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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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.