Open, ClassifiedPosted Aug 3, 2026·Initiated Jun 25, 2025
Brand Name: DASH Rapid PCR Instrument
Product Name: DASH Rapid PCR Instrument
Model/Catalog Number: SG-0002
Software Version: 6.0.2
Product Description: The DASH Rapid PCR Instrument (DASH Instrument) is an automated, fluorescence-based, reverse-transcription polymerase chain reaction (RT-PCR) instrument that extracts specimens and performs nucleic acid amplified tests (NAAT) in DASH test cartridges for the qualitative detection of infectious diseases. The DASH Instrument is intended for use in conjunction with DASH Rapid PCR System tests to aid in the diagnosis of infectious diseases.
Component: No.
Reason: Due to a software issue which may result in false co-infection (e.g., Positive for Flu A, when SARS-CoV-2 is present).
Root cause: Process control
Recalling firm: Nuclein LLCType: Instrumentation For Clinical Multiplex Test SystemsDistribution: US Nationwide distribution in the state of Texas.Recall #Z-2861-2026
Open, ClassifiedPosted Aug 3, 2026·Initiated Jun 8, 2026
STRYKER AHTO TUBE SET PACKAGING, Catalog Number 0250070600
Reason: There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use.
Root cause: Under Investigation by firm
Recalling firm: Stryker CorporationType: Apparatus, Suction, Operating-Room, Wall Vacuum PoweredDistribution: Worldwide distribution - US Nationwide and the countries of Australia, Brazil, Canada, Chile, France, Germany, Indonesia, Italy, Mexico, Netherlands, New Zealand, Philippines, South Korea, Spain, Sweden, Switzerland, Taiwan, United Kingdom.Recall #Z-2862-2026
Open, ClassifiedPosted Aug 3, 2026·Initiated Jun 8, 2026
STRYKER AHTO TUBE SET WITH TIP PACKAGING, Catalog Number 0250070620
Reason: There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use.
Root cause: Under Investigation by firm
Recalling firm: Stryker CorporationType: Apparatus, Suction, Operating-Room, Wall Vacuum PoweredDistribution: Worldwide distribution - US Nationwide and the countries of Australia, Brazil, Canada, Chile, France, Germany, Indonesia, Italy, Mexico, Netherlands, New Zealand, Philippines, South Korea, Spain, Sweden, Switzerland, Taiwan, United Kingdom.Recall #Z-2863-2026
Open, ClassifiedPosted Aug 3, 2026·Initiated Jun 8, 2026
STRYKER AHTO DUAL SPIKE TUBE SET PACKAGING, Catalog Number 0250070640
Reason: There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use.
Root cause: Under Investigation by firm
Recalling firm: Stryker CorporationType: Apparatus, Suction, Operating-Room, Wall Vacuum PoweredDistribution: Worldwide distribution - US Nationwide and the countries of Australia, Brazil, Canada, Chile, France, Germany, Indonesia, Italy, Mexico, Netherlands, New Zealand, Philippines, South Korea, Spain, Sweden, Switzerland, Taiwan, United Kingdom.Recall #Z-2864-2026
Open, ClassifiedPosted Aug 3, 2026·Initiated Jun 8, 2026
STRYKER PKG., SINGLE SPIKE TUBE SET, Catalog Number 0250070530
Reason: There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use.
Root cause: Under Investigation by firm
Recalling firm: Stryker CorporationType: Electrosurgical, Cutting & Coagulation & AccessoriesDistribution: Worldwide distribution - US Nationwide and the countries of Australia, Brazil, Canada, Chile, France, Germany, Indonesia, Italy, Mexico, Netherlands, New Zealand, Philippines, South Korea, Spain, Sweden, Switzerland, Taiwan, United Kingdom.Recall #Z-2865-2026
Open, ClassifiedPosted Aug 3, 2026·Initiated Jun 8, 2026
STRYKER PKG., STRYKEFLOW SUCTION/IRRIGATOR PS, Catalog Number 0250070540
Reason: There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use.
Root cause: Under Investigation by firm
Recalling firm: Stryker CorporationType: Electrosurgical, Cutting & Coagulation & AccessoriesDistribution: Worldwide distribution - US Nationwide and the countries of Australia, Brazil, Canada, Chile, France, Germany, Indonesia, Italy, Mexico, Netherlands, New Zealand, Philippines, South Korea, Spain, Sweden, Switzerland, Taiwan, United Kingdom.Recall #Z-2866-2026
Open, ClassifiedPosted Aug 3, 2026·Initiated Jul 1, 2026
Intramedullary Bone Saw Blade Assembly
Model/Catalog Number: 475620
Product Description: Intramedullary Bone Saw Blade Assembly 12mm
Reason: Zimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedullary Bone Saw Blade Assembly due to potential sterile barrier packaging damage caused by an exposed saw blade.
Root cause: Under Investigation by firm
Recalling firm: Biomet, Inc.Type: Orthopedic Manual Surgical InstrumentDistribution: Refer to the attached ZFA 2026-00096_Initial Consignee List and ZFA 2026-00096_Initial Distribution History containing the distribution and the identification of the affected consignees.Recall #Z-2867-2026
Open, ClassifiedPosted Aug 3, 2026·Initiated Jul 1, 2026
Intramedullary Bone Saw Blade Assembly
Model/Catalog Number: 475625
Product Description: Intramedullary Bone Saw Blade Assembly 13mm
Reason: Zimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedullary Bone Saw Blade Assembly due to potential sterile barrier packaging damage caused by an exposed saw blade.
Root cause: Under Investigation by firm
Recalling firm: Biomet, Inc.Type: Orthopedic Manual Surgical InstrumentDistribution: Refer to the attached ZFA 2026-00096_Initial Consignee List and ZFA 2026-00096_Initial Distribution History containing the distribution and the identification of the affected consignees.Recall #Z-2868-2026
Open, ClassifiedPosted Aug 3, 2026·Initiated Jul 1, 2026
Intramedullary Bone Saw Blade Assembly
Model/Catalog Number: 475630
Product Description: Intramedullary Bone Saw Blade Assembly 14mm
Reason: Zimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedullary Bone Saw Blade Assembly due to potential sterile barrier packaging damage caused by an exposed saw blade.
Root cause: Under Investigation by firm
Recalling firm: Biomet, Inc.Type: Orthopedic Manual Surgical InstrumentDistribution: Refer to the attached ZFA 2026-00096_Initial Consignee List and ZFA 2026-00096_Initial Distribution History containing the distribution and the identification of the affected consignees.Recall #Z-2869-2026
Open, ClassifiedPosted Aug 3, 2026·Initiated Jul 1, 2026
Intramedullary Bone Saw Blade Assembly
Model/Catalog Number: 475635
Product Description: Intramedullary Bone Saw Blade Assembly 15mm
Reason: Zimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedullary Bone Saw Blade Assembly due to potential sterile barrier packaging damage caused by an exposed saw blade.
Root cause: Under Investigation by firm
Recalling firm: Biomet, Inc.Type: Orthopedic Manual Surgical InstrumentDistribution: Refer to the attached ZFA 2026-00096_Initial Consignee List and ZFA 2026-00096_Initial Distribution History containing the distribution and the identification of the affected consignees.Recall #Z-2870-2026
Open, ClassifiedPosted Aug 3, 2026·Initiated Jul 1, 2026
Intramedullary Bone Saw Blade Assembly
Model/Catalog Number: 475640
Product Description: Intramedullary Bone Saw Blade Assembly 16mm
Reason: Zimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedullary Bone Saw Blade Assembly due to potential sterile barrier packaging damage caused by an exposed saw blade.
Root cause: Under Investigation by firm
Recalling firm: Biomet, Inc.Type: Orthopedic Manual Surgical InstrumentDistribution: Refer to the attached ZFA 2026-00096_Initial Consignee List and ZFA 2026-00096_Initial Distribution History containing the distribution and the identification of the affected consignees.Recall #Z-2871-2026
Open, ClassifiedPosted Jul 31, 2026·Initiated Apr 30, 2026
Halyard convenience kits containing recalled Medline Namic Angiographic Star Off Handle Manifolds.
CARDIAC CATH PACK EAMC1000-05
Reason: Affected kits contain Medline Namic Angiographic Star Off Handle Manifolds, which were recalled by the manufacturer due to presence of particulates within fluid path of the Manifolds. Particulate within the fluid path has the potential to be introduced into blood circulation and become lodged within blood vessels.
Root cause: Under Investigation by firm
Recalling firm: AVID Medical, Inc.Type: Cardiac Catheterization KitDistribution: US Nationwide distribution in the states of NC and TX.Recall #Z-2796-2026
Open, ClassifiedPosted Jul 31, 2026·Initiated Apr 30, 2026
Halyard convenience kits containing recalled Medline Namic Angiographic Star Off Handle Manifolds.
SAMMC ANGIOGRAPHY
SAMM066-15
Reason: Affected kits contain Medline Namic Angiographic Star Off Handle Manifolds, which were recalled by the manufacturer due to presence of particulates within fluid path of the Manifolds. Particulate within the fluid path has the potential to be introduced into blood circulation and become lodged within blood vessels.
Root cause: Under Investigation by firm
Recalling firm: AVID Medical, Inc.Type: Cardiac Catheterization KitDistribution: US Nationwide distribution in the states of NC and TX.Recall #Z-2797-2026
Open, ClassifiedPosted Jul 31, 2026·Initiated Apr 30, 2026
Halyard convenience kits containing recalled Medline Namic Angiographic Star Off Handle Manifolds.
HEART CATH, SELF REGIONAL
SELF131-05
Reason: Affected kits contain Medline Namic Angiographic Star Off Handle Manifolds, which were recalled by the manufacturer due to presence of particulates within fluid path of the Manifolds. Particulate within the fluid path has the potential to be introduced into blood circulation and become lodged within blood vessels.
Root cause: Under Investigation by firm
Recalling firm: AVID Medical, Inc.Type: Cardiovascular Procedure KitDistribution: US Nationwide distribution in the states of NC and TX.Recall #Z-2798-2026
Open, ClassifiedPosted Jul 31, 2026·Initiated Apr 29, 2026
REMISOL Advance with Software Version 2.5
UDI-DI code: 15099590802073
The Normand Info REMISOL Advance Data Manager collects and manages data and workflow for 128 connections
Reason: Due to software issues where does not handle combo assay results. The software may replace the final combo test result with one of the sub-results resulting in incorrect reporting of test outcomes.
Root cause: Under Investigation by firm
Recalling firm: Beckman Coulter Biomedical GmbHType: Calculator/Data Processing Module, For Clinical UseDistribution: U.S.: FL, GA, IL, MI, and PA
O.U.S.: Belgium, France, Hungary, Poland, Taiwan (Province of China), Tunisia, United Arab Emirates, and United Kingdom of Great Britain and Northern Ireland.Recall #Z-2834-2026
Open, ClassifiedPosted Jul 31, 2026·Initiated Jun 23, 2026
Charger for the Therabody Theragun, G4 PRO massage device, and products which include the 4th Generation Theragun PRO charger.
G4 PRO Black US - Refurb., SKU TG02428-01
G4 PRO NA, SKU G4-PRO-PKG-NA
G4-PRO-PKG-US, SKU G4 PRO US
G4 PRO Black US - Refurb V, SKU TG0002428-1V10
Pro Charger Single Unit, SKU PRO-CHARGER-SINGLE
Reason: Charging cradle for the device may overheat while charging the device's removable battery pack, presenting risk of thermal event (fire). Firm has received reports alleging the product caught fire and other reports regarding visible smoke, melting, charger burn, burning odor, and overheating.
Root cause: Under Investigation by firm
Recalling firm: Therabody, IncType: Massager, Therapeutic, ElectricDistribution: Worldwide - US Nationwide distribution.Recall #Z-2835-2026
Open, ClassifiedPosted Jul 31, 2026·Initiated Jul 7, 2026
FORWARD Oral Airway Kit (OPA Sizes 5, 6.5, 7, 8, 9, 10, 12). REF Number: 1011-40002.
Containing the affected One-piece Guedel airway components:
1. Size 00, ISO 5.0, blue. Product Code: 1100050.
2. Size 000, ISO 3.5, light green. Product Code: 1000035.
Reason: Devices could potentially contain an occluded or partially occluded Guedel Airway tip.
Root cause: Component design/selection
Recalling firm: INTEGRATED MEDCRAFT LLCType: Airway, Oropharyngeal, AnesthesiologyDistribution: US Nationwide distribution.Recall #Z-2836-2026
Open, ClassifiedPosted Jul 31, 2026·Initiated Jul 7, 2026
Kingfisher Compact Individual First Aid Kit. REF Number: 76656.
Containing the affected One-piece Guedel airway components:
1. Size 00, ISO 5.0, blue. Product Code: 1100050.
2. Size 000, ISO 3.5, light green. Product Code: 1000035.
Reason: Devices could potentially contain an occluded or partially occluded Guedel Airway tip.
Root cause: Component design/selection
Recalling firm: INTEGRATED MEDCRAFT LLCType: First Aid Kit Without DrugDistribution: US Nationwide distribution.Recall #Z-2837-2026
Open, ClassifiedPosted Jul 31, 2026·Initiated Jun 30, 2026
Radial Jaw 4 Standard Capacity Biopsy Forceps with the following descriptions and UPN:
1. Radial Jaw 4 SC 240cm Box 20; Outer Box UPN: M00513401; Inner Box UPN: M00513400.
2. Radial Jaw 4 SC 240cm Box 40; Outer Box UPN: M00513402; Inner Box UPN: M00513400.
3. Radial Jaw 4 SC w/ Needle 240cm Box 20; Outer Box UPN: M00513411; Inner Box UPN: M00513410.
Reason: Potential for breach in sterile barrier of device packaging.
Root cause: Process control
Recalling firm: Boston Scientific CorporationType: Forceps, Biopsy, Non-ElectricDistribution: US Nationwide distribution including in the states of AL, AZ, CA, CO, FL, GA, IA, ID, IL, IN,
KY, MA, MD, ME, MN, MO, MS, MT, NC, NJ, NM, NY, OH, PA, PR, SC, TN, TX, UT, VA, VT, WA, WI and International distribution pending.Recall #Z-2838-2026 Open, ClassifiedPosted Jul 31, 2026·Initiated Jun 30, 2026
Radial Jaw 4 Large Capacity Biopsy Forceps with the following descriptions and UPN:
1. Radial Jaw 4 LC 240cm Box 20; Outer Box UPN: M00513321; Inner Box UPN: M00513320.
2. Radial Jaw 4 LC 240cm Box 40; Outer Box UPN: M00513322; Inner Box UPN: M00513320.
3. Radial Jaw 4 LC w/Needle 240cm Box 20; Outer Box UPN: M00513331; Inner Box UPN: M00513330.
4. Radial Jaw 4 LC w/Needle 240cm Box 40; Outer Box UPN: M00513332; Inner Box UPN: M00513330.
5. Radial Jaw 4 LC w/Needle 240cm Box 5; Outer Box UPN: M00513333; Inner Box UPN: M00513330.
Reason: Potential for breach in sterile barrier of device packaging.
Root cause: Process control
Recalling firm: Boston Scientific CorporationType: Forceps, Biopsy, Non-ElectricDistribution: US Nationwide distribution including in the states of AL, AZ, CA, CO, FL, GA, IA, ID, IL, IN,
KY, MA, MD, ME, MN, MO, MS, MT, NC, NJ, NM, NY, OH, PA, PR, SC, TN, TX, UT, VA, VT, WA, WI and International distribution pending.Recall #Z-2839-2026