🏥 Medical Devices Class I - Dangerous
It was identified internally that two commingle events occurred where the metal support post within the polyethylene articular surface was assembled incorrectly for three units within the scope.
All Recalls
92,900 total recalls in our database
HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx15mm UPN: M00553570
Boston Scientific
🏥 Medical Devices Class I - Dangerous
Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.
HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 6mmx8mm UPN: M00553520
Boston Scientific
🏥 Medical Devices Class I - Dangerous
Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.
AXIOS Stent and Delivery System 15mmx10mm UPN: M00553750
Boston Scientific
🏥 Medical Devices Class I - Dangerous
Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.
Their is a potential that implanted pulse generators may stop delivering therapy due to an internal component issue.
KARL STORZ - ENDOSKOPE, REF: 27010K, Ureteroscope, 7 Fr., 34 cm, NON STERILE, RxONLY, CE 0123
Karl Storz Endoscopy
🏥 Medical Devices Class I - Dangerous
Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
KARL STORZ - ENDOSKOPE, REF: 27011L, Uretero-Renoscope, 8 Fr., 6¿, 43cm, NON STERILE, RxONLY, CE 0123
Karl Storz Endoscopy
🏥 Medical Devices Class I - Dangerous
Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
Medline procedure kits labeled as: 1) SHORT TERM INFUSAPORT ACCESS KIT, Reorder number DYNDC3188; surgery tray
MEDLINE INDUSTRIES, LP - Northfield
🏥 Medical Devices Class I - Dangerous
Certain Medline kits were manufactured and distributed with Procedure Masks with SO SOFT Earloops, and SOFT TOUCH II Surgical Masks which were subsequently recalled for not meeting the bioburden testing requirements of EN 14683.
muRata Vios Monitoring System Model 2050; bedside cardiac monitor, including cardiotachometer and alarm rate
Murata Vios
🏥 Medical Devices Class I - Dangerous
During the set-up and workflow to begin Vios monitoring, it has been noticed that patient vital signs and ECG waveforms can become distorted and will flicker or flash very fast. This issue only occurs on the Central Station Monitor (CSM) in the patient tiles view and is not seen at any other point during patient monitoring & not on the Bedside Monitor.
Their is a potential that implanted pulse generators may stop delivering therapy due to an internal component issue.
🏥 Medical Devices Class I - Dangerous
Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.
6-in-1 Multi Styler and 5-in-1 Multi Styler Hair Dryers
Unknown Manufacturer
🏠 Consumer Products Class I - Dangerous
The handheld hair dryers lack an immersion protection device, posing an electrocution or shock hazard to consumers, if the hair dryers fall into water when plugged in. The CPSC has determined that hair dryers not equipped with the integral immersion protection present a substantial product hazard.
AMX Global Portable Folding Stadium Seats
Unknown Manufacturer
🏠 Consumer Products Class II - Moderate
The recalled stadium seats have bleacher security hooks that can crack and break, posing fall and injury hazards to consumers.
Cabinet Health 4 oz. Refillable Medicine Bottles
Cabinet Health Inc., of Washington, D.C.
🏠 Consumer Products Class II - Moderate
The plastic lid's closure can degrade after repeated openings, causing the lid's child-resistance to diminish, posing a risk of poisoning, if the contents are swallowed by young children.
Cozchique, Tebbis and Beeziac Girls Pajamas
Unknown Manufacturer
🏠 Consumer Products Class II - Moderate
The recalled children's pajamas violate the flammability regulations for children's sleepwear, posing a risk of burn injuries to children.
Greater Goods Digital Kitchen Scales
Unknown Manufacturer
🏠 Consumer Products Class I - Dangerous
The recalled digital kitchen scales violate the mandatory federal regulations for consumer products containing button cell or coin batteries, because the scale has a lithium coin battery that can be easily accessed by children, and a spare coin battery provided with the product not in child resistant packaging, as required by Reese's Law. These violations pose an ingestion hazard. The recalled scales also do not have the required warnings. When button cell or coin batteries are swallowed, the ingested batteries can cause serious injuries, internal chemical burns, and death.
Matrix-brand Training Cycles
Unknown Manufacturer
🏠 Consumer Products Class II - Moderate
The training cycles' adjustable seat can unexpectedly lower while in use, posing a fall hazard to the rider.
Pearhead Infant Learning Toy Sets
Pearhead, of Brooklyn, New York
🏠 Consumer Products Class II - Moderate
Due to its size and shape, the wooden egg-shaped rattle in the recalled learning sets can get lodged in a child's throat, posing a choking hazard. This violates the federal regulations for infant rattles.
🍎 Food Class I - Dangerous
Undeclared yellow #5
Cal Yee's Butter Toffee Almonds (8-oz, 1-lb plastic bags) Boa Vista Butter Toffee Almonds (6-oz plastic bag)
Cal Yee Farm
🍎 Food Class I - Dangerous
Undeclared milk