Open, ClassifiedPosted Jul 10, 2026·Initiated Jun 11, 2026
ABIOMED Intro Kit, 14Fr x 13 and 25 cm, PKGD, JP, Pump Set Code 0052-0023-JP; containing Introducer Product Code 0052-3025-JP. heart pump and accessories
Reason: A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set.
Root cause: Under Investigation by firm
Recalling firm: Abiomed, Inc.Type: Introducer, CatheterDistribution: Worldwide distribution. US Nationwide, Australia (AU), Austria (AT), Belgium (BE), Brazil (BR), Brunei (BN), Canada (CA), China (CN), Croatia (HR), Czech Republic (CZ), Denmark (DK), Finland (FI), France (FR), Germany (DE), Greece (GR), Hong Kong (HK), Ireland (IE), Israel (IL), Italy (IT), Japan (JP), Kuwait (KW), Luxembourg (LU), Malaysia (MY), Mexico (MX), Netherlands (NL), Norway (NO), Panama (PA), Poland (PL), Saudi Arabia (SA), Serbia (RS), Slovenia (SI), South Korea (KR), Spain (ES), Sweden (SE), Switzerland (CH), Taiwan (TW), Thailand (TH), United Arab Emirates (AE), and United Kingdom (GB).Recall #Z-2693-2026 Open, ClassifiedPosted Jul 10, 2026·Initiated Jun 1, 2026
Transvenous Pacing Electrode Tray w/ Bipolar Balloon Pacing Electrode 5F, REF: 008416A, 008566A
Reason: Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.
Root cause: Material/Component Contamination
Recalling firm: Argon Medical Devices, IncType: Cardiovascular Procedure KitDistribution: Distribution US nationwide including Puerto Rico; OUS to Trinidad and Tobago.Recall #Z-2704-2026
Open, ClassifiedPosted Jul 10, 2026·Initiated Jun 1, 2026
One-Piece Introducer Tray, REF: 497455, 497434 cardiovascular
Reason: Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.
Root cause: Material/Component Contamination
Recalling firm: Argon Medical Devices, IncType: Dilator, Vessel, For Percutaneous CatheterizationDistribution: Distribution US nationwide including Puerto Rico; OUS to Trinidad and Tobago.Recall #Z-2705-2026
Open, ClassifiedPosted Jul 10, 2026·Initiated Jun 1, 2026
General Biospy Tray, REF: GUTS1000
Reason: Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.
Root cause: Material/Component Contamination
Recalling firm: Argon Medical Devices, IncType: Instrument, BiopsyDistribution: Distribution US nationwide including Puerto Rico; OUS to Trinidad and Tobago.Recall #Z-2706-2026
Open, ClassifiedPosted Jul 10, 2026·Initiated Jun 1, 2026
T-Lok Bone Marrow Tray, REF: BMT1104STL; BMET1104TL; BMT1104CATL
Reason: Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.
Root cause: Material/Component Contamination
Recalling firm: Argon Medical Devices, IncType: Instrument, BiopsyDistribution: Distribution US nationwide including Puerto Rico; OUS to Trinidad and Tobago.Recall #Z-2707-2026
Open, ClassifiedPosted Jul 10, 2026·Initiated Jun 1, 2026
Arterial Line Kit 20ga x 6, REF: 400115A
Reason: Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.
Root cause: Material/Component Contamination
Recalling firm: Argon Medical Devices, IncType: Gauze/Sponge, Internal, X-Ray DetectableDistribution: Distribution US nationwide including Puerto Rico; OUS to Trinidad and Tobago.Recall #Z-2708-2026
Open, ClassifiedPosted Jul 10, 2026·Initiated Jun 1, 2026
Bone Marrow Tray, REF: CB0033TL; CB0355TLA
Reason: Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.
Root cause: Material/Component Contamination
Recalling firm: Argon Medical Devices, IncType: Instrument, BiopsyDistribution: Distribution US nationwide including Puerto Rico; OUS to Trinidad and Tobago.Recall #Z-2709-2026
Open, ClassifiedPosted Jul 10, 2026·Initiated May 5, 2026
Olympus Toomey Evacuator 30cc with Adaptor. Model Number: 188.
Reason: Some sterilization parameters included in the IFU may not consistently render the devices adequately sterile and therefore should no longer be used to sterilize the devices.
Root cause: Under Investigation by firm
Recalling firm: Olympus Corporation of the AmericasType: Evacuator, Gastro-UrologyDistribution: Worldwide distribution - US Nationwide and the countries of Canada, Japan, EU, and Latin America.Recall #Z-2718-2026
Open, ClassifiedPosted Jul 10, 2026·Initiated May 5, 2026
Olympus Toomey Evacuator 50cc with Adaptor. Model Number: 188A.
Reason: Some sterilization parameters included in the IFU may not consistently render the devices adequately sterile and therefore should no longer be used to sterilize the devices.
Root cause: Under Investigation by firm
Recalling firm: Olympus Corporation of the AmericasType: Evacuator, Gastro-UrologyDistribution: Worldwide distribution - US Nationwide and the countries of Canada, Japan, EU, and Latin America.Recall #Z-2719-2026
Open, ClassifiedPosted Jul 10, 2026·Initiated May 5, 2026
Olympus Ellik Evacuator Includes Glass Body, Male Connecting Tubing & Latex Bulb. Model Number: 194.
Reason: Some sterilization parameters included in the IFU may not consistently render the devices adequately sterile and therefore should no longer be used to sterilize the devices.
Root cause: Under Investigation by firm
Recalling firm: Olympus Corporation of the AmericasType: Evacuator, Gastro-UrologyDistribution: Worldwide distribution - US Nationwide and the countries of Canada, Japan, EU, and Latin America.Recall #Z-2720-2026
Open, ClassifiedPosted Jul 10, 2026·Initiated May 5, 2026
Olympus Glass Body for 194 Ellik Evacuator. Model Number: 190A.
Reason: Some sterilization parameters included in the IFU may not consistently render the devices adequately sterile and therefore should no longer be used to sterilize the devices.
Root cause: Under Investigation by firm
Recalling firm: Olympus Corporation of the AmericasType: Evacuator, Gastro-UrologyDistribution: Worldwide distribution - US Nationwide and the countries of Canada, Japan, EU, and Latin America.Recall #Z-2721-2026
Open, ClassifiedPosted Jul 10, 2026·Initiated May 12, 2025
da Vinci SP Instrument Arm Drape, SP, 1-PACK, Part Number: 430013-13, 430013-15
Reason: Robotic-assisted surgical system arm drapes may detach from the instrument arm due to an issue involving the drape rings located at the top of the product, which may expose a section of instrument arm, which may result in procedure delay or conversion to an alternate minimally invasive approach. Retrospectively reported recall.
Root cause: Process control
Recalling firm: Intuitive Surgical, Inc.Type: System, Surgical, Computer Controlled InstrumentDistribution: Worldwide - US Nationwide distribution in the states of NJ, OR, NY, FL, AL, SD, TX, VA, WV, PA, CA, WA, CT, MA, IL, OK, OH, MI, NC, MO, KY, WI, AZ, CO, GA, MD, SC, IN, NV, TN, MS, KS, IA, UT, MN, LA, NE, ME and the countries of Germany, Sweden, United Kingdom, Italy, Belgium, Switzerland, Denmark, Japan, South Korea, Hong Kong, Taiwan, France, Ireland, Spain.Recall #Z-2722-2026
Open, ClassifiedPosted Jul 10, 2026·Initiated Jun 10, 2026
ICU Medical Plum Duo Infusion Pump, v1.2.3: 1) Item Number 400020401 and 2) Item Number 400020403; infusion pump
Reason: In a specific scenario, the pump will not decrement the Volume to be Infused (VTBI) displayed on the Delivery screen and may deliver up to twice the VTBI at the programmed rate.
Root cause: Under Investigation by firm
Recalling firm: ICU Medical, Inc.Type: Pump, InfusionDistribution: Worldwide distribution - US Nationwide and the country of Canada.Recall #Z-2723-2026
Open, ClassifiedPosted Jul 10, 2026·Initiated Jun 10, 2026
ICU Medical Plum Solo Precision IV Pump, v1.0.3, Item Number 400010401; infusion pump
Reason: In a specific scenario, the pump will not decrement the Volume to be Infused (VTBI) displayed on the Delivery screen and may deliver up to twice the VTBI at the programmed rate.
Root cause: Under Investigation by firm
Recalling firm: ICU Medical, Inc.Type: Pump, InfusionDistribution: Worldwide distribution - US Nationwide and the country of Canada.Recall #Z-2724-2026
Open, ClassifiedPosted Jul 10, 2026·Initiated Jun 30, 2026
Rapid Refill Continuous Injection System, UPN M00566001
Reason: Devices contain recalled Medline Namic Angiographic Control Syringe with Rotating Adaptor. There is a risk of syringe loosening or disconnecting from the manifold, resulting in loose connection or complete disconnection. May lead to difficulty connecting syringe, inability to aspirate or inject properly, fluid leakage, or separation of the syringe from the system, potentially requiring device exchange and prolonging the procedure.
Root cause: Under Investigation by firm
Recalling firm: Boston Scientific CorporationType: Syringe, Irrigating (Non Dental)Distribution: US Nationwide distribution. OUS consignee list pending.Recall #Z-2725-2026 Open, ClassifiedPosted Jul 9, 2026·Initiated Apr 3, 2026
Brand Name: Fletcher CT/MR Shielded Applicator Set
Product Name: Intracavitary Remote Afterloading Applicator
Product Description: The Fletcher CT/MR Shielded Applicator Set is intended for gynecological brachytherapy treatment of the cervix and endometrium.
Reason: Due to safety concerns regarding the detachment of the tip of the intrauterine tube (IU tube) that may remain within a patient.
Root cause: Process control
Recalling firm: Elekta, Inc.Type: System, Applicator, Radionuclide, Remote-ControlledDistribution: Worldwide - U.S. Nationwide distribution including in the states of AR, AZ, CA, CO, CT, DC, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MO, MS, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, SC, SD, TX, UT, VA, WI, and WV. The countries of Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Bolivia, Botswana, Brazil, Burkina Faso, Cambodia, Canada, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Georgia, Germany, Greece, Guatemala, Honduras, Hong Kong, Hungary, India, Indonesia, Iran (Islam Republic of), Iraq, Ireland, Italy, Japan, Kazakhstan, Kenya, Korea (Republic of), Kosovo, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Norway, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Romania, Russian Federation, Rwanda, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Swaziland, Sweden, Switzerland, Taiwan, Thailand, Togo, Turkey, Ukraine, United Arab Emirates, United Kingdom, Venezuela, Viet Nam, and Zambia.Recall #Z-2710-2026
Open, ClassifiedPosted Jul 9, 2026·Initiated Apr 3, 2026
Brand Name: Brachytherapy Applicator
Product Name: Advanced Gynecological Applicator
Product Description: The intended use of the Advanced Gynecological Applicator is intracavitary brachytherapy for cancer treatment of the cervix and endometrium. Optional needles can be placed for interstitial brachytherapy.
Reason: Due to safety concerns regarding the detachment of the tip of the intrauterine tube (IU tube) that may remain within a patient.
Root cause: Process control
Recalling firm: Elekta, Inc.Type: System, Applicator, Radionuclide, Remote-ControlledDistribution: Worldwide - U.S. Nationwide distribution including in the states of AR, AZ, CA, CO, CT, DC, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MO, MS, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, SC, SD, TX, UT, VA, WI, and WV. The countries of Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Bolivia, Botswana, Brazil, Burkina Faso, Cambodia, Canada, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Georgia, Germany, Greece, Guatemala, Honduras, Hong Kong, Hungary, India, Indonesia, Iran (Islam Republic of), Iraq, Ireland, Italy, Japan, Kazakhstan, Kenya, Korea (Republic of), Kosovo, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Norway, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Romania, Russian Federation, Rwanda, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Swaziland, Sweden, Switzerland, Taiwan, Thailand, Togo, Turkey, Ukraine, United Arab Emirates, United Kingdom, Venezuela, Viet Nam, and Zambia.Recall #Z-2711-2026
Open, ClassifiedPosted Jul 9, 2026·Initiated Apr 3, 2026
Brand Name: Geneva
Product Name: Brachytherapy Applicator
Product Description: The device is intended for intracavitary brachytherapy for cancer treatment of the cervix and the endometrium. Optional needles can be placed for interstitial therapy.
Reason: Due to safety concerns regarding the detachment of the tip of the intrauterine tube (IU tube) that may remain within a patient.
Root cause: Process control
Recalling firm: Elekta, Inc.Type: System, Applicator, Radionuclide, Remote-ControlledDistribution: Worldwide - U.S. Nationwide distribution including in the states of AR, AZ, CA, CO, CT, DC, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MO, MS, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, SC, SD, TX, UT, VA, WI, and WV. The countries of Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Bolivia, Botswana, Brazil, Burkina Faso, Cambodia, Canada, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Georgia, Germany, Greece, Guatemala, Honduras, Hong Kong, Hungary, India, Indonesia, Iran (Islam Republic of), Iraq, Ireland, Italy, Japan, Kazakhstan, Kenya, Korea (Republic of), Kosovo, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Norway, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Romania, Russian Federation, Rwanda, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Swaziland, Sweden, Switzerland, Taiwan, Thailand, Togo, Turkey, Ukraine, United Arab Emirates, United Kingdom, Venezuela, Viet Nam, and Zambia.Recall #Z-2712-2026
Open, ClassifiedPosted Jul 9, 2026·Initiated May 18, 2026
GSP Neonatal GALT Kit. Product Codes: 3303-001U, 3303-0010. in vitro diagnostic.
Used in FLUORESCENT PROC. (QUAL), GALACTOSE-1-PHOSPHATE URIDYL TRANSFERASE.
Reason: Reduction in the on-board stability of the GSP GALT assay. This may increase the likelihood of run-QC failures and consequently delay the reporting of patient results.
Root cause: Nonconforming Material/Component
Recalling firm: WALLAC OYType: Fluorescent Proc. (Qual.), Galactose-1-Phosphate Uridyl TransferaseDistribution: Worldwide - US Nationwide distribution in the states and territories of AL, AR, AZ, CO, FL, GA, IL, IN, KY, LA, MA, MD, MN, MO, NJ, OR, PR, SC, TN, TX, VA, WV and the countries of Austria, Belgium, Egypt, France, Germany, Hong Kong, Iraq, Italy, Netherlands, Oman, Philippines, Saudi Arabia, Singapore, Spain, Thailand, United Arab Emirates, Vietnam.Recall #Z-2713-2026
Open, ClassifiedPosted Jul 9, 2026·Initiated Jun 5, 2026
OmniTract Surgical Retractor System, which includes 633 of the firm s product codes.
Reason: The current Omni-Tract Surgical Retractor System IFU states a dry time of 30 minutes. Integra LifeSciences has identified that the dry time needs to be extended to 90 minutes, 110 minutes, or 120 minutes depending on the sterilization cycle exposure time used.
Root cause: Labeling design
Recalling firm: Integra LifeSciences Corp. (NeuroSciences)Type: RetractorDistribution: Worldwide distribution - US Nationwide and the countries of Australia, Austria, Azerbaijan, Bangladesh, Belgium, Brunei Darussalam, Bulgaria, Canada, Chile, China, Czechia, Denmark, Egypt, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Jordan, Korea (the Republic of), Kuwait, Lithuania, Malaysia, Malta, Mauritius, Mexico, Nepal, Netherlands (the), New Zealand, Norway, Pakistan, Palestine, State of, Philippines (the), Poland, Portugal, Puerto Rico, Qatar, Republic of North Macedonia, R¿union, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan (Province of China), Thailand, Trinidad and Tobago, Turkey, United Arab Emirates (the), United Kingdom of Great Britain and Northern Ireland, (the), Viet Nam.Recall #Z-2714-2026