Category

Medical Devices Recalls

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

15,654 recalls
High RiskFDA
Carwild Corporation
FABCO ORS DENTAL ROLLS, 1-1/2" STERILE, COTTON 3/8" Diameter x 1-1/2" (9.5mm x 38.1mm), packaged 5 /Pouch, 50 Pouches/Box Reorder Numb...
Medical Devices·90 affected·Aug 2, 2022
High RiskFDA
Icu Medical, Inc.
6.5 IN (17 cm) APPX 0.78 ml, EXT SET w/Clave CLEAR, Clave 4-WAY Stopcock, Spiros, RED CAP. Accessory for intravascular administratio...
Medical Devices·5,795,989 affected·Aug 1, 2022
High RiskFDA
Carefusion
BD MaxGuard Drop Administration set with 3 Needleless Y-Sites Removable 3-port Manifold and removable 4-way stopcock, REF: MX4436
Medical Devices·19,925 affected·Aug 1, 2022
High RiskFDA
Carefusion
BD MaxGuard 15 Drop Administration Set with 4 Needleless Y-Sites, REF: MX9433
Medical Devices·9,900 affected·Aug 1, 2022
High RiskFDA
Icu Medical, Inc.
MicroClave Clear Neutral Connector; MicroClave Clear Connector; MicroClave Clear Neutral Connector, Approx Priming Volume: 0.04 mL....
Medical Devices·5,795,989 affected·Aug 1, 2022
High RiskFDA
Icu Medical, Inc.
6" (15 cm) Appx 0.85 ml, Smallbore Trifuse Ext Set w/3 MicroClave Clear, 2 Check Valve, 3 Clamps, Rotating Luer;
Medical Devices·5,795,989 affected·Aug 1, 2022
High RiskFDA
Carefusion
BD MaxGuard Extension Set with 1.2 Micron Filter and Needleless Y-Site, REF: MX9171
Medical Devices·100 affected·Aug 1, 2022
High RiskFDA
Carefusion
BD MaxGuard Flow Controller Extension Set with Needleless Y-Site, REF: MFS141
Medical Devices·37,550 affected·Aug 1, 2022
High RiskFDA
Merchsource Llc
The product is a handheld ultraviolet-C germicidal wand and contains two, narrow-diameter, tubular lamps with a peak emission wavelength ...
Medical Devices·0 affected·Aug 1, 2022
High RiskFDA
Icu Medical, Inc.
8.5" (22 cm) Appx 0.85 ml, Bifuse Pressure Infusion (400 psig) Ext Set w/2 Remv MicroClave Clear, 2 Purple Clamps, Rotating Luer;
Medical Devices·5,795,989 affected·Aug 1, 2022
High RiskFDA
Carefusion
BD MaxGuard Flow Controller Extension Set with Needleless Y-Site, REF: MFS106
Medical Devices·54,050 affected·Aug 1, 2022
High RiskFDA
Randox Laboratories Ltd.
The Randox Serology I Positive Control contains the following analytes in human based plasma: Anti HIV 1/2, Anti HTLV 1/2, Anti HCV, HBsA...
Medical Devices·2 affected·Aug 1, 2022
High RiskFDA
Hobbs Medical, Inc.
Hobbs Medical Polypectomy Snare Catalog Number: 4575-OLY
Medical Devices·10 affected·Jul 29, 2022
High RiskFDA
Hobbs Medical, Inc.
Hobbs Transbronchial Aspiration Needle Catalog Number: 4621
Medical Devices·7 affected·Jul 29, 2022
High RiskFDA
Hobbs Medical, Inc.
Hobbs Posi-Stop Injection Needle Catalog Number: 4722
Medical Devices·17 affected·Jul 29, 2022
High RiskFDA
Hobbs Medical, Inc.
Hobbs Medical Polypectomy Snare Catalog Number: 4565-OLY
Medical Devices·10 affected·Jul 29, 2022
High RiskFDA
Hobbs Medical, Inc.
Hobbs Medical Cytology Brush Catalog Number: 4204
Medical Devices·300 affected·Jul 29, 2022
High RiskFDA
Hobbs Medical, Inc.
Hobbs Helical Retrieval Basket Catalog Number: 4822
Medical Devices·14 affected·Jul 29, 2022
High RiskFDA
Hobbs Medical, Inc.
Hobbs Medical Cytology Brush Catalog Number: 4206
Medical Devices·300 affected·Jul 29, 2022
High RiskFDA
Hobbs Medical, Inc.
Hobbs Helical Retrieval Basket Catalog Number: 4832
Medical Devices·13 affected·Jul 29, 2022
High RiskFDA
Hobbs Medical, Inc.
Hobbs Helical Retrieval Basket Catalog Number: 4806
Medical Devices·4 affected·Jul 29, 2022
High RiskFDA
Hobbs Medical, Inc.
Hobbs Posi-Stop Injection Needle Catalog Number: 4718
Medical Devices·30 affected·Jul 29, 2022
High RiskFDA
Hobbs Medical, Inc.
Hobbs Posi-Stop Injection Needle Catalog Number: 4702
Medical Devices·8 affected·Jul 29, 2022
High RiskFDA
Hobbs Medical, Inc.
Hobbs Helical Retrieval Basket Catalog Number: 4824
Medical Devices·10 affected·Jul 29, 2022
High RiskFDA
Hobbs Medical, Inc.
Hobbs Transbronchial Aspiration Needle and Vacu-lok Aspirating Syringe Catalog Number: 4620
Medical Devices·18 affected·Jul 29, 2022
High RiskFDA
Hobbs Medical, Inc.
Hobbs Helical Retrieval Basket Catalog Number: 4808
Medical Devices·2 affected·Jul 29, 2022
High RiskFDA
Hobbs Medical, Inc.
Hobbs Helical Retrieval Basket Catalog Number: 4816
Medical Devices·10 affected·Jul 29, 2022
High RiskFDA
Hobbs Medical, Inc.
Hobbs Posi-Stop Injection Needle Catalog Number: 4704
Medical Devices·7 affected·Jul 29, 2022
High RiskFDA
Hobbs Medical, Inc.
Hobbs Medical Polypectomy Snare Catalog Number: 4563-OLY
Medical Devices·30 affected·Jul 29, 2022
RecallFDA
Microbiologics Inc
Helix Elite Inactivated Standard, labeled as: a. Inactivated SARS-CoV-2 B.1.1.7 Whole Virus, REF HE0071N; b. Inactivated SARS-CoV-2...
Medical Devices·2 affected·Jul 27, 2022
High RiskFDA
Fresenius Medical Care Holdings, Inc.
2008T and 2008TBluestar Hemodialysis Machines with CDX-Indicated for acute and chronic dialysis therapy in a healthcare facility Models...
Medical Devices·2,008 affected·Jul 27, 2022
High RiskFDA
Isopure Corp
Acidified Concentrate Distribution and Storage-The Isopure ACDS (Acidified Concentrate Distribution and Storage) with remote fill is inte...
Medical Devices·595 affected·Jul 26, 2022
High RiskFDA
Nobel Biocare
Nobel Biocare N1 TiUltra TCC NP 3.5x13mm
Medical Devices·347 affected·Jul 25, 2022
High RiskFDA
Baxter Healthcare Corporation
Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Dark Blue: a) 25 pack REF H938693025, b) 100 pack REF H938673100
Medical Devices·24,320 affected·Jul 22, 2022
High RiskFDA
Baxter Healthcare Corporation
Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Green: a) 25 pack, REF H93869025, b) 100 pack, REF H938674100, c) 100 pack, RE...
Medical Devices·168,390 affected·Jul 22, 2022
High RiskFDA
Baxter Healthcare Corporation
Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Orange: a) 25 pack, REF H93867025, b) 100 pack, REF H93867100
Medical Devices·63,190 affected·Jul 22, 2022
High RiskFDA
Corin Ltd
Corin METAFIX HIP STEM, SIZE 3, STANDARD, 135 degrees, COLLARED HIP STEM, CEMENTLESS, Part Number 579.0103
Medical Devices·5 affected·Jul 22, 2022
High RiskFDA
Baxter Healthcare Corporation
Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Purple, 100 pack, REF H938677100
Medical Devices·8,500 affected·Jul 22, 2022
CriticalFDA
Cardiac Assist, Inc
TANDEM LIFE LivaNova LIFESPARC Controller; Controller and Accessories Model 5900-0000; Controller Only Model 5900-0001. For circulato...
Medical Devices·723 affected·Jul 21, 2022
High RiskFDA
Medline Industries Inc.
Medline CHEST TUBE REORDER NO: DYNJ36762A
Medical Devices·300 affected·Jul 21, 2022
High RiskFDA
Aizu Olympus Co., Ltd.
EVIS EXERA III Bronchovideoscope
Medical Devices·0 affected·Jul 20, 2022
High RiskFDA
Qiagen Sciences Llc
FGFR RGQ RT-PCR Kit (RUO, not IVD) REF 8747010
Medical Devices·9 affected·Jul 20, 2022
High RiskFDA
Alcor Scientific, Inc.
iSED Primary Pump Tubing Spare Part Kit- (IVD) tubing is used to move sample and wash solution from the aspiration needle, through the re...
Medical Devices·38 affected·Jul 20, 2022
High RiskFDA
Biomerieux, Inc.
NUCLISENS easyMAG Magnetic Silica, REF 280133, 24 x 1.2mL bottles/kit.
Medical Devices·1,301 affected·Jul 20, 2022
RecallFDA
Nuvasive Inc
NuVasive MD Pulse III Multimodality System REF 1881500 Pulse Software version 369-BL.US and 369-BLN.US
Medical Devices·7 affected·Jul 19, 2022
High RiskFDA
Ortho-clinical Diagnostics, Inc.
VITROS XT 7600 Integrated System with Version 3.7.2 and below Product Code: 6844461
Medical Devices·1,148 affected·Jul 19, 2022
High RiskFDA
Myolyn Inc.
Power electronic box, Part #AS-0066, subassembly for the MyoCycle MC-2.
Medical Devices·45 affected·Jul 19, 2022
High RiskFDA
Becton Dickinson & Company
BD PhaSealTM Y-Site Connector (C80)- airtight and leak-proof Closed System Drug Transfer Device (CSTD) that mechanically prohibits the tr...
Medical Devices·9,340 affected·Jul 18, 2022