Open, ClassifiedPosted May 14, 2025·Initiated May 2, 2025
LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software SUite v2.1 and v2.2
Reason: Firm has identified Drug Library Management defects in the software: 1) DLM software does not allow user to create percentage dose rate or rate change values with certain limits, potentially resulting in over-delivery to patient. 2) An unauthorized user may modify and approve a drug library, potentially leading to incorrect program parameters being used for therapy.
Root cause: Software Design Change
Recalling firm: ICU Medical, Inc.Type: Infusion Safety Management SoftwareDistribution: Worldwide - US Nationwide distribution in the states of CA, FL, IA, KY, LA, MA, MS, NY, PA, TN, and VA. The country of Philippines.Recall #Z-1763-2025
Open, ClassifiedPosted May 14, 2025·Initiated Apr 10, 2025
CMS8000 Patient Monitor
Reason: Patient monitor has nine identified cybersecurity vulnerabilities.
Root cause: Software design
Recalling firm: Contec Medical Systems Co., Ltd.Type: Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)Distribution: US Nationwide distribution in the states of CA, IL, FL, KY, TX.Recall #Z-1764-2025
Open, ClassifiedPosted May 13, 2025·Initiated Apr 9, 2025
PiezoWave 2 Control Unit, Product Number 100506US, compact myofascial acoustic compression therapy device that enables treatment with piezoelectric shockwaves (Therapeutic massager).
Reason: The high voltage capacitor may fail early in the product life cycle after delivery of surge voltages. When this failure occurs, the capacitor may produce smoke and a burning smell. In extremely rare instances a capacitor may cause a spark or excessive heat when an internal capacitor failure occurs.
Root cause: Nonconforming Material/Component
Recalling firm: Richard Wolf GmbHType: Massager, Therapeutic, ElectricDistribution: US State: GARecall #Z-1753-2025
TerminatedPosted May 13, 2025·Initiated Apr 21, 2025
BIB Balloon in Balloon Dilatation Catheter. Model Number: 420
Reason: Balloon extension lumens are not printed correctly. Specifically, the inner balloon inflation hub was labeled as the outer balloon, and the outer balloon inflation hub was labeled as the inner balloon.
Root cause: Mixed-up of materials/components
Recalling firm: Numed IncType: Catheter, Angioplasty, Peripheral, Transluminal, Dual-BalloonDistribution: US distribution to Pennsylvania.Recall #Z-1754-2025
Open, ClassifiedPosted May 13, 2025·Initiated Apr 14, 2025
Augmedics Perc Pin Adaptor, Model/Catalog Number AMCH07200, a component of the xvision Spine (XVS) system, an image-guided navigation system that is designed to assist surgeons in placing pedicle screws accurately, during open or percutaneous computer-assisted spinal surgery.
Reason: The perc pin adaptor AMCH07200 tightening knob was found to be inconvenient to the user and the tightening markings found to be improperly placed.
Root cause: Device Design
Recalling firm: Augmedics Ltd.Type: Orthopedic Stereotaxic InstrumentDistribution: US Nationwide.Recall #Z-1761-2025 Open, ClassifiedPosted May 12, 2025·Initiated Apr 9, 2025
FoundationOne Companion Diagnostic (F1CDx)
Reason: Four (4) total reports were sent to customers with clinically relevant variants requiring amendment, one (1) of which with an incorrect negative CDx claim. The remaining three (3) with tumor profiling result changes did not impact CDx indications.
Root cause: Under Investigation by firm
Recalling firm: Foundation Medicine, Inc.Type: Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection SystemDistribution: Worldwide - US Nationwide distribution in the states of GA, NY and the country of Russia.Recall #Z-1747-2025
Open, ClassifiedPosted May 12, 2025·Initiated Apr 28, 2025
Alinity m Resp-4-Plex Amplification (AMP) Kit (CE), List Number 09N79-090, a multiplex real-time reverse transcription (RT) polymerase chain reaction (PCR) test intended for the qualitative detection and differentiation of RNA from influenza A virus (flu A), influenza B virus (flu B), Respiratory Syncytial Virus (RSV), and SARS-CoV-2 in nasopharyngeal (NP) swab specimens collected by a healthcare provider, from individuals with signs and symptoms of respiratory tract infection
Reason: There were reports of an increase in reactive negative controls and false positive results.
Root cause: Under Investigation by firm
Recalling firm: Abbott Molecular, Inc.Type: Reagents, 2019-Novel Coronavirus Nucleic AcidDistribution: Worldwide - US Nationwide distribution.Recall #Z-1748-2025 Open, ClassifiedPosted May 12, 2025·Initiated Apr 28, 2025
Alinity m Resp-4-Plex AMP Kit, List Number 09N79-096, a multiplex real-time reverse transcription (RT) polymerase chain reaction (PCR) test intended for the simultaneous qualitative detection and differentiation of RNA from SARS-CoV-2, influenza A virus (flu A), influenza B virus (flu B), and/or Respiratory Syncytial Virus (RSV) in anterior nasal or nasopharyngeal swab specimens collected by a healthcare provider (HCP), or in anterior nasal swab specimens that are self-collected at a healthcare location, from individuals suspected by their HCP of respiratory viral infection consistent with COVID-19.
Reason: There were reports of an increase in reactive negative controls and false positive results.
Root cause: Under Investigation by firm
Recalling firm: Abbott Molecular, Inc.Type: Reagents, 2019-Novel Coronavirus Nucleic AcidDistribution: Worldwide - US Nationwide distribution.Recall #Z-1749-2025 Open, ClassifiedPosted May 12, 2025·Initiated Apr 11, 2025
TufTex Over-the-Wire Embolectomy Catheter. All Catalog numbers: 1651-34, 1651-38, 1651-44, 1651-48,
1651-58, 1651-64, 1651-68, 1651-78,
1651-84, 1651-88, E1651-34, E1651-38,
E1651-44, E1651-48, E1651-64, E1651-68,
E1651-78, E1651-84, E1651-88, 1651-44J,
1651-48J, 1651-84J, 1651-88J.
Reason: During internal product testing, it was observed that some packages to have incomplete seals (sterile barrier).
Root cause: Packaging process control
Recalling firm: LeMaitre Vascular, Inc.Type: Catheter, EmbolectomyDistribution: Nationwide distribution. International distribution to ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, BRAZIL, BULGARIA, CAMBODIA, CANADA, CHILE, COLOMBIA, COSTA RICA, CYPRUS, CZECHIA, DENMARK, DOMINICAN REPUBLIC, EGYPT, EL SALVADOR, ESTONIA, FINLAND, FRANCE, GEORGIA, GERMANY, GREECE, GUATEMALA, GUYANA, HONG KONG, HUNGARY, INDIA, INDONESIA, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KUWAIT, LATVIA, LEBANON, LITHUANIA, MALAYSIA, MALTA, MEXICO, MONGOLIA, MOROCCO, NETHERLANDS, NEW ZEALAND, NICARAGUA, NORTH MACEDONIA, NORWAY, OMAN, PANAMA, PARAGUAY, PHILIPPINES, POLAND, QATAR, ROMANIA, RUSSIA, SAUDI ARABIA, SERBIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TRINIDAD AND TOBAGO, TUNISIA, TURKIYE, UNITED ARAB EMIRATES, UNITED KINGDOM, VENEZUELA, VIETNAM.Recall #Z-1750-2025
Open, ClassifiedPosted May 12, 2025·Initiated Apr 11, 2025
Pruitt Occlusion Catheter. Catalog Numbers: 2103-36, 2103-46, 2103-56, E2103-36, E2103-46, E2103-56
Reason: During internal product testing, it was observed that some packages to have incomplete seals (sterile barrier).
Root cause: Packaging process control
Recalling firm: LeMaitre Vascular, Inc.Type: Catheter, Flow DirectedDistribution: Nationwide distribution. International distribution to ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, BRAZIL, BULGARIA, CAMBODIA, CANADA, CHILE, COLOMBIA, COSTA RICA, CYPRUS, CZECHIA, DENMARK, DOMINICAN REPUBLIC, EGYPT, EL SALVADOR, ESTONIA, FINLAND, FRANCE, GEORGIA, GERMANY, GREECE, GUATEMALA, GUYANA, HONG KONG, HUNGARY, INDIA, INDONESIA, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KUWAIT, LATVIA, LEBANON, LITHUANIA, MALAYSIA, MALTA, MEXICO, MONGOLIA, MOROCCO, NETHERLANDS, NEW ZEALAND, NICARAGUA, NORTH MACEDONIA, NORWAY, OMAN, PANAMA, PARAGUAY, PHILIPPINES, POLAND, QATAR, ROMANIA, RUSSIA, SAUDI ARABIA, SERBIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TRINIDAD AND TOBAGO, TUNISIA, TURKIYE, UNITED ARAB EMIRATES, UNITED KINGDOM, VENEZUELA, VIETNAM.Recall #Z-1751-2025
Open, ClassifiedPosted May 12, 2025·Initiated Apr 11, 2025
Pruitt Irrigation Occlusion Catheter. Catalog Numbers: 2102-09, E2102-09.
Reason: During internal product testing, it was observed that some packages to have incomplete seals (sterile barrier).
Root cause: Packaging process control
Recalling firm: LeMaitre Vascular, Inc.Type: Occluder, Catheter TipDistribution: Nationwide distribution. International distribution to ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, BRAZIL, BULGARIA, CAMBODIA, CANADA, CHILE, COLOMBIA, COSTA RICA, CYPRUS, CZECHIA, DENMARK, DOMINICAN REPUBLIC, EGYPT, EL SALVADOR, ESTONIA, FINLAND, FRANCE, GEORGIA, GERMANY, GREECE, GUATEMALA, GUYANA, HONG KONG, HUNGARY, INDIA, INDONESIA, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KUWAIT, LATVIA, LEBANON, LITHUANIA, MALAYSIA, MALTA, MEXICO, MONGOLIA, MOROCCO, NETHERLANDS, NEW ZEALAND, NICARAGUA, NORTH MACEDONIA, NORWAY, OMAN, PANAMA, PARAGUAY, PHILIPPINES, POLAND, QATAR, ROMANIA, RUSSIA, SAUDI ARABIA, SERBIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TRINIDAD AND TOBAGO, TUNISIA, TURKIYE, UNITED ARAB EMIRATES, UNITED KINGDOM, VENEZUELA, VIETNAM.Recall #Z-1752-2025
Open, ClassifiedPosted May 9, 2025·Initiated Apr 10, 2025
Brand Name: AirLife
Product Name: AirLife Infant Heated Wire Circuit
Model/Catalog Number: AH165
Software Version: N/A
Product Description: AirLife Infant Heated Wire Circuit dual-limb, dual-heat, high-flow circuit (>4 L/min)
Component: No. a conduit for respiratory gas between the patient and a ventilator.
Reason: Adapters may disconnect during setup or while in use, potentially interrupting ventilation. Any disconnection can result in severe consequences for neonates, including hypoxia, hypercapnia, and organ failure.
Root cause: Component design/selection
Recalling firm: Vyaire MedicalType: Heater, Breathing System W/Wo Controller (Not Humidifier Or NebulizerDistribution: Worldwide distribution - US Nationwide and the countries of Germany, Poland, Belgium, Spain, Romania, UK, Italy, Netherlands, India, Slovenia, Qatar, and Saudi Arabia.Recall #Z-1697-2025
Open, ClassifiedPosted May 9, 2025·Initiated Apr 10, 2025
Brand Name: AirLife
Product Name: AirLife Infant Heated Wire Circuit
Model/Catalog Number: AH265
Software Version: N/A
Product Description: AirLife Infant Heated Wire Circuit Kit Dual-limb, Dual-heat, high-flow circuit (>4 L/min) Contains AH165 Circuit, AH290 Chamber
Component: No. a conduit for respiratory gas between the patient and a ventilator.
Reason: Adapters may disconnect during setup or while in use, potentially interrupting ventilation. Any disconnection can result in severe consequences for neonates, including hypoxia, hypercapnia, and organ failure.
Root cause: Component design/selection
Recalling firm: Vyaire MedicalType: Heater, Breathing System W/Wo Controller (Not Humidifier Or NebulizerDistribution: Worldwide distribution - US Nationwide and the countries of Germany, Poland, Belgium, Spain, Romania, UK, Italy, Netherlands, India, Slovenia, Qatar, and Saudi Arabia.Recall #Z-1698-2025
Open, ClassifiedPosted May 9, 2025·Initiated Apr 7, 2025
Welch Allyn Life2000 Ventilation system, Product Codes:
1) BT-20-0002;
2) BT-20-0002A;
3) BT-20-0002AP;
4) BT200007;
5) BT-20-0007;
6) BT200011;
7) BT-20-0011;
8) RMS010118CP.
Reason: A cybersecurity vulnerability was discovered through internal testing.
Root cause: Software in the Use Environment
Recalling firm: Baxter Healthcare CorporationType: Ventilator, Continuous, Facility UseDistribution: Worldwide distribution.Recall #Z-1725-2025
Open, ClassifiedPosted May 9, 2025·Initiated Apr 7, 2025
Welch Allyn Life2000 Compressor, Product Codes:
1) BT-80-0004;
2) BT-80-0004A;
3) BT-80-0008;
4) BT-80-0008A;
5) RMS010093CP.
Reason: A cybersecurity vulnerability was discovered through internal testing.
Root cause: Software in the Use Environment
Recalling firm: Baxter Healthcare CorporationType: Ventilator, Continuous, Facility UseDistribution: Worldwide distribution.Recall #Z-1726-2025
Open, ClassifiedPosted May 9, 2025·Initiated Apr 11, 2025
iGo2 DC Car Adapter to be used with iGo2 Portable Oxygen Concentrator Systems. Power cord allows the user to operate the device in a vehicle.
Reason: Potential for DC Power Supply housing to become hot to the touch and deform the plastic housing.
Root cause: Nonconforming Material/Component
Recalling firm: Medical Depot Inc.Type: Generator, Oxygen, PortableDistribution: Worldwide distribution - US Nationwide and the countries of Albania, Austria, Bahrain, Belgium, Bosnia and Herzegovina, Bulgaria, Canada, China, Colombia, Croatia, Cyprus, Czech Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, Iceland, ISRAEL, Italy, JAPAN, Kenya, Kuwait, Latvia, Libya, Lithuania, Malaysia, Maldives, Nepal, Netherlands, Norway, Oman, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Slovak Republic, Slovenia, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Trinidad & Tobago, Turkey, Uganda, Ukraine, United Arab Emirates.Recall #Z-1727-2025
Open, ClassifiedPosted May 9, 2025·Initiated Mar 31, 2025
Halyard CHRIST SUTURE KIT. General Procedure Tray Convenience Kit
Reason: An issue with a raw material used to coat some surgical needles that may result in diminished performance and/or removal of some silicone needle coating during use.
Root cause: Nonconforming Material/Component
Recalling firm: AVID Medical, Inc.Type: General Surgery TrayDistribution: US Nationwide distribution in the states of IL & LA.Recall #Z-1741-2025
Open, ClassifiedPosted May 9, 2025·Initiated Mar 31, 2025
Halyard SUTURE PACK CABG. Cardiovascular Procedure Convenience Kit.
Reason: An issue with a raw material used to coat some surgical needles that may result in diminished performance and/or removal of some silicone needle coating during use.
Root cause: Nonconforming Material/Component
Recalling firm: AVID Medical, Inc.Type: Cardiovascular Procedure KitDistribution: US Nationwide distribution in the states of IL & LA.Recall #Z-1742-2025
Open, ClassifiedPosted May 9, 2025·Initiated Mar 31, 2025
Halyard RAPIDES E-PACK. Cardiovascular Procedure Convenience Kit.
Reason: An issue with a raw material used to coat some surgical needles that may result in diminished performance and/or removal of some silicone needle coating during use.
Root cause: Nonconforming Material/Component
Recalling firm: AVID Medical, Inc.Type: Cardiovascular Procedure KitDistribution: US Nationwide distribution in the states of IL & LA.Recall #Z-1743-2025
Open, ClassifiedPosted May 9, 2025·Initiated Jul 12, 2024
Brand Name: Contour
Product Name: Contour Gold Eyelid Weight
Model/Catalog Number: LL3010
Product Description: Contour Gold Eyelid Weight, 1.0 gm
MedDev Contour and ThinProfile Eyelid Weight Implants are designed for the gravity-assisted treatment of protracted permanent lagophthalmos, usually resulting from facial paralysis.
Reason: Due to mislabeling of products
Root cause: Process control
Recalling firm: Meddev CorpType: Weights, Eyelid, ImplantableDistribution: U.S. Nationwide distribution in the states of CA, CO, CT, FL, IA, IL, MA, ME, MI, NE, NY, OH, OK, OR, SC, TX, and WV.Recall #Z-1744-2025