Open, ClassifiedPosted Aug 6, 2026·Initiated May 21, 2026
GEM Premier 7000 with iQM3
Part Numbers:
00077407508
00077407510
00077415004
00077415008
00077415010
00077430010
Product Description: The GEM Premier 7000 with iQM3 is a portable critical care system for use by health care professionals to rapidly analyze lithium heparinized whole blood samples at the point of health care delivery in a clinical setting and in a central laboratory.
Reason: The active ingredient concentration in the lysing bag solution of specific GEM Premier 7000 with iQM3 PAK lots did not meet established manufacturing specifications. The malfunction could result in delayed recognition and management of Co-Oximetry and total bilirubin abnormalities and their sequelae.
Root cause: Nonconforming Material/Component
Recalling firm: Instrumentation LaboratoryType: Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood PhDistribution: Worldwide - US Nationwide distribution in the states of AZ, CA, FL, GA, IL, IN, KY, MN, MO, MT, OH, PA, VA, WI, WV and the countries of China, Germany, Italy.Recall #Z-2899-2026 Open, ClassifiedPosted Aug 6, 2026·Initiated May 21, 2026
GEM Premier 5000 PAK
Part Numbers:
00055360010
00055360011
00055407504
00055415010
00055430010
00055430011
00055445010
00055445011
00055360010.A
Reason: The active ingredient concentration in the lysing bag solution of specific GEM Premier 5000 lots did not meet established manufacturing specifications. The malfunction could result in delayed recognition and management of Co-Oximetry and total bilirubin abnormalities and their sequelae.
Root cause: Nonconforming Material/Component
Recalling firm: Instrumentation LaboratoryType: Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood PhDistribution: Worldwide - US Nationwide distribution in the states of AZ, CA, FL, GA, IL, IN, KY, MN, MO, MT, OH, PA, VA, WI, WV and the countries of China, Germany, Italy.Recall #Z-2900-2026 Open, ClassifiedPosted Aug 6, 2026·Initiated Jun 15, 2026
Brand Name: COAPTIUM Connect
Product Name: COAPTIUM Connect
Model/Catalog Number: NCOCO1510
Software Version: N/A
Product Description: In situ polymerizing peripheral nerve repair device
Component: N/A
Reason: Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled to reflect revised shelf life of 26 months. The use of a medical device beyond its validated shelf life may result in perioperative breakage of the device rendering device unusable; worst-case outcome would be revision surgery.
Root cause: Incorrect or no expiration date
Recalling firm: TISSIUM SAType: In Situ Polymerizing Peripheral Nerve Repair DeviceDistribution: US Nationwide distribution in the states of CA, FL, IL, NJ, OH, PA.Recall #Z-2901-2026
Open, ClassifiedPosted Aug 6, 2026·Initiated Jun 15, 2026
Brand Name: COAPTIUM CONNECT
Product Name: COAPTIUM CONNECT
Model/Catalog Number: NCOCO1575
Software Version: N/A
Product Description: In situ polymerizing peripheral nerve repair device
Component: No
Reason: Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled to reflect revised shelf life of 26 months. The use of a medical device beyond its validated shelf life may result in perioperative breakage of the device rendering device unusable; worst-case outcome would be revision surgery.
Root cause: Incorrect or no expiration date
Recalling firm: TISSIUM SAType: In Situ Polymerizing Peripheral Nerve Repair DeviceDistribution: US Nationwide distribution in the states of CA, FL, IL, NJ, OH, PA.Recall #Z-2902-2026
Open, ClassifiedPosted Aug 6, 2026·Initiated Jun 15, 2026
Brand Name: COAPTIUM CONNECT
Product Name: COAPTIUM CONNECT
Model/Catalog Number: NCOCO2010
Software Version: N/A
Product Description: In situ polymerizing peripheral nerve repair device
Component: No
Reason: Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled to reflect revised shelf life of 26 months. The use of a medical device beyond its validated shelf life may result in perioperative breakage of the device rendering device unusable; worst-case outcome would be revision surgery.
Root cause: Incorrect or no expiration date
Recalling firm: TISSIUM SAType: In Situ Polymerizing Peripheral Nerve Repair DeviceDistribution: US Nationwide distribution in the states of CA, FL, IL, NJ, OH, PA.Recall #Z-2903-2026
Open, ClassifiedPosted Aug 6, 2026·Initiated Jun 15, 2026
Brand Name: COAPTIUM CONNECT
Product Name: COAPTIUM CONNECT
Model/Catalog Number: NCOCO2075
Software Version: N/A
Product Description: In situ polymerizing peripheral nerve repair device
Component: No
Reason: Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled to reflect revised shelf life of 26 months. The use of a medical device beyond its validated shelf life may result in perioperative breakage of the device rendering device unusable; worst-case outcome would be revision surgery.
Root cause: Incorrect or no expiration date
Recalling firm: TISSIUM SAType: In Situ Polymerizing Peripheral Nerve Repair DeviceDistribution: US Nationwide distribution in the states of CA, FL, IL, NJ, OH, PA.Recall #Z-2904-2026
Open, ClassifiedPosted Aug 6, 2026·Initiated Jun 15, 2026
Brand Name: COAPTIUM CONNECT
Product Name: COAPTIUM CONNECT
Model/Catalog Number: NCOCO3010
Software Version: N/A
Product Description: In situ polymerizing peripheral nerve repair device
Component: No
Reason: Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled to reflect revised shelf life of 26 months. The use of a medical device beyond its validated shelf life may result in perioperative breakage of the device rendering device unusable; worst-case outcome would be revision surgery.
Root cause: Incorrect or no expiration date
Recalling firm: TISSIUM SAType: In Situ Polymerizing Peripheral Nerve Repair DeviceDistribution: US Nationwide distribution in the states of CA, FL, IL, NJ, OH, PA.Recall #Z-2905-2026
Open, ClassifiedPosted Aug 6, 2026·Initiated Jun 15, 2026
Brand Name: COAPTIUM CONNECT
Product Name: COAPTIUM CONNECT
Model/Catalog Number: NCOCO4010
Software Version: N/A
Product Description: In situ polymerizing peripheral nerve repair device
Component: No
Reason: Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled to reflect revised shelf life of 26 months. The use of a medical device beyond its validated shelf life may result in perioperative breakage of the device rendering device unusable; worst-case outcome would be revision surgery.
Root cause: Incorrect or no expiration date
Recalling firm: TISSIUM SAType: In Situ Polymerizing Peripheral Nerve Repair DeviceDistribution: US Nationwide distribution in the states of CA, FL, IL, NJ, OH, PA.Recall #Z-2906-2026
Open, ClassifiedPosted Aug 6, 2026·Initiated Jun 15, 2026
Brand Name: COAPTIUM CONNECT
Product Name: COAPTIUM CONNECT
Model/Catalog Number: NCOCO5010
Software Version: N/A
Product Description: In situ polymerizing peripheral nerve repair device
Component: No
Reason: Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled to reflect revised shelf life of 26 months. The use of a medical device beyond its validated shelf life may result in perioperative breakage of the device rendering device unusable; worst-case outcome would be revision surgery.
Root cause: Incorrect or no expiration date
Recalling firm: TISSIUM SAType: In Situ Polymerizing Peripheral Nerve Repair DeviceDistribution: US Nationwide distribution in the states of CA, FL, IL, NJ, OH, PA.Recall #Z-2907-2026
Open, ClassifiedPosted Aug 6, 2026·Initiated Jun 15, 2026
Brand Name: COAPTIUM CONNECT
Product Name: COAPTIUM CONNECT
Model/Catalog Number: NCOCO6010
Software Version: N/A
Product Description: In situ polymerizing peripheral nerve repair device
Component: No
Reason: Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled to reflect revised shelf life of 26 months. The use of a medical device beyond its validated shelf life may result in perioperative breakage of the device rendering device unusable; worst-case outcome would be revision surgery.
Root cause: Incorrect or no expiration date
Recalling firm: TISSIUM SAType: In Situ Polymerizing Peripheral Nerve Repair DeviceDistribution: US Nationwide distribution in the states of CA, FL, IL, NJ, OH, PA.Recall #Z-2908-2026
Open, ClassifiedPosted Aug 6, 2026·Initiated Jun 17, 2026
Blom-Singer Classic Indwelling Voice Prosthesis, 16Fr/10 mm
REF: 1610-LEF
Reason: Incorrect labeling- The labeled box for the Large Esophageal Flange contains a Large Esophageal and Tracheal Flange, and the labeled box for the Large Esophageal and Tracheal Flange contains a Large Esophageal Flange.
Root cause: Labeling mix-ups
Recalling firm: Freudenberg Medical, LLCType: Prosthesis, Laryngeal (Taub)Distribution: US Nationwide distribution in the states of IN, OH, AZ, WA, FL, MO, KY, IN, NY and the countries of GBR, FRA.Recall #Z-2909-2026
Open, ClassifiedPosted Aug 6, 2026·Initiated Jun 17, 2026
Blom-Singer Classic Indwelling Voice Prosthesis, 16Fr/10 mm
REF: 1610-LF
Reason: Incorrect labeling- The labeled box for the Large Esophageal Flange contains a Large Esophageal and Tracheal Flange, and the labeled box for the Large Esophageal and Tracheal Flange contains a Large Esophageal Flange.
Root cause: Labeling mix-ups
Recalling firm: Freudenberg Medical, LLCType: Prosthesis, Laryngeal (Taub)Distribution: US Nationwide distribution in the states of IN, OH, AZ, WA, FL, MO, KY, IN, NY and the countries of GBR, FRA.Recall #Z-2910-2026
Open, ClassifiedPosted Aug 6, 2026·Initiated Jun 29, 2026
Neuroguard IEP 3 in 1 Carotid Stent and Post-Dilation Balloon System with Integrated Embolic Protection (Neuroguard IEP System), REF: NG-0630-140-2, NG-0640-140-2, NG-0730-140-2, NG-0740-140-2, NG-NV-6-30, NG-NV-6-40, NG-NV-7-30, NG-NV-7-40
Reason: Carotid stent and post-dilation balloon system with integrated embolic protection system has an integrated filter, that due to a wire-to-filter-bond issue, may fail to open following sheath retraction; and if this condition were to occur during a procedure, the result may be loss of intended integrated embolic protection.
Root cause: Process control
Recalling firm: Contego Medical, IncType: Stent, CarotidDistribution: US Nationwide distribution in the states of IL, FL, NC, WI, KY, AL, VA, DE, NJ, PA, IN, MI, CA.Recall #Z-2911-2026
Open, ClassifiedPosted Aug 5, 2026·Initiated Jun 17, 2026
INFINION CX LEAD KIT, 50CM, Model: SC-2317-50, Material: M365SC2317500;
INFINION CX LEAD KIT, 70CM, Model: SC-2317-70, Material: M365SC2317700. part of the Boston Scientific Spinal Cord Stimulator (SCS) Systems.
Reason: Spinal cord stimulation system lead body may be exposed to stress at the anchor site. This may result in high impedance measurements or lead fractures, which may lead to inadequate stimulation, additional intervention, including lead explant and replacement.
Root cause: Device Design
Recalling firm: Boston Scientific Neuromodulation CorporationType: Stimulator, Spinal-Cord, Totally Implanted For Pain ReliefDistribution: US: NY.
OUS: Canada, Portugal, Spain, France, Netherlands, Great Britain, Italy, Israel, Serbia, Greece, Germany, United Arab Emirates, Ireland, Hungary, Czech Republic, Brazil, Colombia, ArgentinaRecall #Z-2879-2026
Open, ClassifiedPosted Aug 5, 2026·Initiated May 20, 2026
Brand Name: U2 Total Knee System
Product Name: PSA Box Trial, L, #1-6 and PSA Box Trial, R, #1-6
Model/Catalog Number: 9323-5511 thru 9323-5516 and 9323-5521 thru 9323-5526
Software Version: N/A
Product Description: Knee femur prosthesis trial, reusable
Component: No, N/A
Reason: Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail.
Root cause: Process design
Recalling firm: United Orthopedic Corp.Type: Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/PolymerDistribution: US Nationwide distribution in the states of Texas and Michigan.Recall #Z-2883-2026
Open, ClassifiedPosted Aug 5, 2026·Initiated May 20, 2026
Brand Name: USTAR II Knee System
Product Name: Hinge Box Trial, L, #1-6 and Hinge Box Trial, R, #1-6
Model/Catalog Number: 9325-5711 thru 9325-5716 and 9325-5721 thru 9325-5726
Software Version: N/A
Product Description: Knee femur prosthesis trial, reusable
Component: No, N/A
Reason: Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail.
Root cause: Process design
Recalling firm: United Orthopedic Corp.Type: Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/PolymerDistribution: US Nationwide distribution in the states of Texas and Michigan.Recall #Z-2884-2026
Open, ClassifiedPosted Aug 5, 2026·Initiated May 20, 2026
Brand Name: U2 Total Knee System
Product Name: Femoral valgus adaptor, left and right
Model/Catalog Number: 9323-5333 and 9323-5334
Software Version: N/A
Product Description: Manual Orthopedic Surgical Instrument
Component: No
Reason: Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail.
Root cause: Process design
Recalling firm: United Orthopedic Corp.Type: Orthopedic Manual Surgical InstrumentDistribution: US Nationwide distribution in the states of Texas and Michigan.Recall #Z-2885-2026
Open, ClassifiedPosted Aug 5, 2026·Initiated May 20, 2026
Brand Name: U2 Total Knee System
Product Name: Femoral valgus offset adaptor, 2mm, 4mm, 6mm, left and Femoral valgus offset adaptor, 2mm, 4mm, 6mm, right
Model/Catalog Number: 9323-5335, 9323-5337, 9323-5339 and 9323-5336, 9323-5338, 9323-5340
Software Version: N/A
Product Description: Manual Orthopedic Surgical Instrument
Component: No
Reason: Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail.
Root cause: Process design
Recalling firm: United Orthopedic Corp.Type: Orthopedic Manual Surgical InstrumentDistribution: US Nationwide distribution in the states of Texas and Michigan.Recall #Z-2886-2026
Open, ClassifiedPosted Aug 5, 2026·Initiated Jun 8, 2026
HardyDisk AST Cefiderocol 30g (FDC30) REF Z9435
HardyDisk AST Cefiderocol 30g (FDC30) for in vitro agar diffusion susceptibility testing is indicated when there is the need to determine the susceptibility of Enterobacterales, Pseudomonas aeruginosa, Acinetobacter baumannii complex and Stenotrophomonas maltophilia to Cefiderocol,
Reason: Due to incorrect cartridges include in affected products that there is the potential for false-susceptible or false-resistant susceptibility results and may lead to selection of an ineffective antimicrobial therapy, potentially resulting in delayed appropriate treatment, prolonged infection, or worsening clinical outcome.
Root cause: Under Investigation by firm
Recalling firm: Hardy DiagnosticsType: Susceptibility Test Discs, AntimicrobialDistribution: U.S. Nationwide distribution in the states of AZ, CA, FL, ID, IN, MA, MS, NJ, NV, NY, OH, PA, and TN.Recall #Z-2887-2026
Open, ClassifiedPosted Aug 5, 2026·Initiated Jun 26, 2026
REF # D23352, MicroScan LabPro V5.03 Panel Update 11 (US), Electronic installed on the following instruments:
- B1018-280 MicroScan autoSCAN-4 Instrument
- B1018-283 MicroScan WalkAway-40 plus Instrument
- B1018-284 MicroScan WalkAway-96 plus Instrument
- B1018-440 DxM-1040 MicroScan WalkAway Instrument
- B1018-496 DxM-1096 MicroScan WalkAway Instrument
Reason: Analyzers contain incorrect algorithms which may affect antimicrobial susceptibility test results, leading to false susceptibility classifications."
Root cause: Software Design Change
Recalling firm: Beckman Coulter Inc.Type: System, Test, Automated, Antimicrobial Susceptibility, Short IncubationDistribution: US Nationwide distribution including in the states of AK, AL, AR, CA, CO, DE, FL, GA, IA, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, VA, WI, WV, WY.Recall #Z-2888-2026