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. 2,657 recalls have been distributed to Massachusetts in the last 12 months.

52,647 total recalls
2,657 in last 12 months

Showing 1482114840 of 29,284 recalls

Medical DeviceJanuary 28, 2019· Applied Medical Resources Corp

Recalled Item: Kii Fios First Entry Recalled by Applied Medical Resources Corp Due to The...

The Issue: The product may not have met sterility requirements . Use of a non-sterile...

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

Class II — Potential Health HazardOngoing
Medical DeviceJanuary 25, 2019· Philips North America, LLC

Recalled Item: Fetal Spiral Electrode Recalled by Philips North America, LLC Due to During...

The Issue: During use of the Philips FSE, it is possible for the metal electrode tip to...

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

Class II — Potential Health HazardOngoing
Medical DeviceJanuary 25, 2019· Medrobotics Corporation

Recalled Item: Obturator (long cone) Recalled by Medrobotics Corporation Due to The weld...

The Issue: The weld may break, resulting in the rod separating from the cone of the...

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

Class II — Potential Health HazardOngoing
Medical DeviceJanuary 25, 2019· Medrobotics Corporation

Recalled Item: Obturator (shortcone) Recalled by Medrobotics Corporation Due to The weld...

The Issue: The weld may break, resulting in the rod separating from the cone of the...

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

Class II — Potential Health HazardOngoing
Medical DeviceJanuary 25, 2019· Philips North America, LLC

Recalled Item: Lithium-ion Rechargeable Batteries for the Philips MX40 Wearable Monitor by...

The Issue: Lithium-ion Rechargeable Batteries for the Philips MX4O Wearable Monitor may...

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

Class II — Potential Health HazardOngoing
Medical DeviceJanuary 25, 2019· Agfa N.V.

Recalled Item: PET Plates Coated Film-MONOMEDBV2S2- Radiographic Film Recalled by Agfa N.V....

The Issue: Due to an inhomogeneous coating solution, pinholes can become visible in...

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

Class III — Low RiskOngoing
Medical DeviceJanuary 24, 2019· Maquet Cardiovascular, LLC

Recalled Item: AXIUS Blower Mister Product Code/: CB-1000 The Axius Blower Recalled by...

The Issue: Potential lack of carbon dioxide (CO2) flow that may result in a procedural...

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

Class II — Potential Health HazardOngoing
Medical DeviceJanuary 19, 2019· GE Healthcare, LLC

Recalled Item: Revolution CT scanners Product Usage: The system is intended for head...

The Issue: Additional low dose radiation exposure.

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

Class II — Potential Health HazardOngoing
Medical DeviceJanuary 18, 2019· Bellus Medical

Recalled Item: SKINFUSE Resuce Calming Complex Kit containing: SKINFUSE LIFT HG - Recalled...

The Issue: Cosmetic Kit was packaged with a mislabel medical product.

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

Class II — Potential Health HazardOngoing
Medical DeviceJanuary 17, 2019· CryoLife, Inc.

Recalled Item: On-X Aortic Heart Valve with Anatomic Sewing Ring Product Usage: Recalled by...

The Issue: On-X Valve was mislabeled with the incorrect serial number.

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

Class II — Potential Health HazardOngoing
Medical DeviceJanuary 16, 2019· Polymer Technology Systems, Inc.

Recalled Item: CHOL+HDL+GLU test strips Recalled by Polymer Technology Systems, Inc. Due to...

The Issue: Some lots of test strips do not fit tightly into the optical block, and may...

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

Class II — Potential Health HazardOngoing
Medical DeviceJanuary 16, 2019· Polymer Technology Systems, Inc.

Recalled Item: Lipid Panel test strips (as a component of smart bundles) Recalled by...

The Issue: Some lots of test strips do not fit tightly into the optical block, and may...

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

Class II — Potential Health HazardOngoing
Medical DeviceJanuary 16, 2019· Polymer Technology Systems, Inc.

Recalled Item: Lipid Panel test strips Recalled by Polymer Technology Systems, Inc. Due to...

The Issue: Some lots of test strips do not fit tightly into the optical block, and may...

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

Class II — Potential Health HazardOngoing
Medical DeviceJanuary 16, 2019· Edwards Lifesciences, LLC

Recalled Item: Edwards Lifesciences(R) IntraClude(TM) Intra-Aortic Occlusion Device is a...

The Issue: Edwards Lifesciences has received a limited number of customer reports...

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

Class II — Potential Health HazardOngoing
Medical DeviceJanuary 15, 2019· Westmed, Inc.

Recalled Item: Neo-Vent Infant T-Piece Resuscitation Circuit With Infant Mask Recalled by...

The Issue: A repair was made to an adapter mold resulting in parts being produced with...

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

Class II — Potential Health HazardOngoing
Medical DeviceJanuary 15, 2019· Westmed, Inc.

Recalled Item: Neo-Vent Infant T-Piece Resuscitation Circuit Recalled by Westmed, Inc. Due...

The Issue: A repair was made to an adapter mold resulting in parts being produced with...

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

Class II — Potential Health HazardOngoing
Medical DeviceJanuary 15, 2019· Westmed, Inc.

Recalled Item: Neo-Vent Infant T-Piece Resuscitation Circuit With Neonatal Mask Recalled by...

The Issue: A repair was made to an adapter mold resulting in parts being produced with...

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

Class II — Potential Health HazardOngoing
Medical DeviceJanuary 15, 2019· Miami Device Solutions, LLC.

Recalled Item: Proximal Humerus Plate Recalled by Miami Device Solutions, LLC. Due to Right...

The Issue: Right Proximal Humerus Plates. Product component parts MDS130108R, may be...

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

Class II — Potential Health HazardOngoing
Medical DeviceJanuary 15, 2019· Fujifilm Medical Systems U.S.A., Inc.

Recalled Item: Fujifilm FDR Go PLUS Recalled by Fujifilm Medical Systems U.S.A., Inc. Due...

The Issue: FUJIFILM Medical Systems U.S.A., Inc., Modality Systems became aware of the...

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

Class II — Potential Health HazardOngoing
Medical DeviceJanuary 14, 2019· Teleflex Medical

Recalled Item: RUSCH Urinary Drainage bag Recalled by Teleflex Medical Due to The device...

The Issue: The device labels are not UDI compliant. The missing UDI compliance...

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

Class III — Low RiskOngoing