Animas determined that the Hebrew language translation in the Vibe Insulin Infusion Pump was incorrect and could lead to potential patient confusion. In addition, one line of Hebrew text was omitted from the display screen.
All Recalls
95,114 total recalls in our database
Zimmer Dental is recalling Tapered Screw-Vent Implants because the incorrect diameter size was printed on the inner vial.
An internal finding identified the presence of pinholes/cuts in some of the Tyvek pouches of the vacuum tubing sets included as an accessory to Acrobat V Vacuum Off-Pump System, Acrobat SUV Vacuum Off-Pump System, Axius XPOSE 3 Access Device and XPOSE 4 Access Device.
A recall of the APTUS Ulna Shortening 2.5 instrument was initiated due to three (3) complaints of breakage of the temporary tension bolt.
Blunt Hurd Cannula Blunt Tip 10 mm with 5 mm Reducer simplifies open laparoscopy.
CooperSurgical, Inc. D.B.A. Lone Star Medical Products
CooperSurgical is recalling two lots of 900-863 because the wrong package insert (IFU) was placed into the shipper.
Distortion (noise interference) of the liquid level capacitance can result in air aspiration instead of liquid aspiration. This might cause a false signal (air detection) with possible dispense errors resulting in erroneous results.
Coloplast is conducting a recall for one lot (4201931) of the Biatain Super Non-Adhesive wound dressing which was mislabeled.
CP Medical Inc. is recalling five lots of Monoswift PGCL [poly(glycolide-co-caprolactone)] Absorbable Surgical Suture for failing to meet the minimum tensile strength as dictated by USP was not met over the length of the product's shelf life.
The insulin pump may lose time and date settings during a power interruption (such as a battery change) due to a faulty capacitor. If the capacitor fails, the time and date will return to default setting. Though the pump prompts customers to confirm the time and date, if the user does not recognize the time and date have returned to default, a shift of their basal rate time block could occur.
Zimmer Dental is recalling Tapered Screw-Vent Implants because the incorrect diameter size was printed on the inner vial.
The GemStar Infusion pump may not receive direct current (DC) power from the power supply. In one instance, smoke was observed and the GemStar pump was operating on battery power while connected to the 3 volt DC power supply.
Routine quality monitoring system has identified that a limited number of lots were manufactured with the cylinder axis outside the allowable specification.
SAM Junctional Tourniquet (SJT) Auxiliary strap, model SJT 102 and SJT 112, is recalled because the snap hook on auxiliary strap broke during training demonstration.
Equate Moisture Last Multi-Purpose Solution, 2 pack, 12 fl. oz. (355 mL), Distributed by Walmart Stores, Inc.
Bausch & Lomb Inc- Greenville Solutions Plant
Product lot did not meet the specification for its disinfectants at the time of manufacture.
The Easy-Care Care-Lock feature installed at the foot of the bed may potentially fail to stay engaged (locked) after the Care-Lock System has been engaged by stepping on the red (locked) pedal.
The GemStar Infusion pump may not receive direct current (DC) power from the power supply. In one instance, smoke was observed and the GemStar pump was operating on battery power while connected to the 3 volt DC power supply.
Lipase Reagent, 7D80. Used to measure lipase in human serum on the Architect system.
Abbott Laboratories
Package inserts have incorrect SmartWash parameters for Triglyceride.
DMI Duro-Med Industries Rollator Transport Chair; Wheel Size: 7 1/4"; Overall Width: 23 1/2"; Seat Height: 21 1/4"; Seat Size: 14" x 12 3/4"; Handle Height: 31" - 36"; Width Between Handles: 18"; Weight: 19 Lbs; Walking assistance device.
Briggs Medical Service Company d.b.a. Mabis
There have been 5 customer reports of a 501-1018 series DMI Rollator Transport Chair collapsing during use.
One of the three pins that is used to hold the ORT200 table alignment block in place on the floor of the MR Suite went missing during testing at a health care facility.
Unintended movement of the operating table during surgical cases due to the use of damaged TITAN remotes.