🏥 Medical Devices Class I - Dangerous
Listeria monocytogenes contamination of non-sterile plated media
All Recalls
92,900 total recalls in our database
Certain iOS and Android App versions contain a program error (bug) in the Bolus Advisor feature. After pairing a meter with the app for the first time, a customer may encounter the rare condition in which the countdown timer is not displayed and correction bolus advice is not available for the most recent, valid glucose reading. This same blood glucose value may become available for bolus advice calculation at a later time (countdown timer is displayed).
SMARTABLATE RF System Generator
Biosense Webster
🏥 Medical Devices Class I - Dangerous
Generator may inadvertently deliver RF energy if the foot pedal is placed in close proximity and oriented toward the Stereotaxis magnets.
🏥 Medical Devices Class I - Dangerous
Possible inner labeling and packaged device not matching the outer label on the box.
BD Precision Glide Needle 18G x 1 RB, Catalog 305195 Product Usage: These needles are intended for general purpose fluid injection/aspiration, infusion, venipuncture to obtain blood collection and insulin injection.
Becton Dickinson & Company
🏥 Medical Devices Class I - Dangerous
Hub damage resulting in breakage and/or leakage during use.
🏥 Medical Devices Class I - Dangerous
The firm received reports of two breakages of the pin tips which occurred during two identical surgery procedures. The breakage occurred at the very distal end of the conical part of the skull pin tip.
🏥 Medical Devices Class I - Dangerous
Potential unexpected movement of robot arm
Distribution of unapproved devices with incorrect air compression level setup
🏥 Medical Devices Class I - Dangerous
Device does not produce a visual or audible impedance respiration APN alarm when an impedance respiration apnea event occurs.
PENTARAY NAV High-Density Mapping Catheter.
Biosense Webster
🏥 Medical Devices Class I - Dangerous
Contraindication language updated in the Instructions For Use (IFU) to indicate that Pentaray Catheters should not be used in patients with prosthetic valves.
For the Fukuda Denshi patient monitor model DS-8100, in less than 0.003% (17) of the 6227 devices sold worldwide, a Short-term Battery Error message has appeared and has been traced back to a bad (damaged) Lithium-Ion capacitor (Short-term battery backup).
Issue 1: The MedNet Meds 6.1 and 6.21 programs, under certain conditions, can change the piggyback medication entry set settings for existing defined medication entries. This includes (a) whether a medication may be piggybacked and (b) whether an infusion may be interrupted by a piggyback. This only occurs when: 1. Medication entries are built with the same displayed name and diluent amount AND; 2. The piggyback or interruptible settings differ from one CCA to another AND; 3. The drug library is exported then imported into the MedNet Meds program. The changed drug library may then be finalized and downloaded to infusers for use in clinical settings. The changes are made without any notice provided to either the MedNet Meds user (pharmacist) or to the clinician operating the infuser that the piggyback or interruptible settings have been altered. Issue 2: The MedNet Meds 6.1 program, under certain conditions different from those described above in Issue 1, can change the piggyback medication entry set settings for existing defined medication entries. This includes (a) whether a medication may be piggybacked and (b) whether an infusion may be interrupted by a piggyback. This only occurs when: 1. The Master Drug Formulary contains medication entries built with the same displayed name and diluent amounts but one is a Limited rule set and the other is a Full rule set AND; 2. The medication entry built as the Full rule set has a blank medication amount with the medication units in mg AND; 3. Both medication entries have different piggyback options set AND; 4. The drug library is exported then imported into the MedNet Meds program. In this case, the piggyback options will be changed during an import of such drug library.
🏥 Medical Devices Class I - Dangerous
Possible inner labeling and packaged device not matching the outer label on the box.
🏥 Medical Devices Class I - Dangerous
Product may have incorrect cation information detailed on the product label.
🏥 Medical Devices Class I - Dangerous
Label on product box contains the incorrect reference #317-09 while the shelf box label with barcode and the internal foil pouch label are correctly labeled with product code 317-07 and lot number NDAR0462.
PENTARAY NAV High-Density Mapping Catheter.
Biosense Webster
🏥 Medical Devices Class I - Dangerous
Contraindication language updated in the Instructions For Use (IFU) to indicate that Pentaray Catheters should not be used in patients with prosthetic valves.
Distribution of unapproved devices with incorrect air compression level setup
Crib and toddler bed mattresses
Dream On Me, of Piscataway, N.J.
🏠 Consumer Products Class I - Dangerous
The mattresses fail to meet the mandatory federal flammability standard for mattresses, posing a fire hazard.
John Deere Compact Utility Tractors
Deere & Company, of Moline, Ill.
🏠 Consumer Products Class II - Moderate
The rollover protective structure (ROPS) at the back of the tractor can loosen and fail to protect the operator in a rollover accident, posing a risk of injury.
Ravin arrow nocks
Venatics Inc. and Ravin Crossbows LLC., of Superior, Wis.
🏠 Consumer Products Class II - Moderate
If the nock is not fully engaged with the bowstring, the crossbow can fail to discharge when the trigger is pulled and can result in the bow discharging while re-nocking of the arrow, posing an injury hazard to users.