Browse Device Recalls
3,276 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,276 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 3,276 FDA device recalls in 2024.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Dec 3, 2024 | ECONO STERILE medical procedure kits labeled as: ECONO STERILE TROUSSEAU D... | Reports of various packaging issues that may result in a breach of the sterile barrier. | Class II | Sklar Instruments |
| Dec 3, 2024 | ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE SIMS UTE... | Reports of various packaging issues that may result in a breach of the sterile barrier. | Class II | Sklar Instruments |
| Dec 3, 2024 | The FastPack IP Sex Hormone Binding Globulin Immunoassay, Part #25000081, is ... | Three lots of the FastPacks kitted into the FastPack SHBG Complete Kits were labeled with the inc... | Class III | Qualigen Inc |
| Dec 3, 2024 | ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE ROCH-PEA... | Reports of various packaging issues that may result in a breach of the sterile barrier. | Class II | Sklar Instruments |
| Dec 3, 2024 | ECONO STERILE medical procedure kits labeled as: ECONO STERILE" CURETTE EX... | Reports of various packaging issues that may result in a breach of the sterile barrier. | Class II | Sklar Instruments |
| Dec 3, 2024 | ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE BACKHAUS... | Reports of various packaging issues that may result in a breach of the sterile barrier. | Class II | Sklar Instruments |
| Dec 3, 2024 | ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE HEGAR DI... | Reports of various packaging issues that may result in a breach of the sterile barrier. | Class II | Sklar Instruments |
| Dec 3, 2024 | UNiD" Adaptive Spine Intelligence UNiD Spine Analyzer Product Number SW300... | Due to software anomalies that may impact on rod planning specifically, certain optional surgical... | Class II | Medicrea International |
| Dec 2, 2024 | Folysil Silicone Foley Catheters, Device Reference Numbers AA6106, AA6108, AA... | A possible sterility issue was detected in Coloplast's facility on some Coloplast products. | Class II | Coloplast Manufacturing US, LLC |
| Dec 2, 2024 | Change Healthcare Cardiology Hemodynamics software | Software defect concerning autosave mechanism may result in the clinician administering incorrect... | Class II | A L I Technologies Ltd |
| Dec 2, 2024 | MISHA Knee System Implant Small, Left, REF: 2-1001. MISHA Knee System Impl... | Knee implant may fracture due to a supplier-related issue with one component that has nonconformi... | Class II | Moximed, Inc. |
| Dec 2, 2024 | McKesson Cardiology Hemo software | Software defect concerning autosave mechanism may result in the clinician administering incorrect... | Class II | A L I Technologies Ltd |
| Dec 2, 2024 | VerifyNow P2Y12 Platelet Reactivity Test, REF: 85064 | Platelet Reactivity Test distributed without appropriate US-FDA market clearance; if used healthc... | Class II | Accriva Diagnostics, Inc. |
| Dec 2, 2024 | Microvention, Headway" 17 Advanced Straight Microcatheter with Hydrophilic Co... | Sterility assurance; microcatheter inner packaging may contain incomplete seal. | Class II | MICROVENTION INC. |
| Dec 2, 2024 | Change Healthcare Cardiology Hemo software | Software defect concerning autosave mechanism may result in the clinician administering incorrect... | Class II | A L I Technologies Ltd |
| Dec 2, 2024 | X-Flow prostatectomy catheter, Device Reference Numbers AB6022, AB6024, AB611... | A possible sterility issue was detected in Coloplast's facility on some Coloplast products. | Class II | Coloplast Manufacturing US, LLC |
| Nov 29, 2024 | Esteem Synergy Stomahesive Skin Barrier, part of Esteem synergy, which is a t... | Ostomy skin barrier package contains a pre-cut wafer of 28mm instead of 16mm and/or 35mm pre-cut... | Class II | ConvaTec, Inc |
| Nov 27, 2024 | Sheath, 18 Fr., 160 mm (REF: WA2PS18L), gastroenterology-urology endoscopic a... | If the inflow speed is too quick, it could result in reduced outflow through the shaft due to blo... | Class I | Trokamed GmbH |
| Nov 27, 2024 | Sheath, 20 Fr., 130 mm (REF: WA2PS20S), gastroenterology-urology endoscopic a... | If the inflow speed is too quick, it could result in reduced outflow through the shaft due to blo... | Class I | Trokamed GmbH |
| Nov 27, 2024 | OsteoCove Putty, 1.25cc, REF 56920013 and Cove Putty, 1.25cc REF 02-9200-01. | Hydration issue resulting in the product being less cohesive and moldable than intended due to an... | Class II | IsoTis OrthoBiologics, Inc. |
| Nov 27, 2024 | OsteoSurge 100 Demineralized Bone Matrix Putty with Accell Bone Matrix, Osteo... | Incorrect expiration date listed on the outer box, which does not align with the correct expirati... | Class II | IsoTis OrthoBiologics, Inc. |
| Nov 27, 2024 | Sheath, 20 Fr., 160 mm (REF: WA2PS20L), gastroenterology-urology endoscopic a... | If the inflow speed is too quick, it could result in reduced outflow through the shaft due to blo... | Class I | Trokamed GmbH |
| Nov 27, 2024 | Brand Name: 3B Medical, Inc. Product Name: Ultrasoft Oxygen Cannula, 12 Foot... | The devices were inadvertently shipped after their expiration date. | Class II | 3B Medical, Inc. |
| Nov 27, 2024 | Sheath, 18 Fr., 130 mm (REF: WA2PS18S), gastroenterology-urology endoscopic a... | If the inflow speed is too quick, it could result in reduced outflow through the shaft due to blo... | Class I | Trokamed GmbH |
| Nov 26, 2024 | 3M Unitek Transbond Plus Self-Etching Primer REF 712-090 (100 unit box) 712... | Due to an increase of complaints for bracket bond failures and skin irritation or blistering. | Class II | 3M Unitek Corporation |
| Nov 26, 2024 | AMT Mini Enteral Extension Set, 12" Right Angle Feeding Set with Y-Port. Mode... | The extension sets subject to this recall have ENFit connections, although they should have non- ... | Class II | Applied Medical Technology Inc |
| Nov 26, 2024 | Brand Name: HALYARD Product Name: Laparotomy Pack Model/Catalog Number: 882... | Elevated residues of anti-block/slip additive used in manufacturing found within sterile packaging. | Class II | O&M HALYARD, INC. |
| Nov 26, 2024 | Access Intact PTH assay, a paramagnetic particle, chemiluminescent immunoassa... | Beckman Coulter has identified that some Access PTH reagent packs from lot 339071 may be over- or... | Class II | Beckman Coulter, Inc. |
| Nov 25, 2024 | Turbo Elite Laser Atherectomy Catheter Model Number / UDI-DI code / Product ... | Due to complaints received for the marker band detaching from the distal tip of the catheter and ... | Class II | Spectranetics Corporation |
| Nov 25, 2024 | Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument P... | The probe tips of the hand instruments are being damaged or breaking including pad damage and det... | Class II | Olympus Corporation of the Americas |
| Nov 25, 2024 | Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument P... | The probe tips of the hand instruments are being damaged or breaking including pad damage and det... | Class II | Olympus Corporation of the Americas |
| Nov 25, 2024 | Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument P... | The probe tips of the hand instruments are being damaged or breaking including pad damage and det... | Class II | Olympus Corporation of the Americas |
| Nov 25, 2024 | Xhibit Telemetry Receiver with Software, Model 96280. Intended to provide mo... | Telemetry receivers with affected software versions may experience unsolicited system shut down a... | Class II | Spacelabs Healthcare, Inc. |
| Nov 25, 2024 | GE Healthcare Optima XR240amx, Mobile Digital Radiographic System, Model Numb... | GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a co... | Class II | GE Medical Systems, LLC |
| Nov 25, 2024 | Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument P... | The probe tips of the hand instruments are being damaged or breaking including pad damage and det... | Class II | Olympus Corporation of the Americas |
| Nov 25, 2024 | Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument P... | The probe tips of the hand instruments are being damaged or breaking including pad damage and det... | Class II | Olympus Corporation of the Americas |
| Nov 25, 2024 | Eclipse Mini REF 98900 The Eclipse MINI Model 98900 is a portable non-inva... | Due to a manufacturing error the incorrect device serial number was potentially programmed into t... | Class II | Spacelabs Healthcare, Ltd. |
| Nov 25, 2024 | Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument P... | The probe tips of the hand instruments are being damaged or breaking including pad damage and det... | Class II | Olympus Corporation of the Americas |
| Nov 25, 2024 | Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument P... | The probe tips of the hand instruments are being damaged or breaking including pad damage and det... | Class II | Olympus Corporation of the Americas |
| Nov 25, 2024 | AURYON LASER SYSTEM 100-120 VAC. Model Number: EXM001. Product Number: EXM-20... | Potential for procedural delays or interruptions during use of the Auryon Atherectomy System due ... | Class II | Angiodynamics, Inc. |
| Nov 25, 2024 | Xhibit Telemetry Receiver, Model 96280, with Service Manual. Intended to pr... | Telemetry receiver systems may experience a Windows proxy Issue causing the system to shut down a... | Class II | Spacelabs Healthcare, Inc. |
| Nov 25, 2024 | Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument P... | The probe tips of the hand instruments are being damaged or breaking including pad damage and det... | Class II | Olympus Corporation of the Americas |
| Nov 25, 2024 | Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument P... | The probe tips of the hand instruments are being damaged or breaking including pad damage and det... | Class II | Olympus Corporation of the Americas |
| Nov 25, 2024 | Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument P... | The probe tips of the hand instruments are being damaged or breaking including pad damage and det... | Class II | Olympus Corporation of the Americas |
| Nov 25, 2024 | GE Healthcare Optima XR200amx, Mobile Digital Radiographic System, Model Numb... | GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a co... | Class II | GE Medical Systems, LLC |
| Nov 25, 2024 | GE Healthcare Optima XR220amx, Mobile Digital Radiographic System, Model Numb... | GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a co... | Class II | GE Medical Systems, LLC |
| Nov 25, 2024 | Eclipse PRO REF 98700 The Spacelabs model 98700 is a portable non-invasive... | Due to a manufacturing error the incorrect device serial number was potentially programmed into t... | Class II | Spacelabs Healthcare, Ltd. |
| Nov 25, 2024 | Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument P... | The probe tips of the hand instruments are being damaged or breaking including pad damage and det... | Class II | Olympus Corporation of the Americas |
| Nov 24, 2024 | Otological Ventilation Tube - Donaldson - Double - Blue Silicone; Product Cod... | Lack of 510(k) clearance. | Class II | Adept Medical Ltd |
| Nov 24, 2024 | Otological Ventilation Tube - T-Tube 12mm - Double - Silicone; Product Code: ... | Lack of 510(k) clearance. | Class II | Adept Medical 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.