Medical DeviceMar 4, 2020
MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Embolization Coil recall — FDA Z-1395-2020
The devices may be missing the implant coil.
Class IIFDA: TerminatedMicrovention, Inc.
March 2020 recalls — page 14
These records include useful source details for the selected month.
Medical DeviceMar 4, 2020
St Jude Medical, Cardiac Rhythm Management Ellipse, Tiered-therapy recall — FDA Z-1351-2020
Past updates to programmers and transmitters may lead some implantable cardioverter defibrillators (ICD) to lose wireless radiofrequency (RF) communication; which means patients can no…
Class IIFDA: TerminatedSt Jude Medical, Cardiac Rhythm Management Division
Medical DeviceMar 4, 2020
MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Embolization Coil recall — FDA Z-1407-2020
The devices may be missing the implant coil.
Class IIFDA: TerminatedMicrovention, Inc.
Medical DeviceMar 4, 2020
Biomet 3i CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 5MM(P) X 4MM(H) Reference recall — FDA Z-1376-2020
Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment
Class IIFDA: TerminatedBiomet 3i, LLC
Medical DeviceMar 4, 2020
Biomet 3i CERTAIN BELLATEK ENCODE HEALING ABUTMENT 3.4MM(D) X 3.8MM(P) X 3MM(H) Reference recall — FDA Z-1366-2020
Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment
Class IIFDA: TerminatedBiomet 3i, LLC
Medical DeviceMar 4, 2020
Zimmer Sterile Disposable Tourniquet Cuff with Protective Sleeve and PLC, Dual Port, Dual recall — FDA Z-1356-2020
When inflating/deflating a single bladder, both bladders could potentially inflate/deflate due to a leak between the bladders.
Class IIFDA: TerminatedZimmer Surgical Inc.
Medical DeviceMar 4, 2020
Maquet Cardiovascular Us Sales Getinge 46-Series Washer Disinfector Model # 46-4, Part recall — FDA Z-1390-2020
Due to a missing water intake for Deionized water on the Getinge 46-Series Washer Disinfector. There were no valve, hose, or clamps for this option included with the device therefore the…
Class IIIFDA: TerminatedMaquet Cardiovascular Us Sales, LLC
Medical DeviceMar 4, 2020
Biomet 3i CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 6MM(P) X 6MM(H) Reference recall — FDA Z-1387-2020
Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment
Class IIFDA: TerminatedBiomet 3i, LLC
Medical DeviceMar 4, 2020
Breas Medical Protective Cover Vivo 55/65 (Used for Vivo 50/65), Part No. 006344 recall — FDA Z-1352-2020
The outlet hole of the exhalation valve control pressure tube on the ventilator may become obstructed by the protective cover.
Class IIFDA: TerminatedBreas Medical, Inc.
Medical DeviceMar 4, 2020
Biomet 3i CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 4.1MM(P) X 4MM(H) Reference recall — FDA Z-1373-2020
Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment
Class IIFDA: TerminatedBiomet 3i, LLC
Medical DeviceMar 4, 2020
Hologic Selenia Dimensions Mammography System, Model number ASY-04160, Selenia Dimensions recall — FDA Z-1343-2020
The recalling firm has received reports from the field of the C-arm on the Selenia Dimensions system seizing or dropping during field repairs and cleaning of the systems.
Class IIFDA: TerminatedHologic, Inc.
Medical DeviceMar 4, 2020
MicroVention Terumo HydroFrame 18, HydroCoil Embolic System, Endovascular Embolization Coil recall — FDA Z-1403-2020
The devices may be missing the implant coil.
Class IIFDA: TerminatedMicrovention, Inc.
Medical DeviceMar 4, 2020
Biomet 3i CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 6MM(P) X 6MM(H) Reference recall — FDA Z-1380-2020
Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment
Class IIFDA: TerminatedBiomet 3i, LLC
Medical DeviceMar 4, 2020
MicroVention Terumo Microplex 18, Platinum Coil System, Endovascular Embolization Coil recall — FDA Z-1397-2020
The devices may be missing the implant coil.
Class IIFDA: TerminatedMicrovention, Inc.
Medical DeviceMar 4, 2020
MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Embolization Coil recall — FDA Z-1404-2020
The devices may be missing the implant coil.
Class IIFDA: TerminatedMicrovention, Inc.
Medical DeviceMar 4, 2020
Medline ROBOTIC-LF REF CDS984543B Lot 20AKA927 Expiration 2020-09-30 GTIN (01)10888277056350 recall — FDA Z-1358-2020
The sterile pack inside the Complete Delivery System (CDS) did not go through a complete sterilization cycle, therefore the sterility of these components cannot be guaranteed.
Class IIFDA: TerminatedMedline Industries Inc.
Medical DeviceMar 4, 2020
Philips DigiTrak XT Holter Recorder Software version number B.1 and C.2 recall — FDA Z-1345-2020
if an AAA battery is inserted in the recorder and a user attempts to start it, or if the recorder is inserted in the docking station, the recorder will display Error: 602 and fail to…
Class IIFDA: TerminatedPhilips North America, LLC
Medical DeviceMar 4, 2020
Zimmer Biomet THP Hip Plating System, Item Nos. 14-451070 14-451075 14-451080 14-451085 recall — FDA Z-1347-2020
Potential increase in fracture rate was detected during internal testing, in addition to potential discoloration inside the inner pouch of the packaging.
Class IIFDA: TerminatedZimmer Biomet, Inc.
Medical DeviceMar 4, 2020
MicroVention Terumo Microplex 18, Platinum Coil System, Endovascular Embolization Coil recall — FDA Z-1401-2020
The devices may be missing the implant coil.
Class IIFDA: TerminatedMicrovention, Inc.
Medical DeviceMar 4, 2020
Biomet 3i CERTAIN BELLATEK ENCODE HEALING ABUTMENT 3.4MM(D) X 5MM(P) X 3MM(H) Reference recall — FDA Z-1369-2020
Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment
Class IIFDA: TerminatedBiomet 3i, LLC
Medical DeviceMar 4, 2020
MicroVention Terumo HydroSoft 10, HydroCoil Embolic System, Endovascular Embolization Coil recall — FDA Z-1392-2020
The devices may be missing the implant coil.
Class IIFDA: TerminatedMicrovention, Inc.
FoodMar 4, 2020
Pro-Form Manufacturing Nature's Sunshine CMapt M - Cmapt Mi- SmartMeal recall — FDA F-0780-2020
Notified by supplier that flax seed used in products is under recall due to detection of unapproved herbicide.
Class IIIFDA: TerminatedPro-Form Manufacturing LLC
FoodMar 4, 2020
Pro-Form Manufacturing Nature's Sunshine SmartMeal Nutritional Shake Mix recall — FDA F-0782-2020
Notified by supplier that flax seed used in products is under recall due to detection of unapproved herbicide.
Class IIIFDA: TerminatedPro-Form Manufacturing LLC
FoodMar 4, 2020
Lotte Int'l 12 pack 11.85 oz recall — FDA F-0753-2020
FDA testing found almond protein in the products, which is not an ingredient in the product.
Class IIFDA: TerminatedLotte Int'l America Corp.
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.