Open, ClassifiedPosted Jun 6, 2025·Initiated May 12, 2025
IVENIX INFUSION SYSTEM LVP Blood Products Administration Set, Dual-Inlet, Low-Sorbing, Y-Site, Mesh Filter, 15 mL. Intravascular Administration Set.
Reason: Mis-assembly error of Blood Products Administrations Sets where the 200-micron drip chamber filter may be incorrectly positioned and unable to filter out large blood particulates.
Root cause: Under Investigation by firm
Recalling firm: Fresenius Kabi USA, LLCType: Set, Administration, IntravascularDistribution: US distribution: CA, CO, DE, GA, IL, MD, MI, MN, MS, NC, NJ, NV, OK, SC, TX, VA, WA & WI.Recall #Z-1869-2025
Open, ClassifiedPosted Jun 6, 2025·Initiated May 28, 2025
Long Nail, RIGHT Gamma4 10x320mm x 125, component of the Gamma4 System. Catalog Number: 84250320S.
Reason: Investigation confirmed that the GAMMA4 Right Long Nail was manufactured with the geometry of a left nail.
Root cause: Process design
Recalling firm: Stryker GmbHType: Rod, Fixation, Intramedullary And AccessoriesDistribution: Worldwide - US Nationwide distribution in the states of AL, FL, NJ, OR and the countries of Australia and Japan.Recall #Z-1914-2025
Open, ClassifiedPosted Jun 6, 2025·Initiated Apr 21, 2025
LOWER EXTREMITY, Model: NCEX20I;
LOWER EXTREMITY, Model: NCEX20J;
TOTAL KNEE PACK, Model: NCTK31K;
TOTAL KNEE PACK, Model: NCTK31L
All convenience kits contain Specialist Blend Cast Padding, Item: QTX30-322NS
Reason: Test results for cast padding component included in procedure trays shows Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals exceeded residual limits, which may lead to a possible loss or lack of functionality that may lead to a delay or prolonged treatment/procedure/therapy.
Root cause: Finished device change control
Recalling firm: American Contract Systems, Inc.Type: Orthopedic TrayDistribution: US Nationwide distribution in the state of CO.Recall #Z-1916-2025 CompletedPosted Jun 6, 2025·Initiated May 13, 2025
SCD Comfort Knee Length Small, SKU 84021; Kendall SCD Small Comfort sleeves when used with the Kendall SCD Smartflow Controller
Reason: Incorrect software logic may cause frequent E1 errors (system high pressure). Issue may cause delay in treatment or therapy.
Root cause: Software change control
Recalling firm: Cardinal Health 200, LLCType: Sleeve, Limb, CompressibleDistribution: Domestic US distribution to AK, CA, FL, MA, TX. International distribution to Japan.Recall #Z-1917-2025 CompletedPosted Jun 6, 2025·Initiated May 13, 2025
Kendall SCD Comfort Sleeves
Knee Length Small, Pediatric -
For use with Kendall SCD
SmartFlow, SKU 84021P
Kendall SCD Small Comfort sleeves when used with the Kendall SCD Smartflow Controller
Reason: Incorrect software logic may cause frequent E1 errors (system high pressure). Issue may cause delay in treatment or therapy.
Root cause: Software change control
Recalling firm: Cardinal Health 200, LLCType: Sleeve, Limb, CompressibleDistribution: Domestic US distribution to AK, CA, FL, MA, TX. International distribution to Japan.Recall #Z-1918-2025 CompletedPosted Jun 6, 2025·Initiated May 13, 2025
Kendall SCD Blended Comfort
Sleeves Knee Length Small -
For use with Kendall SCD
SmartFlow
SKU 84021B
Kendall SCD Small Comfort sleeves when used with the Kendall SCD Smartflow Controller
Reason: Incorrect software logic may cause frequent E1 errors (system high pressure). Issue may cause delay in treatment or therapy.
Root cause: Software change control
Recalling firm: Cardinal Health 200, LLCType: Sleeve, Limb, CompressibleDistribution: Domestic US distribution to AK, CA, FL, MA, TX. International distribution to Japan.Recall #Z-1919-2025 Open, ClassifiedPosted Jun 6, 2025·Initiated May 6, 2025
Brand Name: Powered Laser Surgical Instrument
Product Name: SOLTIVE Pro SuperPulsed Laser System
Model/Catalog Number: TFL-SLS, TFL-SLS-JA (Japan only);
Product Description: SOLTIVE Laser Systems use technology to increase procedural efficiency and flexibility to ureteroscopy, PCNL, and potential soft tissue applications.
Component: No
Reason: Potential for thermal incident including an unexpected occurrence of smoke, sparks, burning, or unsteady flames during clinical use. The fracturing of the fiber is the cause of, or contributes to, these thermal incidents.
Root cause: Under Investigation by firm
Recalling firm: Olympus Corporation of the AmericasType: Powered Laser Surgical InstrumentDistribution: Worldwide distribution - US Nationwide and the countries of AU, CA, CL, DE, HK, JP, SG.Recall #Z-1920-2025
Open, ClassifiedPosted Jun 6, 2025·Initiated May 6, 2025
Brand Name: Powered Laser Surgical Instrument
Product Name: SOLTIVE Premium SuperPulsed Laser System
Model/Catalog Number: TFL-PLS, TFL-PLS-JA (Japan only);
Software Version: N/A
Product Description: SOLTIVE Laser Systems use technology to increase procedural efficiency and flexibility to ureteroscopy, PCNL, and potential soft tissue applications.
Component: N/A
Reason: Potential for thermal incident including an unexpected occurrence of smoke, sparks, burning, or unsteady flames during clinical use. The fracturing of the fiber is the cause of, or contributes to, these thermal incidents.
Root cause: Under Investigation by firm
Recalling firm: Olympus Corporation of the AmericasType: Powered Laser Surgical InstrumentDistribution: Worldwide distribution - US Nationwide and the countries of AU, CA, CL, DE, HK, JP, SG.Recall #Z-1921-2025
Open, ClassifiedPosted Jun 6, 2025·Initiated May 6, 2025
Brand Name: Powered Laser Surgical Instrument
Product Name: Soltive SuperPulsed Laser Fibers - Single Use
Model/Catalog Numbers: TFL-FBX150BS, TFL-FBX200BS, TFL-FBX150S, TFL-FBX200S, TFL-FBX365S, TFL-FBX550S, TLF-FBX940S, TFL-FBX150BS-JA (Japan Only), TFL-FBX550S-JA (Japan Only), TFL-FBX940S-JA (Japan Only), TFL-FBX200BS-JA (Japan Only), TFL-FBX150S-JA (Japan Only), TFL-FBX200S-JA (Japan Only), TFL-FBX365S-JA (Japan Only);
Product Description: SOLTIVE Laser Fibers are delivery devices that transmit laser energy from the laser console to the treatment site through the fiber tip. The laser connector secures the device to the laser.
Reason: Potential for thermal incident including an unexpected occurrence of smoke, sparks, burning, or unsteady flames during clinical use. The fracturing of the fiber is the cause of, or contributes to, these thermal incidents.
Root cause: Under Investigation by firm
Recalling firm: Olympus Corporation of the AmericasType: Powered Laser Surgical InstrumentDistribution: Worldwide distribution - US Nationwide and the countries of AU, CA, CL, DE, HK, JP, SG.Recall #Z-1922-2025
Open, ClassifiedPosted Jun 6, 2025·Initiated May 6, 2025
Brand Name: Powered Laser Surgical Instrument
Product Name: Soltive Reusable Laser Fibers
Model/Catalog Number: TFL-FBX150R, TFL-FBX200R, TFL-FBX365R, TFL-FBX550R, TFL-FBX940R, TFL-FBX940R-JA (Japan Only), TFL-FBX365R-JA (Japan Only), TFL-FBX200BS-JA (Japan Only), TFL-FBX150R-JA (Japan Only), TFL-FBX200R-JA (Japan Only), TFL-FBX550R-JA (Japan Only);
Product Description: SOLTIVE Laser Fibers are delivery devices that transmit laser energy from the laser console to the treatment site through the fiber tip. The laser connector secures the device to the laser.
Reason: Potential for thermal incident including an unexpected occurrence of smoke, sparks, burning, or unsteady flames during clinical use. The fracturing of the fiber is the cause of, or contributes to, these thermal incidents.
Root cause: Under Investigation by firm
Recalling firm: Olympus Corporation of the AmericasType: Powered Laser Surgical InstrumentDistribution: Worldwide distribution - US Nationwide and the countries of AU, CA, CL, DE, HK, JP, SG.Recall #Z-1923-2025
Open, ClassifiedPosted Jun 6, 2025·Initiated Apr 29, 2025
Azure S DR MRI SureScan, Product number W3DR01
Reason: Identified devices may experience sudden battery power failure without alarm, power supply power-on-resets, and interruption of therapy. Potential patient harms include insufficient pacing support leading to cardiac arrest, syncope, or hospitalization; or system revision (explant/replacement) leading to infection, hematoma, or temporary impairment.
Root cause: Process change control
Recalling firm: Medtronic, Inc.Type: Pulse Generator, Permanent, ImplantableDistribution: International distribution of the country of UK. No US distribution.Recall #Z-1924-2025 Open, ClassifiedPosted Jun 6, 2025·Initiated Apr 23, 2025
DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, running software versions 1.20
Reason: A new motor/encoder and cable was introduced into instruments manufactured starting with serial number 300141 incorrectly. This incorrect installation is introducing error codes for the Dxl 9000 which prevents the assay from being performed and a delay in results from being generated, and may require field service to resolve the delay.
Root cause: Nonconforming Material/Component
Recalling firm: Beckman Coulter, Inc.Type: Radioimmunoassay, Thyroid-Stimulating HormoneDistribution: Worldwide distribution: US (Nationwide) and OUS Global (Foreign) to countries of: Italy, Germany, Spain, New Zealand, France, Australia, Slovakia, Switzerland, Ireland, Brazil, Taiwan, Province of China, India, United Kingdom of Great Britain and Northern Ireland, Hungary, Austria, Portugal, Croatia, Kazakhstan, Cote d'lvoire, Poland, Korea, Republic of, Czechia, Algeria, Libya, Oman, Singapore, and Belgium.Recall #Z-1926-2025
Open, ClassifiedPosted Jun 5, 2025·Initiated May 2, 2025
Pre-filled Water Syringe, Model Numbers SW-010-100 and SW-010
Reason: During endoscope surveillance monitoring, a user facility identified contamination from duodenoscope samples that were linked to the Pre-filled Water Syringes as part of their investigation. Healthmark Industries conducted its own investigation and concluded that the Pre-filled Water Syringe had been improperly used outside of the intended purpose.
Root cause: Under Investigation by firm
Recalling firm: Healthmark Industries Co., Inc.Type: Accessories, Cleaning Brushes, For EndoscopeDistribution: US Nationwide and Internationally to countries of: Canada, Malaysia.Recall #Z-1909-2025
Open, ClassifiedPosted Jun 5, 2025·Initiated May 2, 2025
ChannelCheck Convenience Pack, Model Numbers UCC-222CP and UCC-222-ESP (Sample)
Reason: During endoscope surveillance monitoring, a user facility identified contamination from duodenoscope samples that were linked to the Pre-filled Water Syringes as part of their investigation. Healthmark Industries conducted its own investigation and concluded that the Pre-filled Water Syringe had been improperly used outside of the intended purpose.
Root cause: Under Investigation by firm
Recalling firm: Healthmark Industries Co., Inc.Type: Accessories, Cleaning Brushes, For EndoscopeDistribution: US Nationwide and Internationally to countries of: Canada, Malaysia.Recall #Z-1910-2025
Open, ClassifiedPosted Jun 5, 2025·Initiated May 5, 2025
Olympus EVIS EXERA III Duodenovideoscope. Model Number: TJF-Q190V
Reason: Recent post-market surveillance data suggests a possible association of higher microbial contamination levels from TJF duodenoscopes when manual cleaning was delayed beyond one hour and a presoak was performed, compared to those TJF duodenoscopes where manual cleaning began within one hour after patient procedure.
Root cause: Labeling design
Recalling firm: Olympus Corporation of the AmericasType: Endoscope, Accessories, Narrow Band SpectrumDistribution: Worldwide Distribution: US (Nationwide) and OUS (International) countries to: Algeria, Angola, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Belarus, Belgium, Benin, Bolivia, Brazil, Canada, Cayman Islands, Chile, Colombia, Costa Rica, Croatia, Denmark, Dominican Republic, Egypt, El Salvador, Estonia, Ethiopia, Faroe Islands, Finland, France, French Guiana, Georgia, Germany, Ghana, Guadeloupe, Guatemala, Honduras, Hong Kong, Iceland, India, Iraq, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Kuwait, Kyrgyzstan, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Malaysia, Malta, Martinique, Mauritius, Mexico, Monaco, Morocco, Netherlands, New Zealand, Nicaragua, Nigeria, Norway, Oman, Palestinian Authority, Panama, Paraguay, Peru, Poland, Portugal, Qatar, Republic of the Congo, R¿union, Russia, Saudi Arabia, Senegal, Seychelles, Singapore, South Africa, Spain, Sweden, Switzerland, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, Uruguay, Vietnam, Yemen.Recall #Z-1911-2025
Open, ClassifiedPosted Jun 5, 2025·Initiated Apr 23, 2025
DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, running software version 1.20
Reason: A new software update (v1.20) is introducing error codes for the Dxl 9000 which prevents the assay from being performed and a delay in results from being generated, and may require field service to resolve the delay.
Root cause: Software design
Recalling firm: Beckman Coulter, Inc.Type: Radioimmunoassay, Thyroid-Stimulating HormoneDistribution: Worldwide Distribution: US (Nationwide) and OUS (Global) to countries of: Kazakhstan, Spain, Germany, Italy, Belgium, Croatia, Taiwan, Province of China, Poland, India, Singapore, Switzerland, France, Libya, United Kingdom of Great Britain and Northern Irland, Oman, Algeria, Czechia, Korea, Public of, Slovakia, Croatia, Cote d'lvoire, Australia, Ireland, Taiwan, Province of China, New Zealand, Austria, Hungary, Brazil, Israel, Portugal.Recall #Z-1913-2025
CompletedPosted Jun 4, 2025·Initiated Apr 23, 2025
MIRA SURGICAL SYSTEM, Table mounted miniaturized electromechanical surgical system, Catalog Number MIRA-CAP-110, Software Version 4.0.3
Reason: The MIRA Surgical System Software Version 4.0.3 loaded on the Surgeon Control Console may have the potential to exhibit interrupted motion on the display screen, caused by a software latency between the movement of the hand controllers and the movement of the Surgical Minibot arms.
Root cause: Software design
Recalling firm: VIRTUAL INCISION CORPORATIONType: Table Mounted Miniaturized Electromechanical Surgical SystemDistribution: US Distribution to States: CA, FL, NERecall #Z-1905-2025
Open, ClassifiedPosted Jun 4, 2025·Initiated May 5, 2025
Dexcom G7 iOS Application, Ref: SW12300 used in conjunction with the Dexcom G7 Continuous Glucose Monitoring (CGM) system
Reason: A bug in the 2.7.0 version of the G7 iOS App can cause the app to enter a state where it stops updating the estimated glucose value (EGV) and continues to show this stale EGV. If the user is unaware that the EGVs are not being updated
and that glucose alerts will not trigger, there is potential for the missed detection of a hyperglycemic or hypoglycemic event or a treatment decision made based off incorrect data. There is no impact to transmitter communication with concurrently connected displays. A
concurrently connected receiver, Apple Watch, and/or insulin pump will continue to receive EGVs directly from the transmitter when the app is in the problematic state. There is no impact to Automated Insulin Dosing (AID) therapy as the AID system continues to receive EGVs directly from the transmitter.
Root cause: Software design
Recalling firm: Dexcom, Inc.Type: Integrated Continuous Glucose Monitoring System, Factory CalibratedDistribution: Worldwide Distribution: US (nationwide) and OUS (foreign) to countries of: United Arab Emirates (AE), Austria (AT), Australia (AU), Belgium (BE), Bahrain (BH), Canada (CA), Switzerland (CH), Czech Republic (CZ), Germany (DE), Denmark (DK), Spain (ES), Finland (FI), France (FR), United Kingdom (GB), Hong Kong (HK), Ireland (IE), Israel (IL), Iceland (IS), Italy (IT), Jordan (JO), Korea, Repulic (KR), Kuwait (KW), Lebanon (LB), Lithuania (LT), Luxemburg (LU), Malta (MT), Netherlands (NL), Norway (NO), New Zealand (NZ), Oman (OM), Poland (PL), Portugal (PT), Qatar (QA), Saudi Arabia (SA), Sweden (SE), Slovenia (SI), Slovakia (SK), Turkey (TR) and South Africa (ZA).Recall #Z-1906-2025
CompletedPosted Jun 4, 2025·Initiated Apr 30, 2025
Sample probe sucks a sample dispensed into a tube or cup and discharges the
appropriate amount into a cuvette.
Lot 178713114 - 179433670
Reason: A manufacturing defect in the sample probe (S probe). The corners of the tip of the defective S probe are rounded and chamfered, which can prevent the proper formation of the "air layer" required for normal dispensing. The air layer is the air space that separates the cleaning water filled in the probe from the sample sucked into the probe. Maintaining this air space prevents the cleaning water and the sample from mixing. In the defective S probe, the "air layer" was not properly formed, causing the cleaning water and the sample to mix diluting the sample. As a result, the sample mixture dispensed into the cuvette has a lower concentration than the original sample, and the analyte concentration measured is lower than expected results.
Root cause: Nonconforming Material/Component
Recalling firm: Beckman Coulter Mishima K.K.Type: Acid Phosphatase, Naphthyl PhosphateDistribution: Worldwide Distribution: US (nationwide) including states of: CA, PA, VA, TX, NJ, FL, IN, MA, NY, NC, OH, LA, AZ, MO, WA, GA, UT, KY, AL, CO, IL, NE, OK, NV, SC, TN, MD, OR, AR, MS, AK, WI, DE, MT, HI, KS, ME, NH, WV, NM, CT, IA, MI, MN, ID, RI, SD, WY, ND, DC, VT, GUAM, PR and
OUS (foreign) to countries of: Viet Nam, Japan, India, Australia, El Salvador, China, United Arab Emirates, Thailand, Russian Federation, Italy, Germany, Korea (Republic of, Malaysia), Taiwan, Province of China, Turkey, Kazakhstan, Israel, Ecuador, Hungary, Egypt, Serbia, Bangladesh, Bosnia and Herzegovina, Costa Rica, Belarus, United Kingdom, Ireland, Botswana, Kenya, Mauritius, Ghana, Zambia, South Africa, Libya, Croatia, France, Switzerland, Czechia, Philippines, Namibia, Canada, Qatar, Azerbaijan, Lesotho, Bulgaria, Zimbabwe, Poland, Norway, Spain, Brazil, Tanzania (United Republic of), Lithuania, Yemen, Uzbekistan, Algeria, Somalia, Sri Lanka, Nepal, Pakistan, Ukraine, Peru, Morocco, Singapore, Slovakia, Mexico, Myanmar, Lebanon, Jordan, Malawi, Greece, Indonesia, Chile, Romania, Georgia, Ethiopia, Sweden, Albania, Eswatini, Nigeria, Cote d'Ivoire, Argentina, Dominican Republic, Iraq, Maldives, Saudi Arabia, Kuwait, Austria, Eritrea, Bolivia (Plurinational State of), Tunisia, Curacao, Mozambique, Hong Kong, Bahrain, Portugal, Panama, New Zealand, Colombia, Uganda, Oman, Belgium, Saint Pierre and Miquelon, Guyana, Macao, Cabo Verde, Sint Maarten (Dutch part), Liberia, Moldova, Republic of, North Macedonia, Congo (Democratic Republic of the), Uruguay, Cyprus, Netherlands, Suriname, Slovenia, Denmark, Finland, Venezuela, Sierra Leone
CompletedPosted Jun 4, 2025·Initiated Apr 30, 2025
Sample probe sucks a sample dispensed into a tube or cup and discharges the
appropriate amount into a cuvette.
Lot 178713114 - 179433670
Reason: Sample probes with defective probe tips, when used with clinical chemistry analyzers, may lead to a lower concentration being dispensed, which may not be detectable by QC checks, which could lead to the reporting of false low test results (Max 34% error at 1.0 microliters and 7% error at 1.6 microliters sample dispensing volume), which may lead to delayed recognition and treatment.
Root cause: Nonconforming Material/Component
Recalling firm: Beckman Coulter Mishima K.K.Type: Analyzer, Chemistry (Photometric, Discrete), For Clinical UseDistribution: Worldwide Distribution: US (nationwide) including states of: CA, PA, VA, TX, NJ, FL, IN, MA, NY, NC, OH, LA, AZ, MO, WA, GA, UT, KY, AL, CO, IL, NE, OK, NV, SC, TN, MD, OR, AR, MS, AK, WI, DE, MT, HI, KS, ME, NH, WV, NM, CT, IA, MI, MN, ID, RI, SD, WY, ND, DC, VT, GUAM, PR and
OUS (foreign) to countries of: Viet Nam, Japan, India, Australia, El Salvador, China, United Arab Emirates, Thailand, Russian Federation, Italy, Germany, Korea (Republic of, Malaysia), Taiwan, Province of China, Turkey, Kazakhstan, Israel, Ecuador, Hungary, Egypt, Serbia, Bangladesh, Bosnia and Herzegovina, Costa Rica, Belarus, United Kingdom, Ireland, Botswana, Kenya, Mauritius, Ghana, Zambia, South Africa, Libya, Croatia, France, Switzerland, Czechia, Philippines, Namibia, Canada, Qatar, Azerbaijan, Lesotho, Bulgaria, Zimbabwe, Poland, Norway, Spain, Brazil, Tanzania (United Republic of), Lithuania, Yemen, Uzbekistan, Algeria, Somalia, Sri Lanka, Nepal, Pakistan, Ukraine, Peru, Morocco, Singapore, Slovakia, Mexico, Myanmar, Lebanon, Jordan, Malawi, Greece, Indonesia, Chile, Romania, Georgia, Ethiopia, Sweden, Albania, Eswatini, Nigeria, Cote d'Ivoire, Argentina, Dominican Republic, Iraq, Maldives, Saudi Arabia, Kuwait, Austria, Eritrea, Bolivia (Plurinational State of), Tunisia, Curacao, Mozambique, Hong Kong, Bahrain, Portugal, Panama, New Zealand, Colombia, Uganda, Oman, Belgium, Saint Pierre and Miquelon, Guyana, Macao, Cabo Verde, Sint Maarten (Dutch part), Liberia, Moldova, Republic of, North Macedonia, Congo (Democratic Republic of the), Uruguay, Cyprus, Netherlands, Suriname, Slovenia, Denmark, Finland, Venezuela, Sierra Leone