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 |
|---|---|---|---|---|
| Jul 7, 2023 | Five S 5 3x65, REF: 0915612-06, sterile for single use, Sterile EO, Rx Only | Flexible intubation endoscopes sterility assurance can not be confirmed. | Class II | Karl Storz Endoscopy |
| Jul 7, 2023 | 50-GEL20; Ultrasound gel | Ultrasound gel mislabeled with inappropriate use. | Class II | Advance Medical Designs, Inc. |
| Jul 7, 2023 | ASG-001; Ultrasound gel | Ultrasound gel mislabeled with inappropriate use. | Class II | Advance Medical Designs, Inc. |
| Jul 6, 2023 | TECNIS Eyhance IOL, REF: ICB00, STERILE.EO, Rx Only | Their is a potential that intraocular lenses (IOLs) were manufactured with unintended toric fidu... | Class II | Johnson & Johnson Surgical Vision, Inc. |
| Jul 6, 2023 | SofTech Pressure-Sensing Wheelchair Cushions | Defective battery pack in wheelchair cushions can overheat resulting in property damage and one p... | Class II | Aquila Corporation |
| Jul 6, 2023 | TECNIS Symfony, Extended Range of Vision IOL, REF: ZXR00, STERILE.EO, Rx Only | Their is a potential that intraocular lenses (IOLs) were manufactured with unintended toric fidu... | Class II | Johnson & Johnson Surgical Vision, Inc. |
| Jul 6, 2023 | Access Thyroglobulin Calibrators | It has been determined through an internal investigation that the alternate Access Thyroglobulin ... | Class II | Beckman Coulter, Inc. |
| Jul 6, 2023 | Medtronic InterStim Ground Pad REF 041826 | Lot of InterStim Self-Adhesive Ground Pad is being recalled due to the product being labeled with... | Class II | Medtronic Neuromodulation |
| Jul 6, 2023 | APK2 Pressure-Sensing Wheelchair Cushions | Defective battery pack in wheelchair cushions can overheat resulting in property damage and one p... | Class II | Aquila Corporation |
| Jul 3, 2023 | LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 23 - Indicated for p... | Increased force may be required to remove the LINK MP Monoblock trial hip stem (Sizes 14mm - 25mm... | Class II | Waldemar Link GmbH & Co. KG (Mfg Site) |
| Jul 3, 2023 | LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 20 - Indicated for p... | Increased force may be required to remove the LINK MP Monoblock trial hip stem (Sizes 14mm - 25mm... | Class II | Waldemar Link GmbH & Co. KG (Mfg Site) |
| Jul 3, 2023 | LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 24 - Indicated for p... | Increased force may be required to remove the LINK MP Monoblock trial hip stem (Sizes 14mm - 25mm... | Class II | Waldemar Link GmbH & Co. KG (Mfg Site) |
| Jul 3, 2023 | LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 18 - Indicated for p... | Increased force may be required to remove the LINK MP Monoblock trial hip stem (Sizes 14mm - 25mm... | Class II | Waldemar Link GmbH & Co. KG (Mfg Site) |
| Jul 3, 2023 | LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 21 - Indicated for p... | Increased force may be required to remove the LINK MP Monoblock trial hip stem (Sizes 14mm - 25mm... | Class II | Waldemar Link GmbH & Co. KG (Mfg Site) |
| Jul 3, 2023 | LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 19-Indicated for pat... | Increased force may be required to remove the LINK MP Monoblock trial hip stem (Sizes 14mm - 25mm... | Class II | Waldemar Link GmbH & Co. KG (Mfg Site) |
| Jul 3, 2023 | LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 16 - Indicated for p... | Increased force may be required to remove the LINK MP Monoblock trial hip stem (Sizes 14mm - 25mm... | Class II | Waldemar Link GmbH & Co. KG (Mfg Site) |
| Jul 3, 2023 | LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 15 - Indicated for p... | Increased force may be required to remove the LINK MP Monoblock trial hip stem (Sizes 14mm - 25mm... | Class II | Waldemar Link GmbH & Co. KG (Mfg Site) |
| Jul 3, 2023 | LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 22 - Indicated for p... | Increased force may be required to remove the LINK MP Monoblock trial hip stem (Sizes 14mm - 25mm... | Class II | Waldemar Link GmbH & Co. KG (Mfg Site) |
| 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 |
| Jul 3, 2023 | LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 14-Indicated for pat... | Increased force may be required to remove the LINK MP Monoblock trial hip stem (Sizes 14mm - 25mm... | Class II | Waldemar Link GmbH & Co. KG (Mfg Site) |
| Jul 3, 2023 | LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 25 - Indicated for p... | Increased force may be required to remove the LINK MP Monoblock trial hip stem (Sizes 14mm - 25mm... | Class II | Waldemar Link GmbH & Co. KG (Mfg Site) |
| Jul 3, 2023 | LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 17 - indicated for p... | Increased force may be required to remove the LINK MP Monoblock trial hip stem (Sizes 14mm - 25mm... | Class II | Waldemar Link GmbH & Co. KG (Mfg Site) |
| Jun 30, 2023 | 3D9-3v Transducer, accessory to Philips Ultrasound Systems: EPIQ Elite; Affin... | Transducer, an ultrasound system accessory, consists of two parts that are bonded together that m... | Class II | Philips Ultrasound, Inc. |
| Jun 30, 2023 | Wireless Foot Switch distributed with Philips Allura Xper and Azurion Interve... | Loss of availability of the wireless foot switch during procedures. | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Jun 30, 2023 | LifeSPARC Pump (part number 5800-0000) contained within TandemLife LifeSPARC ... | Epoxy used during manufacturing of the LifeSPARC Pump may have uncured epoxy. if undetectable cu... | Class II | Cardiac Assist, Inc |
| Jun 29, 2023 | Impella RP Flex with SmartAssist intracardiac microaxial blood pump, Product ... | A higher than expected rate of thrombus formation or deposition has been observed. The risk is f... | Class I | Abiomed, Inc. |
| Jun 28, 2023 | MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Cur... | Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of th... | Class I | Covidien LP |
| Jun 28, 2023 | MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Str... | Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of th... | Class I | Covidien LP |
| Jun 28, 2023 | MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 16 cm, Cur... | Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of th... | Class I | Covidien LP |
| Jun 28, 2023 | ACROBAT V Vacuum Off-Pump System, Part Number C-OM-9100S. Component of a ches... | The Standard Blade may not securely latch onto the Activator Drive. This may result in the inabil... | Class II | Maquet Cardiovascular, LLC |
| Jun 28, 2023 | MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 13 cm, Cur... | Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of th... | Class I | Covidien LP |
| Jun 28, 2023 | MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Cur... | Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of th... | Class I | Covidien LP |
| Jun 28, 2023 | MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Cur... | Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of th... | Class I | Covidien LP |
| Jun 28, 2023 | MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 13 cm, Cur... | Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of th... | Class I | Covidien LP |
| Jun 28, 2023 | Alcon Custom Pak | Reports of patient injury during use in procedures due to potential for plastic debris from over-... | Class II | Alcon Research, LTD. |
| Jun 28, 2023 | Phaco Standalone Tips | Reports of patient injury during use in procedures due to potential for plastic debris from over-... | Class II | Alcon Research, LTD. |
| Jun 28, 2023 | MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 16 cm, Cur... | Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of th... | Class I | Covidien LP |
| Jun 28, 2023 | MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 16 cm, Curved Extensions... | Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of th... | Class I | Covidien LP |
| Jun 28, 2023 | MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 16 cm, Cur... | Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of th... | Class I | Covidien LP |
| Jun 28, 2023 | MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Str... | Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of th... | Class I | Covidien LP |
| Jun 28, 2023 | ACROBAT-i Vacuum Stabilizer System, Part Number C-OM-10000. Component of a ch... | The Standard Blade may not securely latch onto the Activator Drive. This may result in the inabil... | Class II | Maquet Cardiovascular, LLC |
| Jun 28, 2023 | ACCESSRAIL Platform (Standard Blade) Part Number SB-1000, and (Deep Blades) P... | The Standard Blade may not securely latch onto the Activator Drive. This may result in the inabil... | Class II | Maquet Cardiovascular, LLC |
| Jun 28, 2023 | ACROBAT SUV Vacuum Off-Pump System, Part Number C-OM-9000S. Component of a c... | The Standard Blade may not securely latch onto the Activator Drive. This may result in the inabil... | Class II | Maquet Cardiovascular, LLC |
| Jun 28, 2023 | MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Cur... | Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of th... | Class I | Covidien LP |
| Jun 28, 2023 | MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 13 cm, Cur... | Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of th... | Class I | Covidien LP |
| Jun 28, 2023 | MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensio... | Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of th... | Class I | Covidien LP |
| Jun 28, 2023 | Infinity FMS Pak | Reports of patient injury during use in procedures due to potential for plastic debris from over-... | Class II | Alcon Research, LTD. |
| Jun 28, 2023 | MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 20 cm, Straight Extensio... | Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of th... | Class I | Covidien LP |
| Jun 28, 2023 | MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Cur... | Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of th... | Class I | Covidien LP |
| Jun 28, 2023 | Constellation Procedure Pak | Reports of patient injury during use in procedures due to potential for plastic debris from over-... | Class II | Alcon Research, LTD. |
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.