Browse Device Recalls
2,479 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,479 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 2,479 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jul 30, 2026 | BD Needle Kit for Powered Driver 15mm x 15Ga, REF: D015151NK, BD Needle Kit ... | After placement of intraosseous (IO) needle sets, used when intravenous access is difficult or im... | Class I | Bard Access Systems, Inc. |
| Jul 13, 2026 | GM Helix Implant, Endosseous Dental Implant Article No. 109.984 | There may be a mismatch between the implant contained inside the packaging and the information de... | Class II | Straumann USA LLC |
| Jul 10, 2026 | Custom Made Device Implant 6123 Navicular Cage Nominal Right Rev A, Model/Cat... | Device was recalled due to an elevated oxygen level in excess of the allowable limit. Elevated ox... | Class III | Paragon 28, Inc. |
| Jul 10, 2026 | Custom Made Device Implant 6123 Navicular Cage Small Right Rev A, Model/Catal... | Device was recalled due to an elevated oxygen level in excess of the allowable limit. Elevated ox... | Class III | Paragon 28, Inc. |
| Jun 30, 2026 | Rapid Refill Continuous Injection System, UPN M00566001 | Devices contain recalled Medline Namic Angiographic Control Syringe with Rotating Adaptor. There ... | Class II | Boston Scientific Corporation |
| Jun 24, 2026 | Hotline Fluid Warming Set, single use device, is designed to warm blood and i... | ICU Medical became aware of an increased likelihood of leakage in specific Lots of L-70 HOTLINE F... | Class II | ICU Medical Inc. |
| Jun 17, 2026 | Ventriculostomy Kit, REF: 46154 | Ventriculostomy devices, used during ventriculostomy procedures to gain access to the ventricular... | Class II | Medtronic Neurosurgery |
| Jun 10, 2026 | Orthofix MINIRAIL, ARTICULATED, FIXATOR, VERTICAL AXIS REF: M122, Unilateral... | Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M10... | Class II | Orthofix U.S. LLC |
| Jun 10, 2026 | Orthofix ARTICULATED MINIRAIL FIXATOR HORIZONTAL AXIS REF: M111, Unilateral ... | Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M10... | Class II | Orthofix U.S. LLC |
| Jun 10, 2026 | ICU Medical Plum Solo Precision IV Pump, v1.0.3, Item Number 400010401; infus... | In a specific scenario, the pump will not decrement the Volume to be Infused (VTBI) displayed on ... | Class II | ICU Medical, Inc. |
| Jun 10, 2026 | ICU Medical Plum Duo Infusion Pump, v1.2.3: 1) Item Number 400020401 and 2) ... | In a specific scenario, the pump will not decrement the Volume to be Infused (VTBI) displayed on ... | Class II | ICU Medical, Inc. |
| Jun 8, 2026 | MEDLINE medical procedure convenience kit labeled as: HIP CDS-LF, Medline ... | The procedure kits contain ICU Medical, Inc. pain management kits containing Bupivacaine Hydrochl... | Class I | Medline Industries, LP |
| Jun 8, 2026 | MEDLINE medical procedure convenience kit labeled as: 1) TOTAL KNEE-LF, Med... | The procedure kits contain ICU Medical, Inc. pain management kits containing Bupivacaine Hydrochl... | Class I | Medline Industries, LP |
| May 25, 2026 | Medtronic Bio-Medicus Adult Cannula Kit, Product Number/CFN 96530-115; Cardio... | Medtronic received two complaints of loose foreign material confirmed as containing trace levels ... | Class II | Medtronic Perfusion Systems |
| May 22, 2026 | IntelliCuff, Portable automatic cuff pressure controller REF: 951001 | Due to reported complaints, the cuff device may alarm with a "Cuff System Leakage" error. As a re... | Class II | Hamilton Medical AG |
| May 21, 2026 | Medline Convenience Kits: 1) PI CVC KIT 3L 7 FR 16 CM, Model Number: ECVC8520... | The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(... | Class II | Medline Industries, LP |
| May 15, 2026 | Reprocessed Electrophysiology Catheters and Ultrasound Catheters Item no. ... | Expansion of RES 98277. Specific lots of reprocessed catheters may contain small particles of res... | Class I | Medline Industries, LP |
| May 14, 2026 | Automated Impella Controller (AIC), for use with left heart support blood pum... | Potential software error in the Automated Impella Controller ("AIC" ) when used in conjunction wi... | Class I | Abiomed, Inc. |
| May 13, 2026 | Pack Angiography NCMC 3/Cs BANNER, REF: NCAG62I, containing Medline Namic Ang... | Cardiovascular procedure kits contain manifolds, the subject of another recall, that may have par... | Class I | Medical Action Industries, Inc. 306 |
| May 13, 2026 | Brand Name: HeartMate Product Name: HM 11V Li-ion Backup Battery, ABT Model... | Due to 11 volt Backup Battery failures. | Class II | Thoratec LLC |
| May 13, 2026 | Brand Name: HeartMate Product Name: HeartMate 3 Left Ventricular System (LVA... | Due to 11 volt Backup Battery failures. | Class II | Thoratec LLC |
| May 13, 2026 | Brand Name: HeartMate Product Name: HeartMate 3" System Controller Model/Ca... | Due to 11 volt Backup Battery failures. | Class II | Thoratec LLC |
| Apr 30, 2026 | Halyard convenience kits containing recalled Medline Namic Angiographic Star ... | Affected kits contain Medline Namic Angiographic Star Off Handle Manifolds, which were recalled b... | Class I | AVID Medical, Inc. |
| Apr 30, 2026 | Halyard convenience kits containing recalled Medline Namic Angiographic Star ... | Affected kits contain Medline Namic Angiographic Star Off Handle Manifolds, which were recalled b... | Class I | AVID Medical, Inc. |
| Apr 30, 2026 | Halyard convenience kits containing recalled Medline Namic Angiographic Star ... | Affected kits contain Medline Namic Angiographic Star Off Handle Manifolds, which were recalled b... | Class I | AVID Medical, Inc. |
| Apr 30, 2026 | Allura system; System Code Description (Model Numbers): Allura Xper FD10 (722... | It was identified that HDDs used in the PCs of Azurion and Allura systems may show a decrease in ... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Apr 30, 2026 | Azurion system; System Code Description (Model Numbers): Azurion 3 M12 (72206... | It was identified that HDDs used in the PCs of Azurion and Allura systems may show a decrease in ... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Apr 29, 2026 | Plum Solo Precision IV Pump, 40001-0401 | Under certain conditions, the pump may not display a soft limit alert, and will not notify the cl... | Class II | ICU Medical, Inc. |
| Apr 29, 2026 | Plum Duo Infusion Pump, 40002-0401 | Under certain conditions, the pump may not display a soft limit alert, and will not notify the cl... | Class II | ICU Medical, Inc. |
| Apr 29, 2026 | Plum Duo Precision IV Pump, 40002-0403 | Under certain conditions, the pump may not display a soft limit alert, and will not notify the cl... | Class II | ICU Medical, Inc. |
| Apr 24, 2026 | EXCOR Pediatric Ventricular Assist Device (VAD) System Blood Pump PU Valves: ... | Blood pump inner package expiration date does not match the outer-correct expiration date, which ... | Class II | BERLIN HEART GMBH |
| Apr 24, 2026 | Brand Name: Da Vinci 5 Product Name: ASSY,DV5 TOWER,IS5000 Model/Catalog Nu... | Due to unintentionally activated near infrared handheld camera when attempting to turn off illumi... | Class II | Intuitive Surgical, Inc. |
| Apr 21, 2026 | Description/REF: MIDLINE CATHETER KIT: 3 FR X 20 CM/CDC-02031-MK1A; AM/AT PI ... | Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included... | Class I | ARROW INTERNATIONAL, LLC |
| Apr 21, 2026 | Description/REF: PI AGBA PICC KIT: 3L 6 FR X 40 CM W/VPS/ASK-44063-NS AGBA ... | Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included... | Class I | ARROW INTERNATIONAL, LLC |
| Mar 27, 2026 | Edwards EVOQUE tricuspid delivery system REF:9850TDS Sterile EO | Labeling update to provide warning if functionality of the valve replacement delivery system is ... | Class II | Edwards Lifesciences, LLC |
| Mar 24, 2026 | Oncology Kit w/60" (152 cm) Appx 2.2 ml, Smallbore Ext Set w/ChemoLock Port, ... | Oncology sets/closed system transfer devices with extension sets may leak resulting in therapy de... | Class II | ICU Medical, Inc. |
| Mar 24, 2026 | Medline medical convenience kits, containing Namic Manifold, Labeled as: 1... | Medline has identified the presence of particulate within the fluid path of the Manifolds. | Class I | Medline Industries, LP |
| Mar 24, 2026 | Namic Preceptor Manifold, custom, Medline Product Number/SKU 64039307; Extrav... | Medline has identified the presence of particulate within the fluid path of the Manifolds. | Class I | Medline Industries, LP |
| Mar 24, 2026 | Namic Angiographic Manifold, custom, Medline Product Number/SKU 64038402; Car... | Medline has identified the presence of particulate within the fluid path of the Manifolds. | Class I | Medline Industries, LP |
| Mar 24, 2026 | Namic Angiographic Manifold, custom, Medline Product Number/SKU 64038200; Car... | Medline has identified the presence of particulate within the fluid path of the Manifolds. | Class I | Medline Industries, LP |
| Mar 24, 2026 | Namic Angiographic Manifold, custom, Medline Product Number/SKU 64038301; Car... | Medline has identified the presence of particulate within the fluid path of the Manifolds. | Class I | Medline Industries, LP |
| Mar 24, 2026 | 1. DBD-MTS,3V,MAN,KIT, Medline Kit Number/SKU 60010195; 2. MTS-LEFT HEART,K... | Medline has identified the presence of particulate within the fluid path of the Manifolds. | Class I | Medline Industries, LP |
| Mar 24, 2026 | 1. 3 VALVE MAN KIT, Medline Kit SKU Number: 65101544; 2. 3V MANIFOLD KIT, ... | Medline has identified the presence of particulate within the fluid path of the Manifolds. | Class I | Medline Industries, LP |
| Mar 24, 2026 | Medline medical convenience kits, containing Namic Manifold, Labeled as: 1... | Medline has identified the presence of particulate within the fluid path of the Manifolds. | Class I | Medline Industries, LP |
| Mar 24, 2026 | Medline medical convenience kits, containing Namic Manifold, Labeled as: TAV... | Medline has identified the presence of particulate within the fluid path of the Manifolds. | Class I | Medline Industries, LP |
| Mar 24, 2026 | Namic Preceptor Manifold, custom, Medline Product Number/SKU 64037107; Extrav... | Medline has identified the presence of particulate within the fluid path of the Manifolds. | Class I | Medline Industries, LP |
| Mar 24, 2026 | Medline medical convenience kits, containing Namic Manifold, Labeled as: HEA... | Medline has identified the presence of particulate within the fluid path of the Manifolds. | Class I | Medline Industries, LP |
| Mar 11, 2026 | Medtronic Sphere-9 Catheter, Model Number AFR-00001; catheter, percutaneous, ... | ventricular fibrillation (VF) during radiofrequency (RF) therapy with the Medtronic Sphere-9 cath... | Class II | Medtronic, Inc. |
| Feb 27, 2026 | Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringe... | Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FD... | Class II | Medline Industries, LP |
| Feb 25, 2026 | Medline Kits: 1) MTS LEFT HEART KIT-CAROLINAS HOS, Model Number: 60021775; ... | The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure T... | Class II | Medline Industries, 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.