Browse Device Recalls
3,087 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,087 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 3,087 FDA device recalls in IL.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jul 12, 2023 | nanoDot D2DNN, Model Numbers: a) 18105-000; b) 18105-KIT; radiation moni... | LANDAUER received reports indicating that some nanoDots may potentially be outside of the specifi... | Class II | Landauer |
| Jul 12, 2023 | nanoDot D2DNN, Model Numbers: a) 03053-1MO; b) 03053-1WK ; c) 03053-3M... | LANDAUER received reports indicating that some nanoDots may potentially be outside of the specifi... | Class II | Landauer |
| Jul 12, 2023 | QC (Cs-137) nanoDot D2DNS, Model Numbers: a) 04225-000 (EMEA number VINLNA... | LANDAUER received reports indicating that some nanoDots may potentially be outside of the specifi... | Class II | Landauer |
| Jul 12, 2023 | nanoDot D2DNS, for custom calibrate, OTO, Model Number 03033-OTO; radiation m... | LANDAUER received reports indicating that some nanoDots may potentially be outside of the specifi... | Class II | Landauer |
| Jul 12, 2023 | nanoDot kit (contains nanoDot A, B, C), Model Number 03500-000; radiation mon... | LANDAUER received reports indicating that some nanoDots may potentially be outside of the specifi... | Class II | Landauer |
| Jul 12, 2023 | nanoDot D2DNS, for custom calibrate, OTO, Model Numbers 03034-OTO; radiation ... | LANDAUER received reports indicating that some nanoDots may potentially be outside of the specifi... | Class II | Landauer |
| Jul 12, 2023 | Calibrate (80 kVp) nanoDot D2DNS, Model Numbers: a) 18120-000; b) 18120-... | LANDAUER received reports indicating that some nanoDots may potentially be outside of the specifi... | Class II | Landauer |
| Jul 12, 2023 | Reader, nanoDot adapter, EU Model Number VINLADA003; radiation monitoring dos... | LANDAUER received reports indicating that some nanoDots may potentially be outside of the specifi... | Class II | Landauer |
| Jul 12, 2023 | nanoDot A - item 1 of 3 for 03500-000, Model Number 03501-000; radiation moni... | LANDAUER received reports indicating that some nanoDots may potentially be outside of the specifi... | Class II | Landauer |
| Jul 12, 2023 | QC (80 kVp) screened nanoDot D2DNS, Model Number 03066-OTO; radiation monitor... | LANDAUER received reports indicating that some nanoDots may potentially be outside of the specifi... | Class II | Landauer |
| Jul 12, 2023 | The following Pro.specta Emission Computed Tomography Systems that were manuf... | During a whole-body planar scan with auto-contour, there is a possibility the short-linear drive ... | Class II | Siemens Medical Solutions USA, Inc. |
| Jul 12, 2023 | Constancy (80 kVp) nanoDot D2DNN, Model Numbers: a) 18150-000 (EMEA number... | LANDAUER received reports indicating that some nanoDots may potentially be outside of the specifi... | Class II | Landauer |
| Jul 12, 2023 | nanoDot D2DNS, Model Numbers: a) 03057-1MO; b) 03057-3MO; c) 03057-OT... | LANDAUER received reports indicating that some nanoDots may potentially be outside of the specifi... | Class II | Landauer |
| Jul 12, 2023 | nanoDot D2DNS, Model Numbers: a) 18100-000; b) 18100-1MO; c) 18100-2MO... | LANDAUER received reports indicating that some nanoDots may potentially be outside of the specifi... | Class II | Landauer |
| Jul 3, 2023 | Total Hip Kit, REF DYNJ903275S; surgical convenience kit | The prep solution included in the Total Hip Kit expires prior to the expiration date of the Kit. | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Jun 19, 2023 | GEM FLOW COUPLER Monitor, PN 5156-00000-011 | An issue was identified where the LCD monitor display may not indicate the correct active channel... | Class II | Baxter Healthcare Corporation |
| Jun 16, 2023 | NovaPlus Infant Heel Warmer, Instant Squeeze Activation, Catalog Number V1146... | Cardinal Health has received an increase in burst/leaking complaints from mid-April to May regard... | Class II | Cardinal Health 200, LLC |
| Jun 15, 2023 | SIGMA Spectrum Infusion Pump, Product Code 35700BAX2 | A medical device correction is being issued for SIGMA Spectrum Infusion System (V8 Platform) and ... | Class I | Baxter Healthcare Corporation |
| Jun 15, 2023 | The Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 35... | A medical device correction is being issued for SIGMA Spectrum Infusion System (V8 Platform) and ... | Class I | Baxter Healthcare Corporation |
| Jun 5, 2023 | Verigene Enteric Pathogens Nucleic Acid Test (EP), REF 30-002-023 | It is possible that in rare instances the VERIGENE CDF Nucleic Acid Test Kit (Part No. 20-005-022... | Class II | Luminex Corporation |
| Jun 5, 2023 | VERIGENE Clostridium difficile Nucleic Acid Test, REF 30-002-022 | It is possible that in rare instances the VERIGENE CDF Nucleic Acid Test Kit (Part No. 20-005-022... | Class II | Luminex Corporation |
| May 23, 2023 | Centurion Sterile CirClamp with 1.45cm Bell Reprocessed, Reorder CR3145K, 1 p... | The kits incorrectly contain CirClamp subassembly 345CRSAK which results in the kits containing a... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 19, 2023 | Voalte Patient Safety, Part Number 4.0, V4.0.000 to 4.0.401, used with the Ce... | Baxter identified a potential risk where the "safety" monitoring and "bed exit" monitoring featur... | Class II | Baxter Healthcare Corporation |
| May 19, 2023 | NaviCare Patient Safety V3.9.200 to 3.9.600, used with the Centrella Bed | Baxter identified a potential risk where the "safety" monitoring and "bed exit" monitoring featur... | Class II | Baxter Healthcare Corporation |
| May 18, 2023 | MEDLINE NON-STERILE PVP SOLUTION, packaged in kits as follows: a) OCULOPLAST... | Affected product lots were mislabeled as "STERILE PVP SLN" when they should have been titled "NON... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 18, 2023 | Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the fo... | Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at th... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 18, 2023 | Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the fo... | Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at th... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 18, 2023 | Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the fo... | Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at th... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 18, 2023 | Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the fo... | Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at th... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 18, 2023 | Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the fo... | Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at th... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 18, 2023 | Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the fo... | Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at th... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 18, 2023 | Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the fo... | Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at th... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 18, 2023 | Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the fo... | Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at th... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 18, 2023 | Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the fo... | Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at th... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 18, 2023 | Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the fo... | Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at th... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 18, 2023 | Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the fo... | Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at th... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 18, 2023 | Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the fo... | Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at th... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 18, 2023 | Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the fo... | Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at th... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 18, 2023 | Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the fo... | Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at th... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 18, 2023 | Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the fo... | Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at th... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 18, 2023 | Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the fo... | Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at th... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 18, 2023 | Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the fo... | Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at th... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 18, 2023 | Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the fo... | Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at th... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 18, 2023 | Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the fo... | Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at th... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 18, 2023 | Medline Probe Cover Kits, Model Numbers: DYNJE5900, DYNJE5910, DYNJE5920, DYN... | Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at th... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 18, 2023 | Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the fo... | Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at th... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 18, 2023 | Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the fo... | Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at th... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 18, 2023 | Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the fo... | Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at th... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 18, 2023 | MEDLINE NON-STERILE PVP SOLUTION, packaged in kits as follows: a) TOTAL JOIN... | Affected product lots were mislabeled as "STERILE PVP SLN" when they should have been titled "NON... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 18, 2023 | Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the fo... | Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at th... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
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.