Product Recalls in Massachusetts

Product recalls affecting Massachusetts — including food, drugs, consumer products, medical devices, and vehicles distributed to Massachusetts. RecallDetector monitors distribution data from the FDA, USDA, CPSC, and NHTSA to show you which recalls are relevant to your area. 2,685 recalls have been distributed to Massachusetts in the last 12 months.

52,647 total recalls
2,685 in last 12 months

Showing 1128111300 of 29,284 recalls

Medical DeviceAugust 31, 2020· Roche Diagnostics Operations, Inc.

Recalled Item: DISCOVERY ULTRA Advanced Staining System (RUO-Research Use Only) Material...

The Issue: Potential for Fluid leaks within the instruments, creating an electrical...

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
Medical DeviceAugust 31, 2020· Cook Inc.

Recalled Item: Pediatric Nephrostomy Stent Set Recalled by Cook Inc. Due to The indwell...

The Issue: The indwell time for the Percutaneous Neonatal Pigtail Nephrostomy Set and...

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
Medical DeviceAugust 31, 2020· Cook Inc.

Recalled Item: Percutaneous Neonatal Pigtail Nephrostomy Set Recalled by Cook Inc. Due to...

The Issue: The indwell time for the Percutaneous Neonatal Pigtail Nephrostomy Set and...

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
Medical DeviceAugust 31, 2020· Brainlab AG

Recalled Item: Ultrasound Navigation Software 1.0 and Ultrasound Integration Software for...

The Issue: Brainlab Ultrasound Navigation Software does not support the modification of...

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
Medical DeviceAugust 31, 2020· Roche Diagnostics Operations, Inc.

Recalled Item: BenchMark ULTRA Advanced Staining System (IVD)- Material Number: 05342716001...

The Issue: Potential for Fluid leaks within the instruments, creating an electrical...

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
Medical DeviceAugust 31, 2020· Ultradent Products, Inc.

Recalled Item: PermaFlo Flowable Composite 948 Shade: A2 - Product Usage: Recalled by...

The Issue: Due to a potential manufacturing issue (cross contamination), composite is...

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
Medical DeviceAugust 31, 2020· Olympus Corporation of the Americas

Recalled Item: Olympus Medical Systems Corporation (OMSC) Evis Exera II Bronchovideoscope...

The Issue: The BF-Q180 bronchoscope is being recalled because it does not have a 510(k)...

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
Medical DeviceAugust 28, 2020· Greiner Bio-One North America, Inc.

Recalled Item: VACUETTE TUBE 5 mL CAT Serum Separator Clot Activator Recalled by Greiner...

The Issue: Blood collection tubes experienced an issue with separation and clotting

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
Medical DeviceAugust 28, 2020· Siemens Healthcare Diagnostics Inc

Recalled Item: Siemens epoc BGEM Test Card-In vitro diagnostic device for the Recalled by...

The Issue: Sporadically inconsistent discrepant (low bias) glucose results on card lot...

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
Medical DeviceAugust 27, 2020· Roche Diagnostics Operations, Inc.

Recalled Item: Albumin Gen.2 Recalled by Roche Diagnostics Operations, Inc. Due to Roche...

The Issue: Roche has confirmed customer complaints of low quality (QC) recovery and...

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class III — Low RiskOngoing
Medical DeviceAugust 27, 2020· Roche Diagnostics Operations, Inc.

Recalled Item: Tina-quant Complement C4 ver.2 Recalled by Roche Diagnostics Operations,...

The Issue: Roche has confirmed customer complaints of low quality (QC) recovery and...

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class III — Low RiskOngoing
Medical DeviceAugust 26, 2020· ev3 Inc.

Recalled Item: Pacific Xtreme (PTCA Balloon Dilation Catheter) Recalled by ev3 Inc. Due to...

The Issue: Labeling discrepancy for the Rated Burst Pressure (RBP) value.

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
Medical DeviceAugust 26, 2020· Wright Medical Technology Inc

Recalled Item: EVOLVE STEM 8.5MM Model # 496S085 Recalled by Wright Medical Technology Inc...

The Issue: Lack of sterility assurance

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
Medical DeviceAugust 26, 2020· Beckman Coulter Inc.

Recalled Item: BECKMAN COULTER ACCESS Immunoassay Systems - Access Unconjugated Estriol...

The Issue: Due to alkaline phosphatase (ALP) associated interference causing falsely...

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
Medical DeviceAugust 25, 2020· Medtronic Vascular

Recalled Item: Rashkind Balloon Septostomy Catheter Recalled by Medtronic Vascular Due to...

The Issue: Subsequent failure of catheters in the field and failed quality testing

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class I — Serious Health HazardOngoing
Medical DeviceAugust 25, 2020· Medtronic Vascular

Recalled Item: Rashkind Balloon Septostomy Catheter Recalled by Medtronic Vascular Due to...

The Issue: Subsequent failure of catheters in the field and failed quality testing

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class I — Serious Health HazardOngoing
Medical DeviceAugust 25, 2020· Siemens Healthcare Diagnostics, Inc.

Recalled Item: Siemens Dimension Vista Akaline Phosphatase (ALPI) Flex reagent cartridge -...

The Issue: Low outlier resultsgenerated with Alkaline Phosphatase (ALPI) Flex reagent...

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
Medical DeviceAugust 25, 2020· Medtronic Vascular

Recalled Item: Rashkind Balloon Septostomy Catheter Recalled by Medtronic Vascular Due to...

The Issue: Subsequent failure of catheters in the field and failed quality testing

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class I — Serious Health HazardOngoing
Medical DeviceAugust 25, 2020· Siemens Healthcare Diagnostics, Inc

Recalled Item: Atellica IM HER-2/neu (H2n) assay Recalled by Siemens Healthcare...

The Issue: Siemens confirmed that the Upper Limit of Normal (ULN) as claimed in the...

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
Medical DeviceAugust 25, 2020· Genicon, Inc.

Recalled Item: Aquas PowerFlow Tube Set - Product Usage: The device delivers Recalled by...

The Issue: The product design incorporating a motor driven impeller pump powered by one...

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing