Latest recalls — page 251
Older notices, newest first.
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Class II · 12 months ago
Daye 18 Coated Super Tampons recall: Product lacks 510(k) clearance
Product lacks 510(k) clearance.
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Class II · 12 months ago
ICU Medical Oncology Kit w/31" 20 Drop Admin Set w/Integrated recall: Port weld of drug transfer device may separate or break during use
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
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Class II · 12 months ago
ICU Medical ChemoLock w/Mini Bag Spike ¿ REF: C-17 recall: Port weld of drug transfer device may separate or break during use
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
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Class II · 12 months ago
SyncAR Surgical Navigation Advanced Platform Patient Engagement recall: A software anomaly, under specific conditions when large rotational alignment
A software anomaly, under specific conditions when large rotational alignment values are applied in 2D Image Fusion, may lead to misalignment of any…
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Class II · 12 months ago
Daye Initiation 18 Coated Regular and 18 Nude Regular Tampons recall: Product lacks 510(k) clearance
Product lacks 510(k) clearance.
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Class II · 12 months ago
Cepheid Xpert SA Nasal Complete recall: As a result of Post-Market half-time stability testing
As a result of Post-Market half-time stability testing, false negative test result was observed for a positive sample type.
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Class II · 12 months ago
Daye Initiation 18 Coated Regular and 18 Coated Super Tampons recall: Product lacks 510(k) clearance
Product lacks 510(k) clearance.
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Class II · 12 months ago
Greiner Bio-One Vacuette 2 ml 9NC Coagulation sodium citrate 3.2% recall: Blood collection tubes were manufactured with the label applied too high
Blood collection tubes were manufactured with the label applied too high on the tube, which shifted the printed fill level mark upward, which could…
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Class I · 12 months ago
IMPRIS Imaging Inc Imris Operating Suite, Imris iMRI 3T V recall: There is a potential safety issue associated with the magnet venting paths
There is a potential safety issue associated with the magnet venting paths of the Siemens 3 Tesla MRI system within your IMRIS Operating Suite…
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Class II · 12 months ago
ICU Medical 73" Appx 2.5 ml, Ext Set, Smallbore w/ChemoLock Port recall: Port weld of drug transfer device may separate or break during use
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
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Class II · 12 months ago
Daye Initiation 3 Month Heavy Flow Bundle recall: Product lacks 510(k) clearance
Product lacks 510(k) clearance.
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Class II · 12 months ago
ICU Medical 6" Ext Set w/MicroClave" Clear recall: Port weld of drug transfer device may separate or break during use
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
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Class II · 12 months ago
ICU Medical ChemoLock 13mm Closed Vial Spike REF: CL-82 recall: Port weld of drug transfer device may separate or break during use
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
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Class II · 12 months ago
Daye Refill 36 Coated Super Tampons recall: Product lacks 510(k) clearance
Product lacks 510(k) clearance.
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Class II · 12 months ago
ICU Medical 31" Appx 3.4 ml, Admin Set w/20 Drop Integrated ChemoLock recall: Port weld of drug transfer device may separate or break during use
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
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Class II · 12 months ago
ICU Medical 8" Ext Set w/MicroClave Clear, ChemoLock Port recall: Port weld of drug transfer device may separate or break during use
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
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Class II · 12 months ago
Surgical Navigation Advanced Platform Patient Engagement recall: A software anomaly, under specific conditions when large rotational alignment
A software anomaly, under specific conditions when large rotational alignment values are applied in 2D Image Fusion, may lead to misalignment of any…
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Class II · 12 months ago
Fresenius Kabi USA, LLC Ivenix Infusion System , Large Volume Pump recall: Potential issue that can cause the device to register "phantom" touches
Potential issue that can cause the device to register "phantom" touches in the lower-left corner of the touchscreen during operation.
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Class II · 12 months ago
Daye Refill 3 Month Heavy Flow Bundle recall: Product lacks 510(k) clearance
Product lacks 510(k) clearance.
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Class II · 12 months ago
Daye Refill 18 Coated Super and 18 Nude Super Tampons recall: Product lacks 510(k) clearance
Product lacks 510(k) clearance.
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Class II · 12 months ago
MicroSurgical Technology Inc MST ArcDUO 9mm, REF: ARC-0002, single-use, sterile recall: An ophthalmic knife has a suction set (not direct patient-contacting)
An ophthalmic knife has a suction set (not direct patient-contacting), which contains springs contaminated with an unidentified residue that may…
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Class II · 12 months ago
ICU Medical ChemoLock Closed Vial Spike REF: CL-80 recall: Port weld of drug transfer device may separate or break during use
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
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Class II · 12 months ago
CareFusion 303, Inc. Various models of BD Pyxis Pro 7-Drawer Auxiliary recall: Potential fluid ingress of anesthesia station or med station may result
Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire.
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Class II · 12 months ago
Daye Heavy Flow Bundle recall: Product lacks 510(k) clearance
Product lacks 510(k) clearance.