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 |
|---|---|---|---|---|
| May 18, 2023 | VITROS Immunodiagnostic Products NT-proBNP II Range Verifiers-For in vitro di... | May not meet the stability specifications for shelf life outlined in the Instructions For Use (IFU). | Class III | Ortho-Clinical Diagnostics, Inc. |
| 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 | QUADROX -i Neonatal, Oxygenator used during cardiopulmonary bypass Model ... | Product packaging may exhibit small pinholes which may not be visible to the unaided eye, comprom... | Class II | Maquet Medical Systems USA |
| 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 17, 2023 | Access Hybritech p2PSA reagent, REF B03704 and REF A49752. | Reagent lot numbers include an insufficient concentration of blocking reagent. | Class II | Beckman Coulter, Inc. |
| May 16, 2023 | HeartWare Ventricular Assist Device System. a) Monitor 1521US Explore Tech,... | Medtronic has identified that the logfiles downloaded from the recently updated Model 1521 monito... | Class II | Heartware, Inc. |
| May 16, 2023 | Draeger Softbed Resuscitaire and/or Birthing Room Warmer with Scale [Model(s)... | The Resuscitaire Infant Radiant Warmer with the optional scale could display inaccurate weight va... | Class II | Draeger Medical Systems, Inc. |
| May 16, 2023 | Aeris Balloon Dilation Catheter | Devices were mislabeled. | Class II | Bryan Medical Inc |
| May 16, 2023 | Aptio Automation Storage and Retrieval Module (SRM) | A firmware error may lead to an incorrect association of test result(s) to a sample ID and theref... | Class II | Siemens Healthcare Diagnostics, Inc. |
| May 15, 2023 | Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound ... | Potential for the labeled sterile ultrasound gel component within packs to not meet sterility spe... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 15, 2023 | OEC Elite Systems with 9-inch Image Intensifier | Image intensifiers on systems, used to provide fluoroscopic/digital spot images can become detach... | Class II | GE OEC Medical Systems, Inc |
| May 15, 2023 | Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound ... | Potential for the labeled sterile ultrasound gel component within packs to not meet sterility spe... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 15, 2023 | Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound ... | Potential for the labeled sterile ultrasound gel component within packs to not meet sterility spe... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 15, 2023 | Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound ... | Potential for the labeled sterile ultrasound gel component within packs to not meet sterility spe... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 15, 2023 | OEC 9800 Systems with 9-inch Image Intensifier | Image intensifiers on systems, used to provide fluoroscopic/digital spot images can become detach... | Class II | GE OEC Medical Systems, Inc |
| May 15, 2023 | Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound ... | Potential for the labeled sterile ultrasound gel component within packs to not meet sterility spe... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 15, 2023 | Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound ... | Potential for the labeled sterile ultrasound gel component within packs to not meet sterility spe... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 15, 2023 | Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound ... | Potential for the labeled sterile ultrasound gel component within packs to not meet sterility spe... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 15, 2023 | Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound ... | Potential for the labeled sterile ultrasound gel component within packs to not meet sterility spe... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 15, 2023 | Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound ... | Potential for the labeled sterile ultrasound gel component within packs to not meet sterility spe... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 15, 2023 | Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound ... | Potential for the labeled sterile ultrasound gel component within packs to not meet sterility spe... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 15, 2023 | NeuMoDx SARS-CoV-2 Assay -IVD intended for the qualitative detection of SARS... | Potential for lot number discrepancies between the test strip packaging and the barcode label app... | Class III | NeuMoDx Molecular Inc |
| May 15, 2023 | Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound ... | Potential for the labeled sterile ultrasound gel component within packs to not meet sterility spe... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 15, 2023 | Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound ... | Potential for the labeled sterile ultrasound gel component within packs to not meet sterility spe... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 15, 2023 | Always-On Tip Tracked Instruments (SPiN Drive instruments) 22ga SPiN Flex Nee... | Electromagnetic (EM) sensor tracking malfunction impacts the use of navigation functionality duri... | Class II | Olympus Corporation of the Americas |
| May 15, 2023 | Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound ... | Potential for the labeled sterile ultrasound gel component within packs to not meet sterility spe... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 15, 2023 | Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound ... | Potential for the labeled sterile ultrasound gel component within packs to not meet sterility spe... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 15, 2023 | Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound ... | Potential for the labeled sterile ultrasound gel component within packs to not meet sterility spe... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 15, 2023 | Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound ... | Potential for the labeled sterile ultrasound gel component within packs to not meet sterility spe... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 15, 2023 | Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound ... | Potential for the labeled sterile ultrasound gel component within packs to not meet sterility spe... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 15, 2023 | Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound ... | Potential for the labeled sterile ultrasound gel component within packs to not meet sterility spe... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 15, 2023 | OEC 9900 Systems with 9-inch Image Intensifier | Image intensifiers on systems, used to provide fluoroscopic/digital spot images can become detach... | Class II | GE OEC Medical Systems, Inc |
| May 15, 2023 | Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound ... | Potential for the labeled sterile ultrasound gel component within packs to not meet sterility spe... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 15, 2023 | Always-On Tip Tracked Instruments (SPiN Drive instruments) 19ga ANSO Histolog... | Electromagnetic (EM) sensor tracking malfunction impacts the use of navigation functionality duri... | Class II | Olympus Corporation of the Americas |
| May 15, 2023 | Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound ... | Potential for the labeled sterile ultrasound gel component within packs to not meet sterility spe... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 15, 2023 | Always-On Tip Tracked Instruments (SPiN Drive instruments) SPiN Xtend 2.0mm O... | Electromagnetic (EM) sensor tracking malfunction impacts the use of navigation functionality duri... | Class II | Olympus Corporation of the Americas |
| May 15, 2023 | Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound ... | Potential for the labeled sterile ultrasound gel component within packs to not meet sterility spe... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 15, 2023 | Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound ... | Potential for the labeled sterile ultrasound gel component within packs to not meet sterility spe... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 15, 2023 | Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound ... | Potential for the labeled sterile ultrasound gel component within packs to not meet sterility spe... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 15, 2023 | Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound ... | Potential for the labeled sterile ultrasound gel component within packs to not meet sterility spe... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 15, 2023 | Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound ... | Potential for the labeled sterile ultrasound gel component within packs to not meet sterility spe... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 15, 2023 | Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound ... | Potential for the labeled sterile ultrasound gel component within packs to not meet sterility spe... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 15, 2023 | Always-On Tip Tracked Instruments (SPiN Drive instruments) 21ga ANSO Cytology... | Electromagnetic (EM) sensor tracking malfunction impacts the use of navigation functionality duri... | Class II | Olympus Corporation of the Americas |
| May 15, 2023 | Field Upgrade Kits: P/N 5451208 RIU, 9 INCH, TOSHIBA; P/N 5485304 SERVICE PAR... | Image intensifiers on systems, used to provide fluoroscopic/digital spot images can become detach... | Class II | GE OEC Medical Systems, Inc |
| May 15, 2023 | Medline Probe Cover Kits containing Turkuaz Ultrasound Gel, Labeled as the fo... | Potential for the labeled sterile ultrasound gel component within packs to not meet sterility spe... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 15, 2023 | Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound ... | Potential for the labeled sterile ultrasound gel component within packs to not meet sterility spe... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 15, 2023 | Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound ... | Potential for the labeled sterile ultrasound gel component within packs to not meet sterility spe... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 15, 2023 | Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound ... | Potential for the labeled sterile ultrasound gel component within packs to not meet sterility spe... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 15, 2023 | Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound ... | Potential for the labeled sterile ultrasound gel component within packs to not meet sterility spe... | 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.