Open, ClassifiedPosted Jul 18, 2025·Initiated May 23, 2025
SIGNA Architect
Reason: GE HealthCare has become aware that gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during scanning. As a result, acoustic levels can exceed 99dB, the limit established by International Electrotechnical Commission (IEC 60601-2-33) when using hearing protection with a Noise Reduction Rating (NRR) of 29dB, as currently required in the Operator Manual.
Root cause: Device Design
Recalling firm: GE Medical Systems, LLCType: System, Nuclear Magnetic Resonance ImagingDistribution: Worldwide distribution - US Nationwide and the country of China.Recall #Z-2130-2025
Open, ClassifiedPosted Jul 18, 2025·Initiated May 23, 2025
SIGNA Architect AIR
Reason: GE HealthCare has become aware that gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during scanning. As a result, acoustic levels can exceed 99dB, the limit established by International Electrotechnical Commission (IEC 60601-2-33) when using hearing protection with a Noise Reduction Rating (NRR) of 29dB, as currently required in the Operator Manual.
Root cause: Device Design
Recalling firm: GE Medical Systems, LLCType: System, Nuclear Magnetic Resonance ImagingDistribution: Worldwide distribution - US Nationwide and the country of China.Recall #Z-2131-2025
Open, ClassifiedPosted Jul 18, 2025·Initiated May 23, 2025
Discovery MR750w 3.0T
Reason: GE HealthCare has become aware that gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during scanning. As a result, acoustic levels can exceed 99dB, the limit established by International Electrotechnical Commission (IEC 60601-2-33) when using hearing protection with a Noise Reduction Rating (NRR) of 29dB, as currently required in the Operator Manual.
Root cause: Device Design
Recalling firm: GE Medical Systems, LLCType: System, Nuclear Magnetic Resonance ImagingDistribution: Worldwide distribution - US Nationwide and the country of China.Recall #Z-2132-2025
Open, ClassifiedPosted Jul 18, 2025·Initiated May 23, 2025
SIGNA PET/MR
Reason: GE HealthCare has become aware that gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during scanning. As a result, acoustic levels can exceed 99dB, the limit established by International Electrotechnical Commission (IEC 60601-2-33) when using hearing protection with a Noise Reduction Rating (NRR) of 29dB, as currently required in the Operator Manual.
Root cause: Device Design
Recalling firm: GE Medical Systems, LLCType: System, Nuclear Magnetic Resonance ImagingDistribution: Worldwide distribution - US Nationwide and the country of China.Recall #Z-2133-2025
Open, ClassifiedPosted Jul 18, 2025·Initiated Jun 4, 2025
Azurion 7 M20. Fluoroscopic X-Ray System.
Reason: Potential for bolts connecting the gearbox to the mounting flange of the C-arm to become loose.
Root cause: Device Design
Recalling firm: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Type: Interventional Fluoroscopic X-Ray SystemDistribution: Worldwide distribution: US (nationwide) to states of: CA, CO, DC, DE, FL, IL, IN, KY, MA, MD, MN, MO, MT, NJ, NV, NY, OH, SC, TX, WA; and OUS (Foreign) to countries of: Argentina (AR), Australia (AU), Canada (CA), Chile (CL), Germany (DE), Dominican Republic (DO), Egypt (EG), ES, France (FR), United Kingdom (GB), Italy (IT), Japan (JP), Korea, Republic (KR), Mexico (MX), Netherlands (NL), New Zealand (NZ), Oman (OM), Reunion (RE), Saudi Arabi (SA), Thailand (TH), Viet Nam (VN).Recall #Z-2134-2025
Open, ClassifiedPosted Jul 18, 2025·Initiated Jun 11, 2025
HSG Procedure Tray. Model Number: 6050T.
The HSG Procedure Tray is for use in hysterosalpingography and sonohysterography procedures.
Reason: The HSG Procedure Trays and Endosee System Convenience Kits contain non-sterile iodine pouches, however the peel away lid labels incorrectly identify the iodine pouches as sterile.
Root cause: Under Investigation by firm
Recalling firm: CooperSurgical, Inc.Type: Speculum, Vaginal, NonmetalDistribution: US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and Washington DC.Recall #Z-2135-2025
Open, ClassifiedPosted Jul 18, 2025·Initiated Jun 11, 2025
Endosee System Convenience Kit. Model Number: ES-TRAY.
Endosee System Convenience Kit
Reason: The HSG Procedure Trays and Endosee System Convenience Kits contain non-sterile iodine pouches, however the peel away lid labels incorrectly identify the iodine pouches as sterile.
Root cause: Under Investigation by firm
Recalling firm: CooperSurgical, Inc.Type: Speculum, Vaginal, NonmetalDistribution: US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and Washington DC.Recall #Z-2136-2025
Open, ClassifiedPosted Jul 18, 2025·Initiated Jun 11, 2025
Endosee System Convenience Kit with IV Tube. Model Number: ES-TRAY-IV.
Endosee System Convenience Kit with IV Tube.
Reason: The HSG Procedure Trays and Endosee System Convenience Kits contain non-sterile iodine pouches, however the peel away lid labels incorrectly identify the iodine pouches as sterile.
Root cause: Under Investigation by firm
Recalling firm: CooperSurgical, Inc.Type: Speculum, Vaginal, NonmetalDistribution: US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and Washington DC.Recall #Z-2137-2025
Open, ClassifiedPosted Jul 18, 2025·Initiated Jun 18, 2025
Natus Brain Monitor Breakout Box, Part Number 021911; full-montage standard electroencephalograph
Reason: Natus received two complaints of left side labeling show impedance for right side.
Root cause: Process control
Recalling firm: Natus Neurology DBA Excel Tech., Ltd. (XLTEK)Type: Full-Montage Standard ElectroencephalographDistribution: US: CA, IN, MO, NC, PA, RI, TXRecall #Z-2138-2025
Open, ClassifiedPosted Jul 17, 2025·Initiated Jun 20, 2025
Baxter SIGMA Spectrum Infusion Pump V6, Model Number 35700BAX
Reason: Certain Spectrum infusion pumps may have an incorrect version of software.
Root cause: Employee error
Recalling firm: Baxter Healthcare CorporationType: Infusion Safety Management SoftwareDistribution: US States: CA, FL, IL, KS, MI, MS, NY, OH, OK, and VA.Recall #Z-2095-2025
Open, ClassifiedPosted Jul 17, 2025·Initiated Jun 20, 2025
Baxter SIGMA Spectrum Infusion Pump V8, Model Number 35700BAX2
Reason: Certain Spectrum infusion pumps may have an incorrect version of software.
Root cause: Employee error
Recalling firm: Baxter Healthcare CorporationType: Infusion Safety Management SoftwareDistribution: US States: CA, FL, IL, KS, MI, MS, NY, OH, OK, and VA.Recall #Z-2096-2025
Open, ClassifiedPosted Jul 17, 2025·Initiated Jun 5, 2025
Brand Name: NIO-A
Product Name: NIO Intraosseous Device Adult
Model/Catalog Number: 105000603
Software Version: N/A
Product Description: NIO devices are a spring-based, automatic intra-osseous access device supplied Sterile and single use. Indicated for Intra-osseous access to the Proximal humerus and Proximal Tibia in adult patients, in emergent situations.
Component: N/A
Reason: Due to manufacturing error, Intraosseous device built-in stabilizer may not be released properly after deployment and insertion.
Root cause: Process change control
Recalling firm: Waismed Ltd.Type: Needle, Hypodermic, Single LumenDistribution: Worldwide distribution: US (nationwide) to state of: NC and OUS (international) countries of: Slovenia, Australia, Brazil, Estonia, South Africa, U. Arab Emirate, Greece, Panama, Singapore, Italy, Germany, Portugal, Spain, Ukraine, Lithuania, Chile, Poland, Germany, New Zealand, Montenegro, Switzerland, Argentina, Poland, Austria, Sweden, United Kingdom, Italy, France, Romania, Netherlands, Croatia, Lithuania, New Zealand, Japan,
Cyprus, and Israel.Recall #Z-2118-2025
Open, ClassifiedPosted Jul 17, 2025·Initiated Jun 5, 2025
Brand Name: NIO+
Product Name: NIO Intraosseous Device Adult
Model/Catalog Number: 105000908
Software Version: N/A
Product Description: NIO devices are a spring-based, automatic intraosseous access device supplied Sterile and single use. Indicated for Intraosseous access to the Proximal humerus and Proximal Tibia in adult patients, in emergent situations.
Component: N/A
Reason: Due to manufacturing error, Intraosseous device built-in stabilizer may not be released properly after deployment and insertion.
Root cause: Process change control
Recalling firm: Waismed Ltd.Type: Needle, Hypodermic, Single LumenDistribution: Worldwide distribution: US (nationwide) to state of: NC and OUS (international) countries of: Slovenia, Australia, Brazil, Estonia, South Africa, U. Arab Emirate, Greece, Panama, Singapore, Italy, Germany, Portugal, Spain, Ukraine, Lithuania, Chile, Poland, Germany, New Zealand, Montenegro, Switzerland, Argentina, Poland, Austria, Sweden, United Kingdom, Italy, France, Romania, Netherlands, Croatia, Lithuania, New Zealand, Japan,
Cyprus, and Israel.Recall #Z-2119-2025
Open, ClassifiedPosted Jul 17, 2025·Initiated Jun 10, 2025
Brand Name: VITROS Chemistry Products
Product Name: VITROS Chemistry Products Performance Verifier I
Model/Catalog Number: 806 7324
Software Version: Not Applicable
Product Description: VITROS Chemistry Products Performance Verifier is an assayed control used to monitor performance on VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems.
VITROS Performance Verifier is prepared from processed human serum to which enzymes, electrolytes, stabilizers,mpreservatives and other organic analytes have been added.
Component: No, not a component
Reason: Quality control (QC) drift when certain lots of Performance Verifiers (PVs) are used with certain lots of cholinesterase enzyme (CHE) slides. This drift occurs when the PVs are used 2-7 days after reconstitution; however, the label stability claims for the PV fluids is 7 days following reconstitution. This may lead to inaccurate QC results. The use of the PVs when the QC results are outside of the customer s established ranges could result in delayed results for patients due to the need to repeat QC testing or reconstitute new PV fluids and repeat testing. It could also result in erroneous patient results (small positive bias).
Root cause: Under Investigation by firm
Recalling firm: Ortho-Clinical Diagnostics, Inc.Type: Colorimetry, CholinesteraseDistribution: Worldwide Distribution: US (nationwide) to states of: AZ, CA, FL, GA, IL, MD, MI, MO, MS, NY, TN, TX, VA; and OUS (International) to countries of: Australia, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, Netherlands, Norway, Portugal, Russia, Singapore, Spain, Sweden, and United Kingdom.Recall #Z-2120-2025
Open, ClassifiedPosted Jul 17, 2025·Initiated Jun 10, 2025
Brand Name: VITROS Chemistry Products
Product Name: VITROS Chemistry Products Performance Verifier II
Model/Catalog Number: 8231474
Software Version: N/A
Product Description: VITROS Chemistry Products Performance Verifier is an assayed control used to monitor performance on VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems.
VITROS Performance Verifier is prepared from processed human serum to which enzymes, electrolytes, stabilizers,mpreservatives and other organic analytes have been added.
Component: No, not a component
Reason: Quality control (QC) drift when certain lots of Performance Verifiers (PVs) are used with certain lots of cholinesterase enzyme (CHE) slides. This drift occurs when the PVs are used 2-7 days after reconstitution; however, the label stability claims for the PV fluids is 7 days following reconstitution. This may lead to inaccurate QC results. The use of the PVs when the QC results are outside of the customer s established ranges could result in delayed results for patients due to the need to repeat QC testing or reconstitute new PV fluids and repeat testing. It could also result in erroneous patient results (small positive bias).
Root cause: Under Investigation by firm
Recalling firm: Ortho-Clinical Diagnostics, Inc.Type: Colorimetry, CholinesteraseDistribution: Worldwide Distribution: US (nationwide) to states of: AZ, CA, FL, GA, IL, MD, MI, MO, MS, NY, TN, TX, VA; and OUS (International) to countries of: Australia, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, Netherlands, Norway, Portugal, Russia, Singapore, Spain, Sweden, and United Kingdom.Recall #Z-2121-2025
Open, ClassifiedPosted Jul 17, 2025·Initiated Jun 10, 2025
VITROS Chemistry Products CHE Slides;
Catalog Numbers: (1) 191 4605 (300 slides), (2) 800 4707 (90 slides);
Reason: Quality control (QC) drift when certain lots of Performance Verifiers (PVs) are used with certain lots of cholinesterase enzyme (CHE) slides. This drift occurs when the PVs are used 2-7 days after reconstitution; however, the label stability claims for the PV fluids is 7 days following reconstitution. This may lead to inaccurate QC results. The use of the PVs when the QC results are outside of the customer s established ranges could result in delayed results for patients due to the need to repeat QC testing or reconstitute new PV fluids and repeat testing. It could also result in erroneous patient results (small positive bias).
Root cause: Under Investigation by firm
Recalling firm: Ortho-Clinical Diagnostics, Inc.Type: Colorimetry, CholinesteraseDistribution: Worldwide Distribution: US (nationwide) to states of: AZ, CA, FL, GA, IL, MD, MI, MO, MS, NY, TN, TX, VA; and OUS (International) to countries of: Australia, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, Netherlands, Norway, Portugal, Russia, Singapore, Spain, Sweden, and United Kingdom.Recall #Z-2122-2025
Open, ClassifiedPosted Jul 17, 2025·Initiated Jun 10, 2025
VITROS Chemistry Products CHE Slides (Japan);
Catalog Numbers: (1) 684 4074 (90 slides), (2) 684 4138 (300 slides);
Reason: Quality control (QC) drift when certain lots of Performance Verifiers (PVs) are used with certain lots of cholinesterase enzyme (CHE) slides. This drift occurs when the PVs are used 2-7 days after reconstitution; however, the label stability claims for the PV fluids is 7 days following reconstitution. This may lead to inaccurate QC results. The use of the PVs when the QC results are outside of the customer s established ranges could result in delayed results for patients due to the need to repeat QC testing or reconstitute new PV fluids and repeat testing. It could also result in erroneous patient results (small positive bias).
Root cause: Under Investigation by firm
Recalling firm: Ortho-Clinical Diagnostics, Inc.Type: Colorimetry, CholinesteraseDistribution: Worldwide Distribution: US (nationwide) to states of: AZ, CA, FL, GA, IL, MD, MI, MO, MS, NY, TN, TX, VA; and OUS (International) to countries of: Australia, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, Netherlands, Norway, Portugal, Russia, Singapore, Spain, Sweden, and United Kingdom.Recall #Z-2123-2025
Open, ClassifiedPosted Jul 17, 2025·Initiated Jun 17, 2025
KWIK-STIK and LYFO DISK, quality control kit for culture media
Catalog # 0805K and 0805L
Reason: Affected products contain Staphylococcus epidermidis instead of the expected Brevundimonas diminuta. This may cause the user's quality control to fail and delayed diagnosis for the patient.
Root cause: Under Investigation by firm
Recalling firm: Microbiologics IncType: Kit, Quality Control For Culture MediaDistribution: US distribution to states of: Utah and Ohio; and OUS (International) to countries of: Italy, Netherlands, Argentina, Korea, Jordan, Spain, and Bangladesh.Recall #Z-2124-2025
Open, ClassifiedPosted Jul 17, 2025·Initiated Jun 2, 2025
Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS
Product Name: EMPOWR 3D KNEETM INS, 11L 10MM, VE
Model/Catalog Number: 341-10-711
Software Version: NA
Product Description: Enovis" knee devices are intended for treatment of patients who are candidates for knee arthroplasty per the Indication for use. While total knee replacements are not intended to withstand activity levels and loads of normal healthy bone, they are a means of restoring mobility and reducing pain for many patients.
Component: NA
Reason: Due to packaging discrepancy with the incorrect tibial inserts/implants being packaged. The use of this product may result in the incorrect product being selected. This could result in a revision surgery if used.
Root cause: Packaging change control
Recalling firm: Encore Medical, LPType: Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/PolymerDistribution: U.S Distribution to states of: AZ, IA, ID, IL, IN, LA, MI, MO, MS, NE, NY, OK, OR, PR, SD, UT, VA, and WARecall #Z-2125-2025
Open, ClassifiedPosted Jul 17, 2025·Initiated Jun 2, 2025
Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS
Product Name: EMPOWR 3D KNEETM INS, 11L 12MM, VE
Model/Catalog Number: 341-12-711
Software Version: NA
Product Description: Enovis" knee devices are intended for treatment of patients who are candidates for knee arthroplasty per the Indication for use. While total knee replacements are not intended to withstand activity levels and loads of normal healthy bone, they are a means of restoring mobility and reducing pain for many patients.
Component: NA
Reason: Due to packaging discrepancy with the incorrect tibial inserts/implants being packaged. The use of this product may result in the incorrect product being selected. This could result in a revision surgery if used.
Root cause: Packaging change control
Recalling firm: Encore Medical, LPType: Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/PolymerDistribution: U.S Distribution to states of: AZ, IA, ID, IL, IN, LA, MI, MO, MS, NE, NY, OK, OR, PR, SD, UT, VA, and WARecall #Z-2126-2025