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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 Devices·4,398 affected·May 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 Devices·575 affected·May 18, 2023
High RiskFDA
Baxter Healthcare Corporation
Allen Advance Chest Support with Pad
Medical Devices·1,010 affected·May 18, 2023
High RiskFDA
Medline Industries, Lp - Northfield
MEDLINE NON-STERILE PVP SOLUTION, packaged in kits as follows: EAR CDS, Model Number CDS980089O
Medical Devices·15 affected·May 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 Devices·2,420 affected·May 18, 2023
High RiskFDA
Medline Industries, Lp - Northfield
MEDLINE NON-STERILE PVP SOLUTION, packaged in kits as follows: HYSTERO PACK, Model Number DYNJ61448A
Medical Devices·60 affected·May 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 Devices·4,500 affected·May 18, 2023
High RiskFDA
Maquet Medical Systems Usa
QUADROX-iR, used during cardiopulmonary bypass Model Item No. Description BEQ-HMO 51100-USA ...
Medical Devices·0 affected·May 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 Devices·2,304 affected·May 18, 2023
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Aptio Automation Storage and Retrieval Module (SRM)
Medical Devices·83 affected·May 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 Devices·759 affected·May 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 Devices·154,900 affected·May 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 Devices·211 affected·May 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 Devices·148,445 affected·May 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 Devices·1,816 affected·May 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 Devices·371 affected·May 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 Devices·36 affected·May 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 Devices·7,462 affected·May 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 Devices·3,431 affected·May 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 Devices·9,319 affected·May 15, 2023
High RiskFDA
Ge Oec Medical Systems, Inc
OEC Flexiview 8800 Systems with 9-inch Image Intensifier
Medical Devices·2 affected·May 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 Devices·80 affected·May 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 Devices·192 affected·May 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 Devices·6,733 affected·May 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 Devices·83,541 affected·May 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 Devices·15,945 affected·May 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 Devices·1,231,480 affected·May 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 Devices·16 affected·May 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 Devices·1,158 affected·May 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 Devices·624 affected·May 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 Devices·29,126 affected·May 15, 2023
High RiskFDA
Medline Industries, Lp - Northfield
Medline O.R. Scissors, S/B, Sterile, 5.5, Model #DYND04000
Medical Devices·189,221 affected·May 12, 2023
High RiskFDA
Full Vision Inc
TRACKMASTER, TREADMILL GE T2100-ST2 220V CHINA, MODEL NUMBER 317-07927GE CHINA
Medical Devices·95 affected·May 12, 2023
High RiskFDA
Full Vision Inc
TRACKMASTER, TREADMILL TMX428CP 220V, MODEL NUMBER 317-07929
Medical Devices·96 affected·May 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 Devices·4,190 affected·May 12, 2023
High RiskFDA
Full Vision Inc
TRACKMASTER, TREADMILL TMX428 110V, MODEL NUMBER 317-07926
Medical Devices·565 affected·May 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 Devices·18,905 affected·May 10, 2023
High RiskFDA
Fresenius Kabi Usa, Llc
LVP software of the Ivenix Infusion System (IIS); LVP-SW-0004
Medical Devices·6 affected·May 10, 2023
High RiskFDA
Virtual Radiologic Corp.
vRad PACS with Mammography
Medical Devices·8 affected·May 9, 2023
High RiskFDA
Galt Medical Corporation
Tearaway Introducer Kit, REF: KIT-010-12, KIT-010-17, KIT-900-16
Medical Devices·490 affected·May 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 Devices·6,036 affected·May 8, 2023
High RiskFDA
Biofire Diagnostics, Llc
FilmArray Pneumonia Panel (Pneumo), REF: RFIT-ASY-0145, For FILMARRAY systems, CE 2797, IVD, Rx Only
Medical Devices·24 affected·May 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 Devices·46 affected·May 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 Devices·0 affected·May 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 Devices·0 affected·May 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 Devices·0 affected·May 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 Devices·340 affected·May 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 Devices·4 affected·May 4, 2023