In the syngo.CT VA40 and syngo.CT VA50 myNeedle Guide application, the order of the orientation labels head , center, and feet in the axial thick slice segments are erroneously swapped
All Recalls
95,094 total recalls in our database
Potential for pilot balloon non-inflation or cuff non-deflation.
Invisalign Express 10 REF 8512 Invisalign System Comprehensive REF 9000 Invisalign System Moderate REF 9001
Align Technology
3D orthodontic planning software has a defect that leads to an issue where incorrect number of aligners may be produced (less or greater than the doctor requested) and incorrect packaging is provided.
MyDay Toric (90-pack) Reveal 1 Day Toric (90-pack) Soft (hydrophilic) Contact Lens (daily wear). Single Use.
CooperVision
Lenses may be of the incorrect power. A patient who uses an affected lens may experience poor visual acuity.
The firm identified the following three potential issues which may have impacted ADUs installed on distributed Alinity m Systems. 1. Systems which had their ADUs serviced may have an incorrect board value (calibration data file) referenced causing a misconfiguration of the calibration. 2. Inability of Maintenance and Diagnostics 2300 (Amp Detect Optical Calibrations) to recognize error handling and thermal hold errors during the calibration process, potentially leading to a misconfiguration of the calibration. 3. Under specific conditions during the ADU manufacturing process, an incorrect calibration may potentially have been configured.
Veritas Advanced Infusion Packs, REF: VRT-AI
Johnson & Johnson Surgical Vision
Weld protrusion/physical gap between the housing and phaco pack cover, may exceed design specification, which could lead to priming cycle failure and/or suboptimal vacuum delivered to the phacoemulsification and irrigation/aspiration handpieces during surgery, which could result in surgical delay and/or longer surgical time, which could result in transient corneal edema.
Single-Use Packs, REF: OPO80
Johnson & Johnson Surgical Vision
Weld protrusion/physical gap between the housing and phaco pack cover, may exceed design specification, which could lead to priming cycle failure and/or suboptimal vacuum delivered to the phacoemulsification and irrigation/aspiration handpieces during surgery, which could result in surgical delay and/or longer surgical time, which could result in transient corneal edema.
biokitHSV-2 Rapid Test, REF: 300028001
Biokit, S.A.
HSV-2 rapid test may report false positive results.
CENTURION MEDICAL PRODUCTS, SILVER ANTIMICROBIAL VAD DRIVE, REF DT18760
MEDLINE INDUSTRIES, LP - Northfield
The kit contained an expired component.
Agfa HealthCare Enterprise Imaging XERO Viewer
Agfa Healthcare NV
There is a software defect that can cause issues with images.
There is an orogastric (OG) tube size discrepancy between the labeling in the IFU and the printed text on the device. If the clinician is unable to pass a gastric catheter through one of the channels, the clinician may use a smaller-diameter gastric catheter.
Potential for pilot balloon non-inflation or cuff non-deflation.
Baxter Electrocardiograph, ELI 380 -DCS21
Baxter Healthcare
One ELI 380 Electrocardiograph intended to be used for a pilot program was shipped to a customer by mistake on 26 October 2022.
Children's Lounge Pants
Unknown Manufacturer
The recalled children's sleepwear fails to meet the federal flammability standards for children's sleepwear, posing a risk of burn injuries to children.
ZLINE 30-inch, 36-inch and 48-inch RG gas ranges
Unknown Manufacturer
The oven of the gas ranges can emit dangerous levels of carbon monoxide (CO) while in use, posing a serious risk of injury or death from carbon monoxide poisoning.
Due to presence of mold (Aspergillus brasiliensis) and Ochratoxin A.
Breads: Garlic product 8013 Clear Bag Rolls 140 1.5 oz. 3 Garlic product 8014 Clear Bag Breadsticks 110 1.5 oz. 23
Klosterman Baking Company
Products held under insanitary conditions
Breads: Pretzel product 8309 Clear Bag Buns 48 2.1 oz.
Klosterman Baking Company
Products held under insanitary conditions
Breads: Multigrain product 3481 Clear Bag Buns 12 62 g Multigrain product 8017 Clear Bag Loaf 1 28 oz.
Klosterman Baking Company
Products held under insanitary conditions
Breads: English Muffin product 9525 Clear Bag English Muffins 12 2 oz.
Klosterman Baking Company
Products held under insanitary conditions