Category
Medical Devices Recalls
15,654 medical devices recalls on record from CPSC, FDA, and USDA.
15,654 recalls
High RiskFDA
Medline Industries, Lp - Northfield
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) BREAST PACK, Model Number DYNDH1306; b) BRS...
Medical Devices4,398 affectedMay 18, 2023
High RiskFDA
Medline Industries, Lp - Northfield
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) ULTRASOUND PACK, Model Number DYNDH1112; b) ...
Medical Devices575 affectedMay 18, 2023
High RiskFDA
Baxter Healthcare Corporation
Allen Advance Chest Support with Pad
Medical Devices1,010 affectedMay 18, 2023
High RiskFDA
Medline Industries, Lp - Northfield
MEDLINE NON-STERILE PVP SOLUTION, packaged in kits as follows: EAR CDS, Model Number CDS980089O
Medical Devices15 affectedMay 18, 2023
High RiskFDA
Medline Industries, Lp - Northfield
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) VNUS TRAY, Model Number DYNJ44410G; b) INTRAU...
Medical Devices2,420 affectedMay 18, 2023
High RiskFDA
Medline Industries, Lp - Northfield
MEDLINE NON-STERILE PVP SOLUTION, packaged in kits as follows: HYSTERO PACK, Model Number DYNJ61448A
Medical Devices60 affectedMay 18, 2023
High RiskFDA
Medline Industries, Lp - Northfield
MEDLINE NON-STERILE PVP SOLUTION, packaged in kits as follows: a) TOTAL JOINT, Model Number CDS985555S; b) TOTAL KNEE, Model Number CDS9...
Medical Devices4,500 affectedMay 18, 2023
High RiskFDA
Maquet Medical Systems Usa
QUADROX-iR, used during cardiopulmonary bypass Model Item No. Description BEQ-HMO 51100-USA ...
Medical Devices0 affectedMay 18, 2023
High RiskFDA
Medline Industries, Lp - Northfield
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: CATH LAB BASIN PACK, Model Number DYNJ69864A
Medical Devices2,304 affectedMay 18, 2023
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Aptio Automation Storage and Retrieval Module (SRM)
Medical Devices83 affectedMay 16, 2023
High RiskFDA
Olympus Corporation Of The Americas
Always-On Tip Tracked Instruments (SPiN Drive instruments) Triple Needle Brush, 12mm L, 1.8mm OD-Intended for use in clinical interventio...
Medical Devices759 affectedMay 15, 2023
High RiskFDA
Medline Industries, Lp - Northfield
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. PROBE COVER PACK, Mod...
Medical Devices154,900 affectedMay 15, 2023
High RiskFDA
Medline Industries, Lp - Northfield
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. EGG RETRIEVAL PACK, M...
Medical Devices211 affectedMay 15, 2023
High RiskFDA
Medline Industries, Lp - Northfield
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. SHY IR PICC PACK, Mod...
Medical Devices148,445 affectedMay 15, 2023
High RiskFDA
Olympus Corporation Of The Americas
Always-On Tip Tracked Instruments (SPiN Drive¿ instruments) Brush, 15mm L, 1.8mm OD Intended for use in clinical interventions and for a...
Medical Devices1,816 affectedMay 15, 2023
High RiskFDA
Medline Industries, Lp - Northfield
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. C V MINOR PACK, Model...
Medical Devices371 affectedMay 15, 2023
High RiskFDA
Medline Industries, Lp - Northfield
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. DR MOTT DRAPE PACK, M...
Medical Devices36 affectedMay 15, 2023
High RiskFDA
Medline Industries, Lp - Northfield
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. CHN OR DAVINCI PROSTA...
Medical Devices7,462 affectedMay 15, 2023
High RiskFDA
Medline Industries, Lp - Northfield
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. CAROTID, Model Number...
Medical Devices3,431 affectedMay 15, 2023
High RiskFDA
Medline Industries, Lp - Northfield
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. FETAL INTERVENTION, M...
Medical Devices9,319 affectedMay 15, 2023
High RiskFDA
Ge Oec Medical Systems, Inc
OEC Flexiview 8800 Systems with 9-inch Image Intensifier
Medical Devices2 affectedMay 15, 2023
High RiskFDA
Medline Industries, Lp - Northfield
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. PACK ENDO AAA HYBRID ...
Medical Devices80 affectedMay 15, 2023
High RiskFDA
Medline Industries, Lp - Northfield
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as PEDIATRIC EP PACK, Model Number: DYNJ45158A
Medical Devices192 affectedMay 15, 2023
High RiskFDA
Medline Industries, Lp - Northfield
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. CVC PACK, Model Numbe...
Medical Devices6,733 affectedMay 15, 2023
High RiskFDA
Medline Industries, Lp - Northfield
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. 7F, 20CM TRIPLE LUMEN C...
Medical Devices83,541 affectedMay 15, 2023
High RiskFDA
Medline Industries, Lp - Northfield
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ANGIO, Model Number: ...
Medical Devices15,945 affectedMay 15, 2023
High RiskFDA
Medline Industries, Lp - Northfield
Medline Probe Cover Kits containing Turkuaz Ultrasound Gel, Labeled as the following: a. COVER, PROBE, W/GEL AND BANDS, 4X48 - Model ...
Medical Devices1,231,480 affectedMay 15, 2023
High RiskFDA
Ge Oec Medical Systems, Inc
Field Upgrade Kits: P/N 5451208 RIU, 9 INCH, TOSHIBA; P/N 5485304 SERVICE PART, IMAGE INTENSIFIER, 9 INCH, TOSHIBA; P/N 5761613 SERVICE P...
Medical Devices16 affectedMay 15, 2023
High RiskFDA
Olympus Corporation Of The Americas
Always-On Tip Tracked Instruments (SPiN Drive instruments) 21ga ANSO Cytology Needle, 12mm L, 1.8mm OD-Intended for use in clinical inter...
Medical Devices1,158 affectedMay 15, 2023
High RiskFDA
Medline Industries, Lp - Northfield
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. CATH LAB PACK, Model ...
Medical Devices624 affectedMay 15, 2023
High RiskFDA
Medline Industries, Lp - Northfield
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ANGIOGRAM TRAY, Model...
Medical Devices29,126 affectedMay 15, 2023
High RiskFDA
Medline Industries, Lp - Northfield
Medline O.R. Scissors, S/B, Sterile, 5.5, Model #DYND04000
Medical Devices189,221 affectedMay 12, 2023
High RiskFDA
Full Vision Inc
TRACKMASTER, TREADMILL GE T2100-ST2 220V CHINA, MODEL NUMBER 317-07927GE CHINA
Medical Devices95 affectedMay 12, 2023
High RiskFDA
Full Vision Inc
TRACKMASTER, TREADMILL TMX428CP 220V, MODEL NUMBER 317-07929
Medical Devices96 affectedMay 12, 2023
High RiskFDA
Ossur H / F
Icelock 125 Ratchet, REF: L-125000; Icelock 600XM Ratchet, REF: L-621200; Icelock 621 Ratchet, REF: L-621000; Icelock 621 Ratchet Adap...
Medical Devices4,190 affectedMay 12, 2023
High RiskFDA
Full Vision Inc
TRACKMASTER, TREADMILL TMX428 110V, MODEL NUMBER 317-07926
Medical Devices565 affectedMay 12, 2023
High RiskFDA
Permobil
PushTracker E2 component utilized with the SmartDrive MX2+ Power Assist Device (Part Numbers: MX2-32K, MX2-32P, MX2-32PK, MX2-33D, MX2-3...
Medical Devices18,905 affectedMay 10, 2023
High RiskFDA
Fresenius Kabi Usa, Llc
LVP software of the Ivenix Infusion System (IIS); LVP-SW-0004
Medical Devices6 affectedMay 10, 2023
High RiskFDA
Virtual Radiologic Corp.
vRad PACS with Mammography
Medical Devices8 affectedMay 9, 2023
High RiskFDA
Galt Medical Corporation
Tearaway Introducer Kit, REF: KIT-010-12, KIT-010-17, KIT-900-16
Medical Devices490 affectedMay 8, 2023
High RiskFDA
Galt Medical Corporation
Tearaway Introducer Set, REF: INT-028-27, INT-105-25, INT-106-09, INT-106-12, INT-106-17, DSS-007-04, DSS-007-05, DSS-010-065, DSS-012-07...
Medical Devices6,036 affectedMay 8, 2023
High RiskFDA
Biofire Diagnostics, Llc
FilmArray Pneumonia Panel (Pneumo), REF: RFIT-ASY-0145, For FILMARRAY systems, CE 2797, IVD, Rx Only
Medical Devices24 affectedMay 8, 2023
High RiskFDA
Elekta, Inc.
Elekta Medical Linear Accelerator (ELMA) included in the below platforms: a. Elekta Infinity; b. Versa HD; c. Elekta Synergy
Medical Devices46 affectedMay 5, 2023
High RiskFDA
T.a.g. Medical Products Corporation, Ltd.
Betta Link LG Reusable Fishmouth Guide-Intended for use in soft tissue to bone fixation in the repair of the natural ligament or tendon d...
Medical Devices0 affectedMay 4, 2023
High RiskFDA
T.a.g. Medical Products Corporation, Ltd.
BETTA LINK SR REUSABLE PRONGED GUIDE- Intended for use in soft tissue to bone fixation in the repair of the natural ligament or tendon di...
Medical Devices0 affectedMay 4, 2023
High RiskFDA
T.a.g. Medical Products Corporation, Ltd.
Betta Link LG Reusable ProngED Guide - Intended for use in soft tissue to bone fixation in the repair of the natural ligament or tendon d...
Medical Devices0 affectedMay 4, 2023
High RiskFDA
Olympus Corporation Of The Americas
Single Use Repositionable Clip QUICKCLIP PRO 165 CM 10/BX- Intended for hemostatic metal clip for the GI Tract Catalog Number: HX-202LR.A
Medical Devices340 affectedMay 4, 2023
RecallFDA
Datascope Corp.
Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Model Number 0998-00-0800-55, Part Number 0998-00-0800-XX
Medical Devices4 affectedMay 4, 2023