Browse Device Recalls
39,969 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 39,969 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 39,969 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 | The Air/Water Valve is provided/used with the following Endoscopes: ULTRASON... | The air/water valve MAJ-1444 used with OER-Pro and OER-Elite may become damaged and result in lo... | Class II | Olympus Corporation of the Americas |
| 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 11, 2023 | EMBLEM MRI S-ICD Pulse Generator Model A219; Subcutaneous Implantable Cardiov... | There is a potential for a rare interaction between the EMBLEM S-ICD and LATITUDE communicator, w... | Class II | Boston Scientific Corporation |
| Jul 11, 2023 | EMBLEM S-ICD Pulse Generator Model A209; Subcutaneous Implantable Cardioverte... | There is a potential for a rare interaction between the EMBLEM S-ICD and LATITUDE communicator, w... | Class II | Boston Scientific Corporation |
| Jul 10, 2023 | Atellica CH LDL Cholesterol- In vitro diagnostic use in the quantitative det... | Potential for reagent carryover on the Atellica CH 930 resulting in a positive bias that could im... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jul 10, 2023 | SurgiCount+ Software Application-indicated as an adjunctive technology for au... | Potential for current software to miscount when scanning in multiple sponge-products from the sam... | Class II | Stryker Corporation |
| Jul 10, 2023 | Atellica CH Total Bilirubin_2 -In vitro diagnostic use in the quantitative d... | Potential for reagent carryover on the Atellica CH 930 resulting in a positive bias that could im... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jul 10, 2023 | Atellica¿ CH HDL Cholesterol- In vitro diagnostic use in the quantitative d... | Potential for reagent carryover on the Atellica CH 930 resulting in a positive bias that could im... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jul 10, 2023 | Atellica CH Gamma-Glutamyl Transferase-IIn vitro diagnostic use in the quanti... | Potential for reagent carryover on the Atellica CH 930 resulting in a positive bias that could im... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jul 7, 2023 | procedural kits containing ultrasonic transmission gel, Item Numbers: a)¿¿¿... | Ultrasound gel mislabeled with inappropriate use. | Class II | Advance Medical Designs, Inc. |
| Jul 7, 2023 | Procedural kits containing ultrasonic transmission gel, Item Numbers: a) 2... | Ultrasound gel mislabeled with inappropriate use. | Class II | Advance Medical Designs, Inc. |
| Jul 7, 2023 | LIF AMP, Adjustable Awl, REF 117-165, Part of the AMP System. Used with Spine... | Awl instrument adjustable drill button assembly assembled in the incorrect orientation, preventin... | Class II | Alphatec Spine, Inc. |
| Jul 7, 2023 | Procedural kits containing ultrasonic transmission gel, Item Numbers: a) 20... | Ultrasound gel mislabeled with inappropriate use. | Class II | Advance Medical Designs, Inc. |
| Jul 7, 2023 | Procedural kits containing ultrasonic transmission gel, Item Numbers: a) 2... | Ultrasound gel mislabeled with inappropriate use. | Class II | Advance Medical Designs, Inc. |
| 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 |
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.