Medical device recalls

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

1051–1075 of 13399

HighFDA (Devices)·Z-1196-2026·2026-02-04
Medline Medical Procedure Kits Recalled Due to Tubing Defect Risk
Medline recalled multiple medical procedure kits due to a defect causing butyrate tubing in MASTISOL liquid adhesive vials to crack during use. The affected kits are used in neurological and surgical procedures.
Product
Medline medical procedure convenience kits labeled as: 1) DEPAUL BASIC NEURO-LF, Kit SKU DYNJ20028L; 2) NEURO MINOR PACK, Kit SKU DYNJ46546M; 3) NEURO SHUNT PACK, Kit SKU DYNJ54396K; 4) NEURO PACK, Kit SKU DYNJ59397Q; 5) NEURO BASIC, Kit SKU DYNJ904052L; 6) PK NEURO
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1187-2026·2026-02-04
Medline Medical Procedure Kits Recalled for Defective Adhesive Tubing
Medline Industries is recalling 1,928 units of two procedure convenience kits due to MASTISOL liquid adhesive vials with tubing that can crack during actuation, potentially affecting proper kit function.
Product
Medline medical procedure convenience kits labeled as: 1) CATH LAB PACEMAKER PACK-LF, Kit SKU DYNJ64837C; 2) LOOP RECOVERY PACK, Kit SKU DYNJT7034;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1214-2026·2026-02-04
Philips MR 7700 MRI System Software May Display Incorrect Stiffness Values
Philips MR 7700 MRI systems with software versions R11.1 and R12.1 may display incorrect stiffness values from elastography maps in PACS viewers, potentially affecting diagnostic interpretation.
Product
Upgrade to MR 7700. Product Code (REF): 782130. MR systems with SW version R11.1 and R12.1.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1175-2026·2026-02-04
Siemens LUMINOS fluoroscopic X-ray system automatic flip software error
A Siemens LUMINOS interventional X-ray system may fail to flip ortho images as intended, risking processing of a previous patient's image. No illnesses or injuries have been reported.
Product
Interventional Fluoroscopic X-Ray System: LUMINOS Q.namix T; Siemens Material Number (SMN): 11574003; With Software Version VB10D-SP02
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1206-2026·2026-02-04
Philips Ingenia 1.5T MRI Software Displays Incorrect Elastography Values
Philips Ingenia 1.5T MRI systems with software versions R11.1 or R12.1 may display incorrect stiffness values when viewing MR Elastography images in medical imaging systems. Ten affected units have been identified worldwide.
Product
Ingenia 1.5T. Product Code (REF): (1) 781341, (2) 781396. MR systems with SW version R11.1 and R12.1.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1219-2026·2026-02-04
LSL Healthcare Central Line Dressing Kit Recalled for Open Seal Defect
LSL Healthcare recalls 1,400 Central Line Dressing Kits due to open seals on BD ChloraPrep Swabstick applicators, which may compromise sterility during use. No illnesses have been reported.
Product
LSL Healthcare, Central Line Dressing Kit, Model/Catalog Number: 2519CP, medical procedure convenience kit
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1168-2026·2026-02-04
FDA Recalls Genesis Screw-In Anchor for Device Failure
The FDA is recalling Genesis Screw-In Anchor devices due to reports of device failure including breakage, bending, and pull-out. Approximately 600 units distributed in California and Puerto Rico are affected.
Product
Genesis Screw-In Anchor
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1188-2026·2026-02-04
Medline Cardiac Procedure Kits Recalled Due to Cracking Tubing in Adhesive Vials
Medline Industries recalls eight medical procedure kits nationwide due to MASTISOL liquid adhesive vials with cracking butyrate tubing. The defect could affect proper device function during cardiac and vascular procedures.
Product
Medline medical procedure convenience kits labeled as: 1) PACER / CATH LAB PACK-LF, Kit SKU DYNJ0972604A; 2) PACEMAKER/ICD PACK, Kit SKU DYNJ33822L; 3) VENOUS ACCESS PACK, Kit SKU DYNJ45640B; 4) PACEMAKER SET UP, Kit SKU DYNJ63377D; 5) PACK PACEMAKER CUSTOM,9909178, Ki
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1192-2026·2026-02-04
Medline medical procedure convenience kits recalled due to defective adhesive tubing
Medline is recalling multiple medical procedure convenience kits containing MASTISOL liquid adhesive because the butyrate tubing cracks during use, posing a potential safety risk. The recall affects 66 units distributed nationwide.
Product
Medline medical procedure convenience kits labeled as: 1) MEM MAXILLOFACIAL PACK-LF, Kit SKU DYNJ0660040R; 2) PLASTICS VCH, Kit SKU DYNJ39225K; 3) WT BREAST PACK, Kit SKU DYNJ46620I; 4) ENDO / AUG PACK, Kit SKU DYNJ59250I; 5) KMC PLASTIC/GEN PACK-LF, Kit SKU DYNJ65980J
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1190-2026·2026-02-04
Medline procedure convenience kits recalled for cracking tubing defect
Medline medical procedure kits are being recalled due to complaints that butyrate tubing cracks during actuation of MASTISOL Liquid Adhesive vials. The kits are distributed nationwide.
Product
Medline medical procedure convenience kits labeled as: 1) MIDDLE EAR CDS, Kit SKU CDS984347O; 2) HEAD AND NECK CDS-LF, Kit SKU CDS984857N; 3) NECK PACK-LF, Kit SKU DYNJ0966130K; 4) NECKLINE PACK-LF, Kit SKU DYNJ51440B; 5) THYROID PACK, Kit SKU DYNJ58742J; 6) ENT I, K
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1185-2026·2026-02-04
Conductivity Standard Solutions Recalled for Incorrect Calibration Values
NIPRO Technical Services is recalling Conductivity Standard Solutions due to defective conductivity values that cause meters to report incorrect readings for dialysate calibration.
Product
Conductivity Standard Solution Catalog/Model Numbers: 10001, 10011, 10021, 10032, 10040, 10040c, and 10041 Conductivity Standard Solutions are a secondary standard solution used for the calibration of conductivity cells together with conductivity meters
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1164-2026·2026-02-04
Elekta Medical Linear Accelerators Recalled Due to Manufacturing and Electrical Grounding Issue
Elekta is recalling approximately 5,391 medical linear accelerators (Synergy, Harmony, Infinity, Versa HD models) worldwide due to a manufacturing issue affecting electrical grounding systems.
Product
Brand Name: Elekta Medical Linear Accelerator Product Name: Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HD Software Version: N/A Product Description: Digital Linear Accelerator Component: No
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1198-2026·2026-02-04
Medline Circumcision Kits Recalled for Cracked Tubing Defects
Medline Industries is recalling 1,928 circumcision procedure kits due to cracked tubing in the included MASTISOL liquid adhesive. The defect occurred during actuation of the adhesive vials.
Product
Medline medical procedure convenience kits labeled as: CIRCUMCISION PACK, Kit SKU DYNJ16826O
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1217-2026·2026-02-04
BD Alaris Pump Module with Invalid Timestamp Causes Network Connectivity Issues
CareFusion is recalling 189 BD Alaris Pump Module model 8100 units with invalid daylight savings time timestamps that prevent connection to hospital networks, affecting device interoperability.
Product
BD Alaris" Pump Module model 8100 UDI-DI code: 10885403810046 The BD AlarisTM System with Guardrails" Suite MX is a modular infusion pump and monitoring system for the continuous or intermittent administration of fluids to adult, pediatric, and neonatal patients through clini
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1189-2026·2026-02-04
Medline Medical Procedure Kits Recalled for Defective Tubing
Medline is recalling three types of medical procedure kits containing MASTISOL liquid adhesive with defective tubing that cracks during use. Approximately 1,928 units were distributed nationwide.
Product
Medline medical procedure convenience kits labeled as: 1) BREAST-HERNIA-PORT CDS-LF, Kit SKU CDS984853L; 2) BREAST BIOPSY PACK, Kit SKU DYNJ45641B; 3) DERMATOLOGY PACK, Kit SKU DYNJT3658A.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1191-2026·2026-02-04
Medline medical procedure kits recalled for defective tubing in adhesive
Medline Industries recalls 456 surgical procedure kits nationwide due to MASTISOL liquid adhesive with tubing that cracks when actuated. No illnesses have been reported.
Product
Medline medical procedure convenience kits labeled as: 1) SMJ LAP CHOLE PACK-LF, Kit SKU DYNJ19974P; 2) DEPAUL ABDOMINAL ENDOSCOPY-LF, Kit SKU DYNJ20027K; 3) LAPAROSCOPY PACK-LF, Kit SKU DYNJ20468J; 4) SMJ LAPAROSCOPY PACK, Kit SKU DYNJ25763N; 5) SMJ LAPAROSCOPY PACK,
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1200-2026·2026-02-04
Medline medical procedure kits recalled for defective adhesive vial tubing
Medline Industries recalls 117 surgical procedure kits nationwide due to defective MASTISOL adhesive vials. The tubing in the vials cracks during use, potentially affecting surgical procedures.
Product
Medline medical procedure convenience kits labeled as: 1) WATKINS SPINE PACK-LF, Kit SKU DYNJ0275635M; 2) SM-SPINE PACK-LF, Kit SKU DYNJ0395037X; 3) TOTAL HIP PACK, Kit SKU DYNJ04809N; 4) MAIN/LAMINECTOMY PACK-LF, Kit SKU DYNJ0565499AN; 5) SCC/SPOC HAND & FOOT PACK, Ki
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1213-2026·2026-02-04
Philips MR 7700 MRI Systems May Display Incorrect Elastography Stiffness Values
Philips MR 7700 MRI systems with software versions R11.1 and R12.1 may display incorrect stiffness values when MR Elastography images are exported to medical imaging systems, potentially leading to diagnostic errors.
Product
MR 7700. Product Code (REF): (1) 782120, (2) 782153. MR systems with SW version R11.1 and R12.1.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1166-2026·2026-02-04
Fixone Hybrid Anchor Medical Device Recalled for Structural Failure Risk
Aju Pharm Co., Ltd. is recalling Fixone Hybrid Anchor units due to reports of device failure including anchor breakage, bending, and pull-out. All 233 units distributed nationwide in California and Puerto Rico are affected.
Product
Fixone Hybrid Anchor
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1208-2026·2026-02-04
Ingenia MR system may display inaccurate elastography stiffness values
Philips Ingenia 3.0T CX MR imaging systems with software versions R11.1 and R12.1 may display inaccurate tissue stiffness values in PACS viewers, potentially affecting diagnostic accuracy.
Product
Ingenia 3.0T CX. Product Code (REF): 781271. MR systems with SW version R11.1 and R12.1.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1195-2026·2026-02-04
Medline procedure convenience kits recalled for defective adhesive vial tubing
Medline Industries is recalling 1,928 medical procedure kits distributed nationwide. The kits contain MASTISOL liquid adhesive with defective butyrate tubing that cracks during activation.
Product
Medline medical procedure convenience kits labeled as: 1) INPATIENT CTRL LN DRG CHG, Kit SKU DT22880; 2) ADULT CVC DRSG CHG W/ADHESIVE, Kit SKU DYNDC3283A.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1199-2026·2026-02-04
Medline C-section procedure kits recalled for defective adhesive tubing
Medline C-section procedure kits are recalled because the MASTISOL liquid adhesive they contain has butyrate tubing that cracks during use.
Product
Medline medical procedure convenience kits labeled as: 1) C-SECTION PACK, Kit SKU DYNJ35494C; 2) SMJ C-SECTION PACK-LF, Kit SKU DYNJ38582O; 3) RR-L&D C-SECTION PACK-LF, Kit SKU DYNJ82084F.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1183-2026·2026-02-04
Toothbrushes recalled for potential rodent contamination at distribution center
Gold Star Distribution Inc is recalling toothbrushes due to potential exposure to rodents and rodent activity discovered at the manufacturer's distribution center. Products were distributed in Minnesota.
Product
Toothbrushes, labeled as: ORAL B TOOTH BRUSH SHINY CLEAN SOFT 12CT; COLGATE TOOTH BRUSH MED. 12CT; ADULT TOOTHPASTE W BRUSH (WHITENING) 6.4oz/24ct; ADULT TOOTHPASTE W BRUSH (ANTICAV) 6.4oz/24ct.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1218-2026·2026-02-04
LimFlow Vector medical device recalled for incorrect expiration date
LimFlow Inc. is recalling 33 units of the LimFlow Vector medical device due to incorrect expiration dating on the product label. Healthcare providers should verify the device lot code before use.
Product
Brand Name: LimFlow Vector Product Name: LimFlow Vector Model/Catalog Number: VT-US-23
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1178-2026·2026-02-04
Alphenix X-ray System Ceiling Screws May Loosen, Affecting Equipment Movement
Canon Medical is recalling three Alphenix INFX-8000H interventional x-ray systems. Ceiling-mounted fixing screws may loosen, potentially preventing equipment movement, generating abnormal noise, or triggering sensor errors. No injuries have been reported.
Product
Alphenix INFX-8000H, interventional fluoroscopic x-ray system
Category
Medical Device
Distribution
Distributed nationwide

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