Medical Device Recalls
RSS ↗7,959 medical device recalls from federal enforcement feeds.
Showing 3,651–3,700 of 7,959
- Class II
Medical Device Recall · March 3, 2025
MEDLINE INDUSTRIES, LP - Northfield
Medline Convenience kits used for various procedures: 1) ARTHROSCOPIE DU GENOU-LF, Model Number: DYNJ40229A; 2) ARTHROSCOPY PACK-LF, Model Number: OPK382N; 3) ARTHROSCOPY NEW TEGH-LF, Model NumbeThere is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
- Class II
Medical Device Recall · March 3, 2025
Terumo Cardiovascular Systems Corporation
Terumo CDI OneView Monitoring System Hematocrit / Oxygen Saturation Probe, Catalog Number REF CD1754During some clinical cases, it has been observed that the SO2 value may periodically appear as dashes on the Touchscreen Display indicating unavailable data. In these cases, a yellow low-limit alarm will also be triggered to the user, due to the dashed-out value.
- Class II
Medical Device Recall · March 3, 2025
MEDLINE INDUSTRIES, LP - Northfield
Medline Convenience kits used for various procedures: 1) T A PACK, Model Number: DYNJ67791A; 2) NASAL PACK, Model Number: DYNJ66514; 3) ENT PACK, Model Number: DYNJ67775A; 4) T/A ENDO PACK, MThere is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
- Class II
Medical Device Recall · March 3, 2025
MEDLINE INDUSTRIES, LP - Northfield
Medline Convenience kits used for various procedures: 1) CSTM PACEMAKER DRAPE PACK, Model Number: DYNJCD0339There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
- Class II
Medical Device Recall · March 3, 2025
Baxter NovumIQ Syringe INFUSION SYSTEM , REF 40800BAXUSBaxter Healthcare Corporation is issuing an Urgent Medical Device Recall for the Novum IQ syringe pumps listed below due to an incorrectly installed gasket. A gasket failure could lead to potential fluid ingress due to cleaning, or as a result of an IV fluid spill.
- Class II
Medical Device Recall · March 3, 2025
MEDLINE INDUSTRIES, LP - Northfield
Medline Convenience kits used for various procedures: 1) UNIVERSAL DRAPE PACK, Model Number: DYNJCD0239There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
- Class II
Medical Device Recall · March 3, 2025
MEDLINE INDUSTRIES, LP - Northfield
Refer to RESThere is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
- Class II
Medical Device Recall · February 28, 2025
Monterey AL Implant Inserter; 14/16mm; Catalog 48019120.Potential for the gold unlock button to separate from the inserter.
- Class II
Medical Device Recall · February 28, 2025
Monterey AL Implant Inserter; 10/12mm; Catalog 48019100.Potential for the gold unlock button to separate from the inserter.
- Class II
Medical Device Recall · February 28, 2025
Monterey AL Implant Inserter; 18/20mm; Catalog 48019130.Potential for the gold unlock button to separate from the inserter.
- Class II
Medical Device Recall · February 28, 2025
Philips Medical Systems Nederland B.V.
Spectral CT on Rails, Software Version Number 5.1.0, Model number: 728334;Multiple problems identified with the software version leading to various scanning and image issues, and unintended device movement.
- Class II
Medical Device Recall · February 28, 2025
Monterey AL Implant Inserter; 22mm; Catalog 48019140.Potential for the gold unlock button to separate from the inserter.
- Class II
Medical Device Recall · February 28, 2025
Phoroptor VRx Digital Refraction System Model Numbers: 16241The head of the phoropter head could come loose and potentially detach due to a default in the assembly.
- Class II
Medical Device Recall · February 28, 2025
Phoroptor VRx Digital Refraction System Model Numbers: 16242The head of the phoropter head could come loose and potentially detach due to a default in the assembly.
- Class II
Medical Device Recall · February 27, 2025
Brand Names: MyDay Toric, LensCrafters One Day Premium Daily Disposable Contact Lenses For Astigmatism, Pearle Vision 1 Day Premium For Astigmatism, REVEAL 1-DAY TORIC, Vision Source Reveal Toric, Voya limited number of lots were manufactured with an incorrect cylinder power.
- Class II
Medical Device Recall · February 27, 2025
FilmArra Pneumonia Panel plus (Pneumoplus), REF: RFIT-LBL-0374Increased risk of control failures and false negative test results with multiplexed nucleic acid test.
- Class I
Medical Device Recall · February 27, 2025
t:slim X2 Insulin Pump with Interoperable TechnologyA software defect in Version 7.9 of the pump software for Tandem t:slim X2 and Tandem Mobi pumps, when used with Control IQ+ technology, will cause the pump to incorrectly interpolate glucose trends when the Estimated Glucose Value (EGV) is above 255 mg/dL at the start or end of a gap in data collection due to a lapse in connection from a paired continuous glucose monitor (CGM) sensor, which can lead to under-delivery or over-delivery of insulin based on inaccurate result leading to severe cases of hypoglycemia or hyperglycemia.
- Class I
Medical Device Recall · February 27, 2025
Tandem Mobi Insulin Pump with Interoperable TechnologyA software defect in Version 7.9 of the pump software for Tandem t:slim X2 and Tandem Mobi pumps, when used with Control IQ+ technology, will cause the pump to incorrectly interpolate glucose trends when the Estimated Glucose Value (EGV) is above 255 mg/dL at the start or end of a gap in data collection due to a lapse in connection from a paired continuous glucose monitor (CGM) sensor, which can lead to under-delivery or over-delivery of insulin based on inaccurate result leading to severe cases of hypoglycemia or hyperglycemia.
- Class II
Medical Device Recall · February 27, 2025
NexGen LPS Flex, Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis, Model Number 00-5962-042-10The "Use with plate 7, 8, 9, 10" compatibility statement on top of the label does not match with the compatibility statements "USE WITH PLATE 5, 6" in the translations section of the same label.
- Class II
Medical Device Recall · February 27, 2025
Premier Solo Diamond - Large Invented Cone; SKU: 807016C.The hardness not meeting the material specification and may cause the diamond bur to bend.
- Class II
Medical Device Recall · February 27, 2025
Access Vitamin B12 Reagent, Catalog Number 33000, Lot Number 439850Beckman Coulter has received complaints of erroneous Vitamin B12 results when using Access Vitamin B12 Reagent lot 439850. The affected reagent lot may cause erroneously low or high Vitamin B12 results, leading to a delayed or improper diagnosis and/or repeat testing.
- Class II
Medical Device Recall · February 26, 2025
Brand Name: Da Vinci 5 Product Name: ASSY,DV5 CONSOLE,IS5000 Foot Tray Pedals Model/Catalog Number: 380730 Software Version: N/A . Refer to HHE for additional details. Component: N/ADue to an increase in complaints concerning foot tray pedal spring failing resulting in the pedal remaining pressed
- Class II
Medical Device Recall · February 26, 2025
DxC 500 AU Clinical Chemistry Analyzer, Catalog Numbers/UDI codes: C63519 / 14987666545058 C63520 / 14987666545065 The Beckman Coulter DxC 500 AU Clinical Chemistry Analyzer is an automated chemiBeckman Coulter has determined that device software versions V1.3, V1.4, V1.4.1, V1.4.2, V1.4.3. have a defect due of which, when all constituent tests of a calculated result are rerun, either manually ordered by the operator at the analyzer or automatically triggered by predefined rules in System Configuration, the calculated result will not be recalculated using the constituent tests rerun results. The system will report only the calculated result using the initial constituent tests results to the operator and LIS/Remisol. The issue was identified by Beckman Coulter internal engineering testing. The defect may cause a delay in reporting patient results.
- Class I
Medical Device Recall · February 26, 2025
Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff Reusable Inner Cannula, REF: 7CN80RTracheostomy tube with cuff reusable inner cannula has a flange that may disconnect from the outer cannula of the device, which could cause respiratory failure, aspiration, unspecified tissue injury, aspiration, respiratory tract infection, bronchospasm, a delay to treatment and/or death.
- Class I
Medical Device Recall · February 26, 2025
Hippo 072 Aspiration System including Cheetah Delivery Tool and Aspiration Tubing, REF: APT6072-132. Hippo 072 Aspiration System including Cheetah Delivery Tool, REF: AP6072-132. 072 AspirationAspiration catheter distal tip features and characteristics may not be in the scope of FDA clearance; tip detachment, vessel rupture, and vasospasm could occur.
- Class II
Medical Device Recall · February 25, 2025
Nasopore FD fragmentable nasal dressing, Catalog Numbers 5400-020-108 and 5400-020-108ITLThere is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that the sterility seal has been breached.
- Class II
Medical Device Recall · February 25, 2025
Hemopore 2PK nasal/sinus temporary wound dressing, Catalog Number 5400-222-208SThere is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that the sterility seal has been breached.
- Class II
Medical Device Recall · February 25, 2025
Baxter Mobile column TruSystem 7500, Product Code 1717023There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled.
- Class II
Medical Device Recall · February 25, 2025
Otopore Cylinder Standard outer ear dressings, Catalog Numbers 5400-010-000 and 5400-010-000ITLThere is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that the sterility seal has been breached.
- Class II
Medical Device Recall · February 25, 2025
Nasopore Standard 4cm fragmentable nasal dressing, Catalog Numbers 5400-010-004 and 5400-010-004ITLThere is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that the sterility seal has been breached.
- Class II
Medical Device Recall · February 25, 2025
Baxter Stationary column TruSystem 7500 U, Product Code 1730731There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled.
- Class II
Medical Device Recall · February 25, 2025
Baxter Operating table column TS7500 MOBIUS, Product Code 1704695There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled.
- Class II
Medical Device Recall · February 25, 2025
Baxter TruSystem 7500, Product Code 4091000There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled.
- Class II
Medical Device Recall · February 25, 2025
Progressa Bed Surfaces, intended to be used to treat or prevent pulmonary or other complications associated with immobility, Product Codes P7520A19, P7520A20S, P7520A21, P7520A22S, P7520A23, P7520A24SThe air bladders inside the mattress may move out of position when the head of the bed is elevated, causing a dip in the mattress.
- Class II
Medical Device Recall · February 25, 2025
Baxter Stationary column TruSystem 7500, Product Code 1717020There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled.
- Class II
Medical Device Recall · February 25, 2025
Baxter TruSystem 7500 Hybrid Plus (SC), Product Code 1854088There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled.
- Class II
Medical Device Recall · February 25, 2025
Baxter TruSystem 7500 Hybrid MR IMRIS, Product Code 2067886There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled.
- Class II
Medical Device Recall · February 25, 2025
Baxter TruSystem 7500 Hybrid (FC), Product Code 1854085There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled.
- Class II
Medical Device Recall · February 25, 2025
Baxter Floor mounting column TruSystem 7500, Product Code 1717021There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled.
- Class II
Medical Device Recall · February 25, 2025
Baxter Floor mounting column TS 7500 U, Product Code 1730732There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled.
- Class II
Medical Device Recall · February 25, 2025
Otopore Square outer ear wound dressing, Firm Catalog Number 5400-020-100 and Forte Catalog Number 5400-020-100ITLThere is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that the sterility seal has been breached.
- Class II
Medical Device Recall · February 25, 2025
Baxter TruSystem 7500 Hybrid Plus (FC), Product Code 1854087There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled.
- Class II
Medical Device Recall · February 25, 2025
Nasopore 4cm Standard 2PK fragmentable nasal dressing, Catalog Number 5400-212-004S and Nasopore 4cm Firm 2PK Catalog Number 5400-222-004SThere is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that the sterility seal has been breached.
- Class II
Medical Device Recall · February 25, 2025
Otopore Cylinder outer ear wound dressing, Firm Catalog Number 5400-020-000 and Forte Catalog Number 5400-020-000TLThere is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that the sterility seal has been breached.
- Class II
Medical Device Recall · February 25, 2025
Hemopore 8cm nasal/sinus temporary wound dressing, Catalog Numbers 5400-020-208 and 5400-020-208ITL (OUS)There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that the sterility seal has been breached.
- Class II
Medical Device Recall · February 25, 2025
Zenition 70. Product Code 718133. The devices are used for radiological guidance and visualization during diagnostic, interventional and surgical procedures on all patients, except neonates (birth toA wireless foot switch pedal may get stuck in the active position when the user releases the pedal, resulting in the emission of unintended radiation.
- Class II
Medical Device Recall · February 25, 2025
Baxter Mobile column TruSystem 7500 U, Product Code 1730720There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled.
- Class II
Medical Device Recall · February 25, 2025
Nasopore Standard 8cm fragmentable nasal dressing, Catalog Numbers 5400-010-008 and 5400-010-008ITLThere is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that the sterility seal has been breached.
- Class II
Medical Device Recall · February 25, 2025
Veradius Unity. Product Code 718132. The devices are used for radiological guidance and visualization during diagnostic, interventional and surgical procedures on all patients, except neonates (birthA wireless foot switch pedal may get stuck in the active position when the user releases the pedal, resulting in the emission of unintended radiation.
- Class II
Medical Device Recall · February 25, 2025
Zenition 50. Product Code 718096. The devices are used for radiological guidance and visualization during diagnostic, interventional and surgical procedures on all patients, except neonates (birth tA wireless foot switch pedal may get stuck in the active position when the user releases the pedal, resulting in the emission of unintended radiation.