Class IIOngoingZ-2929-2026
Straumann USA LLC recalls GM Helix Implant
There may be a mismatch between the implant contained inside the packaging and the information described on the outer carton label.…
Straumann USA LLCMAAug 19, 2026
Recalls in Massachusetts
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 13–24 of 415 recalls
Class IOngoingZ-2873-2026
Spectra Medical Devices, LLC recalls Brand Name: Elevaris/Spectra Medical Devices Product Name: Sodium Chloride Injection
Manufacturing firm, Huons, was cited for issues regarding product quality and sterility assurance. If the product sterility is compromised, patients may be exposed to microorganisms, endotoxins, or foreign matter.…
Spectra Medical Device…MAAug 19, 2026
Class IIOngoingZ-2900-2026
Instrumentation Laboratory recalls GEM Premier 5000 PAK Part Numbers: 00055360010 00055360011 00055407504 000554…
The active ingredient concentration in the lysing bag solution of specific GEM Premier 5000 lots did not meet established manufacturing specifications.…
Instrumentation Labora…MAAug 12, 2026
Class IIOngoingZ-2899-2026
Instrumentation Laboratory recalls GEM Premier 7000 with iQM3 Part Numbers: 00077407508 00077407510 00077415004…
The active ingredient concentration in the lysing bag solution of specific GEM Premier 7000 with iQM3 PAK lots did not meet established manufacturing specifications.…
Instrumentation Labora…MAAug 12, 2026
Class IIIOngoingZ-2881-2026
Siemens Healthcare Diagnostics, Inc. recalls Syva Emit tox Serum Tricyclic Antidepressant Calibrator/Controls SMN 10445390 Catalog…
out-of-specification sodium azide concentration in Syva Emit Tox Serum Tricyclic Antidepressant Calibrator/Controls Lot U2.…
Siemens Healthcare Dia…MAAug 12, 2026
Class IIOngoingZ-2840-2026
Boston Scientific Corporation recalls Radial Jaw 4 Jumbo Biopsy Forceps with the following descriptions and UPN: Radial…
Potential for breach in sterile barrier of device packaging.
Boston Scientific Corp…MAAug 12, 2026
Class IIOngoingZ-2839-2026
Boston Scientific Corporation recalls Radial Jaw 4 Large Capacity Biopsy Forceps with the following descriptions and UPN:…
Potential for breach in sterile barrier of device packaging.
Boston Scientific Corp…MAAug 12, 2026
Class IIOngoingZ-2838-2026
Boston Scientific Corporation recalls Radial Jaw 4 Standard Capacity Biopsy Forceps with the following descriptions and UPN:…
Potential for breach in sterile barrier of device packaging.
Boston Scientific Corp…MAAug 12, 2026
Class IIOngoingZ-2826-2026
Instrumentation Laboratory recalls Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog Number: 000…
Potential for Bar Code Reader (BCR) wands, used with the GEM Premier 5000 and GEM Premier 7000 systems, to assign patient results to an incorrect patient ID.
Instrumentation Labora…MAAug 5, 2026
Class IIOngoingZ-2825-2026
Instrumentation Laboratory recalls Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog Number: 000…
Potential for Bar Code Reader (BCR) wands, used with the GEM Premier 5000 and GEM Premier 7000 systems, to assign patient results to an incorrect patient ID.
Instrumentation Labora…MAAug 5, 2026
Class IIOngoingZ-2824-2026
Instrumentation Laboratory recalls Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog Number: 000…
Potential for Bar Code Reader (BCR) wands, used with the GEM Premier 5000 and GEM Premier 7000 systems, to assign patient results to an incorrect patient ID.
Instrumentation Labora…MAAug 5, 2026
Class IIOngoingZ-2823-2026
Instrumentation Laboratory recalls Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog Number: 000…
Potential for Bar Code Reader (BCR) wands, used with the GEM Premier 5000 and GEM Premier 7000 systems, to assign patient results to an incorrect patient ID.
Instrumentation Labora…MAAug 5, 2026