400; inflatable penile Prost... XXX Class II Coloplast Manufacturing US, LLC
Mar 1, 2023 CAPIOX RX15 Hollow Fiber Oxygenator, Catalog Number 3CX*RX15RE30 Some Capiox NX, RX and FX Oxygenators may contain an arterial thermistor component that is improp... Class II Terumo Cardiovascular Systems Corporation
Mar 1, 2023 Titan Touch NB Scrot Zero 16cm, Catalog Number EN29162400; inflatable penile ... A decrease in wall thickness has the potential for a premature pump failure, compared to a pump w... Class II Coloplast Manufacturing US, LLC
Mar 1, 2023 CAPIOX FX25 Hollow Fiber Oxygenator, Catalog Numbers 3CX*FX25REC, 3CX*FX25RWC Some Capiox NX, RX and FX Oxygenators may contain an arterial thermistor component that is improp... Class II Terumo Cardiovascular Systems Corporation
Mar 1, 2023 Color Cuff Single Port, Single Bladder 30 (Royal Blue) Quick Connect, REF: 5... Increased incidence of disposable tourniquet cuffs "not able to achieve desired pressure" and "no... Class II Stryker Sustainability Solutions
Mar 1, 2023 Titan Touch Infr Zero Ang 18cm, Catalog Number ES28182400; inflatable penile ... A decrease in wall thickness has the potential for a premature pump failure, compared to a pump w... Class II Coloplast Manufacturing US, LLC
Mar 1, 2023 Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography (PE... Due to a software issue where the process of patient scanning, the scatter correction may occasio... Class II Shanghai United Imaging Healthcare Co., Ltd.
Mar 1, 2023 Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 18X4,1 BLA... Not able to achieve desired pressure and not holding pressure result from two different causes wh... Class II Stryker Corporation
Mar 1, 2023 Titan Touch Scro Zero Ang 16cm, Catalog Number ES29162400; inflatable penile ... A decrease in wall thickness has the potential for a premature pump failure, compared to a pump w... Class II Coloplast Manufacturing US, LLC
Mar 1, 2023 Express Mini 500 Dry Seal Chest Drain, Part Number 16400 The Instructions for Use (IFU) for the Pneumostat Chest Drain Valve and the Express Mini 500 Dry ... Class II Atrium Medical Corporation
Mar 1, 2023 Step Bladeless Trocars, 10 mm cannula and dilator with radially expandable sl... Medtronic was made aware of a supplier calibration issue during the contract sterilization proces... Class II Covidien, LP
Mar 1, 2023 Titan Touch Scro Zero Ang 20cm, Catalog Number ES29202400; inflatable penile ... A decrease in wall thickness has the potential for a premature pump failure, compared to a pump w... Class II Coloplast Manufacturing US, LLC
Mar 1, 2023 Titan Touch Scro Zero Ang 22cm, Catalog Number ES29222400; inflatable penile ... A decrease in wall thickness has the potential for a premature pump failure, compared to a pump w... Class II Coloplast Manufacturing US, LLC
Mar 1, 2023 Titan Touch NB Scrot Zero 18cm, Catalog Number EN29182400; inflatable penile ... A decrease in wall thickness has the potential for a premature pump failure, compared to a pump w... Class II Coloplast Manufacturing US, LLC
Mar 1, 2023 Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 30X4,1BLA,... Not able to achieve desired pressure and not holding pressure result from two different causes wh... Class II Stryker Corporation
Mar 1, 2023 Titan NB Scrotal Zero Ang 18cm, Catalog Number EN88182400; inflatable penile ... A decrease in wall thickness has the potential for a premature pump failure, compared to a pump w... Class II Coloplast Manufacturing US, LLC
Mar 1, 2023 Titan Pump Assembly, Catalog Number 5177701400; inflatable penile Prosthesis A decrease in wall thickness has the potential for a premature pump failure, compared to a pump w... Class II Coloplast Manufacturing US, LLC
Mar 1, 2023 Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 30X4,1BLA,... Not able to achieve desired pressure and not holding pressure result from two different causes wh... Class II Stryker Corporation
Mar 1, 2023 CAPIOX NX19 Hollow Fiber Oxygenator, Catalog Number 3CX*NX19RE Some Capiox NX, RX and FX Oxygenators may contain an arterial thermistor component that is improp... Class II Terumo Cardiovascular Systems Corporation
Mar 1, 2023 Instructions for Use for the following Leksell Stereotactic System and Leksel... The incorrect IFU was distributed with the devices. Class II Elekta Instrument AB
Feb 28, 2023 EMPOWR Porous Knee Patella Over Drill, REF: 802-05-104; EMPOWR Knee Patella D... Patella drills are marked with incorrect diameter size of 5.6mm, when they should be 5.4mm. Porou... Class II Encore Medical, LP
Feb 28, 2023 Bard Mission Disposable Core Biopsy Instrument Kit: 16G x 10CM, REF: 1610MSK;... The external diameter of the biopsy instrument is larger than the internal diameter of the coaxia... Class II Bard Peripheral 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.