Open, ClassifiedPosted Jan 17, 2025·Initiated Oct 5, 2024
CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEM
CardioMEMSTM HF System Patient Electronics System (PES) REF CM1100
Merlin.net Patient Care Network (PCN) Heart Failure Web Application
(Which interfaces with CardioMEMSTM HF System Patient Electronics System (PES) and CardioMEMSTM HF System Hospital Electronics System (HES)). Model Number MN6000
Reason: As a result of a cloud data migration of Patient and Hospital Electronic Systems (PES and HES) reverted to an outdated configuration causing incorrect/inaccurate pulmonary artery (PA) pressure readings.
Root cause: Under Investigation by firm
Recalling firm: St. Jude MedicalType: System, Hemodynamic, ImplantableDistribution: Worldwide - U.S. Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NE, NH, NJ, NV, NY, NC, ND, OH, OK, OR, PA, SC, SD, TN, TX, VA, WA, WI and the countries of Australia, and Canada.Recall #Z-0988-2025
Open, ClassifiedPosted Jan 17, 2025·Initiated Oct 5, 2024
CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEM
CardioMEMSTM HF System Hosptial Electronics System (PES) REF CM3000
Merlin.net Patient Care Network (PCN) Heart Failure Web Application
(Which interfaces with CardioMEMSTM HF System Patient Electronics System (PES) and CardioMEMSTM HF System Hospital Electronics System (HES)). Model Number MN6000
Reason: As a result of a cloud data migration of Patient and Hospital Electronic Systems (PES and HES) reverted to an outdated configuration causing incorrect/inaccurate pulmonary artery (PA) pressure readings.
Root cause: Under Investigation by firm
Recalling firm: St. Jude MedicalType: System, Hemodynamic, ImplantableDistribution: Worldwide - U.S. Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NE, NH, NJ, NV, NY, NC, ND, OH, OK, OR, PA, SC, SD, TN, TX, VA, WA, WI and the countries of Australia, and Canada.Recall #Z-0989-2025
Open, ClassifiedPosted Jan 17, 2025·Initiated Dec 2, 2024
Microvention, Headway" 17 Advanced Straight Microcatheter with Hydrophilic Coating, REF: MC172150SX-CN, Sterile R, Rx Only, Lot# 0000629846
Reason: Sterility assurance; microcatheter inner packaging may contain incomplete seal.
Root cause: Packaging process control
Recalling firm: MICROVENTION INC.Type: Catheter, PercutaneousDistribution: US: None
OUS: ChinaRecall #Z-0990-2025
CompletedPosted Jan 16, 2025·Initiated Dec 11, 2024
nuwellis AquaFlexFlow UF 500 Plus, REF 114156, Catalog Number A06163, extracorporeal blood circuit which is used with the Aquadex SmartFlow or Aquadex FlexFlow System
Reason: The AquaFlexFlow UF 500 Plus extracorporeal blood circuit used with the Aquadex SmartFlow and FlexFlow Systems may indicate "Ultrafiltrate Weight Mismatch" or Excessive Weight Mismatch Alarms while in use. If not addressed, this failure could result in excess fluid removal from a patient leading to Acute Volume Depletion. This failure is especially serious when the Aquadex System is being used on pediatric patients.
Root cause: Under Investigation by firm
Recalling firm: Nuwellis IncType: Dialyzer, High Permeability With Or Without Sealed Dialysate SystemDistribution: US Nationwide Distribution and the country of Hong KongRecall #Z-0831-2025
Open, ClassifiedPosted Jan 16, 2025·Initiated Dec 20, 2024
Welch Allyn, Inc., Life 2000 Ventilation System, REF BT-20-0002
Reason: There is an issue with the ventilator battery charger that could lead to an audible and visual alarm. If the alarm is engaged, the ventilator becomes inoperable.
Root cause: Process control
Recalling firm: Baxter Healthcare CorporationType: Ventilator, Continuous, Facility UseDistribution: US, Nationwide DistributionRecall #Z-0884-2025
Open, ClassifiedPosted Jan 16, 2025·Initiated Dec 20, 2024
Welch Allyn, Inc., Life2000 Ventilation System, REF BT-20-0002A
Reason: There is an issue with the ventilator battery charger that could lead to an audible and visual alarm. If the alarm is engaged, the ventilator becomes inoperable.
Root cause: Process control
Recalling firm: Baxter Healthcare CorporationType: Ventilator, Continuous, Facility UseDistribution: US, Nationwide DistributionRecall #Z-0885-2025
Open, ClassifiedPosted Jan 16, 2025·Initiated Dec 20, 2024
Welch Allyn, Inc., Life2000 Ventilation System, REF BT-20-0002AP
Reason: There is an issue with the ventilator battery charger that could lead to an audible and visual alarm. If the alarm is engaged, the ventilator becomes inoperable.
Root cause: Process control
Recalling firm: Baxter Healthcare CorporationType: Ventilator, Continuous, Facility UseDistribution: US, Nationwide DistributionRecall #Z-0886-2025
Open, ClassifiedPosted Jan 16, 2025·Initiated Dec 20, 2024
Breathe Technologies, Inc., Life2000 Ventilation System, REF BT-20-0002AP
Reason: There is an issue with the ventilator battery charger that could lead to an audible and visual alarm. If the alarm is engaged, the ventilator becomes inoperable.
Root cause: Process control
Recalling firm: Baxter Healthcare CorporationType: Ventilator, Continuous, Facility UseDistribution: US, Nationwide DistributionRecall #Z-0887-2025
Open, ClassifiedPosted Jan 16, 2025·Initiated Dec 18, 2024
Olympus MAJ-891 Forceps/Irrigation Plug (Isolated Type). Model/Catalog Number: MAJ-891.
This instrument is designed to be attached to the instrument channel port of Olympus endoscopes to allow both irrigation and the use of endo-therapy accessories.
Reason: Potential for inadvertent retention of biomaterial when the reprocessing procedure is not performed as instructed, so as not completely removing and disassembling the device.
Root cause: Labeling design
Recalling firm: Olympus Corporation of the AmericasType: Choledochoscope And Accessories, Flexible/RigidDistribution: US Nationwide DistributionRecall #Z-0905-2025
Open, ClassifiedPosted Jan 16, 2025·Initiated Dec 19, 2024
8MM, Tenaculum Forceps REF 470207
Instrument used with the da Vinci X/Xi Surgical Systems in a wide variety of procedures to perform a variety of surgical tasks including manipulation and retraction of tissue.
Reason: Due to an increase in complaints for pitch cable failures related to forceps and small Graptor instruments
Root cause: Device Design
Recalling firm: Intuitive Surgical, Inc.Type: System, Surgical, Computer Controlled InstrumentDistribution: U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MS, MO, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, SD, TN, TX, UT, VA, VT, WA, WV, WI, and WY. The countries of Canada, Austria, Belgium, Denmark, Finland, France, French Guiana, Germany, Guadeloupe, Ireland, Luxembourg, Martinique, Monaco, Netherlands, Norway, Reunion, Sweden, Switzerland, United Kingdom, India, Japan, South Korea, Taiwan, Brazil, Argentina, Australia, Bulgaria, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Ecuador, Greece, Hong Kong, Hungary, Iceland, Israel, Italy, Kuwait, Lebanon, Malaysia, Malta, Mexico, New Zealand, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Thailand, Turkey, United Arab Emirates, Venezuela, Vietnam.Recall #Z-0923-2025
Open, ClassifiedPosted Jan 16, 2025·Initiated Dec 19, 2024
8MM, Small Graptor REF 470318
Is a grasping retractor Instrument used with the da Vinci X/Xi Surgical Systems in a wide variety of procedures to perform a variety of surgical tasks including manipulation and retraction of tissue.
Reason: Due to an increase in complaints for pitch cable failures related to forceps and small Graptor instruments
Root cause: Device Design
Recalling firm: Intuitive Surgical, Inc.Type: System, Surgical, Computer Controlled InstrumentDistribution: U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MS, MO, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, SD, TN, TX, UT, VA, VT, WA, WV, WI, and WY. The countries of Canada, Austria, Belgium, Denmark, Finland, France, French Guiana, Germany, Guadeloupe, Ireland, Luxembourg, Martinique, Monaco, Netherlands, Norway, Reunion, Sweden, Switzerland, United Kingdom, India, Japan, South Korea, Taiwan, Brazil, Argentina, Australia, Bulgaria, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Ecuador, Greece, Hong Kong, Hungary, Iceland, Israel, Italy, Kuwait, Lebanon, Malaysia, Malta, Mexico, New Zealand, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Thailand, Turkey, United Arab Emirates, Venezuela, Vietnam.Recall #Z-0924-2025
Open, ClassifiedPosted Jan 16, 2025·Initiated Dec 3, 2024
ECONO STERILE brand medical procedure kits labeled as:
1) ECONO STERILE" BUCK EAR CUR BL STR#0STRLCS/25, Model Number 96-2273;
2) ECONO STERILE" BILLEAU EAR LOOP MD STRL CS/25, Model Number 96-2283; for ear cleaning
Reason: Reports of various packaging issues that may result in a breach of the sterile barrier.
Root cause: Under Investigation by firm
Recalling firm: Sklar InstrumentsType: Curette, EarDistribution: Domestic: Nationwide DistributionRecall #Z-0925-2025
Open, ClassifiedPosted Jan 16, 2025·Initiated Dec 3, 2024
ECONO STERILE brand medical procedure kits labeled as:
1) ECONO STERILE FREER ELEV DE S/B 7.25" CS/25, Model Number 96-2483 (multiple purpose);
2) ECONO STERILE LOCKE ELEV #94 NARROW STER 25, Model Number 96-2484 (foot procedures)
Reason: Reports of various packaging issues that may result in a breach of the sterile barrier.
Root cause: Under Investigation by firm
Recalling firm: Sklar InstrumentsType: Elevator, EntDistribution: Domestic: Nationwide DistributionRecall #Z-0926-2025
Open, ClassifiedPosted Jan 16, 2025·Initiated Dec 3, 2024
ECONO STERILE medical procedure kits labeled as:
ECONO STERILE TROUSSEAU DILATOR CS/25, Model Number 941-0191 (tracheal procedures)
Reason: Reports of various packaging issues that may result in a breach of the sterile barrier.
Root cause: Under Investigation by firm
Recalling firm: Sklar InstrumentsType: Dilator, TrachealDistribution: Domestic: Nationwide DistributionRecall #Z-0927-2025
Open, ClassifiedPosted Jan 16, 2025·Initiated Dec 3, 2024
ECONO STERILE medical procedure kits labeled as:
ECONO STERILE SIMS UTERINE SND GRD 13"STER25, Model Numbers: 96-2478 (gynecological use)
Reason: Reports of various packaging issues that may result in a breach of the sterile barrier.
Root cause: Under Investigation by firm
Recalling firm: Sklar InstrumentsType: Sound, Urethral, Metal Or PlasticDistribution: Domestic: Nationwide DistributionRecall #Z-0928-2025
Open, ClassifiedPosted Jan 16, 2025·Initiated Dec 3, 2024
ECONO STERILE medical procedure kits labeled as:
1) ECONO STERILE WEITLANER RETR SH 2X3 4.5"CS25, Model Numbers: 96-2201A;
2) ECONO STERILE WEITLANER RETR BL 2X3 4.5"CS25, Model Numbers: 96-2203A;
3) ECONO STERILE WEITLANER RETR BL 3X4 5.5"CS25, Model Numbers: 96-2207A;
4) ECONO STERILE WEITLANER RETR SH 3X4 5.5"CS25, Model Numbers: 96-2208A;
5) ECONO STERILE WEITLANER RETR 3X4 SH 8" CS/10, Model Numbers: 96-2209A;
6) ECONO STERILE WEITLANER RETR 3X4 BL 8" CS/10 , Model Numbers: 96-2210A;
7) ECONO STERILE HOLZHEIMER RETR 4PRG SH 4"CS25, Model Numbers: 96-2241A;
8) ECONO STERILE HOLZHEIMER RETR 4PRG BL 4"CS25, Model Numbers: 96-2242A; surgical retractor
Reason: Reports of various packaging issues that may result in a breach of the sterile barrier.
Root cause: Under Investigation by firm
Recalling firm: Sklar InstrumentsType: Retractor, Self-RetainingDistribution: Domestic: Nationwide DistributionRecall #Z-0929-2025
Open, ClassifiedPosted Jan 16, 2025·Initiated Dec 3, 2024
ECONO STERILE medical procedure kits labeled as:
1) ECONO STERILE VIENNA NSL SPEC MD STRL CS/25, Model Number 96-2236;
2) ECONO STERILE VIENNA NSL SPEC MD STRL CS/25, Model Number 96-2237M;
3) ECONO STERILE VIENNA NSL SPEC LG STRL CS/25, Model Number 96-2238;
for nasal procedures
Reason: Reports of various packaging issues that may result in a breach of the sterile barrier.
Root cause: Under Investigation by firm
Recalling firm: Sklar InstrumentsType: Speculum, EntDistribution: Domestic: Nationwide DistributionRecall #Z-0930-2025
Open, ClassifiedPosted Jan 16, 2025·Initiated Dec 3, 2024
ECONO STERILE medical procedure kits labeled as:
ECONO STERILE" CURETTE EXCAVATOR STRL CS/25, Model Number 941-1320; general surgical
Reason: Reports of various packaging issues that may result in a breach of the sterile barrier.
Root cause: Under Investigation by firm
Recalling firm: Sklar InstrumentsType: Curette, Surgical, General UseDistribution: Domestic: Nationwide DistributionRecall #Z-0931-2025
Open, ClassifiedPosted Jan 16, 2025·Initiated Dec 3, 2024
ECONO STERILE medical procedure kits labeled as:
1) ECONO STERILE D/A NAIL NIPPER 5.75" STER CS5, Model Number 96-2424A;
2) ECONO STERILE TISS NIPPER 14MM CVX 5"CS/25, Model Number 96-2427;
3) ECONO STERILE NAIL NIPPER 4.5" STERILE 25, Model Number 96-2666;
4) ECONO STERILE NAIL NIPPER FLD SPRG 4.5STER25, Model Number 96-2666A;
5) ECONO STERILE NAIL NIPPER 4 1/2" STERILE 50, Model Number 96-2667;
6) ECONO STERILE NAIL NIPPER BRL SPRG 5.5STER25, Model Number 96-2671A; nail procedures
Reason: Reports of various packaging issues that may result in a breach of the sterile barrier.
Root cause: Under Investigation by firm
Recalling firm: Sklar InstrumentsType: Cutter, SurgicalDistribution: Domestic: Nationwide DistributionRecall #Z-0932-2025
Open, ClassifiedPosted Jan 16, 2025·Initiated Dec 3, 2024
ECONO STERILE medical procedure kits labeled as:
1) ECONO STERILE ARMY RETR (SET OF 2) STER CS25, Model Number 96-2243;
2) ECONO STERILE ARMY RETR (SET OF 2)STRL CS/25, Model Number 96-2243M;
3) ECONO STERILE SENN RETR DE BL 6.25"STRLCS/25, Model Number 96-2267;
4) ECONO STERILE SENN RETR DE BL 6.25"STRLCS/25, Model Number 96-2267A;
5) ECONO STERILE SENN RETR DE SH 6.25"STRLCS/25, Model Number 96-2269A;
6) ECONO STERILE MINI HOHMANN 6MM 6.5" STERCS25, Model Number 96-2959; retractors
Reason: Reports of various packaging issues that may result in a breach of the sterile barrier.
Root cause: Under Investigation by firm
Recalling firm: Sklar InstrumentsType: RetractorDistribution: Domestic: Nationwide DistributionRecall #Z-0933-2025