Medical DeviceOct 13, 2021
Contamac Solutions Nutrifill Scleral, Hybrid, and Gas Permeable (GP) Lens Insertion recall — FDA Z-0030-2022
Contact lens solution may contain foreign material
Class IIFDA: TerminatedContamac Solutions, Inc.
October 2021 recalls — page 7
These records include useful source details for the selected month.
Medical DeviceOct 13, 2021
ZOLL Circulation Zoll, REF 8700-0782-03 (IC-3893AE), ICY Intravascular Heat Intravascular recall — FDA Z-0055-2022
Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
Class IIFDA: TerminatedZOLL Circulation, Inc.
Medical DeviceOct 13, 2021
Zoll REF: 8700-0783-01 (IC-4593), QUATTRO Intravascular Heat Exchange Catheter Kit Custom recall — FDA Z-0048-2022
Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
Class IIFDA: TerminatedZOLL Circulation, Inc.
Medical DeviceOct 13, 2021
Zoll REF: 8700-0783-14 (IC-4593CO), QUATTRO Intravascular Heat Exchange Catheter Kit with recall — FDA Z-0051-2022
Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
Class IIFDA: TerminatedZOLL Circulation, Inc.
Medical DeviceOct 13, 2021
GE Healthcare Centricity Universal Viewer 7.0, Model 5829628-0XX recall — FDA Z-0012-2022
A software anomaly exists in the Centricity Universal Viewer study management feature in which study changes are not propagated to either the Centricity Enterprise Archive (EA) or another…
Class IIFDA: TerminatedGE Healthcare, LLC
Medical DeviceOct 13, 2021
Zoll REF: 8700-0783-40 (IC-4593AE), QUATTRO Intravascular Heat Exchange Catheter Kit with recall — FDA Z-0049-2022
Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
Class IIFDA: TerminatedZOLL Circulation, Inc.
Medical DeviceOct 13, 2021
Zoll REF: 8700-0782-01 (IC-3893), ICY Intravascular Heat Exchange Catheter Kit, with central recall — FDA Z-0039-2022
Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
Class IIFDA: TerminatedZOLL Circulation, Inc.
Medical DeviceOct 13, 2021
Bard Peripheral Vascular REF TIN3015, 15G x 79 mm Bone Marrow Aspiration/Intraosseous recall — FDA Z-0002-2022
Potential for needle protector to become fully dislodge exposing infusion needle which could result in needle stick.
Class IIFDA: OngoingBard Peripheral Vascular Inc.
Medical DeviceOct 13, 2021
AngioDynamics NanoKnife Disposable Single Electrode Probes, Irreversible Electroporation recall — FDA Z-0073-2022
Programming issue affected RFID function of a single lot and did not allow the NanoKnife probes to be recognized by the NanoKnife generator.
Class IIFDA: TerminatedAngiodynamics, Inc.
Medical DeviceOct 13, 2021
ZOLL Circulation Zoll, REF 8700-000869-40, Cool Line (Heparin) IVTM Disposable Pack and recall — FDA Z-0063-2022
Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
Class IIFDA: TerminatedZOLL Circulation, Inc.
Medical DeviceOct 13, 2021
Exactech OPTETRAK Comprehensive Knee System including OPTETRAK All-polyethylene UNI Tibial recall — FDA Z-0020-2022
Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.
Class IIFDA: OngoingExactech, Inc.
Medical DeviceOct 13, 2021
ZOLL Circulation Zoll, REF 8700-000766-01, Quattro IVTM Premium Disposable Pack and Start UP recall — FDA Z-0058-2022
Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
Class IIFDA: TerminatedZOLL Circulation, Inc.
Medical DeviceOct 13, 2021
ZOLL Circulation Zoll, REF 8700-000872-40, SOLEX 7(Heparin) IVTM Disposable Pack and Start recall — FDA Z-0066-2022
Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
Class IIFDA: TerminatedZOLL Circulation, Inc.
Medical DeviceOct 13, 2021
Paltop Advanced Dental Solutions Scan Abutment PCA, Cat recall — FDA Z-0017-2022
Some devices are outside tolerances and showed a maximal deviation of 2 degrees in the orientation between the peek head and titanium base, and an incongruence between the size engraved on…
Class IIFDA: TerminatedPaltop Advanced Dental Solutions Ltd
Medical DeviceOct 13, 2021
ZOLL Circulation Zoll, REF 8700-000868-01, Solex 7 IVTM Disposable Pack and Start UP Kit recall — FDA Z-0062-2022
Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
Class IIFDA: TerminatedZOLL Circulation, Inc.
Medical DeviceOct 13, 2021
CardioQuip recall — FDA Z-0036-2022
Labeling does not include guidance for proper water-quality maintenance and device inspection for heater cooler devices.
Class IIFDA: OngoingCardioQuip, LLC
Medical DeviceOct 13, 2021
Welch Allyn Inc Mortara ELI, Burdick and McKesson brand 280 Resting Electrocardiographs recall — FDA Z-0011-2022
The devices malfunction under specific operator workflows.
Class IIFDA: OngoingWelch Allyn Inc Mortara
Medical DeviceOct 13, 2021
Philips Ultrasound, Inc recall — FDA Z-0070-2022
Battery system data issue with the ultrasound system can intermittently cause a system shutdown, regardless of actual battery state or application of alternating current power.
Class IIFDA: TerminatedPhilips Ultrasound Inc.
Medical DeviceOct 13, 2021
CardioQuip recall — FDA Z-0037-2022
Labeling does not include guidance for proper water-quality maintenance and device inspection for heater cooler devices.
Class IIFDA: OngoingCardioQuip, LLC
Medical DeviceOct 13, 2021
DJO GEL CONDUCTOR, Description/REF: 5 LITER W/DISP/4238, 24-8.5OZ BOTTLES/4248, 5 recall — FDA Z-0009-2022
Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination. On August 18, 2021, FDA published a Letter to Health Care Providers to further…
Class IFDA: OngoingDJO, LLC
Medical DeviceOct 13, 2021
Zoll REF: 8700-0782-40 (IC-3893AE), ICY Intravascular Heat Exchange Catheter Kit with recall — FDA Z-0047-2022
Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
Class IIFDA: TerminatedZOLL Circulation, Inc.
Medical DeviceOct 13, 2021
Paltop Advanced Dental Solutions Scan Abutment SU, Cat recall — FDA Z-0016-2022
Some devices are outside tolerances and showed a maximal deviation of 2 degrees in the orientation between the peek head and titanium base, and an incongruence between the size engraved on…
Class IIFDA: TerminatedPaltop Advanced Dental Solutions Ltd
Medical DeviceOct 13, 2021
Exactech OPTETRAK Comprehensive Knee System, labeled as the following: a recall — FDA Z-0019-2022
Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.
Class IIFDA: OngoingExactech, Inc.
Medical DeviceOct 13, 2021
ZOLL Circulation ZOLL, REF 8700-0781-14 (CL-2295CO), COOL LINE Intravascular Heat Exchange recall — FDA Z-0044-2022
Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
Class IIFDA: TerminatedZOLL Circulation, Inc.
How to use this monthly recall archive
Use this page to compare the recalls reported during the month, then open an individual record for the exact reason, classification, company, remedy or distribution information available from the official source. Monthly counts are descriptive, not a safety rating.