Open, ClassifiedPosted Apr 16, 2025·Initiated Mar 19, 2025
Brand Name: Ballard
Product Name: Closed Suction Catheters
Model/Catalog Number: 2271418-5
Software Version: N/A
Product Description: Ballard Turbo-Cleaning Closed Suction System for Adults, 14 F, DSE, MDI
Component: N/A
Reason: Lack of sterility assurance for closed suction catheter systems
Root cause: Under Investigation by firm
Recalling firm: Avanos Medical, Inc.Type: Catheters, Suction, TracheobronchialDistribution: Worldwide - US Nationwide distribution including in the states of AL, AZ, CA, CO, FL, GA, IA, IL, IN,KS, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI and the countries of South Korea, New Zealand, Canada, Mexico, Germany, England, Slovenia, France, Austria, Guadalajara.Recall #Z-1526-2025 Open, ClassifiedPosted Apr 16, 2025·Initiated Mar 19, 2025
Brand Name: Ballard
Product Name: Closed Suction Catheters
Model/Catalog Number: 227-5
Software Version: N/A
Product Description: Ballard Turbo-Cleaning Closed Suction System for Adults, 14 F, DSE
Component: N/A
Reason: Lack of sterility assurance for closed suction catheter systems
Root cause: Under Investigation by firm
Recalling firm: Avanos Medical, Inc.Type: Catheters, Suction, TracheobronchialDistribution: Worldwide - US Nationwide distribution including in the states of AL, AZ, CA, CO, FL, GA, IA, IL, IN,KS, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI and the countries of South Korea, New Zealand, Canada, Mexico, Germany, England, Slovenia, France, Austria, Guadalajara.Recall #Z-1527-2025 Open, ClassifiedPosted Apr 16, 2025·Initiated Mar 19, 2025
Brand Name: Ballard
Product Name: Closed Suction Catheters
Model/Catalog Number: 22714183-5
Software Version: N/A
Product Description: Ballard Turbo-Cleaning Closed Suction System for Adults, 14 F, DSE, MDI
Component: N/A
Reason: Lack of sterility assurance for closed suction catheter systems
Root cause: Under Investigation by firm
Recalling firm: Avanos Medical, Inc.Type: Catheters, Suction, TracheobronchialDistribution: Worldwide - US Nationwide distribution including in the states of AL, AZ, CA, CO, FL, GA, IA, IL, IN,KS, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI and the countries of South Korea, New Zealand, Canada, Mexico, Germany, England, Slovenia, France, Austria, Guadalajara.Recall #Z-1528-2025 Open, ClassifiedPosted Apr 16, 2025·Initiated Mar 10, 2025
Maquet VH-3010 Power Supply. Used to deliver power to the harvesting tool of the Vasoview Hemopro EVH System (HemoPro 2).
Reason: Incorrect resistor utilized in the VH-3010 Power Supply, which may cause the jaws of the HemoPro 2 to not adequately heat up.
Root cause: Under Investigation by firm
Recalling firm: Maquet Cardiovascular, LLCType: Electrosurgical, Cutting & Coagulation & AccessoriesDistribution: Worldwide - US Nationwide distribution in the states of AL, CA, CO, DC, FL, GA, IA, ID, IL, IN, KY, MD, MI, MN, MO, NC, NH, NJ, NY, OH, PA, PR, TX, UT, VA, WI, WV and the countries of China, Japan, Netherlands, New Zealand, Singapore, United Kingdom, United States.Recall #Z-1577-2025
Open, ClassifiedPosted Apr 16, 2025·Initiated Mar 28, 2025
Brand Name: Rover
Product Name: Mobile X-ray System
Model/Catalog Number: MXU-RV71
Product Description: Rover Mobile X-rays System ("Rover") is a mobile imaging system that incorporates a self-contained X-ray generator, imaging display and software for acquiring medical diagnostic images outside a standard X-ray room. It is designed specifically for Digital Radiography (DR) with vendor-supported detectors.
The Rover is designed to perform radiographic X-ray examinations for disease/injury detection, diagnosis, medical and surgical treatment planning, and therapy monitoring, where patient condition contraindicates transport to a fixed X-ray unit The Rover can be used on pediatric and adult patients, in all patient treatment areas
Component: N/A
Reason: Potential for early life x-ray tube failure for mobile x-ray system due to excessive thermal load on the anode.
Root cause: Device Design
Recalling firm: Micro-X Ltd.Type: System, X-Ray, MobileDistribution: US Nationwide distribution in the states of CA, NJ, and Puerto Rico (US territory).Recall #Z-1578-2025
Open, ClassifiedPosted Apr 16, 2025·Initiated Mar 28, 2025
Brand Name: Rover
Product Name: Mobile X-ray System
Model/Catalog Number: MXU-RV35
Product Description: Rover Mobile X-rays System ("Rover") is a mobile imaging system that incorporates a self-contained X-ray generator, imaging display and software for acquiring medical diagnostic images outside a standard X-ray room. It is designed specifically for Digital Radiography (DR) with vendor-supported detectors.
The Rover is designed to perform radiographic X-ray examinations for disease/injury detection, diagnosis, medical and surgical treatment planning, and therapy monitoring, where patient condition contraindicates transport to a fixed X-ray unit The Rover can be used on pediatric and adult patients, in all patient treatment areas
Component: N/A
Reason: Potential for early life x-ray tube failure for mobile x-ray system due to excessive thermal load on the anode.
Root cause: Device Design
Recalling firm: Micro-X Ltd.Type: System, X-Ray, MobileDistribution: US Nationwide distribution in the states of CA, NJ, and Puerto Rico (US territory).Recall #Z-1579-2025
Open, ClassifiedPosted Apr 16, 2025·Initiated Mar 20, 2025
Brand Name: Cerene Cryotherapy Device
Product Name: DEVICE, THERMAL ABLATION, ENDOMETRIAL
Model/Catalog Number: FGS-7000
Product Description: The Cerene Cryotherapy Device is an endometrial ablation device that uses nitrous oxide (N2O) to freeze and ablate the endometrium to reduce future menstrual bleeding. The device is intended for use by healthcare professionals who have received appropriate training and are familiar with the principles, clinical applications, complications, side effects, and hazards commonly associated with endometrial ablation. The Cerene Device is single use, disposable, and provided sterile. The average procedure time is 7 minutes, with 2.5 minutes of active cryoablation.
Ablation is achieved throughout the uterine cavity through the use of cryothermic energy. The cryothermic energy is provided by a liquid-to-gas phase change of N2O. During the 2.5-minute treatment cycle, liquid N2O (originating from a small Cylinder located in the device handle) flows through a delivery line and into an inflow line with multiple jets. This liquid N2O is infused into an ultra-thin polyurethane Liner, where it converts into gas. The gaseous N2O is exhausted through the Exhaust Hose exiting the bottom of the handle.
Component: N/A
Reason: Due to evaporator gasket not sealing which can cause liquid nitrous oxide to drip/leak from the bottom of the device handle during treatment or after treatment during venting of the device
Root cause: Under Investigation by firm
Recalling firm: Channel Medsystems, Inc.Type: Device, Thermal Ablation, EndometrialDistribution: U.S Nationwide distribution in the states of AL, AZ, CA, CO, CT, DE, FL, GA, IL, IN, KY, LA, MD, MO, NC, NY, OH, PA, PR, RI, TN, TX.Recall #Z-1584-2025
Open, ClassifiedPosted Apr 15, 2025·Initiated Mar 21, 2025
Welch Allyn Connex Integrated Wall System, Product Code/Part Numbers:
1) 84MTVE2-4;
2) 84MTVE2-6;
3) 84MTVE2-B;
4) 84MTVE2-US;
5) 84MTVEC-6;
6) 84MTVEC-B;
7) 84MTVEP-B;
8) 84MTVEX-4;
9) 84MTVX2-4;
10) 84MTVX2-6;
11) 84MTVX2-B;
12) 84MTVX2-US;
13) 84MTVXC-4;
14) 84MTVXC-B;
15) 84MTVXP-2;
16) 84MTVXP-4;
17) 84MTVXP-B;
18) 84MTVXX-2;
19) 84MXVEC-4;
20) 84MXVEC-B;
21) 84MXVEP-4;
22) 84MXVEP-B;
23) 84NTVE2-6;
24) 84NTVE2-B;
25) 84NTVE2-US;
26) 84NTVEC-B;
27) 84NTVX2-6;
28) 84NTVX2-B;
29) 84NTVX2-US;
30) 84NTVXC-4;
31) 84NTVXC-B;
32) 84NTVXP-B;
33) 84NXVEC-4;
34) 84NXVEC-6;
35) 84NXVEC-B;
36) 84XTVXC-2;
37) 84XTVXC-B;
38) 85MTVE3-2;
39) 85MTVE3-4;
40) 85MTVE3-B;
41) 85MTVE3-US;
42) 85MTVEC-4;
43) 85MTVEC-B;
44) 85MTVEP-2;
45) 85MTVEP-B;
46) 85MTVX3-4;
47) 85MTVX3-B;
48) 85MTVX3-US;
49) 85MTVXC-6;
50) 85MTVXC-B;
51) 85MTVXX-6;
52) 85MXVEC-2;
53) 85MXVEC-4;
54) 85MXVEC-B;
55) 85MXVEP-4;
56) 85NTVE3-4;
57) 85NTVE3-6;
58) 85NTVE3-B;
59) 85NTVE3-US;
60) 85NTVEC-B;
61) 85NTVEP-2;
62) 85NTVEP-6;
63) 85NTVEP-B;
64) 85NTVX3-6;
65) 85NTVX3-B;
66) 85NTVX3-US;
67) 85NTVXC-B;
68) 85NTVXP-2;
69) 85NTVXP-B;
70) 85NXVEC-4;
71) 85NXVEC-B;
72) 85NXVEP-6.
Reason: Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.
Root cause: Device Design
Recalling firm: Baxter Healthcare CorporationType: Blood Pressure CuffDistribution: Worldwide distribution.Recall #Z-1562-2025
Open, ClassifiedPosted Apr 15, 2025·Initiated Mar 21, 2025
Welch Allyn Welch Allyn Connex Spot Monitor, Product Code/ Part Numbers:
1) 73WT-B;
2) 74CE-B;
3) 74CT-B;
4) 74CX-B;
5) 74ME-B;
6) 74MT-B;
7) 74MX-B;
8) 74RE-B;
9) 74RT-B;
10) 75CE-B;
11) 75CT-B;
12) 75CT-BR;
13) 75CX-B;
14) 75-HCA-CTB;
15) 75-HCA-MTB;
16) 75ME-B;
17) 75MT-B;
18) 75MT-BR;
19) 75MX-B;
20) 75RE-B;
21) 75RT-B;
22) 75WE-B;
23) 75WT-B.
Reason: Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.
Root cause: Device Design
Recalling firm: Baxter Healthcare CorporationType: Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)Distribution: Worldwide distribution.Recall #Z-1563-2025
Open, ClassifiedPosted Apr 15, 2025·Initiated Mar 21, 2025
Welch Allyn Connex Vital Signs Monitor, Product Code/Part Numbers:
1) ) Product Code/Part # 67MXTP-B-ECG3A;
2) ) Product Code/Part # 67MXTX-B;
3) ) Product Code/Part # 67MXXP-B;
4) ) Product Code/Part # 67MXXX-B;
5) ) Product Code/Part # 67NCTP-B;
6) ) Product Code/Part # 67NCTP-B-ECG3A;
7) ) Product Code/Part # 67NCTX-B;
8) ) Product Code/Part # 67NXEX-B;
9) ) Product Code/Part # 67NXTP-B;
10) ) Product Code/Part # 67NXTP-B-ECG3A;
11) ) Product Code/Part # 67NXTX-B;
12) ) Product Code/Part # 67NXXX-B;
13) ) Product Code/Part # 68MCTP-B;
14) ) Product Code/Part # 68MCTP-B-ECG3A;
15) ) Product Code/Part # 68MCTX-B;
16) ) Product Code/Part # 68MCXX-B;
17) ) Product Code/Part # 68MXDX-B;
18) ) Product Code/Part # 68MXEP-B;
19) ) Product Code/Part # 68MXEX-B;
20) ) Product Code/Part # 68MXTP-B;
21) ) Product Code/Part # 68MXTP-B-ECG3A;
22) ) Product Code/Part # 68MXTX-B;
23) ) Product Code/Part # 68MXTX-BR;
24) ) Product Code/Part # 68NCEP-B;
25) ) Product Code/Part # 68NCTP-B;
26) ) Product Code/Part # 68NCTP-B-ECG3A;
27) ) Product Code/Part # 68NCTX-B;
28) ) Product Code/Part # 68NCXP-B;
29) ) Product Code/Part # 68NXEP-B;
30) ) Product Code/Part # 68NXEX-B;
31) ) Product Code/Part # 68NXTP-B;
32) ) Product Code/Part # 68NXTP-B-ECG3A;
33) ) Product Code/Part # 68NXTX-B;
34) ) Product Code/Part # 68NXTX-BR;
35) ) Product Code/Part # 68NXXX-B;
36) ) Product Code/Part # 67MCTP-B;
37) ) Product Code/Part # 67MCTP-B-ECG3A;
38) ) Product Code/Part # 67MCTX-B;
39) ) Product Code/Part # 67MXEX-B;
40) ) Product Code/Part # 67MXTP-B;
41) ) Product Code/Part # 68MXXX-B.
Reason: Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.
Root cause: Device Design
Recalling firm: Baxter Healthcare CorporationType: Blood Pressure CuffDistribution: Worldwide distribution.Recall #Z-1564-2025
Open, ClassifiedPosted Apr 15, 2025·Initiated Mar 21, 2025
Welch Allyn Spot Vital Signs 4400 Device, Product Code/Part Numbers:
1) 44WT-2;
2) 44WT-3;
3) 44WT-4;
4) 44WT-6;
5) 44WT-B;
6) 44XT-2;
7) 44XT-4;
8) 44XT-6;
9) 44XT-B.
Reason: Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.
Root cause: Device Design
Recalling firm: Baxter Healthcare CorporationType: Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)Distribution: Worldwide distribution.Recall #Z-1565-2025
Open, ClassifiedPosted Apr 15, 2025·Initiated Mar 21, 2025
Welch Allyn Green Series 777 Wall System, Product Code/Part Numbers:
1) 77791-2MP2X;
2) 77791-2MP2XL;
3) 77791-2MPX;
4) 77791-2MPX-HS;
5) 77791-2MPXL;
6) 77796-2MPX;
7) 77796-2MPXL.
Reason: Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.
Root cause: Device Design
Recalling firm: Baxter Healthcare CorporationType: Blood Pressure CuffDistribution: Worldwide distribution.Recall #Z-1566-2025
Open, ClassifiedPosted Apr 15, 2025·Initiated Mar 21, 2025
Welch Allyn DuraShock Aneroid Gauge Sets with a Reusable Blood Pressure Cuff labeled as:
1) WELCH ALLYN DURASHOCK Aneroid Gauge Sets with a Reusable Blood Pressure Cuff,
Product Code Part Numbers: 5098-02, 5098-23, 5098-27, 5098-28, 5098-29, 5098-30, 5098-33, 5098-42, DS44-09, DS44-11, DS44-11C, DS44-MC, DS45-11, DS45-11C, DS45-12, DS45-MC, DS58-11, DS58-MC, DS58-PD, DS58-ST;
2) WELCH ALLYN Gauge Sets with a Reusable Blood Pressure Cuff, Product Code/Part Number 407637;
3) WELCH ALLYN 767 Gauge Sets with a Reusable Blood Pressure Cuff, Product Code/Part Number 7670-10.
Reason: Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.
Root cause: Device Design
Recalling firm: Baxter Healthcare CorporationType: Blood Pressure CuffDistribution: Worldwide distribution.Recall #Z-1567-2025
Open, ClassifiedPosted Apr 15, 2025·Initiated Mar 21, 2025
Welch Allyn 2-Piece Reusable Blood Pressure Cuff Kits labeled as:
1. WELCH ALLYN 2-Piece Reusable Blood Pressure Cuff Kits, Product Code/Part Numbers:
2. WELCH ALLYN Reusable Blood Pressure Cuff Kit, Product Code/Part Numbers: 410519, 5090-41, 5098-20.
Reason: Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.
Root cause: Device Design
Recalling firm: Baxter Healthcare CorporationType: Blood Pressure CuffDistribution: Worldwide distribution.Recall #Z-1568-2025
Open, ClassifiedPosted Apr 15, 2025·Initiated Mar 25, 2025
restor3d Cordera Hip System. ACETABULAR LINER GRP C 36MM LIP. Model Number: HDL-060-C22L-000101
Acetabular Liner for Cordera Hip System
Reason: The hip cup liner that was packaged with the incorrect labeling. HDL-060-C22S-000101 from Lot 1788258 contained a hooded liner, but it was labeled to have a standard
liner.
Root cause: Labeling Change Control
Recalling firm: Conformis Inc.Type: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous UncementedDistribution: US Nationwide distribution in the states of CA, FL, NV, TN.Recall #Z-1569-2025
Open, ClassifiedPosted Apr 15, 2025·Initiated Mar 4, 2025
Brand Name: ID NOW COVID-19 2.0 24T
Product Name: ID NOW COVID-19 2.0 24T
Model/Catalog Number: 192-000
Software Version: N/A
Product Description: Simple Point-Of-Care Device To Detect Sar-Cov-2 Nucleic Acid Targets
Component: No
Reason: The impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use.
Root cause: Process change control
Recalling firm: Abbott Diagnostics Scarborough, Inc.Type: Simple Point-Of-Care Device To Detect Sar-Cov-2 Nucleic Acid Targets From Clinical Specimens In Near-Patient SettingsDistribution: Worldwide distribution - US Nationwide and the countries of Australia; Austria; Belgium; Bulgaria; Canada; Costa Rica; France; French Polynesia; Germany; Italy; Luxembourg; Malaysia; Netherlands; Paraguay; Poland; Qatar; Saudi Arabia; Slovenia; South Korea; Spain; Switzerland; Taiwan; United Kingdom; Uruguay.Recall #Z-1571-2025
Open, ClassifiedPosted Apr 15, 2025·Initiated Mar 4, 2025
Brand Name: ID NOW Influenza A/B 2 24T
Product Name: ID NOW Influenza A/B 2 24T
Model/Catalog Number: 427-000
Software Version: N/A
Product Description: Influenza A And Influenza B Multiplex Nucleic Acid Assay; Real Time Nucleic Acid
Component: No
Reason: The impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use.
Root cause: Process change control
Recalling firm: Abbott Diagnostics Scarborough, Inc.Type: Influenza A And Influenza B Multiplex Nucleic Acid AssayDistribution: Worldwide distribution - US Nationwide and the countries of Australia; Austria; Belgium; Bulgaria; Canada; Costa Rica; France; French Polynesia; Germany; Italy; Luxembourg; Malaysia; Netherlands; Paraguay; Poland; Qatar; Saudi Arabia; Slovenia; South Korea; Spain; Switzerland; Taiwan; United Kingdom; Uruguay.Recall #Z-1572-2025
Open, ClassifiedPosted Apr 15, 2025·Initiated Mar 4, 2025
Brand Name: ID NOW RSV 24T
Product Name: ID NOW RSV 24T
Model/Catalog Number: 435-000
Software Version: N/A
Product Description: Respiratory virus panel nucleic acid assay system
Component: No
Reason: The impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use.
Root cause: Process change control
Recalling firm: Abbott Diagnostics Scarborough, Inc.Type: Respiratory Virus Panel Nucleic Acid Assay SystemDistribution: Worldwide distribution - US Nationwide and the countries of Australia; Austria; Belgium; Bulgaria; Canada; Costa Rica; France; French Polynesia; Germany; Italy; Luxembourg; Malaysia; Netherlands; Paraguay; Poland; Qatar; Saudi Arabia; Slovenia; South Korea; Spain; Switzerland; Taiwan; United Kingdom; Uruguay.Recall #Z-1573-2025
Open, ClassifiedPosted Apr 15, 2025·Initiated Mar 4, 2025
Brand Name: ID NOW COVID-19 2.0 24T
Product Name: ID NOW COVID-19 2.0 24T
Model/Catalog Number: 192-000
Software Version: N/A
Product Description: Simple Point-Of-Care Device To Detect Sar-Cov-2 Nucleic Acid Targets
Component: No
Reason: the impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use.
Root cause: Process change control
Recalling firm: Abbott Diagnostics Scarborough, Inc.Type: Simple Point-Of-Care Device To Detect Sar-Cov-2 Nucleic Acid Targets From Clinical Specimens In Near-Patient SettingsDistribution: US Nationwide distribution.Recall #Z-1574-2025
Open, ClassifiedPosted Apr 15, 2025·Initiated Mar 4, 2025
Brand Name: ID NOW Influenza A/B 2 24T
Product Name: ID NOW Influenza A/B 2 24T
Model/Catalog Number: 427-000
Software Version: N/A
Product Description: Influenza A And Influenza B Multiplex Nucleic Acid Assay; Real Time Nucleic Acid
Component: No
Reason: the impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use.
Root cause: Process change control
Recalling firm: Abbott Diagnostics Scarborough, Inc.Type: Influenza A And Influenza B Multiplex Nucleic Acid AssayDistribution: US Nationwide distribution.Recall #Z-1575-2025