Browse recalls
Alert level: Class II
- 2024-08-08 · US FDA — Medical DevicesClass II
Biolox Option Taper Sleeve, Type 1 Taper, -6mm Neck - Indicated for use in total hip replacement with cemented or non-ce - 2024-08-08 · US FDA — Medical DevicesClass II
Ziehm Solo. Digital Mobile C-arm - 2024-08-08 · US FDA — Medical DevicesClass II
Ziehm Solo FD. Interventional fluoroscopic x-ray system - 2024-08-08 · US FDA — Medical DevicesClass II
Ziehm Vision RFD. Interventional fluoroscopic x-ray system - 2024-08-08 · US FDA — Medical DevicesClass II
DAILIES TOTAL1, DAILIES TOTAL1 for Astigmatism, DAILIES TOTAL1 Multifocal, TOTAL30 Sphere, - 2024-08-08 · US FDA — Medical DevicesClass II
ViewPoint 6, Model Numbers: a) H47581RJ, b) H47591MA, c) H47591MT, d) H47591PE, e) H47591PR, f) H47591RA, g) H47591SD, - 2024-08-08 · US FDA — Medical DevicesClass II
Ziehm Vision system, x-ray, tomography, computed. - 2024-08-08 · US FDA — Medical DevicesClass II
Ziehm Vision R. Iterventional fluoroscopic x-ray system - 2024-08-07 · US FDA — Medical DevicesClass II
PT301US Airvo 3 Respiratory Support Device with software version 1.2.0 and/or 1.5.1 The Airvo 3 is intended to provi - 2024-08-07 · US FDA — Medical DevicesClass II
FILMARRAY 2.0 INSTRUMENT, REF: FLM2-ASY-0001, FLM2-ASY-0001-W - 2024-08-06 · US FDA — Medical DevicesClass II
Philips Azurion 7M20 systems with FlexArm ceiling-mounted system, Interventional Fluoroscopic X-Ray System, Model Number - 2024-08-05 · US FDA — Medical DevicesClass II
ImpellaCP SmartAssistSetAPAC, Delo1895; Product Code: 1000302; - 2024-08-05 · US FDA — Medical DevicesClass II
Impella CP Pump 371 Set, Clinical Trial; Product Code: 0048-0040; - 2024-08-05 · US FDA — Medical DevicesClass II
Impella 5.5 SmartAssist Set, JP; Product Code: 1000211; - 2024-08-05 · US FDA — Medical DevicesClass II
Pump 381 Pump Set (US); Product Code: 1000080; - 2024-08-05 · US FDA — Medical DevicesClass II
Impella 5.5 with SmartAssist Set, EU; Product Code: 0550-0002; - 2024-08-05 · US FDA — Medical DevicesClass II
Impella CP Smart Assist Set APAC; Product Code: 0048-0047; - 2024-08-05 · US FDA — Medical DevicesClass II
Impella CP Smart Assist Set; Product Code: 1000402; - 2024-08-05 · US FDA — Medical DevicesClass II
Impella 5.5 SmartAssist S2 Set, JP; Product Code: 1000459; - 2024-08-05 · US FDA — Medical DevicesClass II
Impella 5.5 with SmartAssist S2 Set, US; Product Code: 1000100; - 2024-08-02 · US FDA — Medical DevicesClass II
Monarch Platform (Endoscopy), REF: MON-000005-01, MON-000005-01R. Monarch Platform (Bronchoscopy), REF: MON-000006, M - 2024-08-01 · US FDA — Medical DevicesClass II
Tablo Console, REF: PN-0003000, PN-0006000, part of the Tablo Hemodialysis System. The Tablo Hemodialysis System is indi - 2024-07-30 · US FDA — Medical DevicesClass II
Dimension Vista Total Bilirubin (TBIL) Flex Reagent Cartridge; Siemens Material Number (SMN): 10445146; - 2024-07-26 · US FDA — Medical DevicesClass II
Atellica IM CA 19-9 (50 Test)-In vitro diagnostic use in the quantitative measurement of the CA 19-9 tumor-associated an - 2024-07-26 · US FDA — Medical DevicesClass II
ADVIA Centaur CA 19-9 (50 Test)-In vitro diagnostic use in the quantitative measurement of the CA 19-9 tumor-associated - 2024-07-26 · US FDA — Medical DevicesClass II
Atellica IM CA 19-9 (250 Test - REF)-In vitro diagnostic use in the quantitative measurement of the CA 19-9 tumor-associ - 2024-07-26 · US FDA — Medical DevicesClass II
ADVIA Centaur CA 19-9 (250 Test)-In vitro diagnostic use in the quantitative measurement of the CA 19-9 tumor-associated - 2024-07-24 · US FDA — Medical DevicesClass II
Stryker iBur 3.0mm Coarse Diamond Round, Distal Bend - intended to cut bone in the following manner: drilling, reaming, - 2024-07-24 · US FDA — Medical DevicesClass II
Stryker iBur 2.0mm Diamond Round, Distal Bend- intended to cut bone in the following manner: drilling, reaming, decorti - 2024-07-24 · US FDA — Medical DevicesClass II
Stryker iBur 5.0mm Coarse Diamond Round, Distal Bend intended to cut bone in the following manner: drilling, reaming - 2024-07-24 · US FDA — Medical DevicesClass II
Stryker iBur 3.0mm Diamond Round, Distal Bend - intended to cut bone in the following manner: drilling, reaming, decort - 2024-07-24 · US FDA — Medical DevicesClass II
Stryker iBur 3.0mm Precision Match Head, Distal Bend- intended to cut bone in the following manner: drilling, reaming, - 2024-07-24 · US FDA — Medical DevicesClass II
Stryker iBur 4.0mm Coarse Diamond Round, Distal Bend - intended to cut bone in the following manner: drilling, reaming, - 2024-07-24 · US FDA — Medical DevicesClass II
Stryker iBur 4.0mm Diamond Round, Distal Bend- intended to cut bone in the following manner: drilling, reaming, decorti - 2024-07-24 · US FDA — Medical DevicesClass II
Stryker iBur 4.0mm Precision Round, Distal Bend- intended to cut bone in the following manner: drilling, reaming, decor - 2024-07-22 · US FDA — Medical DevicesClass II
Sevoflurane E_Vap.(Safety Filling adapter) used with the A9 Anesthesia System-Used to provide the vapor of an anesthetic - 2024-07-22 · US FDA — Medical DevicesClass II
Desflurane E_Vap.(Saf-T-Fill) used with the A9 Anesthesia System-Used to provide the vapor of an anesthetic agent with c - 2024-07-22 · US FDA — Medical DevicesClass II
Isoflurane E_Vap.(Safety Filling adapter): used with the A9 Anesthesia System-Used to provide the vapor of an anesthetic - 2024-07-22 · US FDA — Medical DevicesClass II
SlideView VS200 slide viewer, - 2024-07-22 · US FDA — Medical DevicesClass II
Sevoflurane E_Vap.(Quik-Fil):used with the A9 Anesthesia System-Used to provide the vapor of an anesthetic agent with co - 2024-07-17 · US FDA — Medical DevicesClass II
WAVEWRITER ALPHA: Model: SC-1216, 16 IPG KIT, REF: M365SC12160; Model: SC-1232, 32 IPG KIT, REF: M365SC12320 - 2024-07-17 · US FDA — Medical DevicesClass II
PE Centrifuge Temperature Controlled, REF: B36366, a component of the Power Express. - 2024-07-17 · US FDA — Medical DevicesClass II
Power Express, REF B90918 - 2024-07-17 · US FDA — Medical DevicesClass II
Spectrum Wireless Battery Modules A/B/G/N, product code 36010, used with either of the following 35700BAX2 (Spectrum V8 - 2024-07-17 · US FDA — Medical DevicesClass II
Baxter Spectrum Wireless Battery Modules A/B/G/N, product code 35223, used with either of the following: 35700BAX2 (Spe - 2024-07-12 · US FDA — Medical DevicesClass II
GE Healthcare Proteus XR/a, stationary X-Ray System, Model/Catalog Numbers: 1) 2259973; 2) 2259988; 3) 2266999; - 2024-07-10 · US FDA — Medical DevicesClass II
DxC 500 AU Clinical Chemistry Analyzer, REF C63520 is an automated chemistry analyzer that measures analytes in sampl - 2024-07-10 · US FDA — Medical DevicesClass II
Guidewire 70cm x 1mm (0.038 ) REF 5583705 These accessories are intended for use with Bard 14.5 Fr. Long-Term Dual Lu - 2024-07-10 · US FDA — Medical DevicesClass II
Beckman Coulter DxI 9000 Access Immunoassay Analyzer, Model Number C21510, RSM Pneumatic Tubing Kit item #2, REF C11137; - 2024-07-03 · US FDA — Medical DevicesClass II
VITROS Immunodiagnostic VITROS Folate Reagent Pack 1/2 - 2024-07-02 · US FDA — Medical DevicesClass II
Disposable 5 Lead Cable and Lead Wire System, 50 inches, REF: LW-309DS50/5A - 2024-06-28 · US FDA — Medical DevicesClass II
IntelliVue Patient Monitor MX500 with L.x and M.x; K.x provided with L.x entitlements Model Number: 866064. Indicate - 2024-06-28 · US FDA — Medical DevicesClass II
IntelliVue Patient Monitor MX400 with L.x and M.x; K.x provided with L.x entitlements Model Number: 866060. Indicate - 2024-06-28 · US FDA — Medical DevicesClass II
Baxter PST 500 U, Precision Surgical Table, Part number (product code) 4080300 - 2024-06-27 · US FDA — Medical DevicesClass II
Arctic Sun Temperature Management Systems, Name/REF: Arctic Sun STAT, NA/6000-00-00; Arctic Sun STAT Loaner, NA/6000- - 2024-06-26 · US FDA — Medical DevicesClass II
ARTIS is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventiona - 2024-06-26 · US FDA — Medical DevicesClass II
ARTIS is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventiona - 2024-06-20 · US FDA — Medical DevicesClass II
Cepheid, Sample Collection Device, Part: 900-0370 - 2024-06-19 · US FDA — Medical DevicesClass II
BIOFIRE Blood Culture Identification 2 (BCID2) Panel, REF: RFIT-ASY-0147, for FILMARRAY Systems, when used in conjunctio - 2024-06-18 · US FDA — Medical DevicesClass II
CRANIOTOMY PACK, Pack Number DYNJ46552O - 2024-06-17 · US FDA — Medical DevicesClass II
OUTLOOK PUMP SET 3 CARESITE LADS 133 IN.-Used with an electrically-powered infusion pump for intravenous (IV) administra - 2024-06-17 · US FDA — Medical DevicesClass II
Infusomat UNIV. 15 DROP PUMP SET, 3 CARESITE, ASV-Used with an electrically-powered infusion pump for intravenous (IV) a - 2024-06-17 · US FDA — Medical DevicesClass II
Infusomat 60DROP METRISET PUMP SET, 3 SAFELINE-Used with an electrically-powered infusion pump for intravenous (IV) adm - 2024-06-17 · US FDA — Medical DevicesClass II
Infusomat UNIV. 60 DROP PUMP SET, 2 CARESITES, ASV-Used with an electrically-powered infusion pump for intravenous (IV) - 2024-06-17 · US FDA — Medical DevicesClass II
Infusomat UNIV. 15 DR PUMP SET, 1.2FIL, 2CRSTE ASV-Used with an electrically-powered infusion pump for intravenous (IV) - 2024-06-17 · US FDA — Medical DevicesClass II
Infusomat SPACE PUMP IV SET, 127 IN.-Used with an electrically-powered infusion pump for intravenous (IV) administratio - 2024-06-17 · US FDA — Medical DevicesClass II
Infusomat UNIV. 15 DROP PUMP SET W/3 SAFELINE, ASV-Used with an electrically-powered infusion pump for intravenous (IV) - 2024-06-17 · US FDA — Medical DevicesClass II
Infusomat SPACE PUMP IV SET , 120 IN.- Used with an electrically-powered infusion pump for intravenous (IV) administrati - 2024-06-17 · US FDA — Medical DevicesClass II
Infusomat 60DROP METRISET PUMP, 3 CARESITES, ASV-Used with an electrically-powered infusion pump for intravenous (IV) a - 2024-06-17 · US FDA — Medical DevicesClass II
Infusomat UNIV. 15 DROP PUMP SET, 2 CARESITE, ASV-Used with an electrically-powered infusion pump for intravenous (IV) - 2024-06-17 · US FDA — Medical DevicesClass II
Infusomat UNIV. 15 DROP PUMP SET W/ 3 ULTRASITE LL-Used with an electrically-powered infusion pump for intravenous (IV) - 2024-06-17 · US FDA — Medical DevicesClass II
Infusomat UNIV. 15 DROP PUMP SET W/ 0.2 FILTER- Used with an electrically-powered infusion pump for intravenous (IV) adm - 2024-06-17 · US FDA — Medical DevicesClass II
Infusomat 60 DROP METRISET PUMP SET,3 SFLINE ASV-Used with an electrically-powered infusion pump for intravenous (IV) ad - 2024-06-17 · US FDA — Medical DevicesClass II
Infusomat SPACE PUMP SET 15 DROP W/2 SAFEDAY-Used with an electrically-powered infusion pump for intravenous (IV) admini - 2024-06-17 · US FDA — Medical DevicesClass II
OUTLOOK IV SET 15DROP W/2 CARESITE-Used with an electrically-powered infusion pump for intravenous (IV) administration o - 2024-06-17 · US FDA — Medical DevicesClass II
Infusomat UNIV. 15 DROP PUMP SET, 3 CARESITE, ASV-Used with an electrically-powered infusion pump for intravenous (IV) a - 2024-06-17 · US FDA — Medical DevicesClass II
Infusomat 60 DROP METRISET PUMP SET, 3 CARESITES Used with an electrically-powered infusion pump for intravenous (IV) - 2024-06-17 · US FDA — Medical DevicesClass II
Infusomat UNIV. 15 DROP PUMP SET W 3 CARESITE L.L. Used with an electrically-powered infusion pump for intravenous (IV - 2024-06-17 · US FDA — Medical DevicesClass II
Outlook OUTLOOK PUMP SET,3 CARESITE LADS,115 IN. Used with an electrically-powered infusion pump for intravenous (IV) ad - 2024-06-17 · US FDA — Medical DevicesClass II
Infusomat SPACE PUMP IV SET 15D, 110 IN. -Used with an electrically-powered infusion pump for intravenous (IV) administ - 2024-06-17 · US FDA — Medical DevicesClass II
Infusomat UNIV 60 DROP PUMP SET, W/2 CARESITE INJ. -Used with an electrically-powered infusion pump for intravenous (IV) - 2024-06-14 · US FDA — Medical DevicesClass II
SIGNA Explorer, with affected software versions: SV25.5, SV25.6, SV29.2, MR30.0, MR30.1; Nuclear Magnetic Resonance Ima - 2024-06-14 · US FDA — Medical DevicesClass II
SIGNA Architect, with affected software versions: DV26.0 to DV26.3, DV27.0 to DV27.3, DV28.0 to DV28.5, DV29.0, DV29.1, - 2024-06-14 · US FDA — Medical DevicesClass II
Brand Name: Perfusor Space Product Name: Perfusor Space Syringe Pump, Wireless Model/Catalog Number: 8713031U Softwar - 2024-06-14 · US FDA — Medical DevicesClass II
SIGNA MR355, with affected software versions: SV25.5, SV25.6; Nuclear Magnetic Resonance Imaging System - 2024-06-14 · US FDA — Medical DevicesClass II
SIGNA PET/MR, with affected software versions: MP24.0, MP26.0, MP26.1, MR30.0, MR30.1; Tomographic imager combining emi - 2024-06-14 · US FDA — Medical DevicesClass II
Discrete photometric chemistry analyzer for clinical use. - 2024-06-14 · US FDA — Medical DevicesClass II
Discovery MR450 1.5T, with affected software versions: DV24.0, DV25.0, DV25.1, DV26.0; Nuclear Magnetic Resonance Imagi - 2024-06-14 · US FDA — Medical DevicesClass II
Alinity hq Analyzer, REF: 09P68-01 - 2024-06-14 · US FDA — Medical DevicesClass II
SIGNA Voyager, with affected software versions: PX26.0 to PX26.6, VX28.0, VX29.1, VX29.2, MR30.0, MR30.1; Nuclear Magne - 2024-06-14 · US FDA — Medical DevicesClass II
Optima MR360, with affected software versions: SV20.3, SV23.3, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging Syste - 2024-06-14 · US FDA — Medical DevicesClass II
Brand Name: Perfusor Space Product Name: Perfusor PCA Syringe Pump Model/Catalog Number: 8713080U Product Description - 2024-06-14 · US FDA — Medical DevicesClass II
SIGNA UHP, with affected software versions: RX28.0, MR30.1; Nuclear Magnetic Resonance Imaging System - research use on - 2024-06-14 · US FDA — Medical DevicesClass II
Brand Name: Perfusor Space Product Name: PERFUSOR SPACE ACM-KIT Model/Catalog Number: 8713040U Product Description: P - 2024-06-14 · US FDA — Medical DevicesClass II
SIGNA MR380, with affected software versions: SV25.5, SV25.6; Nuclear Magnetic Resonance Imaging System - 2024-06-14 · US FDA — Medical DevicesClass II
SIGNA MR360, with affected software versions: SV25.5, SV25.6; Nuclear Magnetic Resonance Imaging System - 2024-06-14 · US FDA — Medical DevicesClass II
Optima MR450w 1.5T, with affected software versions: DV24.0, DV25.0, DV25.1, DV26.0, DV29.1, MR30.0, MR30.1; Nuclear Ma - 2024-06-14 · US FDA — Medical DevicesClass II
SIGNA Creator, with affected software versions: HD16.0_V03 to HD16.4, HD23.0_V03, HD28.0, HD29.1, MR30.0, MR30.1; Nucle - 2024-06-14 · US FDA — Medical DevicesClass II
Discovery MR750 3.0T, with affected software versions: DV24.0, DV25.0, DV25.1, DV26.0 to DV26.4, DV29.1, MR30.0, MR30.1 - 2024-06-14 · US FDA — Medical DevicesClass II
SIGNA 7.0T, with affected software versions: 7T29.1, MR30.1; Nuclear Magnetic Resonance Imaging System