Recalls affecting Massachusetts
Notices that name Massachusetts in their distribution area, plus every nationwide recall — nationwide recalls reach Massachusetts too.
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Class II · 6 months ago
DFI Co., Ltd. Qucare Total Cholesterol in vitro diagnostic test REF: 6407 recall: The devices were distributed without required FDA premarket clearance
The devices were distributed without required FDA premarket clearance or approval.
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Class II · 6 months ago
Katalyst Surgical, LLC DEX Ophthalmic Tissue Forceps recall: Field Safety Corrective Action for IFU in DEX Forceps and Scissors
Field Safety Corrective Action for IFU in DEX Forceps and Scissors.
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Class II · 6 months ago
Orthorebirth Co Ltd Zenbone, REF: ORB-0320C-Z, ORB-0310C-Z, ORB-0304C-Z recall: Resorbable bone void filler falls outside standard specifications
Resorbable bone void filler falls outside standard specifications.
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Class II · 6 months ago
Katalyst Surgical, LLC DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Asymmetrical Tano recall: Field Safety Corrective Action for IFU in DEX Forceps and Scissors
Field Safety Corrective Action for IFU in DEX Forceps and Scissors.
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Class II · 6 months ago
Erbeflo CleverCap CO2: Hybrid CO2 Tubing/Cap Set for Olympus Scopes & recall: Devices providing sterile water/CO2/air to endoscopes were manufactured
Devices providing sterile water/CO2/air to endoscopes were manufactured with a distal irrigation segment connector configuration that may be more…
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Class II · 6 months ago
See RES for complete list. Medline Convenience Kits: 1) Drawer 6-IV recall: Medline has identified issues related to calibration of the equipment used
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the…
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Class II · 6 months ago
Boston Scientific Corporation Lux-Dx II Plus, Arrythmia detector and alarm, Model M312 recall: For some patients upgraded from a LUX-Dx M301 device to a new Model M302
For some patients upgraded from a LUX-Dx M301 device to a new Model M302 or M312, the new ICM device is not collecting PVC Burden data (both…
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Class II · 6 months ago
Medline Surgical Drapes: 1) Sheet,Drape,40X58,Sterile recall: Medline has identified issues related to calibration of the equipment used
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the…
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Class II · 6 months ago
Medline Convenience Kits: 1) Angio Procedure Pack recall: Medline has identified issues related to calibration of the equipment used
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the…
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Class II · 6 months ago
Boston Scientific Corporation Lux-Dx II, Arrythmia detector and alarm, Model M302 recall: For some patients upgraded from a LUX-Dx M301 device to a new Model M302
For some patients upgraded from a LUX-Dx M301 device to a new Model M302 or M312, the new ICM device is not collecting PVC Burden data (both…
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Class II · 6 months ago
Medline Convenience Kits: 1) Arthroscopy CDS recall: Medline has identified issues related to calibration of the equipment used
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the…
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Class II · 6 months ago
Medline Convenience Kits: 1) Baptist Floyd Endo GI KIT recall: Medline has identified issues related to calibration of the equipment used
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the…
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Class II · 6 months ago
BioFire Joint Infection Panel REF: RFIT-ASY-0138, 30 test Kit recall: Contamination to in-vitro diagnostic test may result in false positives
Contamination to in-vitro diagnostic test may result in false positives.
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Class II · 6 months ago
Medline Convenience Kits: 1) Picc Line Tray recall: Medline has identified issues related to calibration of the equipment used
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the…
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Class II · 6 months ago
Medline Convenience Kits: 1) Hysteroscopy recall: Medline has identified issues related to calibration of the equipment used
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the…
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Class II · 6 months ago
Centinel Spine, Inc. Prodisc C SK U.S. Implant Extra Large 6MM recall: Product labeling mix up. The prodisc C SK U.S. Implant Extra Large 6mm
Product labeling mix up. The prodisc C SK U.S. Implant Extra Large 6mm product was labeled as a 5mm and prodisc C SK U.S. Implant Extra Large 5mm…
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Class II · 6 months ago
See RES for complete list. Medline Convenience Kits: 1) Major recall: Medline has identified issues related to calibration of the equipment used
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the…
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Class II · 6 months ago
Medline Industries, LP See full list in RES, exceeds character limit 1) GYN recall: Medline has identified issues related to calibration of the equipment used
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the…
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Class II · 6 months ago
Medline Convenience Kits: 1) KIT STC Tracheostomy recall: Medline has identified issues related to calibration of the equipment used
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the…
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Class II · 6 months ago
Katalyst Surgical, LLC DEX Ophthalmic Tissue Forceps recall: Field Safety Corrective Action for IFU in DEX Forceps and Scissors
Field Safety Corrective Action for IFU in DEX Forceps and Scissors.
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Class II · 6 months ago
DFI Co., Ltd. Uric Acid in vitro diagnostic test REF: 31H0P recall: The devices were distributed without required FDA premarket clearance
The devices were distributed without required FDA premarket clearance or approval.
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Class II · 6 months ago
Katalyst Surgical, LLC DEX Ophthalmic Tissue Forceps recall: Field Safety Corrective Action for IFU in DEX Forceps and Scissors
Field Safety Corrective Action for IFU in DEX Forceps and Scissors.
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Class II · 6 months ago
Medline Convenience Kits: 1) Angio Procedure Pack recall: Medline has identified issues related to calibration of the equipment used
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the…
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Class II · 6 months ago
Medline Convenience Kits: 1) KIT Surg ONC Excision Breast recall: Medline has identified issues related to calibration of the equipment used
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the…