Browse Device Recalls
35,307 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 35,307 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 35,307 FDA device recalls, Class II.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Mar 9, 2023 | Philips DigitalDiagnost C50 -intended for use in generating radiographic imag... | If the PM for the telescopic carriage is not performed annually as defined in the Instructions fo... | Class II | Philips North America Llc |
| Mar 9, 2023 | DigitalDiagnost C50 1.1-intended for use in generating radiographic images of... | If the PM for the telescopic carriage is not performed annually as defined in the Instructions fo... | Class II | Philips North America Llc |
| Mar 9, 2023 | VITROS Immunodiagnostic Products Anti-SARSCoV- 2 Total N Antibody Calibrator... | Incorrect Number of Calibrator Levels (2) Set for the VITROS Immunodiagnostics Products Anti-SARS... | Class II | Ortho-Clinical Diagnostics, Inc. |
| Mar 9, 2023 | DEVILBISS HEALTHCARE 1025 SERIES OXYGEN CONCENTRATOR, Model Numbers 1025DS, 1... | The instruction manual is being replaced with an updated version that is in alignment with labeli... | Class II | DeVilbiss Healthcare LLC |
| Mar 8, 2023 | MectaLIF ANTERIOR - Lag Plate Flush H14, REF 03.30.302, interbody fusion device | There is a potential for breakage of the small screw used to affix the anti-backout plate. | Class II | Medacta Usa Inc |
| Mar 8, 2023 | FilmArray Gastrointestinal (GI) Panel for FILMARRAY Systems, REF: RFIT-ASY-01... | Due to manufacturing issue, Gastrointestinal (GI) Panel may result in false negative results. | Class II | BioFire Diagnostics, LLC |
| Mar 8, 2023 | MectaLIF ANTERIOR - Antibackout Lag Cover, REF 03.30.305, interbody fusion de... | There is a potential for breakage of the small screw used to affix the anti-backout plate. | Class II | Medacta Usa Inc |
| Mar 8, 2023 | MectaLIF ANTERIOR - Lag Plate Flush H18, REF 03.30.304, interbody fusion device | There is a potential for breakage of the small screw used to affix the anti-backout plate. | Class II | Medacta Usa Inc |
| Mar 8, 2023 | MectaLIF ANTERIOR - Lag Plate Flush H12, REF 03.30.301, interbody fusion device | There is a potential for breakage of the small screw used to affix the anti-backout plate. | Class II | Medacta Usa Inc |
| Mar 8, 2023 | MectaLIF ANTERIOR - Lag Plate Flush H16, REF 03.30.303, interbody fusion device | There is a potential for breakage of the small screw used to affix the anti-backout plate. | Class II | Medacta Usa Inc |
| Mar 8, 2023 | Samsung GM85 Digital X-ray Imaging System-A Digital Diagnostic Mobile X-ray S... | Issue related to the operation of the arm latch within the column that supports the arm, potentia... | Class II | NeuroLogica Corporation |
| Mar 8, 2023 | MectaLIF ANTERIOR - Lag Plate Flush H10, REF 03.30.300, interbody fusion device | There is a potential for breakage of the small screw used to affix the anti-backout plate. | Class II | Medacta Usa Inc |
| Mar 8, 2023 | AQURE REF 933-599 Software Versions 2.5.2 2.5.3 2.5.4 2.6.0 2.6.1 The... | Due to potential software issue that may result in patient mix-up information. | Class II | Radiometer Medical ApS |
| Mar 7, 2023 | REX (Recovery Exercise X-Trainer) Pressure Therapy System- USER Manual. Inten... | Error in the Introduction section of the user manual that indicates the device may be used for th... | Class II | Compass Health Brands (Corporate Office) |
| Mar 6, 2023 | EARLYVUE VS30 VITAL SIGNS MONITOR Software Version A.00.02 and A.00.01 Produ... | EarlyVue VS30 Vital Signs Monitor and EarlyVue VS30 Vitals monitor Missing Calibration Alarm, a r... | Class II | Philips North America Llc |
| Mar 6, 2023 | EarlyVue VS30 Vitals monitor with Software Versions A.00.02 and A.00.01 Pr... | EarlyVue VS30 Vital Signs Monitor and EarlyVue VS30 Vitals monitor Missing Calibration Alarm, a r... | Class II | Philips North America 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 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 Endoscopic Vessel Harvesting System, Model Number C-VH-3500 | 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 | 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 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 | 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 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 | Cirq Arm System 2.0 | Risk of mechanical instability due to potential manufacturing error of the device | Class II | Brainlab AG |
| 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 | 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 | Instructions for Use for the following Leksell Stereotactic System and Leksel... | The incorrect IFU was distributed with the devices. | Class II | Elekta Instrument AB |
| 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 | 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 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 | 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 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 | 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 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 | 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 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 | 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 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 | 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 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 | 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 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 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 | 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 | 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 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 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 | 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 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 |
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.