Refill 3 Month Heavy Flow Bundle; Model Number: FG-BNDL-PC-MM-REFHF;
DAYE (ANNE'S DAY LTD)
Class I - Dangerous
Product lacks 510(k) clearance.
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Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
37,779 Total Recalls
Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004.
Fresenius Kabi USA
Class I - Dangerous
Potential issue that can cause the device to register "phantom" touches in the lower-left corner of the touchscreen during operation.
Surgical Navigation Advanced Platform Patient Engagement (PE SNAP), software version SNP.3.12.0, imaging processing radiological system
Surgical Theater
Class I - Dangerous
A software anomaly, under specific conditions when large rotational alignment values are applied in 2D Image Fusion, may lead to misalignment of any secondary image layer(s) to the primary image layer.
ICU Medical 8" (20 cm) Ext Set w/MicroClave Clear, ChemoLock Port, Y-Connector, Rotating Luer, REF: CL-3950
ICU Medical
Class I - Dangerous
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Class I - Dangerous
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Refill 36 Coated Super Tampons; Model Number: FG-TMP-MM-REF00360000;
DAYE (ANNE'S DAY LTD)
Class I - Dangerous
Product lacks 510(k) clearance.
Class I - Dangerous
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
ICU Medical 6" (15 cm) Ext Set w/MicroClave" Clear, ChemoLock" Port, Y-Connector, Rotating Luer REF: CL4118
ICU Medical
Class I - Dangerous
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Initiation 3 Month Heavy Flow Bundle; Model Number: FG-BNDL-PC-MM-IBHF;
DAYE (ANNE'S DAY LTD)
Class I - Dangerous
Product lacks 510(k) clearance.
Class I - Dangerous
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Class I - Dangerous
There is a potential safety issue associated with the magnet venting paths of the Siemens 3 Tesla MRI system within your IMRIS Operating Suite. Siemens notified IMRIS that an ice blockage may exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed vent paths, leading to a pressure build-up within the helium containment system which could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.
Greiner BIO-ONE VACUETTE 2 ml 9NC Coagulation sodium citrate 3.2%, REF: 454322
Greiner Bio-One North America
Class I - Dangerous
Blood collection tubes were manufactured with the label applied too high on the tube, which shifted the printed fill level mark upward, which could result in unnecessary sample rejection and repeat collections.
Initiation 18 Coated Regular and 18 Coated Super Tampons; Model Number: FG-TMP-MM-IB18180000;
DAYE (ANNE'S DAY LTD)
Class I - Dangerous
Product lacks 510(k) clearance.
As a result of Post-Market half-time stability testing, false negative test result was observed for a positive sample type.
Initiation 18 Coated Regular and 18 Nude Regular Tampons; Model Number: FG-TMP-MM-IB18001800;
DAYE (ANNE'S DAY LTD)
Class I - Dangerous
Product lacks 510(k) clearance.
SyncAR Surgical Navigation Advanced Platform Patient Engagement (SyncAR SNAP), software version SNP.1.12.0, imaging processing radiological system
Surgical Theater
Class I - Dangerous
A software anomaly, under specific conditions when large rotational alignment values are applied in 2D Image Fusion, may lead to misalignment of any secondary image layer(s) to the primary image layer.
Class I - Dangerous
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Class I - Dangerous
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
18 Coated Super Tampons; Model Number: FG-TMP-REF00180000;
DAYE (ANNE'S DAY LTD)
Class I - Dangerous
Product lacks 510(k) clearance.
ICU Medical 7.5" (19 cm) Appx 1.5 ml, Ext Set w/ChemoLock" Port, Clamp, Graduated Adapter REF: CL3967
ICU Medical
Class I - Dangerous
Port weld of drug transfer device may separate or break during use and potentially result in a leak.