Category

Medical Devices Recalls

15,654 medical devices recalls on record from CPSC, FDA, and USDA.

15,654 recalls
High RiskFDA
Philips North America Llc
Mammotrak Interventional Coil 3.0T
Medical Devices·5,231 affected·Nov 4, 2024
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Atellica CI Analyzer. Catalog Numbers: 10947347.
Medical Devices·559 affected·Nov 4, 2024
High RiskFDA
Philips North America Llc
dS Breast 7ch 3.0T
Medical Devices·5,231 affected·Nov 4, 2024
High RiskFDA
Philips North America Llc
ST SENSE Breast Dx Coil
Medical Devices·5,231 affected·Nov 4, 2024
High RiskFDA
Philips North America Llc
SENSE Breast Coil
Medical Devices·5,231 affected·Nov 4, 2024
High RiskFDA
Securitas Healthcare Llc
Arial Server Software Versions 11.1.4 through 11.1.6, SKU 54305, in conjunction with the Arial Mobile Application or Arial Care Giver App...
Medical Devices·111 affected·Nov 1, 2024
CriticalFDA
Medtronic Neurosurgery
Exacta External Drainage and Monitoring System: 27581 KIT 27581 EXACTA W/EDM VCATH 35CM 27636 EDM 27636 EXACTA W/BRAIDED CORD LOCK 276...
Medical Devices·258,367 affected·Nov 1, 2024
High RiskFDA
Cardinal Health 200, Llc
Cardinal Health SMS Elastic Cuff Thumbhook Level 3 Isolation Gown, Full-Back, Product Codes AT6588-2XL, AT6588-BD, AT6588-XL, AT6688-2XL,...
Medical Devices·940,203 affected·Nov 1, 2024
High RiskFDA
Cardinal Health 200, Llc
Convertor Isolation Gown, AAMI Level 3 protection, Product Codes AT6100, AT6100-XL, AT6200, and AT6200-XL
Medical Devices·940,203 affected·Nov 1, 2024
High RiskFDA
Becton Dickinson & Co.
BD COR GX Instrument Version or Model: 443990 Catalog Number: 443990
Medical Devices·70 affected·Oct 31, 2024
High RiskFDA
Becton Dickinson & Co.
BD Synapsys Informatics Solution (Laboratory Solution) Version or Model: 444150 Catalog Number: 444150
Medical Devices·56 affected·Oct 31, 2024
High RiskFDA
Becton Dickinson & Co.
BD MAX System, BD MAX Instrument Version or Model: 441916 Catalog Number: 441916
Medical Devices·2,537 affected·Oct 31, 2024
High RiskFDA
Becton Dickinson & Co.
BD BACTEC FX, Instrument Top, Packaged Version or Model: 441385 Catalog Number: 441385
Medical Devices·10,129 affected·Oct 31, 2024
High RiskFDA
Becton Dickinson & Co.
BD EpiCenter Single User Software Version or Model: 441007 Catalog Number: 441007
Medical Devices·0 affected·Oct 31, 2024
High RiskFDA
Becton Dickinson & Co.
BD EpiCenter Data Management System, Multi User Software Version or Model: 440981 Catalog Number: 440981
Medical Devices·7,974 affected·Oct 31, 2024
High RiskFDA
Becton Dickinson & Co.
BACTEC 9240 System Version or Model: 445475 Catalog Number: 445475
Medical Devices·584 affected·Oct 31, 2024
High RiskFDA
Hermes Medical Solutions Ab
Hybrid Recon software on Hermes Medical Imaging Suite version 6.1 Hybrid Recon software versions affected are 4.0.0x and 5.0.0
Medical Devices·778 affected·Oct 31, 2024
High RiskFDA
Seaspine Orthopedics Corporation
Brand Name: Daytona Small Stature Product Name: CoCr LockingCap 4.5mm, Small Stature, T25, BT Model/Catalog Number: 79-0002 Software V...
Medical Devices·92 affected·Oct 29, 2024
High RiskFDA
Smith & Nephew Inc.
BIORAPTOR Suture Anchors. Tendon/ligament, non-bioabsorbable bone anchor.
Medical Devices·2,156 affected·Oct 29, 2024
High RiskFDA
Boston Scientific Corporation
AMS Artificial Urinary Sphincter Control Pump
Medical Devices·16 affected·Oct 28, 2024
High RiskFDA
Boston Scientific Corporation
AMS Artificial Urinary Sphincter Pressure Regulating Balloon 61-70 cm H2O
Medical Devices·52 affected·Oct 28, 2024
High RiskFDA
Smiths Medical Asd, Inc.
smiths medical PORTEX Tracheal Tube Exchange Guide, 15Ch x 70cm, REF 14-504-68 and REF 14-504-68JP
Medical Devices·10,223 affected·Oct 28, 2024
High RiskFDA
Ge Medical Systems, Llc
SIGNA Architect AIR, Nuclear Magnetic Resonance Imaging System
Medical Devices·3 affected·Oct 28, 2024
High RiskFDA
Smiths Medical Asd, Inc.
smiths medical PORTEX Tracheal Tube Exchange Guide, 10Ch x 70cm, REF 14-504-76
Medical Devices·12,282 affected·Oct 28, 2024
High RiskFDA
Ge Medical Systems, Llc
Discovery MR750w 3.0T, whole body magnetic resonance scanner
Medical Devices·8 affected·Oct 28, 2024
High RiskFDA
Smiths Medical Asd, Inc.
smiths medical portex Venn Reusable Tracheal Tube Introducer, 15Ch x 60cm, REF 14-504-17 and REF 14-504-17JP
Medical Devices·142,327 affected·Oct 28, 2024
High RiskFDA
Ge Medical Systems, Llc
SIGNA Architect, Nuclear Magnetic Resonance Imaging System
Medical Devices·53 affected·Oct 28, 2024
High RiskFDA
Noah Medical
Galaxy bronchoscope (Product GALB-001) used with Instructions for use, Part: 10000752, part of the Noah Medical Galaxy System (GAL-001)
Medical Devices·26 affected·Oct 25, 2024
High RiskFDA
Ge Healthcare (china) Co., Ltd.
GE Proteus XR/A radiographic system
Medical Devices·956 affected·Oct 24, 2024
High RiskFDA
Baxter Healthcare Corporation
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482EJ; use in Peritoneal Dialysis
Medical Devices·22,392 affected·Oct 23, 2024
High RiskFDA
Baxter Healthcare Corporation
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482; use in Peritoneal Dialysis
Medical Devices·409,464 affected·Oct 23, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Lab Kit, SKU DYLAB1018; Component No. 503581
Medical Devices·626,305 affected·Oct 23, 2024
High RiskFDA
Medline Industries, Lp - Northfield
URINE COLLECTION VHC, SKU DYLAB1016; Component No. 503581
Medical Devices·626,305 affected·Oct 23, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Clean Catch Kit, SKU DYKM1833A; Component No. 503581
Medical Devices·626,305 affected·Oct 23, 2024
CriticalFDA
Micro-x Ltd.
MICRO-X Rover Mobile X-ray System, # MXU-RV19
Medical Devices·23 affected·Oct 23, 2024
High RiskFDA
Baxter Healthcare Corporation
Baxter MiniCap Extended Life PD Transfer Set (short) with Titanium Spike, Part Number T5C4326K; use in Peritoneal Dialysis
Medical Devices·13,376 affected·Oct 23, 2024
High RiskFDA
Medline Industries, Lp - Northfield
UA KIT, SKU DYKM1690A; Component No. 503581
Medical Devices·626,305 affected·Oct 23, 2024
High RiskFDA
Baxter Healthcare Corporation
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4483; use in Peritoneal Dialysis
Medical Devices·62,718 affected·Oct 23, 2024
High RiskFDA
Medline Industries, Lp - Northfield
URINE COLLECTION KIT, SKU DYKM1848A DYKM2005 DYKM2151 DYLAB1004 DYLAB1004A DYLAB1006 DYLAB1012 ; Component No. 503581
Medical Devices·626,305 affected·Oct 23, 2024
High RiskFDA
Micro-x Ltd.
MICRO-X Rover Mobile X-ray System, # MXU-RV35
Medical Devices·6 affected·Oct 22, 2024
CriticalFDA
Baxter Healthcare Corporation
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482; use in Peritoneal Dialysis
Medical Devices·2,706,558 affected·Oct 21, 2024
CriticalFDA
Baxter Healthcare Corporation
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482S; use in Peritoneal Dialysis
Medical Devices·151,020 affected·Oct 21, 2024
CriticalFDA
Baxter Healthcare Corporation
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4482; use in Peritoneal Dialysis
Medical Devices·410,862 affected·Oct 21, 2024
High RiskFDA
Karl Storz Endoscopy
Irrigation Tubing for KARL STORZ Endomat Select UP210 REF 031523-10 Tubing Set, Irrigation, PC
Medical Devices·40 affected·Oct 21, 2024
CriticalFDA
Baxter Healthcare Corporation
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4483; use in Peritoneal Dialysis
Medical Devices·62,394 affected·Oct 21, 2024
CriticalFDA
Baxter Healthcare Corporation
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4482E; use in Peritoneal Dialysis
Medical Devices·58,680 affected·Oct 21, 2024
High RiskFDA
Human Med Ag
human med Biofill Infiltration Cannula, diameter 2.5mm, 15cm, REF 2024-012, REF 1580107, sterile, single use.
Medical Devices·775 affected·Oct 18, 2024
High RiskFDA
Zyno Medical Llc
Z-800 Infusion System. Model/Catalog Number: Z-800, Z-800F, Z-800W, Z-800WF. The Z-800 Infusion system is intended to provide intrav...
Medical Devices·34,994 affected·Oct 18, 2024