Open, ClassifiedPosted May 9, 2025·Initiated Jul 12, 2024
Brand Name: Contour
Product Name: Contour Gold Eyelid Weight
Model/Catalog Number: LL3012
Product Description: Contour Gold Eyelid Weight, 1.2 gm
MedDev Contour and ThinProfile Eyelid Weight Implants are designed for the gravity-assisted treatment of protracted permanent lagophthalmos, usually resulting from facial paralysis.
Reason: Due to mislabeling of products
Root cause: Process control
Recalling firm: Meddev CorpType: Weights, Eyelid, ImplantableDistribution: U.S. Nationwide distribution in the states of CA, CO, CT, FL, IA, IL, MA, ME, MI, NE, NY, OH, OK, OR, SC, TX, and WV.Recall #Z-1745-2025
Open, ClassifiedPosted May 8, 2025·Initiated Apr 10, 2025
Blueprint Software, BPUE001.
Intended for use by surgeons as a pre surgical planner for shoulder replacement.
Reason: A software bug in Blueprint version 4.2.1 prevents users from accessing cases initiated in previous versions of the software.
Root cause: Software Design Change
Recalling firm: Tornier S.A.S.Type: Shoulder Prosthesis, Reverse ConfigurationDistribution: Blueprint Version 4.2.1 is only currently available in the US. Domestic distribution nationwide.Recall #Z-1738-2025
Open, ClassifiedPosted May 8, 2025·Initiated Apr 3, 2025
Atalante X, Powered Exoskeleton.
Atalante X is intended to perform ambulatory functions and mobility exercises, hands-free, in rehabilitation institutions under the supervision of a trained operator.
Reason: Potential for exoskeleton to lose lateral balance and cause patient to fall.
Root cause: Use error
Recalling firm: WANDERCRAFT SASType: Powered ExoskeletonDistribution: Domestic: PA & NY.Recall #Z-1739-2025
Open, ClassifiedPosted May 8, 2025·Initiated Apr 7, 2025
IntelliSpace Cardiovascular software versions 6.x, 7.x, and 8.x; Model Number: 830089.
Reason: An issue was identified with the software when using the Echo Module of ISCV, the issue may result in missing or incomplete information in the report.
Root cause: Software in the Use Environment
Recalling firm: Philips Medical Systems Nederland B.V.Type: System, Image Processing, RadiologicalDistribution: Domestic: Nationwide Distribution
International: Australia, Austria, Belgium, Canada, Denmark, Estonia, Finland, France, Germany, Greece, Hong Kong, Indonesia, Ireland, Italy, Japan, Luxembourg, Mexico, Netherlands, Norway, Poland, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Thailand, United Kingdom.Recall #Z-1740-2025
Open, ClassifiedPosted May 7, 2025·Initiated Apr 10, 2025
CADD Solis HSPCA Pump
***Updated 5/27/26***
Scope updated to apply specifically to customers using the wireless system. Affected products associated with the change in scope:
PUMP KIT, CADD SOLIS HPCA, MDL 2110, V4.3, ENGLISH, 1/EA
21-2111-0403-51
PUMP KIT, CADD SOLIS HPCA, MDL 2110, V4.3, TRIAL, LOANER, ENGLISH, 1/EA
21-2111-0403-78
PUMP KIT, CADD SOLIS HPCA, MDL 2110, V4.3, YELLOW, ENGLISH, 1/EA
21-2112-0403-51
PUMP KIT, CADD SOLIS HPCA, MDL 2110, V4.3, YELLOW, FRENCH, 1/EA
21-2112-0403-02
PUMP KIT, CADD-SOLIS HPCA PIB, MODEL 2110, NA ENGLISH 1/EA
21-2111-0300-01
PUMP KIT, CADD-SOLIS HPCA PIB, MODEL 2110, OUS ENGLISH 1/EA
21-2111-0300-50
PUMP KIT, CADD-SOLIS HPCA PIB, YELLOW KEYPAD, MODEL 2110, NA ENGLISH 1/EA
21-2112-0300-01
PUMP KIT, CADD-SOLIS HPCA PIB, YELLOW, MODEL 2110, FRENCH 1/EA
21-2112-0300-02
PUMP KIT, CADD-SOLIS HPCA PIB, YELLOW, MODEL 2110, OUS ENGLISH 1/EA
21-2112-0300-50
PUMP KIT, CADD-SOLIS, MDL 2100, CE ENGLISH 1/EA
21-2101-51
PUMP KIT, CADD-SOLIS, MDL 2110, TRIAL/LOANER, V4.1, CE ENGLISH 1/EA
21-2111-0401-78
PUMP KIT, CADD-SOLIS, MDL 2110, TRIAL/LOANER, V4.2, CE ENGLISH 1/EA
21-2111-0402-78
PUMP KIT, CADD-SOLIS, MDL 2110, v4.0, ENGLISH 1/EA
21-2111-0400-51
PUMP KIT, CADD-SOLIS, MDL 2110, v4.0, YELLOW, ENGLISH 1/EA
21-2112-0400-51
PUMP KIT, CADD-SOLIS, MDL 2110, V4.1, CE ENGLISH 1/EA
21-2111-0401-51
PUMP KIT, CADD-SOLIS, MDL 2110, V4.1, YELLOW, CE ENGLISH 1/EA
21-2112-0401-51
PUMP KIT, CADD-SOLIS, MDL 2110, V4.2, CE ENGLISH 1/EA
21-2111-0402-51
PUMP KIT, CADD-SOLIS, MDL 2110, V4.2, TRIAL/LOANER YELLOW, CE ENGLISH 1/EA
21-2112-0402-78
PUMP KIT, CADD-SOLIS, MDL 2110, V4.2, YELLOW, CE ENGLISH 1/EA
21-2112-0402-51
PUMP KIT, CADD-SOLIS, MODEL 2110, CE ENGLISH 1/EA
21-2111-0100-51
PUMP KIT, CADD-SOLIS, YELLOW, MODEL 2110 1/EA
21-2112-0100-51
Reason: Pumps may experience Wireless Connection Modules intermittent connection alarms, which will interrupt an active infusion. Interruption or delay of therapy can lead to serious patient injury or death.
Root cause: Software design
Recalling firm: Smiths Medical ASD, Inc.Type: Pump, Infusion, PcaDistribution: Worldwide - US Nationwide distribution.Recall #Z-1662-2025
Open, ClassifiedPosted May 7, 2025·Initiated Apr 10, 2025
CADD-Solis HPCA Ambulatory Infusion Pump;
Model/Number:
21-2111-0402-09-KYO
21-2111-0402-09-KYO
CADD SOLIS PIB PUMP FOR CLINICAL EVALUATION/DEMO PUMP
21-2111-0300-09_LOAN
CADD SOLIS PIB PUMP FOR CLINICAL EVALUATION/DEMO PUMP FOR CMSA
21-2111-0300-09_CMSA
CADD Solis PIB PUMP FOR CLINICAL EVALUATION/DEMO PUMP FOR FUKUOKA
21-2111-0300-09_FUK
CADD SOLIS PIB PUMP FOR CLINICAL EVALUATION/DEMO PUMP FOR KYOTO
21-2111-0300-09_KYO
CADD SOLIS PIB PUMP FOR CLINICAL EVALUATION/DEMO PUMP FOR OKAYAMA
21-2111-0300-09_OKA
CADD SOLIS PIB PUMP FOR CLINICAL EVALUATION/DEMO PUMP FOR OOMIYA
21-2111-0300-09_OMI
CADD SOLIS PIB PUMP FOR CLINICAL EVALUATION/DEMO PUMP FOR OSAKA
21-2111-0300-09_OSA
CADD SOLIS PIB PUMP FOR CLINICAL EVALUATION/DEMO PUMP FOR SAPPORO
21-2111-0300-09_SAP
CADD SOLIS PIB PUMP FOR CLINICAL EVALUATION/DEMO PUMP FOR TOKYO
21-2111-0300-09_TOK
CADD_SOLIS_MODEL 2110_ENGLISH_1/EA
21-2111-0200-50JP
CADD-Solis VIP
CADD-SOLIS V4.2 LOAN FUK
21-2111-0402-09-FUK
CADD-SOLIS V4.2 LOAN NAG
21-2111-0402-09-NAG
CADD-SOLIS V4.2 LOAN OKA
21-2111-0402-09-OKA
CADD-SOLIS V4.2 LOAN OSA
21-2111-0402-09-OSA
CADD-SOLIS V4.2 LOAN SAI
21-2111-0402-09-SAI
CADD-SOLIS V4.2 LOAN SAP
21-2111-0402-09-SAP
CADD-SOLIS V4.2 LOAN TOKE
21-2111-0402-09-TOKE
CADD-SOLIS V4.2 LOAN TOKW
21-2111-0402-09-TOKW
CADD-SOLIS V4.2 LOAN YELLOW KYO
21-2112-0402-09-KYO
CADD-SOLIS V4.2 LOAN YELLOW NAG
21-2112-0402-09-NAG
CADD-SOLIS V4.2 LOAN YELLOW YOK
21-2112-0402-09-YOK
CADD-SOLIS V4.2 LOAN YOK
21-2111-0402-09-YOK
Number:21-2111-0403-02Part Type:List Number/Finished GoodLifecycle Phase:03-ReleasedDescription:PUMP KIT, CADD SOLIS HPCA, MDL 2110, V4.3, FRENCH, 1/EA
21-2111-0403-02
PUMP KIT, CADD SOLIS HPCA, MDL 2110, V4.3, ENGLISH, 1/EA
21-2111-0403-51
PUMP KIT, CADD SOLIS HPCA, MDL 2110, V4.3, TRIAL, LOANER, ENGLISH, 1/EA
21-2111-0403-78
PUMP KIT, CADD SOLIS HPCA, MDL 2110, V4.3, TRIAL, LOANER, YELLOW, ENGLISH, 1/EA
21-2112-0403-78
PUMP KIT, CADD SOLIS HPCA, MDL 2110, V4.3, YELLOW, ENGLISH, 1/EA
21-2112-0403-51
PUMP KIT, CADD SOLIS HPCA, MDL 2110, V4.3, YELLOW, FRENCH, 1/EA
21-2112-0403-02
PUMP KIT, CADD-SOLIS HPCA PIB, MODEL 2110 TRIAL/LOANER, NA ENGLISH 1/EA
21-2111-0300-00
PUMP KIT, CADD-SOLIS HPCA PIB, MODEL 2110, DANISH 1/EA
21-2111-0300-12
PUMP KIT, CADD-SOLIS HPCA PIB, MODEL 2110, DUTCH 1/EA
21-2111-0300-06
PUMP KIT, CADD-SOLIS HPCA PIB, MODEL 2110, FRENCH 1/EA
21-2111-0300-02
PUMP KIT, CADD-SOLIS HPCA PIB, MODEL 2110, GERMAN 1/EA
21-2111-0300-03
PUMP KIT, CADD-SOLIS HPCA PIB, MODEL 2110, ITALIAN 1/EA
21-2111-0300-07
PUMP KIT, CADD-SOLIS HPCA PIB, MODEL 2110, JAPANESE
21-2111-0300-09JP
PUMP KIT, CADD-SOLIS HPCA PIB, MODEL 2110, NA ENGLISH 1/EA
21-2111-0300-01
PUMP KIT, CADD-SOLIS HPCA PIB, MODEL 2110, NFHU, FRENCH 1/EA
21-2111-0300-232
PUMP KIT, CADD-SOLIS HPCA PIB, MODEL 2110, NFHU, NA ENGLISH 1/EA
21-2111-0300-231
PUMP KIT, CADD-SOLIS HPCA PIB, MODEL 2110, NFHU, SWEDISH 1/EA
21-2111-0300-244
PUMP KIT, CADD-SOLIS HPCA PIB, MODEL 2110, OUS ENGLISH 1/EA
21-2111-0300-50
Not
PUMP KIT, CADD-SOLIS HPCA PIB, MODEL 2110, PORTUGUESE 1/EA
21-2111-0300-17
PUMP KIT, CADD-SOLIS HPCA PIB, MODEL 2110, SPANISH 1/EA
21-2111-0300-08
PUMP KIT, CADD-SOLIS HPCA PIB, MODEL 2110, SWEDISH 1/EA
21-2111-0300-14
PUMP KIT, CADD-SOLIS HPCA PIB, YELLOW KEYPAD, MODEL 2110, NA ENGLISH 1/EA
21-2112-0300-01
PUMP KIT, CADD-SOLIS HPCA PIB, YELLOW, MODEL 2110, DUTCH 1/EA
21-2112-0300-06
PUMP KIT, CADD-SOLIS HPCA PIB, YELLOW, MODEL 2110, FRENCH 1/EA
21-2112-0300-02
PUMP KIT, CADD-SOLIS HPCA PIB, YELLOW, MODEL 2110, GERMAN 1/EA
21-2112-0300-03
PUMP KIT, CADD-SOLIS HPCA PIB, YELLOW, MODEL 2110, OUS ENGLISH 1/EA
21-2112-0300-50
PUMP KIT, CADD-SOLIS HPCA PIB, YELLOW, MODEL 2110,TRIAL/LOANER, NA ENGLISH 1/EA
21-2112-0300-00
PUMP KIT, CADD-SOLIS HPCA, MDL 2100, DANISH 1/EA
21-2101-0200-12
PUMP KIT, CADD-SOLIS HPCA, MDL 2100, FRENCH 1/EA
21-2101-0200-02
PUMP KIT, CADD-SOLIS HPCA, MDL 2100, GERMAN 1/EA
21-2101-0200-03
PUMP KIT, CADD-SOLIS HPCA, MDL 2100, ITALIAN 1/EA
21-2101-02
Open, ClassifiedPosted May 7, 2025·Initiated Apr 10, 2025
CADD-Solis VIP Ambulatory Infusion Pump;
Model/Number:
21-2120-0100-02
21-2120-0100-03
21-2120-0100-06
21-2120-0100-232
21-2120-0100-233
21-2120-0100-50
21-2120-0100-51
21-2120-0100-95
21-2120-0102-02
21-2120-0102-03
21-2120-0102-06
21-2120-0102-07
21-2120-0102-08
21-2120-0102-12
21-2120-0102-13
21-2120-0102-14
21-2120-0102-15
21-2120-0102-17
21-2120-0102-237
21-2120-0102-238
21-2120-0102-247
21-2120-0102-249
21-2120-0102-51
21-2120-0102-78
21-2120-0102-92
21-2120-0102-97
21-2120-0102-98
21-2120-0103-01
21-2120-0103-02
21-2120-0103-03
21-2120-0103-06
21-2120-0103-07
21-2120-0103-08
21-2120-0103-12
21-2120-0103-14
21-2120-0103-15
21-2120-0103-17
21-2120-0103-249
21-2120-0103-51
21-2120-0103-78
21-2120-0104-01
21-2120-0104-231
21-2120-0105-00
21-2120-0105-01
21-2120-0105-02L
21-2120-0105-03L
21-2120-0105-06L
21-2120-0105-07L
21-2120-0105-08
21-2120-0105-08L
21-2120-0105-12L
21-2120-0105-13L
21-2120-0105-14L
21-2120-0105-15L
21-2120-0105-17L
21-2120-0105-50
21-2120-0105-50L
21-2125-0104-01
21-2125-0105-03L
21-2125-0105-07L
21-2125-0105-08L
21-2125-0105-50L
21-2127-0104-01
21-2127-0105-01
21-2127-0105-02L
21-2127-0105-03L
21-2127-0105-06L
21-2127-0105-08L
21-2127-0105-50L
Reason: Affected pumps may trigger an erroneous (false) Upstream Occlusion Alarm under certain conditions, which will interrupt an active infusion. Interruption or delay of therapy can lead to serious patient injury or death.
Root cause: Labeling design
Recalling firm: Smiths Medical ASD, Inc.Type: Pump, InfusionDistribution: Worldwide - US nationwide distribution.Recall #Z-1668-2025
Open, ClassifiedPosted May 7, 2025·Initiated Apr 15, 2025
Philips Tempus Pro Patient Monitor, REF: 00-1004-R, 00-1007-R, 00-1024-R,
00-1026-R, 00-1004, 00-1007
Reason: Patient Monitor software update to address issues:1)May freeze at startup with MPM Application error and Attention Restart Required messages,2)Monitor may freeze and reboot at start of 12-lead ECG or after, 3)May reboot after intermittent connection with Smart Mount, 4) 12-lead ECG measurements with Louvain algorithm and software before vx.36 could produce inaccurate rhythm/morphology statements.
Root cause: Software design
Recalling firm: Remote Diagnostic Technologies Ltd.Type: Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)Distribution: Worldwide - US Nationwide distribution including in the states of AZ, VA, FL, CA, TX, NM, IA, NJ, TN, OH, KS, IN, NC, IL, WY, WI, NV, NY, NE, PA, AL, , MA, GA, MO, CO, OK, KY, OR, MS, MI, HI, WA, UT, WV, ID, ND, NH, MN, MT, ME, MD, DE, DC and the countries of AU, GB, IT, SA, DE, AE, BO, FR, ES, BE, IL, SG, CA, IE, TH, NL, MY, AT, DK, RO, CH, IS, PT, NO, HK, PL, KY, OM, CZ, SI, SL, ZA, AF, SE, FI.Recall #Z-1729-2025
Open, ClassifiedPosted May 7, 2025·Initiated Mar 27, 2025
GALT Centeze Catheter
REF:
DRC-002-05
DRC-002-06
The Centeze is intended for use in percutaneous fluid aspirations and small volume drainage procedures. For both adult and adolescent groups.
Reason: Due to a potential open seal in the sterile barrier packaging .
Root cause: Process control
Recalling firm: Galt Medical CorporationType: Accessories, CatheterDistribution: Worldwide - U.S. Nationwide distribution in the states of AL, FL, GA, IL, MA, OH, PA, and UT. The countries of Canada, Ireland, Israel, Korea, Qatar, and United Kingdom.Recall #Z-1731-2025
Open, ClassifiedPosted May 7, 2025·Initiated Mar 27, 2025
B Braun Interventional Coaxial Dilator
REF:
KIT-018-47,
KIT-019-67,
KIT-018-41,
KIT-019-37
These Micro-Introducer Kits are intended to introduce up to a .038 inch
guidewire or catheter into the vascular system following a small gauge
needle stick.
Reason: Due to a potential open seal in the sterile barrier packaging .
Root cause: Process control
Recalling firm: Galt Medical CorporationType: Dilator, Vessel, For Percutaneous CatheterizationDistribution: Worldwide - U.S. Nationwide distribution in the states of AL, FL, GA, IL, MA, OH, PA, and UT. The countries of Canada, Ireland, Israel, Korea, Qatar, and United Kingdom.Recall #Z-1732-2025
Open, ClassifiedPosted May 7, 2025·Initiated Mar 27, 2025
B Braun Interventional ELITE HV Hemostasis Valve Introducer System
REF 612802
Model Number: BCL-100-04
The Elite HV Introducer System is indicated for use in percutaneous
procedures to introduce catheters and other intravascular devices into the
vasculature.
Reason: Due to a potential open seal in the sterile barrier packaging .
Root cause: Process control
Recalling firm: Galt Medical CorporationType: Introducer, CatheterDistribution: Worldwide - U.S. Nationwide distribution in the states of AL, FL, GA, IL, MA, OH, PA, and UT. The countries of Canada, Ireland, Israel, Korea, Qatar, and United Kingdom.Recall #Z-1733-2025
Open, ClassifiedPosted May 7, 2025·Initiated Mar 27, 2025
GALT Guidewire
REF SGW-051-07
Guidewires are intended for use in percutaneous procedures, to introduce and position catheters and other interventional devices within the Coronary and peripheral vasculature.
Reason: Due to a potential open seal in the sterile barrier packaging.
Root cause: Process control
Recalling firm: Galt Medical CorporationType: Wire, Guide, CatheterDistribution: Worldwide - U.S. Nationwide distribution in the states of AL, FL, GA, IL, MA, OH, PA, and UT. The countries of Canada, Ireland, Israel, Korea, Qatar, and United Kingdom.Recall #Z-1734-2025
Open, ClassifiedPosted May 7, 2025·Initiated Mar 27, 2025
Introducer Kit- Coaxial Dilator
REF:
KIT-002-28, 00841268104730
KIT-002-34, 00841268104792
KIT-002-35, 00841268104808
KIT-011-40, 00841268105553
KIT-011-62, 00841268105614
KIT-038-04, 00841268104556
KIT-039-03, 00841268104587
KIT-039-13, 00841268106055
KIT-081-02 / PS2-38, 00841268108394
These Micro-Introducer Kits are intended to introduce up to a .038 inch guidewire or catheter into the peripheral vascular system following a small gauge needle stick.
Reason: Due to a potential open seal in the sterile barrier packaging.
Root cause: Process control
Recalling firm: Galt Medical CorporationType: Percutaneous Sheath Introducer KitDistribution: Worldwide - U.S. Nationwide distribution in the states of AL, FL, GA, IL, MA, OH, PA, and UT. The countries of Canada, Ireland, Israel, Korea, Qatar, and United Kingdom.Recall #Z-1735-2025
Open, ClassifiedPosted May 7, 2025·Initiated Mar 27, 2025
Introducer Needle
REF NDL-107-04
These needles are used for the percutaneous introduction of guidewires
Reason: Due to a potential open seal in the sterile barrier packaging.
Root cause: Process control
Recalling firm: Galt Medical CorporationType: Instruments, Surgical, CardiovascularDistribution: Worldwide - U.S. Nationwide distribution in the states of AL, FL, GA, IL, MA, OH, PA, and UT. The countries of Canada, Ireland, Israel, Korea, Qatar, and United Kingdom.Recall #Z-1736-2025
Open, ClassifiedPosted May 7, 2025·Initiated Mar 27, 2025
Introducer Kit- Tearaway MicroSlide
REF
KIT-051-01, 00841268106130
INT-101-15, 00841268107380
These introducers are used for the procedures to introduce catheters and other intravascular devices into the coronary and peripheral vasculature of adult and pediatric patients of all ages.
Reason: Due to a potential open seal in the sterile barrier packaging.
Root cause: Process control
Recalling firm: Galt Medical CorporationType: Percutaneous Sheath Introducer KitDistribution: Worldwide - U.S. Nationwide distribution in the states of AL, FL, GA, IL, MA, OH, PA, and UT. The countries of Canada, Ireland, Israel, Korea, Qatar, and United Kingdom.Recall #Z-1737-2025
Open, ClassifiedPosted May 6, 2025·Initiated Apr 11, 2025
CODMAN Disposable Perforator, 14mm. Cranial perforator.
Reason: Inadequate weld that can potentially cause the product to disassemble.
Root cause: Process control
Recalling firm: Integra LifeSciences Corp. (NeuroSciences)Type: Drills, Burrs, Trephines & Accessories (Compound, Powered)Distribution: Worldwide distribution - US Nationwide including Puerto Rico and the countries of Argentina, Australia, Austria, Bahamas, Barbados, Belgium, Brazil, Canada, Chile, Colombia, Cyprus, Czechia, Dominican Republic, Ecuador, El Salvador, France, French Guiana, Germany, Ghana, Greece, Hong Kong, India, Ireland, Israel, Italy, Japan, Jordan, Kenya, Korea (the Republic of), Lebanon, Lithuania, Malaysia, Morocco, Nepal, Netherlands, New Zealand, Pakistan, Poland, Portugal, Qatar, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Tunisia, Turkey, United Arab Emirates, United Kingdom.Recall #Z-1716-2025
Open, ClassifiedPosted May 6, 2025·Initiated Apr 11, 2025
CODMAN Craniotomy Kit, Disposable Perforator Cranio-blade Wire Pass Drill, 14mm. Cranial perforator kit.
Reason: Inadequate weld that can potentially cause the product to disassemble.
Root cause: Process control
Recalling firm: Integra LifeSciences Corp. (NeuroSciences)Type: Drills, Burrs, Trephines & Accessories (Compound, Powered)Distribution: Worldwide distribution - US Nationwide including Puerto Rico and the countries of Argentina, Australia, Austria, Bahamas, Barbados, Belgium, Brazil, Canada, Chile, Colombia, Cyprus, Czechia, Dominican Republic, Ecuador, El Salvador, France, French Guiana, Germany, Ghana, Greece, Hong Kong, India, Ireland, Israel, Italy, Japan, Jordan, Kenya, Korea (the Republic of), Lebanon, Lithuania, Malaysia, Morocco, Nepal, Netherlands, New Zealand, Pakistan, Poland, Portugal, Qatar, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Tunisia, Turkey, United Arab Emirates, United Kingdom.Recall #Z-1717-2025
Open, ClassifiedPosted May 6, 2025·Initiated Apr 7, 2025
Ambu aScope" 5 Broncho HD 5.6/2.8 Sampler Set. Model Number: 622002000US
Reason: Incorrect labeling in which the front red pouch label did not match the actual size of the medical device. The label on the front of the scope incorrectly states 5.0/2.2 while the back label, shipping box and product inside correctly states 5.6/2.8.
Root cause: Process control
Recalling firm: Ambu Inc.Type: Bronchoscope (Flexible Or Rigid)Distribution: US Nationwide distribution in the states of CA, CO, FL, GA, KY, MD, MT, NJ, NV, PA, TN, TX, VA.Recall #Z-1723-2025
Open, ClassifiedPosted May 6, 2025·Initiated Apr 4, 2025
INSPIRA AIR BALLOON DILATION SYSTEM 10x40, 1 PK. Airway balloon dilation catheter.
Reason: Incorrect product packaged in INSPIRA AIR Balloon Dilation System carton.
Root cause: Under Investigation by firm
Recalling firm: Integra LifeSciences Corp. (NeuroSciences)Type: Bronchoscope AccessoryDistribution: US Nationwide distribution in the states of TX, MT, AL & OK.Recall #Z-1724-2025
Open, ClassifiedPosted May 6, 2025·Initiated Apr 8, 2025
Artix MT Thrombectomy Device, REF: 32-102
Reason: Thrombectomy device specifies vessel range of 2.5-6 mm on the pouch, carton, and Instructions for Use rather than the correct vessel range of 3-6 mm, which could incrementally increase the radial force on the artery, which has the potential of vascular complications.
Root cause: Labeling Change Control
Recalling firm: Inari Medical - Oak CanyonType: Peripheral Mechanical Thrombectomy With AspirationDistribution: US Nationwide distribution in the states of FL, IL, WI, KY, TX, CA, OH, GA, AK, MI, PA, WA, CO, OH.Recall #Z-1728-2025