Browse Device Recalls
35,307 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 35,307 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 35,307 FDA device recalls, Class II.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jun 23, 2023 | TRANS-RAY IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide... | During IAB catheter insertion, the introducer dilator may fracture at the hub, leaving the body o... | Class II | Datascope Corp. |
| Jun 23, 2023 | ellacor System with Micro-Coring Technology-Indicated for use by medical prof... | Potential failure of a bearing adhesive joint that can occur due to an assembly issue of the X/Y ... | Class II | Cytrellis Biosystems, Inc. |
| Jun 23, 2023 | MEGA 7.5Fr.IAB , Intra-Aortic Balloon Catheter and Accessories, used to provi... | During IAB catheter insertion, the introducer dilator may fracture at the hub, leaving the body o... | Class II | Datascope Corp. |
| Jun 22, 2023 | STATCLAVE G4 Chamber Autoclave -Tabletop steam sterilizer intended for use by... | The STATCLAVE G4 is a dynamic air removal (prevacuum) tabletop steam sterilizer intended for use ... | Class II | Scican Ltd. |
| Jun 22, 2023 | Fusion Lithotripsy Extraction Basket, Model Number FS-LXB-3X6 G48278; Fusion ... | Non-conforming product may appear in the field as inability to advance or retract the basket, or ... | Class II | Wilson-Cook Medical Inc. |
| Jun 22, 2023 | Gore Tips Set Device, Catalog Number TSET1016, percutaneous liver access | Three lots of product may be labeled with an incorrect expiration day | Class II | Creganna Medical Devices |
| Jun 22, 2023 | Fusion Lithotripsy Extraction Basket, Model Number FS-LXB-2X4 G48277; Fusion... | Non-conforming product may appear in the field as inability to advance or retract the basket, or ... | Class II | Wilson-Cook Medical Inc. |
| Jun 22, 2023 | INFX-8000C XGCP-930AA TABLE SIDE CONSOLE, INFX-8000C XGCP-930BA TABLE SIDE C... | The C-arm, used to set the position and angle of the x-ray exposure field, may not function due t... | Class II | Canon Medical System, USA, INC. |
| Jun 22, 2023 | STATCLAVE G4 Chamber Autoclave -Tabletop steam sterilizer intended for use by... | The STATCLAVE G4 is a dynamic air removal (prevacuum) tabletop steam sterilizer intended for use ... | Class II | Scican Ltd. |
| Jun 21, 2023 | Randox Liquid Urine Control Level 2- intended for in vitro diagnostic use, in... | (1) There is vial to vial variation resulting in some vials recovering positive for hCG, which sh... | Class II | Randox Laboratories Ltd. |
| Jun 21, 2023 | HoverMatt, 39" W x 78" L, REF: HM39SPU-B | 39-inche-wide inflatable air transfer mattress packages contain 34-Inch-wide mattresses, so there... | Class II | Stryker Sustainability Solutions |
| Jun 21, 2023 | A901 Communication Manager Application, used in conjunction with the A710 Cli... | When an update to the A710 Clinician Programmer software application for the Intellis Neurostimul... | Class II | Medtronic Neuromodulation |
| Jun 20, 2023 | Ringed DxI Reaction Vessels (RVs) | Beckman Coulter, Inc. is recalling Ringed DxI Reaction Vessels (RVs) as part of Unicel DxI Immuno... | Class II | Beckman Coulter, Inc. |
| Jun 19, 2023 | GEM FLOW COUPLER Monitor, PN 5156-00000-011 | An issue was identified where the LCD monitor display may not indicate the correct active channel... | Class II | Baxter Healthcare Corporation |
| Jun 19, 2023 | ARTIS icono floor-Angiography systems developed for single and biplane diagno... | Due to a hardware issue in the cable connectors of the system generator, a thermal overload in th... | Class II | Siemens Medical Solutions USA, Inc |
| Jun 19, 2023 | ProPlan CMF Patient-Specific Guide, Mandible guides (3A & 3B)-Intended to gui... | Wrong versions of guides 3A and 3B (Patient Specific) were shipped prior to the re-design request | Class II | Materialise N.V. |
| Jun 19, 2023 | ARTIS pheno-Angiography systems developed for single and biplane diagnostic i... | Due to a hardware issue in the cable connectors of the system generator, a thermal overload in th... | Class II | Siemens Medical Solutions USA, Inc |
| Jun 19, 2023 | ARTIS icono biplane -Angiography systems developed for single and biplane dia... | Due to a hardware issue in the cable connectors of the system generator, a thermal overload in th... | Class II | Siemens Medical Solutions USA, Inc |
| Jun 16, 2023 | NovaPlus Infant Heel Warmer, Instant Squeeze Activation, Catalog Number V1146... | Cardinal Health has received an increase in burst/leaking complaints from mid-April to May regard... | Class II | Cardinal Health 200, LLC |
| Jun 16, 2023 | CONFORMIS HIP-SCREW-6.5MM X 25MM, STERILE EO | 30mm screws were labeled as 25mm screws. | Class II | Conformis, Inc. |
| Jun 15, 2023 | DOLOMITE GLOSS ROLLATOR - intended to support during walking and may also ser... | Premature failure of the seat during use, the plastic eyelets of the folding mechanism of the dev... | Class II | Invacare Corporation |
| Jun 15, 2023 | Brand Name: Rio" II Product Name: Rio" II Nasal Pillows Interface Model/Cat... | Packaging and labeling discrepancy involving product size identification and associated Unique De... | Class II | 3B Medical, Inc. |
| Jun 15, 2023 | MEGADYNE Suction Coagulators, Product Code 004125 (Suction Coagulator, Handsw... | An issue with the Suction Coagulator product family may lead to fluid ingress into the handpiece.... | Class II | Megadyne Medical Products, Inc. |
| Jun 14, 2023 | Simplexa Direct Amplification Disc Kit, Rx Only, IVD The Simplexa Direct A... | There is a potential for the direct amplification disc to malfunction which may result in spilla... | Class II | DiaSorin Molecular LLC |
| Jun 14, 2023 | IntelliVue Patient Monitor MX400/MX450/MX500/MX550 with software version P.01... | Devices with Option CP2 and initially programmed to software version P.01.01 were configured inco... | Class II | Philips North America Llc |
| Jun 13, 2023 | Randox RX Series Urea Enzymatic Kinetic Assay Ref. Numbers: (1) UR3825 (... | Carryover from the Direct LDL-cholesterol assay on the Rx instruments may result in a negative bi... | Class II | Randox Laboratories Ltd. |
| Jun 13, 2023 | Stryker Infinity Alignment Frame Distal Sub-Assembly, Catalog #33600020, non-... | The devices were manufactured with the pin sleeve holes too narrow, which does not allow the pin... | Class II | Wright Medical Technology, Inc. |
| Jun 13, 2023 | Durepair Dura Regeneration Matrix: DUREPAIR DURA SUBSTITUTE 2 X 2, 61100; ... | Dura regeneration matrix may have out-of-specification endotoxin levels due to issues with in-pro... | Class II | Medtronic Neurosurgery |
| Jun 12, 2023 | Ingenia Elition S Magnetic Resonance (MR) system, Product Numbers 781357 and ... | The system operator is able to bypass the SmokeDetector Interlock system locking mechanism after ... | Class II | Philips North America |
| Jun 12, 2023 | Ingenia Elition S Magnetic Resonance (MR) system, Product Numbers 781357 and ... | During installation of the SmokeDetector Interlock, a connecting cable, between the SmokeDetector... | Class II | Philips North America |
| Jun 12, 2023 | Azurion 7 M20. X-ray Image guided Therapy System. | The bolts supporting the FlexMove Carriage may become loose and/or break, and cracks may appear i... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Jun 12, 2023 | Ingenia Elition X Magnetic Resonance (MR) system, Product Numbers 781358, 782... | During installation of the SmokeDetector Interlock, a connecting cable, between the SmokeDetector... | Class II | Philips North America |
| Jun 12, 2023 | AEQUALIS FLEX REVIVE Assembly Screw 0mm Short, Model Number ARS655118 | A comingle/swap resulted in the labeling and laser marking on the product to state it is a Aequal... | Class II | Tornier, Inc |
| Jun 12, 2023 | da Vinci Xi/X Tip-Up Fenestrated Grasper, REF: 470347, VER: 12 | Fenestrated Graspers have a manufacturing issue has the potential to cause breakage on both upper... | Class II | Intuitive Surgical, Inc. |
| Jun 12, 2023 | MR 7700 Magnetic Resonance (MR) system, Product Numbers 782120 and 782130 (Up... | During installation of the SmokeDetector Interlock, a connecting cable, between the SmokeDetector... | Class II | Philips North America |
| Jun 12, 2023 | Ingenia Elition X Magnetic Resonance (MR) system, Product Numbers 781358, 782... | The system operator is able to bypass the SmokeDetector Interlock system locking mechanism after ... | Class II | Philips North America |
| Jun 12, 2023 | AEQUALIS FLEX REVIVE Assembly Screw 0mm, Model Number ARS655101 | A comingle/swap resulted in the labeling and laser marking on the product to state it is a Aequal... | Class II | Tornier, Inc |
| Jun 12, 2023 | Allura Xper FD10 and FD20. X-ray Imaging System. | The bolts supporting the FlexMove Carriage may become loose and/or break, and cracks may appear i... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Jun 12, 2023 | MR 7700 Magnetic Resonance (MR) system, Product Numbers 782120 and 782130 (Up... | The system operator is able to bypass the SmokeDetector Interlock system locking mechanism after ... | Class II | Philips North America |
| Jun 9, 2023 | REF: 126590, MEDLINE, STERILE ULTRASOUND GEL, 0.70 FL oz. (20 mL), QTY: 50, S... | Sterility of Ultrasound gel can not be guaranteed. | Class II | Turkuaz Saglik Hizmetleri Medikal Temizlik Kim.... |
| Jun 8, 2023 | BD Synapsys Informatics Solution, Catalog Number 444150 | There is a risk of mis-association of patient demographic data for users who choose to report res... | Class II | Becton Dickinson & Co. |
| Jun 8, 2023 | Argon Medical Devices, REF 352506070E, Option Elite Retrievable Vena Cava Fil... | There is the potential that the vena Cava Filter may not perform as intended which may result in ... | Class II | Argon Medical Devices, Inc |
| Jun 8, 2023 | HF Resection Electrodes - HF resection electrodes are part of a resectoscope ... | Additional Caution statements in IFU: (1) Due to complaints where the loop wire at the distal end... | Class II | Olympus Corporation of the Americas |
| Jun 7, 2023 | FRED Flow Re-Direction Endoluminal Device, REF: FRED3507-PMA, FRED3511, FRED3... | Intracranial aneurysm flow diverter device may be manufactured with an incorrect inner stent leng... | Class II | MICROVENTION INC. |
| Jun 7, 2023 | BeamAdjust software Version 2.3.3 Ref: S080032 The following devices are a... | Generated calibration file will not be correct in case of a relative calibration of an OCTAVIUS D... | Class II | PTW-FREIBURG |
| Jun 6, 2023 | OmniTom/OmniTom Elite- X-ray computed tomography applications for anatomy tha... | 1. Wheels loosening over time with use of the device could lead to the inability to effectively d... | Class II | NeuroLogica Corporation |
| Jun 6, 2023 | Vanta with AdaptiveStim Implantable Neurostimulator, Model 977006; spinal cho... | A cardioversion procedure may damage the electronics in the Vanta INS device, making the INS unre... | Class II | Medtronic Neuromodulation |
| Jun 6, 2023 | Medtronic Catalyft LS Expandable Interbody System Implant Kit, Anterior Stand... | There is the potential for out of specification device geometries. widths, lengths, heights, and... | Class II | Medtronic Sofamor Danek USA Inc |
| Jun 6, 2023 | Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, ... | There is the potential for out of specification device geometries. widths, lengths, heights, and... | Class II | Medtronic Sofamor Danek USA Inc |
| Jun 6, 2023 | Vios Monitoring System Bedside Monitor, Model BSM2050, Software Version Numbe... | A premature failure condition was identified with the L2050R pulse oximeter SpO2 sensor that conn... | Class II | Murata Vios, Inc. |
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.