Open, ClassifiedPosted Apr 21, 2025·Initiated Feb 25, 2025
Zenition 50. Product Code 718096.
The devices are used for radiological guidance and visualization during diagnostic, interventional and
surgical procedures on all patients, except neonates (birth to one month), within the limits of the devices.
Reason: A wireless foot switch pedal may get stuck in the active position when the user releases the pedal,
resulting in the emission of unintended radiation.
Root cause: Labeling design
Recalling firm: Philips North America LlcType: Interventional Fluoroscopic X-Ray SystemDistribution: USRecall #Z-1580-2025 Open, ClassifiedPosted Apr 21, 2025·Initiated Feb 25, 2025
Zenition 70. Product Code 718133. The devices are used for radiological guidance and visualization during diagnostic, interventional and
surgical procedures on all patients, except neonates (birth to one month), within the limits of the devices.
Reason: A wireless foot switch pedal may get stuck in the active position when the user releases the pedal,
resulting in the emission of unintended radiation.
Root cause: Labeling design
Recalling firm: Philips North America LlcType: Interventional Fluoroscopic X-Ray SystemDistribution: USRecall #Z-1581-2025 Open, ClassifiedPosted Apr 21, 2025·Initiated Feb 25, 2025
Veradius Unity. Product Code 718132. The devices are used for radiological guidance and visualization during diagnostic, interventional and
surgical procedures on all patients, except neonates (birth to one month), within the limits of the devices.
Reason: A wireless foot switch pedal may get stuck in the active position when the user releases the pedal, resulting in the emission of unintended radiation.
Root cause: Labeling design
Recalling firm: Philips North America LlcType: Interventional Fluoroscopic X-Ray SystemDistribution: USRecall #Z-1582-2025 Open, ClassifiedPosted Apr 21, 2025·Initiated Jul 20, 2023
Zenition 70. The device is to be used in health care facilities both inside and outside the operating room, sterile as well as non-sterile environment in a variety of procedures.
Reason: Philips has become aware of the potential for unintended radiation exposure with Zenition 70 systems with Vascular Extension option and a Wireless Foot Switch.
Root cause: Software design
Recalling firm: Philips Medical Systems Nederland B.V.Type: Interventional Fluoroscopic X-Ray SystemDistribution: US Nationwide distributionRecall #Z-1583-2025
Open, ClassifiedPosted Apr 21, 2025·Initiated Mar 14, 2025
Merit Medical, REF: R2007, EsophyX Z+, (1) Fastener Delivery Device, SterileEO, RxOnly
Reason: Update to IFU to provide additional information related to risk with device over-rotation and multiple deployment of fasteners.
Root cause: Under Investigation by firm
Recalling firm: Merit Medical Systems, Inc.Type: Endoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd)Distribution: Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV and the countries of Brazil, Egypt, Israel, Saudi Arabia, Spain, Thailand, Turkey, United Arab Emirates.Recall #Z-1640-2025 Open, ClassifiedPosted Apr 21, 2025·Initiated Mar 14, 2025
Merit Medical , REF: R2275, EsophyX Z+ with SerosaFuse Implantable Fasteners, (1) Fastener Delivery Device, (2) 7.5mm Cartridges, STERILEEO,RxOnly
Reason: Update to IFU to provide additional information related to risk with device over-rotation and multiple deployment of fasteners.
Root cause: Under Investigation by firm
Recalling firm: Merit Medical Systems, Inc.Type: Endoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd)Distribution: Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV and the countries of Brazil, Egypt, Israel, Saudi Arabia, Spain, Thailand, Turkey, United Arab Emirates.Recall #Z-1641-2025 Open, ClassifiedPosted Apr 21, 2025·Initiated Mar 17, 2025
Amplatzer TorqVue LP Delivery System (TVLP), Model nos. 9-TVLP4F90/060 and 9-TVLP4F90/080
Reason: Device may have a small breach in the proximal end of the shaft under the strain relief of the delivery system. Breach is not visibly detectable and may lead to prolonged procedure, blood loss, or air ingress with potential for air embolism.
Root cause: Process control
Recalling firm: AbbottType: Catheter, PercutaneousDistribution: Worldwide - US Nationwide distribution.Recall #Z-1643-2025 Open, ClassifiedPosted Apr 21, 2025·Initiated Mar 17, 2025
Amplatzer TorqVue LP Catheter (TVLPC), Model no. 9-TVLPC4F90/080
Reason: Device may have a small breach in the proximal end of the shaft under the strain relief of the delivery system. Breach is not visibly detectable and may lead to prolonged procedure, blood loss, or air ingress with potential for air embolism.
Root cause: Process control
Recalling firm: AbbottType: Catheter, PercutaneousDistribution: Worldwide - US Nationwide distribution.Recall #Z-1644-2025 Open, ClassifiedPosted Apr 21, 2025·Initiated Mar 24, 2025
Zimmer Biomet Ceramic Head, 22.2 mm Diameter, 12/14 Taper, +0 Neck, Model Number 802602202; Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented or Non-
Porous, Uncemented
Reason: The associated product labeling does not adequately provide compatibility information for use of the 22.2 mm Diameter Ceramic Femoral Heads with cobalt-chrome femoral stems or stainless-steel femoral stems.
Root cause: Under Investigation by firm
Recalling firm: Zimmer, Inc.Type: Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, UncementedDistribution: Worldwide distribution - US Nationwide and the countries of Panama, Hong Kong, China.Recall #Z-1645-2025
Open, ClassifiedPosted Apr 21, 2025·Initiated Mar 24, 2025
Zimmer Biomet Ceramic Head, 22.2 mm Diameter, 12/14 Taper, +3 Neck, Model Number 802602203; Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented or Non-
Porous, Uncemented
Reason: The associated product labeling does not adequately provide compatibility information for use of the 22.2 mm Diameter Ceramic Femoral Heads with cobalt-chrome femoral stems or stainless-steel femoral stems.
Root cause: Under Investigation by firm
Recalling firm: Zimmer, Inc.Type: Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, UncementedDistribution: Worldwide distribution - US Nationwide and the countries of Panama, Hong Kong, China.Recall #Z-1646-2025
Open, ClassifiedPosted Apr 21, 2025·Initiated Mar 24, 2025
Zimmer Biomet Ceramic Head, 22.2 mm Diameter, Type 1, -3 Neck, Model Number 802802201; Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented or Non-
Porous, Uncemented
Reason: The associated product labeling does not adequately provide compatibility information for use of the 22.2 mm Diameter Ceramic Femoral Heads with cobalt-chrome femoral stems or stainless-steel femoral stems.
Root cause: Under Investigation by firm
Recalling firm: Zimmer, Inc.Type: Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, UncementedDistribution: Worldwide distribution - US Nationwide and the countries of Panama, Hong Kong, China.Recall #Z-1647-2025
Open, ClassifiedPosted Apr 21, 2025·Initiated Mar 24, 2025
Zimmer Biomet Ceramic Head, 22.2 mm Diameter, Type 1, +0 Neck, Model Number 802802202; Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented or Non-
Porous, Uncemented
Reason: The associated product labeling does not adequately provide compatibility information for use of the 22.2 mm Diameter Ceramic Femoral Heads with cobalt-chrome femoral stems or stainless-steel femoral stems.
Root cause: Under Investigation by firm
Recalling firm: Zimmer, Inc.Type: Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, UncementedDistribution: Worldwide distribution - US Nationwide and the countries of Panama, Hong Kong, China.Recall #Z-1648-2025
Open, ClassifiedPosted Apr 21, 2025·Initiated Mar 24, 2025
Zimmer Biomet Ceramic Head, 22.2 mm Diameter, Type 1, +3 Neck, Model Number 802802203; Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented or Non-
Porous, Uncemented
Reason: The associated product labeling does not adequately provide compatibility information for use of the 22.2 mm Diameter Ceramic Femoral Heads with cobalt-chrome femoral stems or stainless-steel femoral stems.
Root cause: Under Investigation by firm
Recalling firm: Zimmer, Inc.Type: Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, UncementedDistribution: Worldwide distribution - US Nationwide and the countries of Panama, Hong Kong, China.Recall #Z-1649-2025
Open, ClassifiedPosted Apr 21, 2025·Initiated Mar 4, 2025
InPen smart insulin pen, REF: MMT-105NNBLNA, MMT-105NNGYNA, MMT-105NNPKNA, MMT-105ELBLNA, MMT-105ELGYNA, MMT105ELPKNA
Reason: Insulin pens may have been incorrectly assembled therefore users could experience the following: either the insulin cartridge will not fit into the cartridge holder; or the cartridge holder may be difficult to remove from the insulin pen. If the issue is present, and if the user does not have backup insulin they may experience temporary hyperglycemia.
Root cause: Mixed-up of materials/components
Recalling firm: Medtronic MiniMed, Inc.Type: Syringe, PistonDistribution: US: OK, IA, NC, SC, MI, MN, CA, AZ, AL, MO, WA, IL, KS, TX, FL, MT, MD, OH, VA, NY, TN, HI, MA, NJ, PA, CO, WI, GA, CT, NE, OR, LA, NM, SD, ND, IN, NV, WV, RI, AR, NHRecall #Z-1650-2025 Open, ClassifiedPosted Apr 18, 2025·Initiated Mar 20, 2025
The VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System is designed for use in conjunction with the 7 mm extended length endoscope. The Harvesting Cannula has four lumens which house the endoscope, C-Ring, distal lens washer tube, and Harvesting Tool for cutting and cauterizing vessel branches. The Harvesting Tool has two curved jaws. One of the jaws contains the heating elements for branch cutting and cauterization and spot cautery. An area near the tip of the convex side of the jaw is used for spot cautery. The activation toggle is used to control the jaws to activate the heating elements. Positioning the device, cutting, and cauterization are performed under endoscopic visualization. The device is intended for specific use with the VASOVIEW HEMOPRO Power Supply, VASOVIEW HEMOPRO 2 extension cable, and an adapter cable.
Reason: There have been at least 12 complaints from users as of March 3, 2025, reporting that they identified the ceramic C-Ring to be broken in half during use of the device. The ceramic C-Ring has a potential to break while in use. Maquet/Getinge determined that the issue was limited to the units of VH-4000 and VH-4001 manufactured with ceramic C-Ring, and the ceramic C-Ring was implemented in the Hemopro 2 devices from November 5, 2024, through February 14, 2025.
Root cause: Under Investigation by firm
Recalling firm: Maquet Cardiovascular, LLCType: Electrosurgical, Cutting & Coagulation & AccessoriesDistribution: Worldwide distribution - US Nationwide and the countries of Mexico, United Arab Emirates, Singapore, India, Australia, Canada, Brazil, Hong Kong, Japan, South Korea, New Zealand.Recall #Z-1622-2025
Open, ClassifiedPosted Apr 18, 2025·Initiated Mar 10, 2025
NIM Vital Nerve Monitoring System:
CONSOLE NIM4CM01 NIM 4.0, REF: NIM4CM01;
CONSOLE NIM4CM01RF NIM 4.0 REFURBISHED, REF: NIM4CM01RF;
PATIENT INTERFACE NIM4CPB1 NIM 4.0, REF: NIM4CPB1;
PATIENT INTFC NIM4CPB1RF NIM 4.0 REFURB, REF: NIM4CPB1RF;
SOFTWARE NIM4SWU143 UPGRADE V1.4.3, REF: NIM4SWU143;
SOFTWARE NIM4SWU154 UPGRADE V1.5.4, REF: NIM4SWU154;
SOFTWARE NIM4SWU164 UPGRADE V1.6.4, REF: NIM4SWU164
Reason: Nerve Monitoring System with certain software versions has potential for increased stimulus artifact, which may require troubleshooting, and may lead to procedure delay, extubation, and medical intervention.
Root cause: Software change control
Recalling firm: Medtronic Xomed, Inc.Type: Stimulator, Electrical, Evoked ResponseDistribution: Worldwide - US Nationwide distribution including in the states of MD, MN, PA, OK, OH, FL, CO, GA, NC, KS, IL, WY, AK, NE, VA, MI, CA, NY, WI, UT, AZ, AR, TX, WA, AL, NJ, SD, MS, KY, TN, MO, OR, MT, MA, CT, NM, LA, WV, NH, DC, DE, IN, NV, IA, SC, ID, ME, HI, RI, VT, ND, GU, PR and the countries of Algeria, Argentina, Armenia, Australia, Austria, Bahrain, Belgium, Bulgaria, Canada, Canary Islands, Cayman Islands, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Egypt, El Salvador, Finland, France, French Guiana, French Polynesia, Georgia, Germany, Greece, Guadeloupe, Guatemala, Honduras, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Jordan, Kosovo, Kuwait, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Malaysia, Mauritius, Mexico, Namibia, Nepal, Netherlands, New Zealand, North Macedonia, Northern Ireland, Norway, Oman, Panama, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Viet Nam.Recall #Z-1623-2025
Open, ClassifiedPosted Apr 18, 2025·Initiated Mar 11, 2025
BD PYXIS MEDBANK (Name, REF):
MEDPASS MODULE, 139088-01;
MINI 1FH-1FM, 169-137;
MINI 1HH-1FH-1HM, 169-101;
MINI 1HH-1HM-1FM, 169-102;
MINI 2FH, 138902-01;
MINI 2FH, 169-104;
MINI 2FM, 169-105;
MINI 2HH-1FH, 169-106;
MINI 2HH-1FH, 138908-01;
MINI 2HH-1FM, 169-107;
MINI 2HH-1FM, 138906-01;
MINI 3HH-1FG, 169-110;
MINI 3HH-1FG, 139091-01;
MINI 3HH-1HM, 169-111;
MINI 4HH, 138910-01;
MINI 4HH, 169-112;
MINI 4HM, 169-113;
MINI 4HM, 138915-01;
TWR MN 10HH-1FH-1FM, 169-23;
TWR MN 10HH-2FH, 169-24;
TWR MN 10HH-2FH, 138955-01;
TWR MN 10HH-2FM, 169-25;
TWR MN 10HH-2FM, 138924-01;
TWR MN 12HH-1FF, 169-26;
TWR MN 12HH-1FF, 138960-01;
TWR MN 12HH-1FH, 169-27;
TWR MN 12HH-1FH, 138961-01;
TWR MN 12HH-1FM, 169-28;
TWR MN 12HH-1FM, 138926-01;
TWR MN 14HH, 138927-01;
TWR MN 14HH, 169-29;
TWR MN 1HH-1HM-2FM-4FF, 169-30;
TWR MN 2FH-2HM-4FM, 169-31;
TWR MN 2HH-10HM-1FM, 169-32;
TWR MN 2HH-1FH-5FM, 169-33;
TWR MN 2HH-2FH-4FM, 169-34;
TWR MN 2HH-4FH-2FM, 169-139;
TWR MN 2HH-4HM-4FM, 139125-01;
TWR MN 2HH-6FM, 169-38;
TWR MN 2HH-6FM, 138919-01;
TWR MN 2HH-6HM-3FM, 169-39;
TWR MN 2HH-8HM-2FM, 169-40;
TWR MN 2HM-6FM, 169-41;
TWR MN 3FH-4FM, 169-42;
TWR MN 3FH-4FM, 138933-01;
TWR MN 3FH-8HH MEDPASS, 169-140;
TWR MN 3HH-7HM-2FM, 169-43;
TWR MN 4HH-10HM, 169-44;
TWR MN 4HH-10HM, 138959-01;
TWR MN 4HH-1FH-2HM-3FM, 169-45;
TWR MN 4HH-1FH-4FM, 169-46;
TWR MN 4HH-1FH-4HM-2FM, 169-47;
TWR MN 4HH-2FH-2HM-2FM, 169-49;
TWR MN 4HH-2FH-3FM, 169-50;
TWR MN 4HH-2FH-3FM, 138931-01;
TWR MN 4HH-3FH-2FM, 169-52;
TWR MN 4HH-4FH-1FM, 169-53;
TWR MN 4HH-4FH-1FM, 138940-01;
TWR MN 4HH-4HM-3FM, 169-54;
TWR MN 4HH-4HM-3FM, 138952-01;
TWR MN 4HH-5FH, 169-55;
TWR MN 4HH-5FM, 169-56;
TWR MN 4HH-5FM, 138918-01;
TWR MN 4HH-6HM-2FM, 169-57;
TWR MN 4HM-5FM, 169-59;
TWR MN 5HH-3HM-3FM, 169-60;
TWR MN 5HH-9HM, 138914-01;
TWR MN 5HH-9HM, 169-61;
TWR MN 6FH-1FM, 169-62;
TWR MN 6HH-1FH-2HM-2FM, 169-63;
TWR MN 6HH-1FH-3FM, 169-64;
TWR MN 6HH-2FH-2FM, 169-65;
TWR MN 6HH-4FH, 169-67;
TWR MN 6HH-4FH, 138957-01;
TWR MN 6HH-4FM, 169-68;
TWR MN 6HH-4FM, 138922-01;
TWR MN 6HH-4HM-2FM, 169-69;
TWR MN 6HH-8HM, 169-71;
TWR MN 6HH-8HM, 138958-01;
TWR MN 7FH, 169-72;
TWR MN 7FH, 138920-01;
TWR MN 7FM, 169-73;
TWR MN 7FM, 138937-01;
TWR MN 7HH-1HM-3FM, 139086-01;
TWR MN 7HH-1HM-3FM, 169-74;
TWR MN 8HH-1FH-2FM, 169-75;
TWR MN 8HH-2FH-1FM, 169-77;
TWR MN 8HH-2HM-2FM, 169-78;
TWR MN 8HH-2HM-2FM, 138939-01;
TWR MN 8HH-3FF, 169-79;
TWR MN 8HH-3FH, 169-80;
TWR MN 8HH-3FH, 138956-01;
TWR MN 8HH-3FM, 169-81;
TWR MN 8HH-3FM, 138923-01.
BD PYXIS MEDFLEX MN (Name, REF):
1000 12HH, 139055-01;
1000 2HH-2FM, 139041-01;
1000 2HH-5FM, 139046-01;
1000 4HH-4FM, 139049-01;
1000 6HH-3FM, 139051-01;
1000 8HH-2FM, 139052-01;
2000 8HH-2FH, 139165-01;
2000 8HH-2FM, 139069-01.
MEDBANK MAIN, 1137-00;
MEDBANK MINI MAIN, 1147-00;
MEDBANK TOWER MAIN, 1145-00;
MEDFLEX, 1119-00;
MEDFLEX 2.0, 1139-00
Open, ClassifiedPosted Apr 17, 2025·Initiated Mar 13, 2025
HeartMate Mobile Power Unit: REF: 107754, NA; 107758, EU; 107758AU, AU; 107758UK, UK; L107758, EU Rental. Used with HeartMate 3 and II Left Ventricular Assist System.
Reason: Left Ventricular Assist System Mobile Power Unit (MPU) may have electrical component that may cause MPU not to turn on, unprompted shut down, or turning off/restarting, may cause system controller to indicate Yellow Wrench or No External Power alarms. If MPU losses power, System Controller can support the pump up to 15 minutes, and if not switched to rechargeable batteries, pump may lose power.
Root cause: Process control
Recalling firm: Thoratec LLCType: Ventricular (Assist) BypassDistribution: Worldwide - US Nationwide distribution in the states of WA, NE, VA, PA, DC, KY, CA, IL, WI, TX, MA, AR, MS, MI, OH, FL, NC, TN, LA, NJ, UT, NY, DE, CT, GA, IN, AZ, OK, MO, OR, MN, SC, NM, MD, IA, KS, AL, CO, ME and the countries of ALGERIA, AUSTRALIA, AUSTRIA, BELGIUM, BRAZIL, CHILE, CZECH REPUBLIC, FINLAND, FRANCE, GEORGIA, GERMANY, HONG KONG, ISRAEL, ITALY, JAPAN, KUWAIT, LEBANON, LITHUANIA, NETHERLANDS, NEW ZEALAND, NORWAY, OMAN, POLAND, PORTUGAL, ROMANIA, SERBIA, SINGAPORE, SOUTH AFRICA, SOUTH KOREA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, TUNISIA, TURKEY, UK, UNITED ARAB EMIRATES.Recall #Z-1570-2025
Open, ClassifiedPosted Apr 17, 2025·Initiated Mar 3, 2025
Medline Convenience kits used for various procedures:
1) INTUBATION TRAY, Model Number: MNS10395;
Reason: There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
Root cause: Under Investigation by firm
Recalling firm: MEDLINE INDUSTRIES, LP - NorthfieldType: Circuit, Breathing (W Connector, Adaptor, Y Piece)Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Mexico, Panama, Virgin Islands.Recall #Z-1586-2025
Open, ClassifiedPosted Apr 17, 2025·Initiated Mar 3, 2025
Medline Convenience kits used for various procedures:
1) RHINOPLASTY PACK, Model Number: DYNJ84116A
Reason: There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
Root cause: Under Investigation by firm
Recalling firm: MEDLINE INDUSTRIES, LP - NorthfieldType: Tracheotomy Care KitDistribution: Worldwide distribution - US Nationwide and the countries of Canada, Mexico, Panama, Virgin Islands.Recall #Z-1587-2025