Browse Device Recalls
3,419 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,419 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 3,419 FDA device recalls in MA.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Sep 29, 2023 | GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Na+, K+, Ca++, Part Numbers 000243... | Internal testing identified that the GEM Premier PAKs (cartridges) may exhibit an over-recovery (... | Class II | Instrumentation Laboratory |
| Sep 27, 2023 | EXALT Model D Single-Use Duodenoscope, 2 pack: Outer box UPN# M00542421, Inne... | Poor image quality due to fluid ingress in the lens. | Class II | Boston Scientific Corporation |
| Sep 27, 2023 | EXALT Model D Single-Use Duodenoscope: Outer box UPN# M00542420 & Outer box U... | Poor image quality due to fluid ingress in the lens. | Class II | Boston Scientific Corporation |
| Sep 26, 2023 | RAPIDPOINT 500e Blood Gas System | There are potential drug interferences from Perhexiline Maleate or Atomoxetine Hydrochloride that... | Class II | Siemens Healthcare Diagnostics Inc |
| Sep 26, 2023 | RAPIDPOINT 500 Blood Gas System | There are potential drug interferences from Perhexiline Maleate or Atomoxetine Hydrochloride that... | Class II | Siemens Healthcare Diagnostics Inc |
| Sep 21, 2023 | DigitalDiagnost 4 Flex/Value, used to acquire, process, store, display and ex... | Potential for units suspended on the ceiling to fail and fall. | Class II | Philips North America Llc |
| Sep 21, 2023 | EasyDiagnost Eleva DRF, Release 5, used to acquire, process, store, display a... | Potential for units suspended on the ceiling to fail and fall. | Class II | Philips North America Llc |
| Sep 21, 2023 | DigitalDiagnost C90 Flex/Value/Chest/ER, used to acquire, process, store, dis... | Potential for units suspended on the ceiling to fail and fall. | Class II | Philips North America Llc |
| Sep 21, 2023 | DigitalDiagnost C90 High Performance, used to acquire, process, store, displa... | Potential for units suspended on the ceiling to fail and fall. | Class II | Philips North America Llc |
| Sep 21, 2023 | ProxiDiagnost N90, Radiography and Fluoroscopy (R/F) system | Potential for units suspended on the ceiling to fail and fall. | Class II | Philips North America Llc |
| Sep 21, 2023 | DigitalDiagnost C90 Release 3.1, used to acquire, process, store, display and... | Potential for units suspended on the ceiling to fail and fall. | Class II | Philips North America Llc |
| Sep 21, 2023 | DigitalDiagnost C90 Release 3, used to acquire, process, store, display and e... | Potential for units suspended on the ceiling to fail and fall. | Class II | Philips North America Llc |
| Sep 21, 2023 | DigitalDiagnost 4 High Performance, used to acquire, process, store, display ... | Potential for units suspended on the ceiling to fail and fall. | Class II | Philips North America Llc |
| Sep 21, 2023 | CombiDiagnost R90, Radiography and Fluoroscopy (R/F) system | Potential for units suspended on the ceiling to fail and fall. | Class II | Philips North America Llc |
| Sep 21, 2023 | DigitalDiagnost 4 Chest/Emergency, used to acquire, process, store, display a... | Potential for units suspended on the ceiling to fail and fall. | Class II | Philips North America Llc |
| Sep 19, 2023 | LeadCare II Blood Lead Test Kit-For in vitro diagnostic use only. The test ki... | During an internal audit a small percentage (<10%) of plastic caps used to close the treatment re... | Class II | Magellan Diagnostics, Inc. |
| Sep 19, 2023 | NeuroSync EYE-SYNC containing Pico Neo 2 Headsets. Each unit consists of a Pi... | Eye syncing issues causing the device to be inoperable. Unable to be repaired due to discontinuat... | Class II | NeuroSync, Inc. |
| Sep 18, 2023 | Nova Biomedical Prime Plus Analyzer -Intended to measure certain gases in blo... | Potential risk of reporting erroneous creatinine patient results associated with the initial star... | Class II | Nova Biomedical Corporation |
| Sep 18, 2023 | Nova Stat Profile Prime Plus POC Analyzer (CE)-Intended to measure certain ga... | Potential risk of reporting erroneous creatinine patient results associated with the initial star... | Class II | Nova Biomedical Corporation |
| Sep 6, 2023 | 2008T HD SYS. CDX BLUESTAR | Potential PCBA leaching from tubing of hemodialysis machines. | Class I | Fresenius Medical Care Holdings, Inc. |
| Sep 6, 2023 | 2008T Hemodialysis System without CDX | Potential PCBA leaching from tubing of hemodialysis machines. | Class I | Fresenius Medical Care Holdings, Inc. |
| Sep 6, 2023 | 2008T HD SYS. CDX W/BIBAG BLUESTAR | Potential PCBA leaching from tubing of hemodialysis machines. | Class I | Fresenius Medical Care Holdings, Inc. |
| Sep 6, 2023 | 2008T GEN 2 Bibag without CDX | Potential PCBA leaching from tubing of hemodialysis machines. | Class I | Fresenius Medical Care Holdings, Inc. |
| Sep 6, 2023 | 2008T Hemodialysis System w/Bibag | Potential PCBA leaching from tubing of hemodialysis machines. | Class I | Fresenius Medical Care Holdings, Inc. |
| Sep 6, 2023 | 2008T HD SYS. W/O CDX W/BIBAG BLUESTAR | Potential PCBA leaching from tubing of hemodialysis machines. | Class I | Fresenius Medical Care Holdings, Inc. |
| Sep 6, 2023 | 2008T Hemodialysis SYS, with CDX | Potential PCBA leaching from tubing of hemodialysis machines. | Class I | Fresenius Medical Care Holdings, Inc. |
| Sep 6, 2023 | 2008T HD SYS. W/O CDX BLUESTAR | Potential PCBA leaching from tubing of hemodialysis machines. | Class I | Fresenius Medical Care Holdings, Inc. |
| Sep 1, 2023 | Solea Models 2.0 and 3.0 Laser Surgical Instrument, Foot Pedal assembly SUB-0... | It has been found that potential unintended laser activation can occur without foot pedal depress... | Class II | Convergent Dental |
| Aug 31, 2023 | EarlyVue VS30 Vital Signs Monitor, utilizing E01 (Oridion Microstream sidest... | A software issue prevents the monitor from alarming when the high/low acoustic respiration rate (... | Class II | Philips North America Llc |
| Aug 31, 2023 | HydroPICC 5Fr Dual Lumen Maximal Barrier Kit, Product Model Number 80002004 | Specific lots of the Dual Lumen HydroPICC Kits were provided with the incorrect revision of the I... | Class II | Access Vascular, Inc |
| Aug 31, 2023 | HydroPICC 5Fr Dual Lumen, 80cm guidewire - Basic Kit, Product Model Number 80... | Specific lots of the Dual Lumen HydroPICC Kits were provided with the incorrect revision of the I... | Class II | Access Vascular, Inc |
| Aug 31, 2023 | EarlyVue VS30 Vitals Monitor, utilizing E01 (Oridion Microstream sidestream e... | A software issue prevents the monitor from alarming when the high/low acoustic respiration rate (... | Class II | Philips North America Llc |
| Aug 30, 2023 | Citrine QTRAP Mass Spectrometer, Part Number 5063685 | In rare occasions, the combination of a leak of a highly flammable solvent at the ion source prob... | Class II | AB Sciex, LLC |
| Aug 30, 2023 | API3200MD Mass Spectrometer, Part Number 4466230 | In rare occasions, the combination of a leak of a highly flammable solvent at the ion source prob... | Class II | AB Sciex, LLC |
| Aug 30, 2023 | 4500MD Triple Quad Mass Spectrometer, Part Number 5032522 | In rare occasions, the combination of a leak of a highly flammable solvent at the ion source prob... | Class II | AB Sciex, LLC |
| Aug 30, 2023 | Citrine Triple Quad Mass Spectrometer, Part Number 5063684 | In rare occasions, the combination of a leak of a highly flammable solvent at the ion source prob... | Class II | AB Sciex, LLC |
| Aug 25, 2023 | Conventional Knife Crescent 2.5mm, 55 degrees bevel up, Part Number 373807 | One lot of Conventional Crescent Knife 2.5mm, 55 degrees bevel-up contains a bevel down blade. | Class II | Beaver Visitec International, Inc. |
| Aug 22, 2023 | Palindrome Chronic Catheter Kit Symmetrical Tip14.5 Fr/Ch(4.8mm)x23cm | Some catheter kits labeled as 23 cm implant length incorrectly included catheters of 28 cm implan... | Class II | Covidien LP |
| Aug 22, 2023 | Apellis Injection Kit 29g Injection Needle -single use intended to inject flu... | 19-gauge x 1" inch filter needles showed appearances of a small fraction of non-preferred charact... | Class II | Apellis Pharmaceuticals, Inc. |
| Aug 17, 2023 | Patient Information Center iX with Software Version Number 4.x in the followi... | Patient Information Center (PIC iX) Release 4.x Surveillance Crash Caused by Intel Graphics Driv... | Class II | Philips North America Llc |
| Aug 8, 2023 | 10ML SYRINGE LUER LOCK W/OUT NEEDLE, Part Number 15-R010-0, 100 per box, 12 b... | There is a potential for blood backfill leakage and foreign material. | Class I | Fresenius Medical Care Holdings, Inc. |
| Aug 8, 2023 | 10ML SYRINGE LUER LOCK W/NEEDLE, Part Number 15-10ML-0, 100 per box, 12 boxes... | There is a potential for blood backfill leakage and foreign material. | Class I | Fresenius Medical Care Holdings, Inc. |
| Aug 8, 2023 | 3ML Syringe Luer Lock with needle 20GX1, Part Number 15-03ML-0, 100 per box, ... | There is a potential for blood backfill leakage and foreign material. | Class I | Fresenius Medical Care Holdings, Inc. |
| Aug 2, 2023 | Incisive CT, software version 5.0 | Philips has identified three software issues with compliance concerns to Subchapter J: Issue 1: C... | Class II | Philips Healthcare |
| Jul 25, 2023 | The O-arm O2 Imaging System is a mobile x-ray system designed for 2D fluorosc... | Ground cable installed incorrectly. | Class II | Medtronic Navigation, Inc.-Littleton |
| Jul 13, 2023 | The Chevalier Valvulotome is a device used to disrupt the valves of veins whi... | Burrs (molding flash) on the cutter may tear the harvested vien | Class II | LeMaitre Vascular, Inc. |
| Jul 13, 2023 | ACL TOP Family 50 Series Models as follows: In vitro diagnostic clinical use... | Sample misidentification could occur under specific conditions and patient management altered b... | Class II | Instrumentation Laboratory |
| 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 |
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.