Open, ClassifiedPosted Mar 21, 2025·Initiated Jan 31, 2025
Brand Name: Banner Health Systems
Product Name: Cysto Pack
Model/Catalog Number: BHCY31E
Product Description: Convenience Kit
Component: No
Reason: Sterility assurance with procedure trays
Root cause: Process change control
Recalling firm: American Contract Systems, Inc.Type: Endoscope Introducer KitDistribution: US: AZ
OUS: NoneRecall #Z-1424-2025 Open, ClassifiedPosted Mar 21, 2025·Initiated Jan 31, 2025
Brand Name: Banner Health Systems
Product Name: Lap Pack - 170307
Model/Catalog Number: BHLP62H
Software Version: N/A
Product Description: Convenience Kit
Component: No
Reason: Sterility assurance with procedure trays
Root cause: Process change control
Recalling firm: American Contract Systems, Inc.Type: Laparoscopy KitDistribution: US: AZ
OUS: NoneRecall #Z-1425-2025 Open, ClassifiedPosted Mar 21, 2025·Initiated Jan 31, 2025
Brand Name: Banner University Med Ctr.
Product Name: Cardiac Cath Lab Pack-170278
Model/Catalog Number: GSCC40G
Software Version: N/A
Product Description: Convenience Kit
Component: No
Reason: Sterility assurance with procedure trays
Root cause: Process change control
Recalling firm: American Contract Systems, Inc.Type: Cardiac Catheterization KitDistribution: US: AZ
OUS: NoneRecall #Z-1426-2025 Open, ClassifiedPosted Mar 21, 2025·Initiated Feb 3, 2025
CardioMEMS Heart Failure (HF) System that consist of:
-CardioMEMS Hospital System Model CM3100
-CardioMEMS Backend Web Application Model CM4000
-Merlin.net Patient Care Network (PCN) Heart Failure Web Application Model MN6000
The CardioMEMS" HF System provides pulmonary artery (PA) hemodynamic data used for monitoring and management of heart failure (HF) patients. The system measures changes in pulmonary artery (PA) pressure which physicians use to initiate or modify heart failure treatment.
Reason: Due to issues associated with data migration of patient information and results to a Cloud service, the firm has received complaint associated with some patient profile information being duplicated while other patient information is missing.
Root cause: Software design
Recalling firm: St. Jude MedicalType: System, Hemodynamic, ImplantableDistribution: U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA WI, and WV.Recall #Z-1427-2025
Open, ClassifiedPosted Mar 21, 2025·Initiated Feb 12, 2025
namic convenience kits labeled as:
PML,72,ADULT,FLL-MLL,-,OEM, REF 80641722; medical convenience kit
Reason: The female luer fittings on the Pressure Monitoring Lines (PMLs) were manufactured with excess material near the fluid pathway.
Root cause: Process change control
Recalling firm: MEDLINE INDUSTRIES, LP - NorthfieldType: Monitor, Line IsolationDistribution: Worldwide distribution - US Nationwide and the countries of The Netherlands, New Zealand, SlovakiaRecall #Z-1428-2025
Open, ClassifiedPosted Mar 21, 2025·Initiated Feb 12, 2025
namic convenience kits labeled as:
KIT,ARTERIAL,60,(152CM),PG; medical convenience kit, REF 70036160
Reason: The female luer fittings on the Pressure Monitoring Lines (PMLs) were manufactured with excess material near the fluid pathway.
Root cause: Process change control
Recalling firm: MEDLINE INDUSTRIES, LP - NorthfieldType: Transducer, Blood-Pressure, ExtravascularDistribution: Worldwide distribution - US Nationwide and the countries of The Netherlands, New Zealand, SlovakiaRecall #Z-1429-2025
Open, ClassifiedPosted Mar 21, 2025·Initiated Feb 12, 2025
namic convenience kits labeled as:
MTS,COLOR,PML,KIT,-,FRENCH HOSPITAL PG; medical convenience kit, REF 600605710
Reason: The female luer fittings on the Pressure Monitoring Lines (PMLs) were manufactured with excess material near the fluid pathway.
Root cause: Process change control
Recalling firm: MEDLINE INDUSTRIES, LP - NorthfieldType: Angiography/Angioplasty KitDistribution: Worldwide distribution - US Nationwide and the countries of The Netherlands, New Zealand, SlovakiaRecall #Z-1430-2025
Open, ClassifiedPosted Mar 21, 2025·Initiated Feb 12, 2025
namic convenience kits labeled as:
1) MTS,4 VALVE,LFT,HRT,KIT-AHS-A*,NW, REF 60010468;
2) MTS,RIGHT HEART,KIT,W/TRANS,ST. *, REF 60010511;
3) MTS,LT,HT,KIT-BRYAN,LGH,M.C.,EAST, REF 60020323;
4) MTO,RIGHT,KIT-BRONSON,M* HOSP PG, REF 60020676;
5) MTS,LEFT HEART,KIT-C*,MEM HLTHCARE, REF 60035977;
6) MTS,LEFT HEART,KIT,J*,M*,C*, REF 60040273;
7) MTS,LEFT HEART,KIT,C*,C*, REF 60100313;
8) MTS,3V,KIT-M*,MEMORIAL, REF 60131208;
9) MTS,3V,KIT-M*,MEMORIAL, REF 60131208;
10) MTO,LEFT HEART,KIT,-,N* HOSPITAL PG, REF 60140101;
11) MTO,LEFT HEART,KIT,-,N* HOSPITAL PG, REF 60140101;
12) MTS,LEFT HEART,MAN,KIT,S*-BALTIMORE, REF 60190947;
13) MTS-LEFT HEART,KIT-W*,H* HOSP PG, REF 60231052;
14) MTO,3-VALVE,KIT-T*,A*-PG, REF 65190182;
15) MTO,LEFT HEART,KIT,-,S* F*,-,PG, REF 65190474;
16) MTS,DR.,MCKAYS,4V,KIT,-,H* HOSP PG, REF 600800516;
17) MTS,EP,KIT,-,S*,TEACHING HOSPITAL PG, REF 601309013;
18) MTS,RHT,HRT-S* HOSP &,MC, REF 601905413;
19) MTS,PEDS,LFT,&,RT,HRT-S* HOSP, REF 601905414;
20) MTO,SCH,BEL,J*,H*-ST-PAUL,-,PG, REF 606604328;
21) LHK,-,MID,3VCOMP,OFF,PS,S10RA, REF 613000122;
22) MTS,LHK,W* HOSPITAL, REF 6010034281;
23) MTS,LHK,W* HOSPITAL, REF 6010034281;
24) MTS,LHK,P*,P* MED CTR, REF 6010171931;
25) MTS,LHK,M* HEALTHCARE,MGMT, REF 6061073001;
26) TVR US B* INTEGRATED SERVICE CENT, REF 601316711A;
27) LHK-S* MEDICAL CENTER,A*, REF 60190776A;
28) LHK,-,S*,AND,W* HOSPITAL, REF 60191118A.
Reason: The female luer fittings on the Pressure Monitoring Lines (PMLs) were manufactured with excess material near the fluid pathway.
Root cause: Process change control
Recalling firm: MEDLINE INDUSTRIES, LP - NorthfieldType: Cardiovascular Procedure KitDistribution: Worldwide distribution - US Nationwide and the countries of The Netherlands, New Zealand, SlovakiaRecall #Z-1431-2025
Open, ClassifiedPosted Mar 21, 2025·Initiated Feb 20, 2025
Orthofix Pillar SA Ti Spacer System Intervertebral Body Fusion Spinal Device, sterile, implant grade titanium alloy:
(1) REF 82-3300SP, 33mm W x 24mm D x 10mm H, 7 degrees;
(2) REF 82-3700SP, 37mm W x 28mm D x 10mm H, 7 degrees; and
(3) REF 82-4000SP, 40mm W x 32mm D x 10mm H, 7 degrees.
Reason: The product is mislabeled with the incorrect anterior height of 10mm, but the laser marking on the implant and corresponding trial both show the correct anterior height of 10.5mm.
Root cause: Labeling Change Control
Recalling firm: Orthofix U.S. LLCType: Intervertebral Fusion Device With Bone Graft, LumbarDistribution: US Nationwide distribution in the states of California, Colorado, and Missouri.Recall #Z-1432-2025
Open, ClassifiedPosted Mar 20, 2025·Initiated Feb 19, 2025
VERICIS, Merge Cardio, Model/Catalog Number: Version 9.x, Software Version: 9.0.6 and 9.0.8; VERICIS is an integrated cardiovascular information system classified as a
picture archiving and communications system.
Reason: When following a specific less typical workflow in which the user remeasures using the ultrasound device or manually edits primitive or derived measurement values directly in Clinical Reporting, derived measurements may be inconsistent with the associated primitive measurements in the final patient report.
Root cause: Software design
Recalling firm: Merge Healthcare, Inc.Type: System, Image Processing, RadiologicalDistribution: USRecall #Z-1398-2025
Open, ClassifiedPosted Mar 20, 2025·Initiated Feb 19, 2025
VERICIS, Merge Cardio, Model/Catalog Number: Version 10.x, Software Version: 10.0, 10.1.1.1, 10.1.2, 10.2.0, 10.2 P2 , 10.3; The VERICIS is an integrated cardiovascular information system classified as a picture archiving and communications system.
Reason: When following a specific less typical workflow in which the user remeasures using the ultrasound device or manually edits primitive or derived measurement values directly in Clinical Reporting, derived measurements may be inconsistent with the associated primitive measurements in the final patient report.
Root cause: Software design
Recalling firm: Merge Healthcare, Inc.Type: System, Image Processing, RadiologicalDistribution: USRecall #Z-1399-2025
Open, ClassifiedPosted Mar 20, 2025·Initiated Feb 19, 2025
VERICIS, Merge Cardio, Model/Catalog Number: Version 11.x, Software Version: 11.0.2, 11.0.3, 11.0.4, 11.1, 11.1.1; The VERICIS is an integrated cardiovascular information system classified as a picture archiving and communications system.
Reason: When following a specific less typical workflow in which the user remeasures using the ultrasound device or manually edits primitive or derived measurement values directly in Clinical Reporting, derived measurements may be inconsistent with the associated primitive measurements in the final patient report.
Root cause: Software design
Recalling firm: Merge Healthcare, Inc.Type: System, Image Processing, RadiologicalDistribution: USRecall #Z-1400-2025
Open, ClassifiedPosted Mar 20, 2025·Initiated Feb 19, 2025
VERICIS, Merge Cardio, Model/Catalog Number: Version 12.X, Software Version: 12.0.1, 12.0.2; The VERICIS is an integrated cardiovascular information system classified as a picture archiving and communications system.
Reason: When following a specific less typical workflow in which the user remeasures using the ultrasound device or manually edits primitive or derived measurement values directly in Clinical Reporting, derived measurements may be inconsistent with the associated primitive measurements in the final patient report.
Root cause: Software design
Recalling firm: Merge Healthcare, Inc.Type: System, Image Processing, RadiologicalDistribution: USRecall #Z-1401-2025
Open, ClassifiedPosted Mar 20, 2025·Initiated Feb 19, 2025
Merge Cardio, Model/Catalog Number: Version 12.X, Software Version: 12.1, 12.1.1, 12.2, 12.3, 12.3.1, 12.3.2, 12.3.3, 12.4, 12.4.1, 12.4.2; Merge Cardio is a software medical device that is an integrated multi-modality image cardiovascular information management system.
Reason: When following a specific less typical workflow in which the user remeasures using the ultrasound device or manually edits primitive or derived measurement values directly in Clinical Reporting, derived measurements may be inconsistent with the associated primitive measurements in the final patient report.
Root cause: Software design
Recalling firm: Merge Healthcare, Inc.Type: System, Image Processing, RadiologicalDistribution: USRecall #Z-1402-2025
Open, ClassifiedPosted Mar 20, 2025·Initiated Mar 3, 2025
Comprehensive Shoulder Stem, Comprehensive Micro Stem, Comprehensive Mini Stem; uncemented shoulder prosthesis, Model Nos. 113605, 113606, 113607, 113627
Reason: Five complaints received where surgeon was unable to remove and/or connect the inserter with the stem during surgery due to excess material remaining within the taper. Issue may lead to clinically significant extension of surgery to find a replacement.
Root cause: Nonconforming Material/Component
Recalling firm: ZIMMER ORTHOPEDICS MANFACTURING LIMITED-GALWAYType: Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, UncementedDistribution: US distribution nationwide.
International distribution to Dominican Republic, Canada, India, Australia, Japan, EMEA, Korea, Taiwan, and Hong Kong.Recall #Z-1403-2025
Open, ClassifiedPosted Mar 20, 2025·Initiated Feb 14, 2025
CAPNOCHECK BCI Airway Adapter; Model Number BSR; Product Code WW1100
Reason: Airway adapter does not meet specification and may break off when attaching a valve or tube. Device failure may result in inaccurate readings, a break in airway circuit, and loss of ventilation. A break in the airway circuit could result in inability to ventilate, hypoxia, cardiopulmonary collapse, or death.
Root cause: Process control
Recalling firm: Smiths Medical ASD, Inc.Type: Analyzer, Gas, Carbon-Dioxide, Gaseous-PhaseDistribution: US Nationwide distribution. International distribution pending.Recall #Z-1404-2025
Open, ClassifiedPosted Mar 20, 2025·Initiated Feb 14, 2025
CAPNOCHECK BCI Airway Adapter; Model Number BSR; Product Code WW8214
Reason: Airway adapter does not meet specification and may break off when attaching a valve or tube. Device failure may result in inaccurate readings, a break in airway circuit, and loss of ventilation. A break in the airway circuit could result in inability to ventilate, hypoxia, cardiopulmonary collapse, or death.
Root cause: Process control
Recalling firm: Smiths Medical ASD, Inc.Type: Analyzer, Gas, Carbon-Dioxide, Gaseous-PhaseDistribution: US Nationwide distribution. International distribution pending.Recall #Z-1405-2025
Open, ClassifiedPosted Mar 20, 2025·Initiated Feb 4, 2025
CRANI PACK, Model/Catalog Number WECR41D, medical procedure kit.
Reason: During an internal investigation, ACS was unable to confirm that the CODMAN component achieved the required Sterility Assurance Level and therefore is not suitable for sterilization according to ACS procedures.
Root cause: Device Design
Recalling firm: American Contract Systems IncType: Neurological TrayDistribution: US: MIRecall #Z-1406-2025 Open, ClassifiedPosted Mar 20, 2025·Initiated Feb 11, 2025
Synapse PACS Software Version 7.4.x; Software Versions: 7.4.000, 7.4.001, 7.4.010, 7.4.100, 7.4.110, 7.4.200.
Reason: The incorrect computed patient age is showing in VX for patients less than 3 months old.
Root cause: Software change control
Recalling firm: FUJIFILM Healthcare Americas CorporationType: System, Image Processing, RadiologicalDistribution: Domestic: AR, AZ, CA, CO, CT, FL, GA, HI, IL, IN, KS, KY, LA, MA, MN, MO, MS, NC, NJ, NY, OH, OK, OR, TN, TX, VT, WA, WI, WV, WY.
International: Australia, Belgium, Brazil, France, Germany, Portugal, UKRecall #Z-1407-2025
Open, ClassifiedPosted Mar 19, 2025·Initiated Feb 12, 2025
Zebra Thermal Barcode Printer GX430t, Model no. YSW 1000 or YSW 2000, may have been sold as an optional accessory for Sensititre Aris HIQ system YV4000-VZ
Reason: Power supply unit for Zebra Printers used with the device can potentially overheat or cause a fire hazard.
Root cause: Nonconforming Material/Component
Recalling firm: Remel, IncType: Instrument For Auto Reader & Interpretation Of Overnight Suscept. SystemsDistribution: Domestic distribution to AL, AZ, CA, FL, GA, IN, KS, KY, MD, MI, NE, NY, OH, PA, TN, TX, WI.
International distribution to Canada and the Bahamas.Recall #Z-1395-2025