Medical device recalls — page 8
1,617 recent medical device recalls in our current data.
Showing 1,401–1,600, newest first.
FDA Class I · Medical device · May 13, 2026
Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
Company / brand: AVID Medical recalls
Affected product: Halyard CATH LAB kit recall status
Official ID Z-1974-2026 ·
Official record ↗
FDA Class I · Medical device · May 13, 2026
Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
Company / brand: AVID Medical recalls
Affected product: Halyard CATH LAB kit recall status
Official ID Z-1973-2026 ·
Official record ↗
FDA Class I · Medical device · May 13, 2026
Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
Company / brand: AVID Medical recalls
Affected product: Halyard CARDIAC CATH TRAY SHANDS JAX kit recall status
Official ID Z-1972-2026 ·
Official record ↗
FDA Class I · Medical device · May 13, 2026
Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
Company / brand: AVID Medical recalls
Affected product: Halyard CARDIAC CATH PACK SAN23CARDQ kit recall status
Official ID Z-1971-2026 ·
Official record ↗
FDA Class I · Medical device · May 13, 2026
Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
Company / brand: AVID Medical recalls
Affected product: Halyard CARDIAC CATH PACK kit recall status
Official ID Z-1970-2026 ·
Official record ↗
FDA Class I · Medical device · May 13, 2026
Respiratory system intended to provide continuous/intermittent ventilator support, may not have been evaluated under all intended high-pressure conditions during production testing…
Company / brand: Ventec Life Systems recalls
Affected product: VOCSN V+Pro package recall status
Official ID Z-1942-2026 ·
Official record ↗
FDA Class I · Medical device · May 13, 2026
Marker bands may be at an increased risk of cracking/breakage. Potential adverse events that may result include increased procedural time, harms associated with device fragmentatio…
Company / brand: Cook Incorporated recalls
Affected product: Beacon Tip Centimeter Sizing Catheter RPN/GPN NR5 recall status
Official ID Z-1936-2026 ·
Official record ↗
FDA Class I · Medical device · May 13, 2026
Marker bands may be at an increased risk of cracking/breakage. Potential adverse events that may result include increased procedural time, harms associated with device fragmentatio…
Company / brand: Cook Incorporated recalls
Affected product: Aurous Centimeter Sizing Catheter RPN N5 recall status
Official ID Z-1935-2026 ·
Official record ↗
FDA Class I · Medical device · May 13, 2026
Marker bands may be at an increased risk of cracking/breakage. Potential adverse events that may result include increased procedural time, harms associated with device fragmentatio…
Company / brand: Cook Incorporated recalls
Affected product: Centimeter Sizing Catheter RPN N5 recall status
Official ID Z-1934-2026 ·
Official record ↗
FDA Class I · Medical device · May 13, 2026
Reloads for curved-tipped stapler may potentially produce an incomplete staple line.
Company / brand: Intuitive Surgical recalls
Affected product: Intuitive 8 mm SureForm 30 Gray Reloads Reference Numbers recall status
Official ID Z-1855-2026 ·
Official record ↗
FDA Class II · Medical device · May 6, 2026
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Cardinal Health Webcol Large Alcohol Prep Pads. Cardinal Health has deemed Web…
Company / brand: Medline Industries recalls
Affected product: Medline and Centurion medical convenience kits recall status
Official ID Z-2045-2026 ·
Official record ↗
FDA Class II · Medical device · May 6, 2026
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Cardinal Health Webcol Large Alcohol Prep Pads. Cardinal Health has deemed Web…
Company / brand: Medline Industries recalls
Affected product: Centurion medical convenience kits recall status
Official ID Z-2044-2026 ·
Official record ↗
FDA Class II · Medical device · May 6, 2026
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Cardinal Health Webcol Large Alcohol Prep Pads. Cardinal Health has deemed Web…
Company / brand: Medline Industries recalls
Affected product: Medline or Centurion medical convenience kits recall status
Official ID Z-2043-2026 ·
Official record ↗
FDA Class II · Medical device · May 6, 2026
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Cardinal Health Webcol Large Alcohol Prep Pads. Cardinal Health has deemed Web…
Company / brand: Medline Industries recalls
Affected product: Centurion medical convenience kits recall status
Official ID Z-2042-2026 ·
Official record ↗
FDA Class II · Medical device · May 6, 2026
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Cardinal Health Webcol Large Alcohol Prep Pads. Cardinal Health has deemed Web…
Company / brand: Medline Industries recalls
Affected product: Medline and Centurion medical convenience kits recall status
Official ID Z-2041-2026 ·
Official record ↗
FDA Class II · Medical device · May 6, 2026
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Cardinal Health Webcol Large Alcohol Prep Pads. Cardinal Health has deemed Web…
Company / brand: Medline Industries recalls
Affected product: Medline medical convenience kits recall status
Official ID Z-2040-2026 ·
Official record ↗
FDA Class II · Medical device · May 6, 2026
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Cardinal Health Webcol Large Alcohol Prep Pads. Cardinal Health has deemed Web…
Company / brand: Medline Industries recalls
Affected product: Centurion medical convenience kits recall status
Official ID Z-2039-2026 ·
Official record ↗
FDA Class II · Medical device · May 6, 2026
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-o…
Company / brand: Medline Industries recalls
Affected product: Medline medical procedure kits recall status
Official ID Z-2038-2026 ·
Official record ↗
FDA Class II · Medical device · May 6, 2026
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-o…
Company / brand: Medline Industries recalls
Affected product: Medline medical procedure kits recall status
Official ID Z-2037-2026 ·
Official record ↗
FDA Class II · Medical device · May 6, 2026
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-o…
Company / brand: Medline Industries recalls
Affected product: Medline medical procedure kits recall status
Official ID Z-2036-2026 ·
Official record ↗
FDA Class II · Medical device · May 6, 2026
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-o…
Company / brand: Medline Industries recalls
Affected product: Medline medical procedure kits recall status
Official ID Z-2035-2026 ·
Official record ↗
FDA Class II · Medical device · May 6, 2026
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-o…
Company / brand: Medline Industries recalls
Affected product: Medline medical procedure kits recall status
Official ID Z-2034-2026 ·
Official record ↗
FDA Class II · Medical device · May 6, 2026
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-o…
Company / brand: Medline Industries recalls
Affected product: Medline medical procedure kits recall status
Official ID Z-2033-2026 ·
Official record ↗
FDA Class II · Medical device · May 6, 2026
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-o…
Company / brand: Medline Industries recalls
Affected product: Medline medical procedure kits recall status
Official ID Z-2032-2026 ·
Official record ↗
FDA Class II · Medical device · May 6, 2026
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-o…
Company / brand: Medline Industries recalls
Affected product: Medline medical procedure kits recall status
Official ID Z-2031-2026 ·
Official record ↗
FDA Class II · Medical device · May 6, 2026
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-o…
Company / brand: Medline Industries recalls
Affected product: Medline medical procedure kits recall status
Official ID Z-2030-2026 ·
Official record ↗
FDA Class II · Medical device · May 6, 2026
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-o…
Company / brand: Medline Industries recalls
Affected product: Medline medical procedure kits recall status
Official ID Z-2029-2026 ·
Official record ↗
FDA Class II · Medical device · May 6, 2026
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-o…
Company / brand: Medline Industries recalls
Affected product: Centurion medical procedure kits recall status
Official ID Z-2028-2026 ·
Official record ↗
FDA Class II · Medical device · May 6, 2026
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-o…
Company / brand: Medline Industries recalls
Affected product: Medline medical procedure kits recall status
Official ID Z-2027-2026 ·
Official record ↗
FDA Class II · Medical device · May 6, 2026
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-o…
Company / brand: Medline Industries recalls
Affected product: Medline medical procedure kits recall status
Official ID Z-2026-2026 ·
Official record ↗
FDA Class II · Medical device · May 6, 2026
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-o…
Company / brand: Medline Industries recalls
Affected product: Medline medical procedure kits recall status
Official ID Z-2025-2026 ·
Official record ↗
FDA Class II · Medical device · May 6, 2026
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-o…
Company / brand: Medline Industries recalls
Affected product: Medline medical procedure kits recall status
Official ID Z-2024-2026 ·
Official record ↗
FDA Class II · Medical device · May 6, 2026
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-o…
Company / brand: Medline Industries recalls
Affected product: Medline medical procedure kits recall status
Official ID Z-2023-2026 ·
Official record ↗
FDA Class II · Medical device · May 6, 2026
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-o…
Company / brand: Medline Industries recalls
Affected product: Medline medical procedure kits recall status
Official ID Z-2022-2026 ·
Official record ↗
FDA Class II · Medical device · May 6, 2026
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-o…
Company / brand: Medline Industries recalls
Affected product: Medline and Centurion medical procedure kits recall status
Official ID Z-2021-2026 ·
Official record ↗
FDA Class II · Medical device · May 6, 2026
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-o…
Company / brand: Medline Industries recalls
Affected product: Medline medical procedure kits recall status
Official ID Z-2020-2026 ·
Official record ↗
FDA Class II · Medical device · May 6, 2026
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-o…
Company / brand: Medline Industries recalls
Affected product: Medline medical procedure kits recall status
Official ID Z-2019-2026 ·
Official record ↗
FDA Class II · Medical device · May 6, 2026
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-o…
Company / brand: Medline Industries recalls
Affected product: Medline medical procedure kits recall status
Official ID Z-2018-2026 ·
Official record ↗
FDA Class II · Medical device · May 6, 2026
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-o…
Company / brand: Medline Industries recalls
Affected product: Medline medical procedure kits recall status
Official ID Z-2017-2026 ·
Official record ↗
FDA Class II · Medical device · May 6, 2026
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-o…
Company / brand: Medline Industries recalls
Affected product: Medline medical procedure kits recall status
Official ID Z-2016-2026 ·
Official record ↗
FDA Class II · Medical device · May 6, 2026
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-o…
Company / brand: Medline Industries recalls
Affected product: Medline medical procedure kits recall status
Official ID Z-2015-2026 ·
Official record ↗
FDA Class II · Medical device · May 6, 2026
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-o…
Company / brand: Medline Industries recalls
Affected product: Medline medical procedure kits recall status
Official ID Z-2014-2026 ·
Official record ↗
FDA Class II · Medical device · May 6, 2026
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-o…
Company / brand: Medline Industries recalls
Affected product: Medline medical procedure kits recall status
Official ID Z-2013-2026 ·
Official record ↗
FDA Class II · Medical device · May 6, 2026
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-o…
Company / brand: Medline Industries recalls
Affected product: Medline medical procedure kits recall status
Official ID Z-2012-2026 ·
Official record ↗
FDA Class II · Medical device · May 6, 2026
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-o…
Company / brand: Medline Industries recalls
Affected product: Medline medical procedure kits recall status
Official ID Z-2011-2026 ·
Official record ↗
FDA Class II · Medical device · May 6, 2026
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-o…
Company / brand: Medline Industries recalls
Affected product: Medline medical procedure kits recall status
Official ID Z-2010-2026 ·
Official record ↗
FDA Class II · Medical device · May 6, 2026
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-o…
Company / brand: Medline Industries recalls
Affected product: Medline medical procedure kits recall status
Official ID Z-2009-2026 ·
Official record ↗
FDA Class II · Medical device · May 6, 2026
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-o…
Company / brand: Medline Industries recalls
Affected product: Medline Neuro Sponges recall status
Official ID Z-2008-2026 ·
Official record ↗
FDA Class II · Medical device · May 6, 2026
Locking mechanisms may not properly secure to the Arc system, resulting in shifting of coordinates during procedures.
Company / brand: Elekta recalls
Affected product: Brand Name recall status
Official ID Z-2006-2026 ·
Official record ↗
FDA Class II · Medical device · May 6, 2026
Use of the affected product can result in discrepant low pH and measured Total Carbon Dioxide (mTCO2) results and corresponding calculated values in arterial, venous, and capillary…
Company / brand: Siemens Healthcare Diagnostics recalls
Affected product: epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System recall status
Official ID Z-2005-2026 ·
Official record ↗
FDA Class II · Medical device · May 6, 2026
catheter may experience resistance when being advanced over the guidewire
Company / brand: Merit Medical Systems recalls
Affected product: Philips Bridge Prep Kit REF recall status
Official ID Z-2004-2026 ·
Official record ↗
FDA Class II · Medical device · May 6, 2026
catheter may experience resistance when being advanced over the guidewire
Company / brand: Merit Medical Systems recalls
Affected product: Philips Bridge Prep Kit REF recall status
Official ID Z-2003-2026 ·
Official record ↗
FDA Class II · Medical device · May 6, 2026
catheter may experience resistance when being advanced over the guidewire
Company / brand: Merit Medical Systems recalls
Affected product: Philips Bridge Prep Kit REF recall status
Official ID Z-2002-2026 ·
Official record ↗
FDA Class II · Medical device · May 6, 2026
Approximately 7.6% of cartridges from specific i-STAT EG7+ (list number 03P76-25), i-STAT EG6+ (list number 03P77-25) and i-STAT G3+ (list number 03P78-26) cartridge lots in the U.…
Company / brand: Abbott Point Of Care recalls
Affected product: i-STAT G3+ cartridge recall status
Official ID Z-2001-2026 ·
Official record ↗
FDA Class II · Medical device · May 6, 2026
Approximately 7.6% of cartridges from specific i-STAT EG7+ (list number 03P76-25), i-STAT EG6+ (list number 03P77-25) and i-STAT G3+ (list number 03P78-26) cartridge lots in the U.…
Company / brand: Abbott Point Of Care recalls
Affected product: i-STAT EG6+ cartridge recall status
Official ID Z-2000-2026 ·
Official record ↗
FDA Class II · Medical device · May 6, 2026
Approximately 7.6% of cartridges from specific i-STAT EG7+ (list number 03P76-25), i-STAT EG6+ (list number 03P77-25) and i-STAT G3+ (list number 03P78-26) cartridge lots in the U.…
Company / brand: Abbott Point Of Care recalls
Affected product: i-STAT EG7+ cartridge recall status
Official ID Z-1999-2026 ·
Official record ↗
FDA Class III · Medical device · May 6, 2026
Based on long-term stability testing, it was determined that in units older than 1.5 years (17 months) the mixing rod may, in rare cases, come loose from its lock during the mixing…
Company / brand: Heraeus Medical (Dental Division) recalls
Affected product: Heraeus recall status
Official ID Z-1998-2026 ·
Official record ↗
FDA Class III · Medical device · May 6, 2026
Based on long-term stability testing, it was determined that in units older than 1.5 years (17 months) the mixing rod may, in rare cases, come loose from its lock during the mixing…
Company / brand: Heraeus Medical (Dental Division) recalls
Affected product: Heraeus recall status
Official ID Z-1997-2026 ·
Official record ↗
FDA Class II · Medical device · May 6, 2026
insulin pump software versions 1.4.2, and 1.4.3 issue with Dexcom Continuous Glucose Monitoring (CGM) G7 sensor may result in delayed CGM reading then switch to non-CGM dosing, lea…
Company / brand: Beta Bionics recalls
Affected product: iLet Bionic Pancreas recall status
Official ID Z-1996-2026 ·
Official record ↗
FDA Class II · Medical device · May 6, 2026
Includes an incorrect screw seat interface.
Company / brand: Straumann USA recalls
Affected product: Straumann n!ce Zr recall status
Official ID Z-1995-2026 ·
Official record ↗
FDA Class II · Medical device · May 6, 2026
Includes an incorrect screw seat interface.
Company / brand: Straumann USA recalls
Affected product: Straumann n!ce PMMA Full-arch Restoration recall status
Official ID Z-1994-2026 ·
Official record ↗
FDA Class II · Medical device · May 6, 2026
The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.
Company / brand: DEPUY (IRELAND) recalls
Affected product: Depuy Synthes recall status
Official ID Z-1993-2026 ·
Official record ↗
FDA Class II · Medical device · May 6, 2026
The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.
Company / brand: DEPUY (IRELAND) recalls
Affected product: Depuy Synthes recall status
Official ID Z-1992-2026 ·
Official record ↗
FDA Class II · Medical device · May 6, 2026
The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.
Company / brand: DEPUY (IRELAND) recalls
Affected product: Depuy Synthes recall status
Official ID Z-1991-2026 ·
Official record ↗
FDA Class II · Medical device · May 6, 2026
The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.
Company / brand: DEPUY (IRELAND) recalls
Affected product: Depuy Synthes recall status
Official ID Z-1990-2026 ·
Official record ↗
FDA Class II · Medical device · May 6, 2026
The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.
Company / brand: DEPUY (IRELAND) recalls
Affected product: Depuy Synthes recall status
Official ID Z-1989-2026 ·
Official record ↗
FDA Class II · Medical device · May 6, 2026
The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.
Company / brand: DEPUY (IRELAND) recalls
Affected product: Depuy Synthes recall status
Official ID Z-1988-2026 ·
Official record ↗
FDA Class II · Medical device · May 6, 2026
The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.
Company / brand: DEPUY (IRELAND) recalls
Affected product: Depuy Synthes recall status
Official ID Z-1987-2026 ·
Official record ↗
FDA Class II · Medical device · May 6, 2026
The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.
Company / brand: DEPUY (IRELAND) recalls
Affected product: Depuy Synthes recall status
Official ID Z-1986-2026 ·
Official record ↗
FDA Class II · Medical device · May 6, 2026
The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.
Company / brand: DEPUY (IRELAND) recalls
Affected product: Depuy Synthes recall status
Official ID Z-1985-2026 ·
Official record ↗
FDA Class II · Medical device · May 6, 2026
Neutralization Buffer may contain contaminants
Company / brand: Immuno-Mycologics recalls
Affected product: Immy recall status
Official ID Z-1984-2026 ·
Official record ↗
FDA Class II · Medical device · May 6, 2026
BD identified an issue affecting certain lots of BD GasPak EZ CO2 and BD GasPak EZ Campy Gas Generating Pouch Systems, where gas generating sachets may produce carbon dioxide level…
Company / brand: Becton Dickinson & Co recalls
Affected product: BD GasPak EZ Campy Pouch System recall status
Official ID Z-1983-2026 ·
Official record ↗
FDA Class II · Medical device · May 6, 2026
BD identified an issue affecting certain lots of BD GasPak EZ CO2 and BD GasPak EZ Campy Gas Generating Pouch Systems, where gas generating sachets may produce carbon dioxide level…
Company / brand: Becton Dickinson & Co recalls
Affected product: BD GasPak EZ CO2 Pouch System recall status
Official ID Z-1982-2026 ·
Official record ↗
FDA Class II · Medical device · May 6, 2026
Siemens Healthcare Diagnostics is recalling certain lots of Dimension Creatinine Flex reagent cartridge (Dimension CRE2) because a potential imprecision in the Dimension CRE2 quali…
Company / brand: Siemens Healthcare Diagnostics recalls
Affected product: Dimension Creatinine Flex reagent cartridge recall status
Official ID Z-1980-2026 ·
Official record ↗
FDA Class II · Medical device · May 6, 2026
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction …
Company / brand: Philips North America recalls
Affected product: Philips Upgrade to MR 7700 with MR Elastography (MRE) recall status
Official ID Z-1969-2026 ·
Official record ↗
FDA Class II · Medical device · May 6, 2026
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction …
Company / brand: Philips North America recalls
Affected product: Philips SmartPath to Ingenia Elition X with MR Elastography (MRE) recall status
Official ID Z-1968-2026 ·
Official record ↗
FDA Class II · Medical device · May 6, 2026
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction …
Company / brand: Philips North America recalls
Affected product: Philips SmartPath to dStream for XR and 3 recall status
Official ID Z-1967-2026 ·
Official record ↗
FDA Class II · Medical device · May 6, 2026
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction …
Company / brand: Philips North America recalls
Affected product: Philips SmartPath to dStream for 3 recall status
Official ID Z-1966-2026 ·
Official record ↗
FDA Class II · Medical device · May 6, 2026
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction …
Company / brand: Philips North America recalls
Affected product: Philips SmartPath to dStream for 1 recall status
Official ID Z-1965-2026 ·
Official record ↗
FDA Class II · Medical device · May 6, 2026
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction …
Company / brand: Philips North America recalls
Affected product: Philips MR 7700 with MR Elastography (MRE) recall status
Official ID Z-1964-2026 ·
Official record ↗
FDA Class II · Medical device · May 6, 2026
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction …
Company / brand: Philips North America recalls
Affected product: Philips Ingenia Elition X with MR Elastography (MRE) recall status
Official ID Z-1963-2026 ·
Official record ↗
FDA Class II · Medical device · May 6, 2026
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction …
Company / brand: Philips North America recalls
Affected product: Philips Ingenia Elition S with MR Elastography (MRE) recall status
Official ID Z-1962-2026 ·
Official record ↗
FDA Class II · Medical device · May 6, 2026
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction …
Company / brand: Philips North America recalls
Affected product: Philips Ingenia Ambition X with MR Elastography (MRE) recall status
Official ID Z-1961-2026 ·
Official record ↗
FDA Class II · Medical device · May 6, 2026
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction …
Company / brand: Philips North America recalls
Affected product: Philips Ingenia Ambition S with MR Elastography (MRE) recall status
Official ID Z-1960-2026 ·
Official record ↗
FDA Class II · Medical device · May 6, 2026
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction …
Company / brand: Philips North America recalls
Affected product: Philips Ingenia 3 recall status
Official ID Z-1959-2026 ·
Official record ↗
FDA Class II · Medical device · May 6, 2026
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction …
Company / brand: Philips North America recalls
Affected product: Philips Ingenia 3 recall status
Official ID Z-1958-2026 ·
Official record ↗
FDA Class II · Medical device · May 6, 2026
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction …
Company / brand: Philips North America recalls
Affected product: Philips Ingenia 1 recall status
Official ID Z-1957-2026 ·
Official record ↗
FDA Class II · Medical device · May 6, 2026
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction …
Company / brand: Philips North America recalls
Affected product: Philips Ingenia 1 recall status
Official ID Z-1956-2026 ·
Official record ↗
FDA Class II · Medical device · May 6, 2026
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction …
Company / brand: Philips North America recalls
Affected product: Philips Evolution upgrade 3 recall status
Official ID Z-1955-2026 ·
Official record ↗
FDA Class II · Medical device · May 6, 2026
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction …
Company / brand: Philips North America recalls
Affected product: Philips Evolution Upgrade 1 recall status
Official ID Z-1954-2026 ·
Official record ↗
FDA Class II · Medical device · May 6, 2026
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction …
Company / brand: Philips North America recalls
Affected product: Philips Achieva 3 recall status
Official ID Z-1953-2026 ·
Official record ↗
FDA Class II · Medical device · May 6, 2026
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction …
Company / brand: Philips North America recalls
Affected product: Philips Achieva 1 recall status
Official ID Z-1952-2026 ·
Official record ↗
FDA Class II · Medical device · May 6, 2026
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction …
Company / brand: Philips North America recalls
Affected product: Philips Achieva 1 recall status
Official ID Z-1951-2026 ·
Official record ↗
FDA Class II · Medical device · May 6, 2026
The non-tamperproof battery door supplied with the sound processor fails to conform to IEC 60601-1-11:2015 by not requiring the use of a tool to replace the button/coin cell batter…
Company / brand: Advanced Bionics recalls
Affected product: Brand Name recall status
Official ID Z-1950-2026 ·
Official record ↗
FDA Class II · Medical device · May 6, 2026
It was identified that certain devices were being operated outside the validated and FDA-cleared display configuration due to user modification of the manufacturer-installed settin…
Company / brand: Hologic recalls
Affected product: Brand Name recall status
Official ID Z-1949-2026 ·
Official record ↗
FDA Class II · Medical device · May 6, 2026
Ventricular fibrillation (VF) occurred during radiofrequency (RF) therapy with the Medtronic Sphere-9 catheter in patients who have a Biotronik Implantable Cardioverter Defibrillat…
Company / brand: Medtronic recalls
Affected product: Medtronic Sphere-9 Catheter recall status
Official ID Z-1948-2026 ·
Official record ↗
FDA Class I · Medical device · May 6, 2026
Kits contain the McKesson TRUE Metrix PRO Professional Monitoring Blood Glucose System that has been recalled for an issue with the software design of the E-5 Error Code where the …
Company / brand: North American Rescue recalls
Affected product: AIDBAGs are first aid kits of convenience composed of individually labeled devices designe recall status
Official ID Z-1947-2026 ·
Official record ↗
FDA Class II · Medical device · May 6, 2026
Ten complaints have been received identifying issues at the time of use related to the package seal, including incomplete seals, wrinkles in the seals or peeling seals. Compromised…
Company / brand: Zimmer recalls
Affected product: Brand Name recall status
Official ID Z-1946-2026 ·
Official record ↗
FDA Class II · Medical device · May 6, 2026
Due to complaints of device breakage at the traction force gauge to handle joint.
Company / brand: Clinical Innovations recalls
Affected product: Brand Name recall status
Official ID Z-1945-2026 ·
Official record ↗
FDA Class II · Medical device · May 6, 2026
There is a possibility of reagent leakage from the specimen container.
Company / brand: Milestone S.R.L recalls
Affected product: VACUUM BAG SU LARGE recall status
Official ID Z-1944-2026 ·
Official record ↗
FDA Class II · Medical device · May 6, 2026
Product does not have FDA clearance.
Company / brand: Healthmark Industries Co recalls
Affected product: Mesh Style Tip Protectors CSW-03-2 recall status
Official ID Z-1943-2026 ·
Official record ↗
FDA Class I · Medical device · May 6, 2026
Cyber vulnerability of BLE communication was found by CISA VDP program.
Company / brand: WHILL recalls
Affected product: WHILL Model F recall status
Official ID Z-1827-2026 ·
Official record ↗
FDA Class I · Medical device · May 6, 2026
Cyber vulnerability of BLE communication was found by CISA VDP program.
Company / brand: WHILL recalls
Affected product: WHILL Model C2 recall status
Official ID Z-1826-2026 ·
Official record ↗
FDA Class I · Medical device · May 6, 2026
Updated software, Brady software maintenance release 6 (SMR6), is now available for the ACCOLADE" family of pacemakers and cardiac resynchronization therapy pacemakers (CRT-Ps)1 an…
Company / brand: Boston Scientific recalls
Affected product: Boston Scientific Cardiac Resynchronization Therapy (CRT)labeled as recall status
Official ID Z-1771-2026 ·
Official record ↗
FDA Class I · Medical device · May 6, 2026
Updated software, Brady software maintenance release 6 (SMR6), is now available for the ACCOLADE" family of pacemakers and cardiac resynchronization therapy pacemakers (CRT-Ps)1 an…
Company / brand: Boston Scientific recalls
Affected product: Boston Scientific Pacemaker recall status
Official ID Z-1770-2026 ·
Official record ↗
FDA Class II · Medical device · April 29, 2026
The catheter inflation tag attached to the device may contain an incorrect part number with incorrect balloon diameter sizes and inflation pressures for each stage.
Company / brand: Diversatek Healthcare recalls
Affected product: Diversatek Healthcare Viper¿ 3-Stage Wire Guided Balloon Dilator recall status
Official ID Z-1941-2026 ·
Official record ↗
FDA Class II · Medical device · April 29, 2026
The catheter inflation tag attached to the device may contain an incorrect part number with incorrect balloon diameter sizes and inflation pressures for each stage.
Company / brand: Diversatek Healthcare recalls
Affected product: Diversatek Healthcare Viper¿ 3-Stage Wire Guided Balloon Dilator recall status
Official ID Z-1940-2026 ·
Official record ↗
FDA Class II · Medical device · April 29, 2026
The catheter inflation tag attached to the device may contain an incorrect part number with incorrect balloon diameter sizes and inflation pressures for each stage.
Company / brand: Diversatek Healthcare recalls
Affected product: Diversatek Healthcare Viper¿ 3-Stage Wire Guided Balloon Dilator recall status
Official ID Z-1939-2026 ·
Official record ↗
FDA Class II · Medical device · April 29, 2026
The catheter inflation tag attached to the device may contain an incorrect part number with incorrect balloon diameter sizes and inflation pressures for each stage.
Company / brand: Diversatek Healthcare recalls
Affected product: Diversatek Healthcare Viper¿ 3-Stage Fixed Wire Balloon Dilator recall status
Official ID Z-1938-2026 ·
Official record ↗
FDA Class II · Medical device · April 29, 2026
Potential for spontaneous closures of Hamilton HxRunControl software during execution of Autolys protocols after deployment of the PCT software for AutoLys Hamilton STAR.
Company / brand: Foundation Medicine recalls
Affected product: Protocol Configuration Tool (PCT) software v1 recall status
Official ID Z-1937-2026 ·
Official record ↗
FDA Class II · Medical device · April 29, 2026
Medical procedure kits were distributed containing Webcol Large Alcohol Prep Pads which were subsequently recalled for non-sterility.
Company / brand: LSL Healthcare recalls
Affected product: LSL Healthcare Wound Closure Tray recall status
Official ID Z-1933-2026 ·
Official record ↗
FDA Class II · Medical device · April 29, 2026
Medical procedure kits were distributed containing Webcol Large Alcohol Prep Pads which were subsequently recalled for non-sterility.
Company / brand: LSL Healthcare recalls
Affected product: LSL Healthcare recall status
Official ID Z-1932-2026 ·
Official record ↗
FDA Class II · Medical device · April 29, 2026
Medical procedure kits were distributed containing Webcol Large Alcohol Prep Pads which were subsequently recalled for non-sterility.
Company / brand: LSL Healthcare recalls
Affected product: LSL Healthcare recall status
Official ID Z-1931-2026 ·
Official record ↗
FDA Class II · Medical device · April 29, 2026
Medical procedure kits were distributed containing Webcol Large Alcohol Prep Pads which were subsequently recalled for non-sterility.
Company / brand: LSL Healthcare recalls
Affected product: LSL Healthcare recall status
Official ID Z-1930-2026 ·
Official record ↗
FDA Class II · Medical device · April 29, 2026
Medical procedure kits were distributed containing Webcol Large Alcohol Prep Pads which were subsequently recalled for non-sterility.
Company / brand: LSL Healthcare recalls
Affected product: LSL Healthcare recall status
Official ID Z-1929-2026 ·
Official record ↗
FDA Class II · Medical device · April 29, 2026
Medical procedure kits were distributed containing Webcol Large Alcohol Prep Pads which were subsequently recalled for non-sterility.
Company / brand: LSL Healthcare recalls
Affected product: LSL Healthcare recall status
Official ID Z-1928-2026 ·
Official record ↗
FDA Class II · Medical device · April 29, 2026
Possible increase in phasing, potentially resulting in false-positive BARD1 splice site indel artifact variants
Company / brand: Foundation Medicine recalls
Affected product: Sequencing Agent SEQ0067 recall status
Official ID Z-1927-2026 ·
Official record ↗
FDA Class II · Medical device · April 29, 2026
Certain lots of product were associated with a manufacturing nonconformance involving use of a non-gamma sterilization compatible drape.
Company / brand: SurgiSmoke Solutions recalls
Affected product: Flamingo Funnel Large recall status
Official ID Z-1926-2026 ·
Official record ↗
FDA Class II · Medical device · April 29, 2026
Certain lots of product were associated with a manufacturing nonconformance involving use of a non-gamma sterilization compatible drape.
Company / brand: SurgiSmoke Solutions recalls
Affected product: Flamingo Funnel Medium recall status
Official ID Z-1925-2026 ·
Official record ↗
FDA Class II · Medical device · April 29, 2026
Certain lots of product were associated with a manufacturing nonconformance involving use of a non-gamma sterilization compatible drape.
Company / brand: SurgiSmoke Solutions recalls
Affected product: Flamingo Funnel Small recall status
Official ID Z-1924-2026 ·
Official record ↗
FDA Class II · Medical device · April 29, 2026
Affected lots are not performing to IFU criteria showing cross reactions with 2-0 within 60 seconds. Cross-reactivity may result in the misidentification of a Salmonella 9-O seroty…
Company / brand: Remel Europe recalls
Affected product: Oxoid Agglutinating Sera recall status
Official ID Z-1923-2026 ·
Official record ↗
FDA Class II · Medical device · April 29, 2026
Beckman Coulter has identified that Access Total T4 Calibrator lots (PN 33805) exhibit a negative bias on DxI 600/800 instruments, with slopes outside product specifications. A fal…
Company / brand: Beckman Coulter recalls
Affected product: Access Total T4 Calibrator recall status
Official ID Z-1922-2026 ·
Official record ↗
FDA Class II · Medical device · April 29, 2026
The product correction was initiated because B Braun is issuing a voluntary Urgent Medical Device Correction for gravity IV administration sets as well as pump administration sets …
Company / brand: Windstone Medical Packaging recalls
Affected product: Custom Convenience Kits Pre Op Kit - NS recall status
Official ID Z-1921-2026 ·
Official record ↗
FDA Class II · Medical device · April 29, 2026
The product correction was initiated because B Braun is issuing a voluntary Urgent Medical Device Correction for gravity IV administration sets as well as pump administration sets …
Company / brand: Windstone Medical Packaging recalls
Affected product: Custom Convenience Kits Pre Op Kit - NS recall status
Official ID Z-1920-2026 ·
Official record ↗
FDA Class II · Medical device · April 29, 2026
The product correction was initiated because B Braun is issuing a voluntary Urgent Medical Device Correction for gravity IV administration sets as well as pump administration sets …
Company / brand: Windstone Medical Packaging recalls
Affected product: Custom Convenience Kits Pre Op Kit - NS recall status
Official ID Z-1919-2026 ·
Official record ↗
FDA Class II · Medical device · April 29, 2026
X-Ray generator may malfunction resulting in the X-Ray being inoperable.
Company / brand: Micro-X recalls
Affected product: Rover Mobile X-ray System Model/Catalog Number recall status
Official ID Z-1918-2026 ·
Official record ↗
FDA Class II · Medical device · April 29, 2026
Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured
Company / brand: ARROW INTERNATIONAL recalls
Affected product: Arrowg+ard Blue¿ MAC" Two-Lumen Central Venous Access Kit for use with 7 recall status
Official ID Z-1917-2026 ·
Official record ↗
FDA Class II · Medical device · April 29, 2026
Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured
Company / brand: ARROW INTERNATIONAL recalls
Affected product: MAC" Two-Lumen Central Venous Access Kit for use with 7 recall status
Official ID Z-1916-2026 ·
Official record ↗
FDA Class II · Medical device · April 29, 2026
Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured
Company / brand: ARROW INTERNATIONAL recalls
Affected product: Pressure Injectable Arrowg+ard Blue Plus¿ Four-Lumen CVC Kit REF ASK-45854-PUPM1 UDI code recall status
Official ID Z-1915-2026 ·
Official record ↗
FDA Class II · Medical device · April 29, 2026
Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured
Company / brand: ARROW INTERNATIONAL recalls
Affected product: ARROW recall status
Official ID Z-1914-2026 ·
Official record ↗
FDA Class II · Medical device · April 29, 2026
Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured
Company / brand: ARROW INTERNATIONAL recalls
Affected product: FLEXTIP PLUS EPIDURAL CATHETER recall status
Official ID Z-1913-2026 ·
Official record ↗
FDA Class II · Medical device · April 29, 2026
Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured
Company / brand: ARROW INTERNATIONAL recalls
Affected product: PERCUTANEOUS SHEATH INTRODUCER with 7 recall status
Official ID Z-1912-2026 ·
Official record ↗
FDA Class II · Medical device · April 29, 2026
Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured
Company / brand: ARROW INTERNATIONAL recalls
Affected product: ARROW RADIAL ARTERY CATHETERIZATION KIT REF ASK-04220-UCL1 UDI code recall status
Official ID Z-1911-2026 ·
Official record ↗
FDA Class II · Medical device · April 29, 2026
Due to receiving a notice from a supplier that the liquid adhesive were incorrectly manufactured
Company / brand: ARROW INTERNATIONAL recalls
Affected product: Arrow Echogenic Introducer Needle REF ASK-04001-BWK2 UDI code recall status
Official ID Z-1910-2026 ·
Official record ↗
FDA Class II · Medical device · April 29, 2026
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
Company / brand: Olympus of the Americas recalls
Affected product: OER-ELITE Endoscope Reprocessor Connecting Tubes recall status
Official ID Z-1909-2026 ·
Official record ↗
FDA Class II · Medical device · April 29, 2026
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
Company / brand: Olympus of the Americas recalls
Affected product: OER-ELITE Endoscope Reprocessor Connecting Tubes recall status
Official ID Z-1908-2026 ·
Official record ↗
FDA Class II · Medical device · April 29, 2026
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
Company / brand: Olympus of the Americas recalls
Affected product: OER-ELITE Endoscope Reprocessor Connecting Tubes recall status
Official ID Z-1907-2026 ·
Official record ↗
FDA Class II · Medical device · April 29, 2026
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
Company / brand: Olympus of the Americas recalls
Affected product: OER-ELITE Endoscope Reprocessor Connecting Tubes recall status
Official ID Z-1906-2026 ·
Official record ↗
FDA Class II · Medical device · April 29, 2026
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
Company / brand: Olympus of the Americas recalls
Affected product: OER-ELITE Endoscope Reprocessor Connecting Tubes recall status
Official ID Z-1905-2026 ·
Official record ↗
FDA Class II · Medical device · April 29, 2026
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
Company / brand: Olympus of the Americas recalls
Affected product: OER-ELITE Endoscope Reprocessor Connecting Tubes recall status
Official ID Z-1904-2026 ·
Official record ↗
FDA Class II · Medical device · April 29, 2026
XXX
Company / brand: Olympus of the Americas recalls
Affected product: OER-ELITE Endoscope Reprocessor Connecting Tubes recall status
Official ID Z-1903-2026 ·
Official record ↗
FDA Class II · Medical device · April 29, 2026
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
Company / brand: Olympus of the Americas recalls
Affected product: OER-ELITE Endoscope Reprocessor Connecting Tubes recall status
Official ID Z-1902-2026 ·
Official record ↗
FDA Class II · Medical device · April 29, 2026
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
Company / brand: Olympus of the Americas recalls
Affected product: OER-ELITE Endoscope Reprocessor Connecting Tubes recall status
Official ID Z-1901-2026 ·
Official record ↗
FDA Class II · Medical device · April 29, 2026
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
Company / brand: Olympus of the Americas recalls
Affected product: OER-ELITE Endoscope Reprocessor Connecting Tubes recall status
Official ID Z-1900-2026 ·
Official record ↗
FDA Class II · Medical device · April 29, 2026
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
Company / brand: Olympus of the Americas recalls
Affected product: OER-ELITE Endoscope Reprocessor Connecting Tubes recall status
Official ID Z-1899-2026 ·
Official record ↗
FDA Class II · Medical device · April 29, 2026
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
Company / brand: Olympus of the Americas recalls
Affected product: OER-ELITE Endoscope Reprocessor Connecting Tubes recall status
Official ID Z-1898-2026 ·
Official record ↗
FDA Class II · Medical device · April 29, 2026
Products were incorrectly labeled with a 5-year shelf life. The approved and validated shelf life is four years.
Company / brand: XTANT Medical Holdings recalls
Affected product: nanOss 3D Advanced Bone Graft Substitute nanOss 3D Plus Advanced Bone Graft Substitute 90- recall status
Official ID Z-1897-2026 ·
Official record ↗
FDA Class II · Medical device · April 29, 2026
Potential for product to contain foreign matter, confirmed to be inspect fragments.
Company / brand: Davol recalls
Affected product: Avitene Ultrafoam Microfibrillar Collagen Hemostat - 8cm x 6 recall status
Official ID Z-1896-2026 ·
Official record ↗
FDA Class II · Medical device · April 29, 2026
Customers reported observing unexpectedly elevated results when using certain third-party micro-collection devices to collect capillary samples for testing with the LeadCare Test S…
Company / brand: Magellan Diagnostics recalls
Affected product: LeadCare Ultra Blood Lead Test Kit recall status
Official ID Z-1895-2026 ·
Official record ↗
FDA Class II · Medical device · April 29, 2026
Customers reported observing unexpectedly elevated results when using certain third-party micro-collection devices to collect capillary samples for testing with the LeadCare Test S…
Company / brand: Magellan Diagnostics recalls
Affected product: LeadCare¿ Plus Blood Lead Test Kit recall status
Official ID Z-1894-2026 ·
Official record ↗
FDA Class II · Medical device · April 29, 2026
Customers reported observing unexpectedly elevated results when using certain third-party micro-collection devices to collect capillary samples for testing with the LeadCare Test S…
Company / brand: Magellan Diagnostics recalls
Affected product: (1)(2) LeadCare¿ II Blood Lead Test Kit recall status
Official ID Z-1893-2026 ·
Official record ↗
FDA Class II · Medical device · April 29, 2026
Unapproved design changes to the products outside of the 510(k) clearance.
Company / brand: Medline Industries recalls
Affected product: Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes ENS recall status
Official ID Z-1892-2026 ·
Official record ↗
FDA Class II · Medical device · April 29, 2026
Unapproved design changes to the products outside of the 510(k) clearance.
Company / brand: Medline Industries recalls
Affected product: Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes ART recall status
Official ID Z-1891-2026 ·
Official record ↗
FDA Class II · Medical device · April 29, 2026
Unapproved design changes to the products outside of the 510(k) clearance.
Company / brand: Medline Industries recalls
Affected product: Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes ADD recall status
Official ID Z-1890-2026 ·
Official record ↗
FDA Class II · Medical device · April 29, 2026
Unapproved design changes to the products outside of the 510(k) clearance.
Company / brand: Medline Industries recalls
Affected product: Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes E P recall status
Official ID Z-1889-2026 ·
Official record ↗
FDA Class II · Medical device · April 29, 2026
Unapproved design changes to the products outside of the 510(k) clearance.
Company / brand: Medline Industries recalls
Affected product: Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes ART recall status
Official ID Z-1888-2026 ·
Official record ↗
FDA Class II · Medical device · April 29, 2026
Unapproved design changes to the products outside of the 510(k) clearance.
Company / brand: Medline Industries recalls
Affected product: Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes EXT recall status
Official ID Z-1887-2026 ·
Official record ↗
FDA Class II · Medical device · April 29, 2026
Unapproved design changes to the products outside of the 510(k) clearance.
Company / brand: Medline Industries recalls
Affected product: Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes EYE recall status
Official ID Z-1886-2026 ·
Official record ↗
FDA Class II · Medical device · April 29, 2026
Unapproved design changes to the products outside of the 510(k) clearance.
Company / brand: Medline Industries recalls
Affected product: Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes GU recall status
Official ID Z-1885-2026 ·
Official record ↗
FDA Class II · Medical device · April 29, 2026
Unapproved design changes to the products outside of the 510(k) clearance.
Company / brand: Medline Industries recalls
Affected product: Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes ANG recall status
Official ID Z-1884-2026 ·
Official record ↗
FDA Class II · Medical device · April 29, 2026
Unapproved design changes to the products outside of the 510(k) clearance.
Company / brand: Medline Industries recalls
Affected product: Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes Med recall status
Official ID Z-1883-2026 ·
Official record ↗
FDA Class II · Medical device · April 29, 2026
Unapproved design changes to the products outside of the 510(k) clearance.
Company / brand: Medline Industries recalls
Affected product: Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes FAC recall status
Official ID Z-1882-2026 ·
Official record ↗
FDA Class II · Medical device · April 29, 2026
Unapproved design changes to the products outside of the 510(k) clearance.
Company / brand: Medline Industries recalls
Affected product: Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes BAR recall status
Official ID Z-1881-2026 ·
Official record ↗
FDA Class II · Medical device · April 29, 2026
Unapproved design changes to the products outside of the 510(k) clearance.
Company / brand: Medline Industries recalls
Affected product: Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes MIN recall status
Official ID Z-1880-2026 ·
Official record ↗
FDA Class II · Medical device · April 29, 2026
Unapproved design changes to the products outside of the 510(k) clearance.
Company / brand: Medline Industries recalls
Affected product: Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes BIO recall status
Official ID Z-1879-2026 ·
Official record ↗
FDA Class II · Medical device · April 29, 2026
Unapproved design changes to the products outside of the 510(k) clearance.
Company / brand: Medline Industries recalls
Affected product: Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes TAV recall status
Official ID Z-1878-2026 ·
Official record ↗
FDA Class II · Medical device · April 29, 2026
Unapproved design changes to the products outside of the 510(k) clearance.
Company / brand: Medline Industries recalls
Affected product: Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes ADU recall status
Official ID Z-1877-2026 ·
Official record ↗
FDA Class II · Medical device · April 29, 2026
Unapproved design changes to the products outside of the 510(k) clearance.
Company / brand: Medline Industries recalls
Affected product: Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes JUD recall status
Official ID Z-1876-2026 ·
Official record ↗
FDA Class II · Medical device · April 29, 2026
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
Company / brand: Angiodynamics recalls
Affected product: AccuVu Angiographic Catheter recall status
Official ID Z-1875-2026 ·
Official record ↗
FDA Class II · Medical device · April 29, 2026
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
Company / brand: Angiodynamics recalls
Affected product: AccuVu Angiographic Catheter recall status
Official ID Z-1874-2026 ·
Official record ↗
FDA Class II · Medical device · April 29, 2026
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
Company / brand: Angiodynamics recalls
Affected product: AccuVu Angiographic Catheter recall status
Official ID Z-1873-2026 ·
Official record ↗
FDA Class II · Medical device · April 29, 2026
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
Company / brand: Angiodynamics recalls
Affected product: AccuVu Angiographic Catheter recall status
Official ID Z-1872-2026 ·
Official record ↗
FDA Class II · Medical device · April 29, 2026
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
Company / brand: Angiodynamics recalls
Affected product: Soft-Vu Angiographic Catheter recall status
Official ID Z-1871-2026 ·
Official record ↗
FDA Class II · Medical device · April 29, 2026
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
Company / brand: Angiodynamics recalls
Affected product: Soft-Vu Angiographic Catheter recall status
Official ID Z-1870-2026 ·
Official record ↗
FDA Class II · Medical device · April 29, 2026
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
Company / brand: Angiodynamics recalls
Affected product: Soft-Vu Angiographic Catheter recall status
Official ID Z-1869-2026 ·
Official record ↗
FDA Class II · Medical device · April 29, 2026
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
Company / brand: Angiodynamics recalls
Affected product: Soft-Vu Angiographic Catheter recall status
Official ID Z-1868-2026 ·
Official record ↗
FDA Class II · Medical device · April 29, 2026
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
Company / brand: Angiodynamics recalls
Affected product: Soft-Vu Angiographic Catheter recall status
Official ID Z-1867-2026 ·
Official record ↗
FDA Class II · Medical device · April 29, 2026
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
Company / brand: Angiodynamics recalls
Affected product: Soft-Vu Angiographic Catheter recall status
Official ID Z-1866-2026 ·
Official record ↗
FDA Class II · Medical device · April 29, 2026
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
Company / brand: Angiodynamics recalls
Affected product: Soft-Vu Angiographic Catheter recall status
Official ID Z-1865-2026 ·
Official record ↗
FDA Class II · Medical device · April 29, 2026
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
Company / brand: Angiodynamics recalls
Affected product: Soft-Vu Angiographic Catheter recall status
Official ID Z-1864-2026 ·
Official record ↗
FDA Class II · Medical device · April 29, 2026
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
Company / brand: Angiodynamics recalls
Affected product: Soft-Vu Angiographic Catheter recall status
Official ID Z-1863-2026 ·
Official record ↗
FDA Class II · Medical device · April 29, 2026
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
Company / brand: Angiodynamics recalls
Affected product: Soft-Vu Angiographic Catheter recall status
Official ID Z-1862-2026 ·
Official record ↗
FDA Class II · Medical device · April 29, 2026
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
Company / brand: Angiodynamics recalls
Affected product: Soft-Vu Angiographic Catheter recall status
Official ID Z-1861-2026 ·
Official record ↗
FDA Class II · Medical device · April 29, 2026
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
Company / brand: Angiodynamics recalls
Affected product: Soft-Vu Angiographic Catheter recall status
Official ID Z-1860-2026 ·
Official record ↗
FDA Class II · Medical device · April 29, 2026
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
Company / brand: Angiodynamics recalls
Affected product: Soft-Vu Angiographic Catheter recall status
Official ID Z-1859-2026 ·
Official record ↗
FDA Class II · Medical device · April 29, 2026
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
Company / brand: Angiodynamics recalls
Affected product: Soft-Vu Angiographic Catheter recall status
Official ID Z-1858-2026 ·
Official record ↗
FDA Class II · Medical device · April 29, 2026
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
Company / brand: Angiodynamics recalls
Affected product: Soft -Vu Angiographic Catheter recall status
Official ID Z-1857-2026 ·
Official record ↗
FDA Class II · Medical device · April 29, 2026
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
Company / brand: Angiodynamics recalls
Affected product: Soft-Vu Angiographic Catheter recall status
Official ID Z-1856-2026 ·
Official record ↗
FDA Class II · Medical device · April 29, 2026
Potential for detachment of a distal tip component of the device during use.
Company / brand: Olympus of the Americas recalls
Affected product: Olympus Thunderbeat II Shears w/Ultrasonic Mode recall status
Official ID Z-1854-2026 ·
Official record ↗
FDA Class II · Medical device · April 29, 2026
Potential for detachment of a distal tip component of the device during use.
Company / brand: Olympus of the Americas recalls
Affected product: Olympus Thunderbeat II Shears w/Ultrasonic Mode recall status
Official ID Z-1853-2026 ·
Official record ↗
FDA Class II · Medical device · April 29, 2026
Potential for detachment of a distal tip component of the device during use.
Company / brand: Olympus of the Americas recalls
Affected product: Olympus Thunderbeat II Shears w/Ultrasonic Mode recall status
Official ID Z-1852-2026 ·
Official record ↗
FDA Class II · Medical device · April 29, 2026
Potential for detachment of a distal tip component of the device during use.
Company / brand: Olympus of the Americas recalls
Affected product: Olympus Thunderbeat II Shears w/Ultrasonic Mode recall status
Official ID Z-1851-2026 ·
Official record ↗
FDA Class II · Medical device · April 29, 2026
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
Company / brand: Medline Industries recalls
Affected product: Medline Kits recall status
Official ID Z-1850-2026 ·
Official record ↗
FDA Class II · Medical device · April 29, 2026
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
Company / brand: Medline Industries recalls
Affected product: Medline Kits recall status
Official ID Z-1849-2026 ·
Official record ↗
FDA Class II · Medical device · April 29, 2026
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
Company / brand: Medline Industries recalls
Affected product: Medline Kits recall status
Official ID Z-1848-2026 ·
Official record ↗
FDA Class II · Medical device · April 29, 2026
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
Company / brand: Medline Industries recalls
Affected product: Medline Kits recall status
Official ID Z-1847-2026 ·
Official record ↗
FDA Class II · Medical device · April 29, 2026
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
Company / brand: Medline Industries recalls
Affected product: Medline Kits recall status
Official ID Z-1846-2026 ·
Official record ↗
FDA Class II · Medical device · April 29, 2026
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
Company / brand: Medline Industries recalls
Affected product: Medline Kits recall status
Official ID Z-1845-2026 ·
Official record ↗
FDA Class II · Medical device · April 29, 2026
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
Company / brand: Medline Industries recalls
Affected product: Medline Kits recall status
Official ID Z-1844-2026 ·
Official record ↗
FDA Class II · Medical device · April 29, 2026
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
Company / brand: Medline Industries recalls
Affected product: Medline Kits recall status
Official ID Z-1843-2026 ·
Official record ↗
Sources last checked October 22, 2026 at 12:00 PM UTC.