The Recall Desk

Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

Filters

Agency

Category

Minimum severity

Clear filters

1051–1075 of 13381

  • 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
  • ModerateFDA (Devices)·Z-1184-2026·2026-02-04

    Pregnancy Test 24-Count Recalled Due to Rodent Exposure in Distribution Center

    Gold Star Distribution Inc is recalling Pregnancy Test 24CT units due to potential rodent exposure and rodent activity in the distribution center. The product was distributed in Minnesota.

    Product
    PREGNANCY TEST 24CT
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1179-2026·2026-02-04

    Alphenix Interventional X-Ray Systems Ceiling Movement Gear Fasteners May Loosen

    Canon Medical's Alphenix INFX-8000V x-ray systems may have loose ceiling movement gear screws, risking loss of ceiling lateral movement, abnormal noise, and sensor errors across 332 units worldwide.

    Product
    Alphenix INFX-8000V, interventional fluoroscopic x-ray system
    Category
    Medical Device
    Distribution
    Distributed nationwide