Medical device recalls

FDA recalls of medical devices including diagnostics, implants, and consumer health hardware.

226–250 of 390

HighFDA (Devices)·Z-2020-2026·2026-05-06
Medline Medical Procedure Kits With Neuro Sponges Recalled
Medline Industries is recalling medical procedure kits containing Medline Neuro Sponges due to higher-than-expected endotoxin levels that may be out-of-specification.
Product
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. ZALE STEREOTACTIC CDS, Medline Kit Number/SKU CDS983173G; 2. EPISTAXIS TRAY, Medline Kit Number/SKU DYNDA3240; 3. RHINO PACK, Medline Kit Number/SKU DYNJ46504B; 4. MSC SEPTO RHINO PA
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1960-2026·2026-05-06
Philips Ingenia Ambition S MRI Systems Recalled for Stiffness Value Errors
Philips is recalling certain Ingenia Ambition S MRI systems with MR Elastography software due to potential stiffness value errors that may occur when specific image reconstruction parameters are used in combination with Resoundant's algorithm.
Product
Philips Ingenia Ambition S with MR Elastography (MRE). 1. Model Number (REF): 781359. 2. Model Number (REF): 782108. 3. Model Number (REF): 782139.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2006-2026·2026-05-06
Leksell Vantage Arc System locking mechanism may not secure properly
Elekta, Inc. is recalling the Leksell Vantage Arc System because locking mechanisms may fail to properly secure to the Arc system, which could cause coordinate shifting during medical procedures.
Product
Brand Name: Leksell Vantage Arc System REF: 1053958
Category
Medical Device
Distribution
32 states
HighFDA (Devices)·Z-2032-2026·2026-05-06
Medline Neuro Sponges recalled for higher-than-expected endotoxin levels
Medline Industries is recalling medical procedure kits containing Medline Neuro Sponges due to higher-than-expected endotoxin levels that may exceed specifications.
Product
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: SPNG NEURO 1X1 10/PK XR, Medline Kit Number/SKU DNSC38133
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2045-2026·2026-05-06
Medline medical convenience kits recalled for non-sterile alcohol prep pads
Medline Industries is recalling multiple medical convenience kits nationwide due to Webcol Large Alcohol Prep Pads that were found to be non-sterile. A contaminant (Paenibacillus phoenicis) was discovered during a routine sterilization dose audit.
Product
Medline and Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as: 1. LVAD DRIVELINE KIT (Centurion), Medline Kit SKU DT17360 (Centurion); 2. LONG TERM/INPATIENT IV SECUREMENT SET (Centurion), Medline Kit SKU IVS1975A; 3. CVC DRESSING C
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1994-2026·2026-05-06
Straumann n!ce PMMA Dental Implant Abutments Recalled for Screw Seat Defect
Straumann USA LLC is recalling Straumann n!ce PMMA Full-arch Restoration screw-retained bridge abutments (Article 010.0304) due to an incorrect screw seat interface. Five units were distributed to dental offices in eight states.
Product
Straumann n!ce PMMA Full-arch Restoration. Screw-retained Bridge. Article 010.0304. Endosseous Dental Implant Abutments
Category
Medical Device
Distribution
8 states
HighFDA (Devices)·Z-2036-2026·2026-05-06
Medline medical procedure kits with neuro sponges recalled for endotoxin
Medline Industries is recalling approximately 7004 medical procedure kits containing Medline Neuro Sponges due to higher-than-expected endotoxin levels that indicate out-of-specification product.
Product
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. ANTERIOR CERVICAL FUSION PACK, Medline Kit Number/SKU DYNJ40566C; 2. OB PACK (OBSJD)642-LF, Medline Kit Number/SKU DYNJ47491F; 3. ANTERIOR CERVICAL-LF, Medline Kit Number/SKU DYNJ58274;
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1951-2026·2026-05-06
Philips Achieva 1.5T MRI Scanner Stiffness Calculation Error Recall
Philips is recalling Achieva 1.5T MRI systems with MR Elastography software due to potential stiffness value errors that may occur with specific image reconstruction parameters, causing incorrect voxel size display in the default scan protocol.
Product
Philips Achieva 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781196. 2. Model Number (REF): 781296.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2039-2026·2026-05-06
Medline Medical Convenience Kits Recalled for Non-Sterile Alcohol Prep Pads
Medline Industries is recalling specific lots of medical convenience kits containing Webcol Large Alcohol Prep Pads because the pads were found to be non-sterile due to contamination with Paenibacillus phoenicis bacteria discovered during a sterilization audit.
Product
Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as: Universal Central/Art Line Insertion Kit, Medline Kit SKU ART155A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1954-2026·2026-05-06
Philips Evolution Upgrade 1.5T MRI Stiffness Calculation Error
Philips North America is recalling Philips Evolution Upgrade 1.5T MRI systems with MR Elastography due to potential stiffness value errors that may result in incorrect voxel size settings in the default scan protocol.
Product
Philips Evolution Upgrade 1.5T with MR Elastography (MRE). 1. Model Number (REF): 782116 2. Model Number (REF): 782148. 3. Model Number (REF): 782166.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2010-2026·2026-05-06
Medline Neuro Sponges in Medical Procedure Kits Recalled for High Endotoxin
Medline Industries is recalling Medline medical procedure kits containing Neuro Sponges (EH BRONCHOSCOPY, Kit Number DYNJT3270) due to higher-than-expected endotoxin levels that may be out of specification.
Product
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: EH BRONCHOSCOPY, Medline Kit Number/SKU DYNJT3270
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2019-2026·2026-05-06
Medline Medical Procedure Kits with Neuro Sponges Recalled for Endotoxin
Medline is recalling medical procedure kits containing Medline Neuro Sponges due to higher-than-expected endotoxin levels found during an internal review, indicating in-market product may be out-of-specification.
Product
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. RR-OMFS PACK-LF, Medline Kit Number/SKU DYNJ0045920D; 2. RR-OMFS PACK-LF, Medline Kit Number/SKU DYNJ0045920F; 3. MEM MAXILLOFACIAL PACK-LF, Medline Kit Number/SKU DYNJ0660040S; 4. O
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2000-2026·2026-05-06
i-STAT Blood Gas Analyzer Cartridges Recalled for Inaccurate Results
Abbott is recalling certain i-STAT EG6+, EG7+, and G3+ blood gas cartridges that may report falsely high CO2 and falsely low pH results due to a manufacturing issue, potentially leading to unnecessary or harmful clinical interventions.
Product
i-STAT EG6+ cartridge; List Number: 03P77-25;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2035-2026·2026-05-06
Medline robotic hysterectomy procedure kits recalled for elevated endotoxin
Medline Industries is recalling robotic hysterectomy procedure kits containing Medline Neuro Sponges due to higher-than-expected endotoxin levels that may indicate out-of-specification product in distribution worldwide.
Product
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. ROBOTIC HYSTERECTOMY, Medline Kit Number/SKU DYNJ904269B; 2. ROBOTIC HYSTERECTOMY, Medline Kit Number/SKU DYNJ904269C; 3. ROBOTIC HYSTERECTOMY, Medline Kit Number/SKU DYNJ904269D.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1990-2026·2026-05-06
DePuy Synthes ATTUNE Revision Hinge Femoral Component Sterility Recall
DePuy Synthes is recalling 3 units of the ATTUNE REVISION HINGE FEMORAL RT SZ 4 CEM due to external sterile packaging found adhered to internal packaging, potentially compromising sterility.
Product
Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 4 CEM. Part Number: 150450204.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2041-2026·2026-05-06
Medline and Centurion Medical Convenience Kits Recalled for Non-Sterile Alcohol Prep Pads
Medline Industries is recalling specific lots of medical convenience kits containing non-sterile Webcol Large Alcohol Prep Pads due to discovery of Paenibacillus phoenicis contamination. Affected kits were distributed nationwide.
Product
Medline and Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as: 1. FOLEY CARE KIT, Medline Kit SKU UROT1044; 2. IV START KIT WITH EXTENSION TUBING, Medline Kit SKU IV8770; 3. IV START KIT, Medline Kit SKU DYNDV2520; 4. ARTERIAL LINE
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1953-2026·2026-05-06
Philips Achieva 3.0T MR Elastography system stiffness value error recall
Philips is recalling the Achieva 3.0T with MR Elastography system due to potential stiffness value errors in image reconstruction when specific parameters are used, which may cause incorrect voxel size display in the default scan protocol.
Product
Philips Achieva 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781278.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1966-2026·2026-05-06
Philips SmartPath dStream 3.0T MRI Scanner Software Parameter Error Recall
Philips is recalling one unit of the SmartPath to dStream 3.0T MRI scanner with MR Elastography due to potential stiffness value calculation errors when specific image reconstruction parameters are used.
Product
Philips SmartPath to dStream for 3.0T with MR Elastography (MRE). 1. Model Number (REF): 782145.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1988-2026·2026-05-06
DePuy Synthes ATTUNE Revision Hinge Femoral Component Sterility Recall
DePuy Synthes is recalling 3 units of ATTUNE REVISION HINGE FEMORAL LT SZ 8 CEM due to external sterile packaging adhered to internal packaging, potentially compromising sterility.
Product
Depuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 8 CEM. Part Number: 150450108.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1967-2026·2026-05-06
Philips SmartPath to dStream MR Elastography Software Parameter Error
Philips is recalling specific units of SmartPath to dStream for XR and 3.0T with MR Elastography due to potential stiffness value errors when certain image reconstruction parameters are used with Resoundant's algorithm, which may cause voxel size settings in the default MRE scan protocol to display incorrectly.
Product
Philips SmartPath to dStream for XR and 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781270. 2. Model Number (REF): 782113.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1952-2026·2026-05-06
Philips Achieva 1.5T MRI System MRE Protocol Parameter Error Recall
Philips Achieva 1.5T MRI systems with MR Elastography may display incorrect stiffness values and voxel size settings when certain image reconstruction parameters are used together, potentially affecting diagnostic accuracy.
Product
Philips Achieva 1.5T Initial system with MR Elastography (MRE). 1. Model Number (REF): 781178.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2003-2026·2026-05-06
Philips Bridge Prep Kit catheter may experience resistance during advancement
Merit Medical Systems is recalling the Philips Bridge Prep Kit (REF K12-09098C) because the catheter may experience resistance when advanced over the guidewire, potentially affecting proper device function.
Product
Philips Bridge Prep Kit REF: K12-09098C Sterile EO, Rx ONLY
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1986-2026·2026-05-06
Depuy Synthes ATTUNE Revision Hinge Femoral Component Sterility Compromise
Depuy Synthes is recalling ATTUNE Revision Hinge Femoral components because external sterile packaging was found adhered to internal sterile packaging, potentially compromising sterility.
Product
Depuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 5 CEM. Part Number: 150450105.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1949-2026·2026-05-06
Genius Review Station Display Modified Outside Validated Configuration
Hologic is correcting Genius Review Station displays (model CMP-01669) that were modified by users outside the FDA-cleared configuration. The devices need restoration to validated settings per the manufacturer's Operator's Manual.
Product
Brand Name: Genius" Review Station Product Name: Genius" Review Station Display (Barco Monitor) Model/Catalog Number: CMP-01669 Software Version: N/A - not software version specific Component: Yes, the Genius" Review Station is a component of the Genius" Digital Diagnostics S
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1958-2026·2026-05-06
Philips Ingenia 3.0T MRI System with Elastography Software Recall
Philips Ingenia 3.0T MRI systems with MR Elastography software may display incorrect stiffness values and voxel size settings when specific image reconstruction parameters are used, potentially affecting diagnostic accuracy.
Product
Philips Ingenia 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781342. 2. Model Number (REF): 781377. 3. Model Number (REF): 782103. 510(k) Numbers: K163116, K173079, K183063, K193215, K213516, K213583, K223458, K251397, K251808
Category
Medical Device
Distribution
Distributed nationwide

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