Medical Device Recalls
RSS ↗8,689 medical device recalls from federal enforcement feeds.
Showing 4,001–4,050 of 8,689
- Class II
Medical Device Recall · May 5, 2025
Olympus Corporation of the Americas
Olympus EVIS EXERA III Duodenovideoscope. Model Number: TJF-Q190VRecent post-market surveillance data suggests a possible association of higher microbial contamination levels from TJF duodenoscopes when manual cleaning was delayed beyond one hour and a presoak was performed, compared to those TJF duodenoscopes where manual cleaning began within one hour after patient procedure.
- Class II
Medical Device Recall · May 2, 2025
Catalog No. 8888160325; Umbilical Vessel Catheter 2.5 French single lumenPackaging defect may compromise sterility of the product. Use of a non-sterile product on the patient could lead to infection in neonates.
- Class II
Medical Device Recall · May 2, 2025
Catalog No. 8888160648; Umbilical Vessel Catheter 5 French triple lumenPackaging defect may compromise sterility of the product. Use of a non-sterile product on the patient could lead to infection in neonates.
- Class II
Medical Device Recall · May 2, 2025
BD BBL CultureSwab EZ Collection and Transport System, REF 220144, in vitro Diagnostic, SterileR, Rx OnlySwabs for specimen collection may be prone to breakage during product usage.
- Class II
Medical Device Recall · May 2, 2025
Catalog No. 8888160341; Umbilical Vessel Catheter 5 French single lumenPackaging defect may compromise sterility of the product. Use of a non-sterile product on the patient could lead to infection in neonates.
- Class II
Medical Device Recall · May 2, 2025
LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software SUite v2.1 and v2.2Firm has identified Drug Library Management defects in the software: 1) DLM software does not allow user to create percentage dose rate or rate change values with certain limits, potentially resulting in over-delivery to patient. 2) An unauthorized user may modify and approve a drug library, potentially leading to incorrect program parameters being used for therapy.
- Class II
Medical Device Recall · May 2, 2025
Healthmark Industries Co., Inc.
Pre-filled Water Syringe, Model Numbers SW-010-100 and SW-010During endoscope surveillance monitoring, a user facility identified contamination from duodenoscope samples that were linked to the Pre-filled Water Syringes as part of their investigation. Healthmark Industries conducted its own investigation and concluded that the Pre-filled Water Syringe had been improperly used outside of the intended purpose.
- Class II
Medical Device Recall · May 2, 2025
Catalog No. 8888160556; Umbilical Vessel Catheter 5 French dual lumenPackaging defect may compromise sterility of the product. Use of a non-sterile product on the patient could lead to infection in neonates.
- Class II
Medical Device Recall · May 2, 2025
Healthmark Industries Co., Inc.
ChannelCheck Convenience Pack, Model Numbers UCC-222CP and UCC-222-ESP (Sample)During endoscope surveillance monitoring, a user facility identified contamination from duodenoscope samples that were linked to the Pre-filled Water Syringes as part of their investigation. Healthmark Industries conducted its own investigation and concluded that the Pre-filled Water Syringe had been improperly used outside of the intended purpose.
- Class II
Medical Device Recall · May 2, 2025
Catalog No. 8888160333; Umbilical Vessel Catheter 3.5 French single lumenPackaging defect may compromise sterility of the product. Use of a non-sterile product on the patient could lead to infection in neonates.
- Class II
Medical Device Recall · 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 SystemDue to labeling error. Product incorrectly labeled.
- Class II
Medical Device Recall · May 2, 2025
Catalog No. 8888160119; Umbilical Vessel Catheter Insertion Tray with 2.5 and 5 French UVCsPackaging defect may compromise sterility of the product. Use of a non-sterile product on the patient could lead to infection in neonates.
- Class II
Medical Device Recall · May 1, 2025
GM Helix Acqua Implant, Article Number: 140.985It is possible that a package labelled as an 11.5 mm implant may contain a 13 mm implant instead.
- Class II
Medical Device Recall · May 1, 2025
GM Helix Acqua Implant, Article Number: 140.984It is possible that a package labelled as an 11.5 mm implant may contain a 13 mm implant instead.
- Class II
Medical Device Recall · May 1, 2025
Civco Medical Instruments Co. Inc.
BX2 Needle Guide, Part Number 644-094, tool for performing needle-guided (or catheter) procedures with the use of diagnostic ultrasound transducersDuring the attachment of the needle guide to the covered probe, the tight tolerance and fit of the needle guide can cause a pinhole breach in the transducer cover when latching the guide in place.
- Class II
Medical Device Recall · May 1, 2025
Implant Direct Sybron Manufacturing LLC
The Drill Stop Kit is the version of the Mini Sterilizable Tray that is used to store, sterilize, verify Drill Stop length, and facilitate the mounting/removal of the Drill Stops. The Drill Stop Kit iThe Drill stop kit contains incorrect components.
- Class I
Medical Device Recall · May 1, 2025
Adult Manual Resuscitator with Medium Adult Mask, Bag REservoir, Filter, Manometer and 7 ft Oxygen Tubing, REF CPRM1116FAffected lots were manufactured with B/V Filter incorrectly attached to the wrong port (patient port instead of the exhalation port). If not noticed prior to patient use, there would be interruption or delay in patient resuscitation, which may lead to life threatening consequences, including hypoxia, hypercapnia, organ failure, and death.
- Class II
Medical Device Recall · May 1, 2025
Thermo SCIENTIFIC Sensititre Cation Adjusted AutoRead Mueller-Hinton Broth w/ TES w/ Lysed Horse Blood, REF CP11410; invitro diagnostic deviceProduct may have an off color affecting perfomance
- Class II
Medical Device Recall · April 30, 2025
Sample probe sucks a sample dispensed into a tube or cup and discharges the appropriate amount into a cuvette. Lot 178713114 - 179433670A manufacturing defect in the sample probe (S probe). The corners of the tip of the defective S probe are rounded and chamfered, which can prevent the proper formation of the "air layer" required for normal dispensing. The air layer is the air space that separates the cleaning water filled in the probe from the sample sucked into the probe. Maintaining this air space prevents the cleaning water and the sample from mixing. In the defective S probe, the "air layer" was not properly formed, causing the cleaning water and the sample to mix diluting the sample. As a result, the sample mixture dispensed into the cuvette has a lower concentration than the original sample, and the analyte concentration measured is lower than expected results.
- Class II
Medical Device Recall · April 30, 2025
Sample probe sucks a sample dispensed into a tube or cup and discharges the appropriate amount into a cuvette. Lot 178713114 - 179433670Sample probes with defective probe tips, when used with clinical chemistry analyzers, may lead to a lower concentration being dispensed, which may not be detectable by QC checks, which could lead to the reporting of false low test results (Max 34% error at 1.0 microliters and 7% error at 1.6 microliters sample dispensing volume), which may lead to delayed recognition and treatment.
- Class II
Medical Device Recall · April 30, 2025
BioFire Respiratory Panel 2.1 plus Kit, REF: 423740, For Filmarray systemsDue to manufacturing error, respiratory panel may result in elevated control failures and/or false negative results.
- Class II
Medical Device Recall · April 30, 2025
Cardiohelp System HKH 8820 Wall Holder. Mounting bracket designed to hold the CARDIOHELP-i system for interhospital transport by vehicle.HKH 8820 Wall Holder does not comply with standard DIN EN 1789:20 and has the potential to detach.
- Class II
Medical Device Recall · April 29, 2025
Fresenius Medical Care Holdings, Inc.
5008X HDF Hemodialysis Blood Tubing Set, 24 units per case, with the following models: a. 5008X Standard HDF Bloodline, Model Number: 03-5100-7. b. 5008X Standard HDF Bloodline w/CLIC, Model Number:Potential of blood leak occurring between the lower port of the venous chamber and the tubing include: hemodiafiltration (HDF), hemodialysis (HD), hemofiltration (HF), and isolated ultrafiltration.
- Class II
Medical Device Recall · April 29, 2025
Azure S DR MRI SureScan, Product number W3DR01Identified devices may experience sudden battery power failure without alarm, power supply power-on-resets, and interruption of therapy. Potential patient harms include insufficient pacing support leading to cardiac arrest, syncope, or hospitalization; or system revision (explant/replacement) leading to infection, hematoma, or temporary impairment.
- Class II
Medical Device Recall · April 28, 2025
NxStage PureFlow-B Solution. Catalog numbers: RFP-400, RFP-401, RFP-402, RFP-403, RFP-404, RFP-406, RFP-453, RFP-454, RFP-456.Potential for the perimeter seal on the small chamber of the two-chamber bag to fail causing the electrolyte fluid to splash into the face of the user when attempting to open the peel seam to mix the two chambers prior to treatment.
- Class II
Medical Device Recall · April 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 aDue 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.
- Class II
Medical Device Recall · April 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/ADue 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.
- Class II
Medical Device Recall · April 28, 2025
Alinity m Resp-4-Plex AMP Kit, List Number 09N79-096, a multiplex real-time reverse transcription (RT) polymerase chain reaction (PCR) test intended for the simultaneous qualitative detection and diffThere were reports of an increase in reactive negative controls and false positive results.
- Class II
Medical Device Recall · April 28, 2025
Alinity m Resp-4-Plex Amplification (AMP) Kit (CE), List Number 09N79-090, a multiplex real-time reverse transcription (RT) polymerase chain reaction (PCR) test intended for the qualitative detectionThere were reports of an increase in reactive negative controls and false positive results.
- Class II
Medical Device Recall · April 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/ADue 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.
- Class II
Medical Device Recall · April 25, 2025
Brand Name: Tecfen Medical Product Name: 2.0mm Crescent Knife Angled Bevel Up Model/Catalog Number: QKN1010 Software Version: No software Product Description: This is an ophthalmic knife (manual)Sterility assurance for Ophthalmic knives.
- Class III
Medical Device Recall · April 25, 2025
HANGZHOU ACOSOUND TECHNOLOGY CO., LTD.
AcoSound. Model Number: LW12-BTE-MThree issues 1. Label error: The manufacturer information in the labeling is not correct, the manufacturer's name is mislabeled as "Developed by AcoSound," Correct should be "Manufactured by Hangzhou AcoSound." And the labeling has no statement of the place of business for the manufacturer. 2. Customer information: The customer "Blaid" information is not correctly marked; Blaid is not the manufacturer. 3. UDI Information: The UDI information is incomplete and without DI information and correct Pl information, not complied with UDI label requirements.
- Class II
Medical Device Recall · April 25, 2025
Brand Name: Tecfen Medical Product Name: 3.2mm Slit Knife, Angled Model/Catalog Number: QKN3261 Software Version: No software Product Description: This is an ophthalmic knife (manual) that is to bSterility assurance for Ophthalmic knives.
- Class II
Medical Device Recall · April 25, 2025
Brand Name: Tecfen Medical Product Name: 20G (1.2mm) MVR Sideport Knife Straight Model/Catalog Number: QKN2312 Software Version: No software Product Description: This is an ophthalmic knife (manuaSterility assurance for Ophthalmic knives.
- Class II
Medical Device Recall · April 25, 2025
GE Medical Systems Information Technologies Inc
MUSE 5 Systems, Model Numbers 2021274-001, 2023032-005, 2027478-001, Large capacity client-server-based computer system that accesses stores and manages cardiovascular information.The MUSE Administrator Account active directory or local credential could potentially be used from your local network to log into a GE HealthCare MUSE 5 system and potentially manipulate recorded patient data.
- Class II
Medical Device Recall · April 25, 2025
Brand Name: Tecfen Medical Product Name: 2.2mm Slit Knife, Angled Model/Catalog Number: QKN2261 Software Version: No software Product Description: This is an ophthalmic knife (manual) that is to bSterility assurance for Ophthalmic knives.
- Class II
Medical Device Recall · April 25, 2025
Brand Name: Tecfen Medical Product Name: 15 degree Stab Knife Model/Catalog Number: QKN1501 Software Version: No software Product Description: This is an ophthalmic knife (manual) that is to be stSterility assurance for Ophthalmic knives.
- Class II
Medical Device Recall · April 25, 2025
Brand Name: Tecfen Medical Product Name: 2.8mm Slit Knife, Angled Model/Catalog Number: QKN2808 Software Version: No software Product Description: This is an ophthalmic knife (manual) that is to bSterility assurance for Ophthalmic knives.
- Class II
Medical Device Recall · April 25, 2025
Brand Name: Tecfen Medical Product Name: 2.4mm Slit Knife, Angled Model/Catalog Number: QKN2461 Software Version: No software Product Description: This is an ophthalmic knife (manual) that is to bSterility assurance for Ophthalmic knives.
- Class II
Medical Device Recall · April 24, 2025
Mckesson Medical-Surgical Inc. Corporate Office
ABBOTT DIAGNOSTICS ARC CARBON DIOXIDE6X5ML B CALIBRATOR.transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failure could increase the probability of an incorrect test result or a delayed test result.
- Class II
Medical Device Recall · April 24, 2025
Mckesson Medical-Surgical Inc. Corporate Office
HEMOCUE INC GLUC AQUEOUS 1HI/LO HEMCUE CONTROL KIT.transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failure could increase the probability of an incorrect test result or a delayed test result.
- Class II
Medical Device Recall · April 24, 2025
Mckesson Medical-Surgical Inc. Corporate Office
HEMOCUE INC HEMOTROL HIGH 2X1ML LEVEL 3 HEMCUE CONTROL.transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failure could increase the probability of an incorrect test result or a delayed test result.
- Class II
Medical Device Recall · April 24, 2025
Mckesson Medical-Surgical Inc. Corporate Office
ABBOTT RAPID DX N AMERICA LLC, TEST CHOLESTEC LDXLIPID PROFILE (10/BX 50BX/CS) CASSETTES.transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failure could increase the probability of an incorrect test result or a delayed test result.
- Class II
Medical Device Recall · April 24, 2025
Mckesson Medical-Surgical Inc. Corporate Office
HEMOCUE INC HEMOTROL LOW 2X1ML LEVEL 1 HEMCUE CONTROL.transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failure could increase the probability of an incorrect test result or a delayed test result.
- Class II
Medical Device Recall · April 24, 2025
Mckesson Medical-Surgical Inc. Corporate Office
ABBOTT DIAGNOSTICS ARC ANTI-TPO ASSAY 100TST B REAGENT.transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failure could increase the probability of an incorrect test result or a delayed test result.
- Class II
Medical Device Recall · April 24, 2025
Mckesson Medical-Surgical Inc. Corporate Office
ORTHO CLINICAL DIAGNOSTICS INC FS(3PK/BX)ORCLNL DILUENT PACK 3.transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failure could increase the probability of an incorrect test result or a delayed test result.
- Class II
Medical Device Recall · April 24, 2025
Mckesson Medical-Surgical Inc. Corporate Office
ABBOTT RAPID DX N AMERICA LLC HBA1C HEMOGLOBIN AFINION GLYCTD (15TST/BX) TEST KIT.transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failure could increase the probability of an incorrect test result or a delayed test result.
- Class I
Medical Device Recall · April 24, 2025
Baxter Novum IQ LVP INFUSION SYSTEM, REF 40700BAXUSThere is a potential for the Novum IQ LVP due to the potential for underinfusion following use of the "standby mode" feature or if the device is powered off with the set loaded.
- Class II
Medical Device Recall · April 24, 2025
Mckesson Medical-Surgical Inc. Corporate Office
BD MICROBIOLOGY MAC CONKEY II AGAR (100/CT) 21270 MEDIA.transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failure could increase the probability of an incorrect test result or a delayed test result.
- Class II
Medical Device Recall · April 24, 2025
Mckesson Medical-Surgical Inc. Corporate Office
ABBOTT POINT OF CARE TEST CREA I-STAT (25/BX) ABBTPT CARTRIDGE.transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failure could increase the probability of an incorrect test result or a delayed test result.