Open, ClassifiedPosted Jul 10, 2025·Initiated Jun 24, 2025
Preat, Astra EV-compatible 4.2mm Digital Analog
REF: 9006603 (single) and 9006603-10(10 pack), Rx Only
Reason: Due to manufacturing error, digital analog rotational feature is 180 degrees off.
Root cause: Employee error
Recalling firm: Preat CorpType: Abutment, Implant, Dental, EndosseousDistribution: US Nationwide distribution in the states of AL, CA, FL, GA, KY, MD, MN, NY, OK, PA.Recall #Z-2107-2025
Open, ClassifiedPosted Jul 10, 2025·Initiated Apr 28, 2025
Brand Name: Alcon Laboratories, Inc.
Product Name: Constellation Vision System Vitrectomy Procedure Pak
Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List'
Software Version: N/A
Product Description: Surgical procedure pack to interface with Alcon Constellation Surgical console.
Component: N/A
Reason: Due to the potential that some units within specific lots were damaged during the manufacturing process. The area of damage is within the same area of the lidding. While the damage in the lidding is visibly noticeable, due to risk of sterility being compromised.
Root cause: Under Investigation by firm
Recalling firm: Alcon Research LLCType: Vitrectomy, Instrument CutterDistribution: Worldwide - 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, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV. The countries of Albania, Argentina, Australia, Austria, Bahamas, Bahrain, Bangladesh,
Brazil, Bulgaria, Cambodia, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Ecuador, El Salvador, Finland, France, French Polynesia, Georgia, Germany, Guadeloupe,
Guatemala, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Ireland, Israel, Italy,
Jamaica, Japan, Kazakhstan, Kenya, Korea, Kosovo, Kuwait, Latvia, Lebanon, Luxembourg,
Macao, Malaysia, Malta, Mexico, Moldova, Mongolia, Montenegro, Morocco, Netherlands,
New Zealand, Oman, Pakistan, Peru, Philippines, Poland, Qatar, Republic of North Macedonia, R¿union, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine,
United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Viet Nam.Recall #Z-2108-2025
Open, ClassifiedPosted Jul 10, 2025·Initiated Apr 28, 2025
Brand Name: Alcon Laboratories, Inc.
Product Name: Constellation Vision System Combined Procedure Pak
Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List'
Software Version: N/A
Product Description: Surgical procedure pack to interface with Alcon Constellation Surgical console.
Component: N/A
Reason: Due to the potential that some units within specific lots were damaged during the manufacturing process. The area of damage is within the same area of the lidding. While the damage in the lidding is visibly noticeable, due to risk of sterility being compromised.
Root cause: Under Investigation by firm
Recalling firm: Alcon Research LLCType: Unit, PhacofragmentationDistribution: Worldwide - 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, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV. The countries of Albania, Argentina, Australia, Austria, Bahamas, Bahrain, Bangladesh,
Brazil, Bulgaria, Cambodia, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Ecuador, El Salvador, Finland, France, French Polynesia, Georgia, Germany, Guadeloupe,
Guatemala, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Ireland, Israel, Italy,
Jamaica, Japan, Kazakhstan, Kenya, Korea, Kosovo, Kuwait, Latvia, Lebanon, Luxembourg,
Macao, Malaysia, Malta, Mexico, Moldova, Mongolia, Montenegro, Morocco, Netherlands,
New Zealand, Oman, Pakistan, Peru, Philippines, Poland, Qatar, Republic of North Macedonia, R¿union, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine,
United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Viet Nam.Recall #Z-2109-2025
Open, ClassifiedPosted Jul 10, 2025·Initiated Apr 28, 2025
Brand Name: Alcon Laboratories, Inc.
Product Name: Custom Pak
Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List'
Software Version: N/A
Product Description: Alcon Custom Paks are customer-designed sterile surgical procedure packs / convenience kits intended for use by trained ophthalmic surgeons in a variety of ophthalmic surgeries. Custom Pak is a collection of various ophthalmic surgical instruments and the necessary materials necessary to perform an ophthalmic surgical procedure.
Component: N/A
Reason: Due to the potential that some units within specific lots were damaged during the manufacturing process. The area of damage is within the same area of the lidding. While the damage in the lidding is visibly noticeable, due to risk of sterility being compromised.
Root cause: Under Investigation by firm
Recalling firm: Alcon Research LLCType: General Surgery TrayDistribution: Worldwide - 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, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV. The countries of Albania, Argentina, Australia, Austria, Bahamas, Bahrain, Bangladesh,
Brazil, Bulgaria, Cambodia, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Ecuador, El Salvador, Finland, France, French Polynesia, Georgia, Germany, Guadeloupe,
Guatemala, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Ireland, Israel, Italy,
Jamaica, Japan, Kazakhstan, Kenya, Korea, Kosovo, Kuwait, Latvia, Lebanon, Luxembourg,
Macao, Malaysia, Malta, Mexico, Moldova, Mongolia, Montenegro, Morocco, Netherlands,
New Zealand, Oman, Pakistan, Peru, Philippines, Poland, Qatar, Republic of North Macedonia, R¿union, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine,
United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Viet Nam.Recall #Z-2110-2025
Open, ClassifiedPosted Jul 9, 2025·Initiated May 30, 2025
Hillrom Q-Link 13 component, Product Code 3156509, used with the following Mobile Patient Lifts:
1) Uno 102 EE Mobile lift - Product Code 2010004;
2) Viking L Mobile lift - Product Code 2040044;
3) Viking XL Mobile lift - Product Code 2040043;
4) Viking M Mobile lift - Product Code 2040045A;
5) Viking S Mobile Lift - Product Code 2040006;
6) Viking XS Mobile Lift - Product Code 2040007;
7) LikoLight Mobile lift - Product Code 2030001. .
Reason: The Q-link 13 could allow for an improper attachment (false latching) of the Quick-Release Hook used on Sling Bars and other accessories. This could result in a critical injury from a patient fall as the false latched component may initially bear weight but can loosen from the Q-link resulting in a detachment and drop.
Root cause: Device Design
Recalling firm: Baxter Healthcare CorporationType: Lift, Patient, Non-Ac-PoweredDistribution: WorldwideRecall #Z-2031-2025
Open, ClassifiedPosted Jul 9, 2025·Initiated May 30, 2025
Hillrom LikoScale component, Product Code 3156232, used with the following adapter kits for patient lifts:
1) LikoScale 200 Accessory - Product Code 3156225;
2) LikoScale 350 Accessory - Product Code 3156228;
3) LikoScale 400 Accessory - Product Code 3156226.
Reason: The Q-link 13 could allow for an improper attachment (false latching) of the Quick-Release Hook used on Sling Bars and other accessories. This could result in a critical injury from a patient fall as the false latched component may initially bear weight but can loosen from the Q-link resulting in a detachment and drop.
Root cause: Device Design
Recalling firm: Baxter Healthcare CorporationType: Lift, Patient, Non-Ac-PoweredDistribution: WorldwideRecall #Z-2032-2025
Open, ClassifiedPosted Jul 9, 2025·Initiated May 19, 2025
Brand Name: Hummingbird
Product Name: Stimulated EMG Kit with Hummingbird -
Model/Catalog Number: REF I-D-BMF90, 1 Single-Use Bipolar Minifork Stimulation Probe, 90mm, and 1 Green Ground Needle ;
REF 1-D-BMF90-5, lot number 050925219, expiration 2028-11-30
I-D-BMF90-5 Stimulated EMG Kit with Hummingbird - Box of 5 Kits - Each Kit Includes: 1 Single-Use Bipolar Minifork Stimuation Probe, 90mm, and 1 Green Ground Needle
Reason: Product packaging contains the wrong part number and kit contents.
Root cause: Process control
Recalling firm: Neurovision Medical Products IncType: Stimulator, NerveDistribution: US distribution to CA onlyRecall #Z-2100-2025
Open, ClassifiedPosted Jul 9, 2025·Initiated May 27, 2025
O-arm O2 Imaging System. Mobile X-Ray System.
Reason: A mechanical component that supports the O2 gantry to the support structure in affected devices may have been damaged during manufacture.
Root cause: Under Investigation by firm
Recalling firm: Medtronic Navigation, Inc.-BoxboroughType: Interventional Fluoroscopic X-Ray SystemDistribution: US Nationwide distribution in the states of IN, MN, MS.Recall #Z-2101-2025
Open, ClassifiedPosted Jul 8, 2025·Initiated Jun 20, 2025
Infinia, Infinia Hawkeye, Infinia II, Infinia II Hawkeye 4 Nuclear Medicine system
Reason: Unintended radial detector motion may occur during patient setup or during patient scan if system does not have correct version of gantry software installed. Unintended detector motion may result in life-threatening injury.
Root cause: Software design
Recalling firm: GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGINGType: System, Tomography, Computed, EmissionDistribution: Worldwide - US Nationwide distribution.Recall #Z-2097-2025
Open, ClassifiedPosted Jul 8, 2025·Initiated Jun 20, 2025
Varicam, Millennium VG, Millennium VG Hawkeye, Discovery VH Nuclear Medicine System
Reason: Unintended radial detector motion may occur during patient setup or during patient scan if system does not have correct version of gantry software installed. Unintended detector motion may result in life-threatening injury.
Root cause: Software design
Recalling firm: GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGINGType: System, Tomography, Computed, EmissionDistribution: Worldwide - US Nationwide distribution.Recall #Z-2098-2025
Open, ClassifiedPosted Jul 8, 2025·Initiated May 2, 2025
Brand Name: Canturio Smart Extension
Product Name: CSE Implant
Model/Catalog Number: 43-5570-030-14
Product Description: Tibial stem extension for use with Zimmer Persona Personalized Knee System; 14mm diameter x 30mm height. Implantable device with integrated electronics for passive kinematic data collection. Single-use, sterile. Packaged in a sterile blister and outer shelf pack. Sold individually.
Component: Yes. The Canturio Smart Extension (CSE) is a tibial implant component intended for use with the Zimmer Persona Personalized Knee System.
Reason: Due to labeling error. Product incorrectly labeled.
Root cause: Process change control
Recalling firm: Canary Medical, Inc.Type: Implantable Post-Surgical Kinematic Measurement Knee DeviceDistribution: US Distribution to IN only.Recall #Z-2099-2025
CompletedPosted Jul 7, 2025·Initiated Jan 19, 2024
TrueDent Clear, TDM 100, Model No. OBJ-09164
Light-curable methacrylate-based resin that enables fabrication of dental appliances
Reason: Customers unable to use cartridges due to formatting error in expiration date which leads to switching the day with the month. Or, the system will not recognize that a resin is expired and will not prevent the user from using an expired material.
Root cause: Software design
Recalling firm: STRATASYS LTDType: Resin, Denture, Relining, Repairing, RebasingDistribution: US Nationwide distribution including in the states of Arizona, Arkansas, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Maryland, Massachusetts,
Michigan, Nebraska, New York, North Carolina, North Dakota, Oklahoma, Oregon, Utah,
Wisconsin.Recall #Z-2090-2025
CompletedPosted Jul 7, 2025·Initiated Jan 19, 2024
TrueDent Cyan, TDM 120, Model No. OBJ-09165
Light-curable methacrylate-based resin that enables fabrication of dental appliances
Reason: Customers unable to use cartridges due to formatting error in expiration date which leads to switching the day with the month. Or, the system will not recognize that a resin is expired and will not prevent the user from using an expired material.
Root cause: Software design
Recalling firm: STRATASYS LTDType: Resin, Denture, Relining, Repairing, RebasingDistribution: US Nationwide distribution including in the states of Arizona, Arkansas, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Maryland, Massachusetts,
Michigan, Nebraska, New York, North Carolina, North Dakota, Oklahoma, Oregon, Utah,
Wisconsin.Recall #Z-2091-2025
CompletedPosted Jul 7, 2025·Initiated Jan 19, 2024
TrueDent Magenta, TDM130, Model No. OBJ-09166
Light-curable methacrylate-based resin that enables fabrication of dental appliances
Reason: Customers unable to use cartridges due to formatting error in expiration date which leads to switching the day with the month. Or, the system will not recognize that a resin is expired and will not prevent the user from using an expired material.
Root cause: Software design
Recalling firm: STRATASYS LTDType: Resin, Denture, Relining, Repairing, RebasingDistribution: US Nationwide distribution including in the states of Arizona, Arkansas, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Maryland, Massachusetts,
Michigan, Nebraska, New York, North Carolina, North Dakota, Oklahoma, Oregon, Utah,
Wisconsin.Recall #Z-2092-2025
CompletedPosted Jul 7, 2025·Initiated Jan 19, 2024
TrueDent Yellow, TDM140, Model No. OBJ-09169
Light-curable methacrylate-based resin that enables fabrication of dental appliances
Reason: Customers unable to use cartridges due to formatting error in expiration date which leads to switching the day with the month. Or, the system will not recognize that a resin is expired and will not prevent the user from using an expired material.
Root cause: Software design
Recalling firm: STRATASYS LTDType: Resin, Denture, Relining, Repairing, RebasingDistribution: US Nationwide distribution including in the states of Arizona, Arkansas, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Maryland, Massachusetts,
Michigan, Nebraska, New York, North Carolina, North Dakota, Oklahoma, Oregon, Utah,
Wisconsin.Recall #Z-2093-2025
CompletedPosted Jul 7, 2025·Initiated Jan 19, 2024
TrueDent White, TDM110, Model No. OBJ-09168
Light-curable methacrylate-based resin that enables fabrication of dental appliances
Reason: Customers unable to use cartridges due to formatting error in expiration date which leads to switching the day with the month. Or, the system will not recognize that a resin is expired and will not prevent the user from using an expired material.
Root cause: Software design
Recalling firm: STRATASYS LTDType: Resin, Denture, Relining, Repairing, RebasingDistribution: US Nationwide distribution including in the states of Arizona, Arkansas, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Maryland, Massachusetts,
Michigan, Nebraska, New York, North Carolina, North Dakota, Oklahoma, Oregon, Utah,
Wisconsin.Recall #Z-2094-2025
Open, ClassifiedPosted Jul 3, 2025·Initiated Jun 3, 2025
BD Heyman Follower Straight Tip for following sizes:
10Fr - REF:21110,
12Fr - REF:21112,
14Fr - REF: 21114,
20Fr - REF: 21120
Reason: Cather packaging may contain the incorrect French size.
Root cause: Under Investigation by firm
Recalling firm: C.R. Bard IncType: Catheter, UrologicalDistribution: Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, FL, GA, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WI, WV and the country of Canada.Recall #Z-2074-2025
Open, ClassifiedPosted Jul 3, 2025·Initiated Jun 3, 2025
BD Heyman Follower Coude Tip for following sizes:
12Fr - REF:021312
14Fr - REF:021314,
16Fr - REF: 021316
Reason: Cather packaging may contain the incorrect French size.
Root cause: Under Investigation by firm
Recalling firm: C.R. Bard IncType: Catheter, UrologicalDistribution: Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, FL, GA, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WI, WV and the country of Canada.Recall #Z-2075-2025
Open, ClassifiedPosted Jul 3, 2025·Initiated Jun 3, 2025
REF: 123400,Bard Urologist's Tray, For the Obstructed Urethra
Reason: Cather packaging may contain the incorrect French size.
Root cause: Under Investigation by firm
Recalling firm: C.R. Bard IncType: Catheter, CoudeDistribution: Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, FL, GA, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WI, WV and the country of Canada.Recall #Z-2076-2025
Open, ClassifiedPosted Jul 3, 2025·Initiated May 20, 2025
ColoSense Test Kit, Part No. 80-001, component of ColoSense test
Reason: Multiple plate failures documented as a result of the Low Positive Template Control being too high and out of range using the affected lot of ColoSense Test Kit.
Root cause: Unknown/Undetermined by firm
Recalling firm: Geneoscopy, Inc.Type: System, Colorectal Neoplasia, Rna Markers And Hemoglobin DetectionDistribution: US Nationwide distribution in the state of Missouri.Recall #Z-2077-2025