Browse Device Recalls
3,013 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,013 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 3,013 FDA device recalls in 2018.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jun 29, 2018 | Pure Rayz, Light Therapy System, packaging, box, sleeve and user manual. Hand... | Quasar did not receive FDA clearance for claims of collagen/elastin production as stated on the p... | Class II | Quasar Bio-Tech, Inc. |
| Jun 29, 2018 | Atellica Sample Handler Additional (SMN 11069004). The Atellica" Solution ... | Atellica Solution system software (SW) version 1.13 and lower, five (5) behavioral issues were id... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jun 29, 2018 | Dymaxeon 5.5 Curved Rod Size 5.5 x 110mm (Yellow), Model Number 06.6441B P... | Packages labeled as containing 110mm rods may contain 100mm rods. | Class II | Back 2 Basics Direct LLC |
| Jun 29, 2018 | Atellica IM 1600 Analyzer (SMN 11066000). The Atellica" Solution is a multi-... | Atellica Solution system software (SW) version 1.13 and lower, five (5) behavioral issues were id... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jun 29, 2018 | MAYFIELD SPINE TABLE ADAPTOR RADIOLUCENT, Part Number A2600R The MAYFIELD... | There is a potential for the knob assembly in the swivel adapter to fracture/break during use. | Class II | Integra LifeSciences Corp. |
| Jun 29, 2018 | Atellica Sample Handler Prime (SMN 11069001). The Atellica" Solution is a ... | Atellica Solution system software (SW) version 1.13 and lower, five (5) behavioral issues were id... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jun 28, 2018 | Overhead Counterpoise Systems (OCS), OCS CONF,STD CEIL MNT, STD HORZ ARM, Cat... | The torque wrench used on the ceiling column assembly during a recent service visit was outside o... | Class II | Bayer Medical Care, Inc. |
| Jun 28, 2018 | Overhead Counterpoise Systems (OCS), OCS, 580mm CEILING MOUNT, PORTEGRA2, Cat... | The torque wrench used on the ceiling column assembly during a recent service visit was outside o... | Class II | Bayer Medical Care, Inc. |
| Jun 28, 2018 | The Neonatal Flow Sensor Cable used on devices CARESCAPE R860, ENGSTROM CARES... | The Neonatal Flow Sensor Cable may be missing the connector housing exposing the wires in the cable. | Class II | Datex-Ohmeda, Inc. |
| Jun 28, 2018 | Overhead Counterpoise Systems (OCS) OCS CONF an accessory device for use with... | The torque wrench used on the ceiling column assembly during a recent service visit was outside o... | Class II | Bayer Medical Care, Inc. |
| Jun 28, 2018 | Final Pack, Esteem II, Sound Processor Model 2001, containing 2 Sterile Wipes... | Sterile Wipes packed in these four Esteem II Sound Processors had an earlier expiration date than... | Class II | Envoy Medical Corporation |
| Jun 27, 2018 | DigitalDiagnost Rel.4 Upgrades (Stitching Patient Support) 712084 | The hook does not securely hold the footplate in the vertical position. Therefore, the footplate... | Class II | Philips Medical Systems Gmbh, DMC |
| Jun 27, 2018 | DigitalDiagnost 4.1 High Performance (Stitching Patient Support) 712031 | The hook does not securely hold the footplate in the vertical position. Therefore, the footplate... | Class II | Philips Medical Systems Gmbh, DMC |
| Jun 27, 2018 | BACT/ALERT VIRTUO system, A Unit, with Version R2.0 Firmware Product Usage... | The BACT/ALERT VIRTUO Instrument Firmware version R2.0 allows relocation of the four (4) resident... | Class II | bioMerieux, Inc. |
| Jun 27, 2018 | DigitalDiagnost, Dual-Detector (Stitching Patient Support) 712052 | The hook does not securely hold the footplate in the vertical position. Therefore, the footplate... | Class II | Philips Medical Systems Gmbh, DMC |
| Jun 27, 2018 | DigitalDiagnost 4 Flex / Value (Stitching Patient Support) 712028 | The hook does not securely hold the footplate in the vertical position. Therefore, the footplate... | Class II | Philips Medical Systems Gmbh, DMC |
| Jun 27, 2018 | Proteus 235, Universal Nozzle with snout 300x400; PBS dedicated nozzle with s... | Gantry rotation or proton irradiation can be allowed even if apertures or accessories are not cor... | Class II | Ion Beam Applications S.A. |
| Jun 27, 2018 | DigitalDiagnost Dual Detector (Stitching Patient Support) 712022 | The hook does not securely hold the footplate in the vertical position. Therefore, the footplate... | Class II | Philips Medical Systems Gmbh, DMC |
| Jun 27, 2018 | Stryker T2 ANKLE ARTHRODESIS NAIL RIGHT 10MMX200MM Item Number: 1819-1020S T... | Incomplete seal on the Tyvek lid may compromise the sterility of the device | Class II | Stryker GmbH |
| Jun 27, 2018 | DigitalDiagnost Classic, Dual-Detector (Stitching Patient Support) 712052 | The hook does not securely hold the footplate in the vertical position. Therefore, the footplate... | Class II | Philips Medical Systems Gmbh, DMC |
| Jun 27, 2018 | CombiDiagnost R90 (Stitching Patient Support) 709030 | The hook does not securely hold the footplate in the vertical position. Therefore, the footplate... | Class II | Philips Medical Systems Gmbh, DMC |
| Jun 27, 2018 | DigitalDiagnost Classic 1.x Upgrades (Stitching Patient Support) 712081 | The hook does not securely hold the footplate in the vertical position. Therefore, the footplate... | Class II | Philips Medical Systems Gmbh, DMC |
| Jun 27, 2018 | DigitalDiagnost 4.1 (Stitching Patient Support) 712225 | The hook does not securely hold the footplate in the vertical position. Therefore, the footplate... | Class II | Philips Medical Systems Gmbh, DMC |
| Jun 27, 2018 | EasyDiagnost Eleva DRF, Release 5 (Stitching Patient Support) 706050 | The hook does not securely hold the footplate in the vertical position. Therefore, the footplate... | Class II | Philips Medical Systems Gmbh, DMC |
| Jun 27, 2018 | DigitalDiagnost 4 Chest / Emergency (Stitching Patient Support) 712029 | The hook does not securely hold the footplate in the vertical position. Therefore, the footplate... | Class II | Philips Medical Systems Gmbh, DMC |
| Jun 27, 2018 | DigitalDiagnost Release 3.1 (Stitching Patient Support) 712026 | The hook does not securely hold the footplate in the vertical position. Therefore, the footplate... | Class II | Philips Medical Systems Gmbh, DMC |
| Jun 27, 2018 | DigitalDiagnost 2.x Upgrades (Stitching Patient Support) 712082 | The hook does not securely hold the footplate in the vertical position. Therefore, the footplate... | Class II | Philips Medical Systems Gmbh, DMC |
| Jun 27, 2018 | DigitalDiagnost, Single-Detect (Stitching Patient Support) 712062 | The hook does not securely hold the footplate in the vertical position. Therefore, the footplate... | Class II | Philips Medical Systems Gmbh, DMC |
| Jun 27, 2018 | BACT/ALERT VIRTUO system, A Unit China, with Version R2.0 Firmware Product... | The BACT/ALERT VIRTUO Instrument Firmware version R2.0 allows relocation of the four (4) resident... | Class II | bioMerieux, Inc. |
| Jun 27, 2018 | DigitalDiagnost 4.1 Chest / Emergency (Stitching Patient Support) 712029 | The hook does not securely hold the footplate in the vertical position. Therefore, the footplate... | Class II | Philips Medical Systems Gmbh, DMC |
| Jun 27, 2018 | DigitalDiagnost Upgrades (Stitching Patient Support) 712083 | The hook does not securely hold the footplate in the vertical position. Therefore, the footplate... | Class II | Philips Medical Systems Gmbh, DMC |
| Jun 27, 2018 | Genicon EZee Single Use Specimen Retrieval Bag - Product Usage: This device i... | Genicon is providing updated IFU labeling to users to provide clarity on how to use the device fo... | Class II | Genicon, Inc. |
| Jun 27, 2018 | DigitalDiagnost Release 3 (Stitching Patient Support) 712025 | The hook does not securely hold the footplate in the vertical position. Therefore, the footplate... | Class II | Philips Medical Systems Gmbh, DMC |
| Jun 27, 2018 | Leksell GammaPlan 11.1 Product Usage: Leksell GammaPlan is a computer-bas... | The margin tool in Leksell GammaPlan 11.1 systematically overestimates margin in certain areas of... | Class II | Elekta Instrument AB |
| Jun 27, 2018 | BACT/ALERT VIRTUO system, B Unit, with Version R2.0 Firmware Product Usage... | The BACT/ALERT VIRTUO Instrument Firmware version R2.0 allows relocation of the four (4) resident... | Class II | bioMerieux, Inc. |
| Jun 27, 2018 | DigitalDiagnost 2.x Upgrades (Stitching Patient Support) 712081 | The hook does not securely hold the footplate in the vertical position. Therefore, the footplate... | Class II | Philips Medical Systems Gmbh, DMC |
| Jun 27, 2018 | DigitalDiagnost Release 3 (Stitching Patient Support) 712025 | The hook does not securely hold the footplate in the vertical position. Therefore, the footplate... | Class II | Philips Medical Systems Gmbh, DMC |
| Jun 27, 2018 | DigitalDiagnost 4 High Performance (Stitching Patient Support) 712027 | The hook does not securely hold the footplate in the vertical position. Therefore, the footplate... | Class II | Philips Medical Systems Gmbh, DMC |
| Jun 27, 2018 | DigitalDiagnost 4.1 Flex / Value (Stitching Patient Support) 712028 | The hook does not securely hold the footplate in the vertical position. Therefore, the footplate... | Class II | Philips Medical Systems Gmbh, DMC |
| Jun 27, 2018 | DigitalDiagnost Release 3.1 (Stitching Patient Support) 712026 | The hook does not securely hold the footplate in the vertical position. Therefore, the footplate... | Class II | Philips Medical Systems Gmbh, DMC |
| Jun 27, 2018 | DigitalDiagnost 4 Flex / Value (Stitching Patient Support) 712028 | The hook does not securely hold the footplate in the vertical position. Therefore, the footplate... | Class II | Philips Medical Systems Gmbh, DMC |
| Jun 27, 2018 | EasyDiagnost Eleva DRF (Stitching Patient Support) 706032 | The hook does not securely hold the footplate in the vertical position. Therefore, the footplate... | Class II | Philips Medical Systems Gmbh, DMC |
| Jun 27, 2018 | DigitalDiagnost Single Detector (Stitching Patient Support) 712020 | The hook does not securely hold the footplate in the vertical position. Therefore, the footplate... | Class II | Philips Medical Systems Gmbh, DMC |
| Jun 27, 2018 | DigitalDiagnost 4.1 High Performance (Stitching Patient Support) 712031 | The hook does not securely hold the footplate in the vertical position. Therefore, the footplate... | Class II | Philips Medical Systems Gmbh, DMC |
| Jun 27, 2018 | DigitalDiagnost Dual Detector (Stitching Patient Support) 712022 | The hook does not securely hold the footplate in the vertical position. Therefore, the footplate... | Class II | Philips Medical Systems Gmbh, DMC |
| Jun 27, 2018 | BuckyDiagnost Ceiling System (Stitching Patient Support) 704031 | The hook does not securely hold the footplate in the vertical position. Therefore, the footplate... | Class II | Philips Medical Systems Gmbh, DMC |
| Jun 26, 2018 | Instrument trays used to store AltiVate Small Shell Trials (FA S ALTIVATE RSP... | A black, aluminum oxide coating may appear on the tray after cleaning. The black, aluminum oxide ... | Class II | Encore Medical, Lp |
| Jun 26, 2018 | Monitor with one Blood Parameter Module and one HSat Probe; 500AHCT Monitor ... | H/Sat Hybrid Intensity Shift has been seen in a subset of the H/Sat population, which has resulte... | Class II | Terumo Cardiovascular Systems Corporation |
| Jun 26, 2018 | CDI Blood parameter monitoring system 500 H/SAT, Part No. 145883 Product U... | H/Sat Hybrid Intensity Shift has been seen in a subset of the H/Sat population, which has resulte... | Class II | Terumo Cardiovascular Systems Corporation |
| Jun 25, 2018 | This is an accessory to Intelect Advanced, Intelect Mobile, Intelect Neo, and... | The device accessories were not labeled with appropriate latex warning. | Class II | DJO, 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.