Medical DeviceMay 8, 2024
RAYSEARCH LABORATORIES AB RayStation 10.0.0.1154, 10.0.1.52 & 10.0.2.10 recall — FDA Z-1746-2024
Potential for reported SSD to be too high.
Class IIFDA: OngoingRAYSEARCH LABORATORIES AB
Latest records
Latest recalls — page 402
The newest recall records with useful source details are listed here.
Medical DeviceMay 8, 2024
IVOCLAR VIVADENT AG IPS e.max ZirCAD CER/in recall — FDA Z-1703-2024
Defective blocks may show cracks after sintering If cracks are unnoticed, restorations may fracture in the patient's mouth and require restoration
Class IIFDA: OngoingIVOCLAR VIVADENT AG
Medical DeviceMay 8, 2024
Covidien Medtronic Invos, Reusable Sensor Cable for PM7100, REF: PMAC71RSC recall — FDA Z-1732-2024
manufacturing defects to sensor cable connectors may result in error codes or non-functioning channel
Class IIFDA: OngoingCovidien
Medical DeviceMay 8, 2024
Olympus Corporation of the Americas POWERSEAL 5 mm, 44 cm, Curved Jaw Sealer and Divider recall — FDA Z-1701-2024
Upon initial activation of the seal function, the POWERSEAL non-conformance results in an immediate Incomplete Seal Cycle tone with the accompanying message on the generator screen, and no…
Class IIFDA: OngoingOlympus Corporation of the Americas
Medical DeviceMay 8, 2024
Zimmer ZPLP Distal Lateral Fibular Plate, Left, 4 Holes, 80 MM, Nonsterile- Indicated for recall — FDA Z-1726-2024
Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be readily recognizable by the user since the…
Class IIFDA: OngoingZimmer, Inc.
Medical DeviceMay 8, 2024
Allergan Sales Keller Funnel 2, REF: HA-001, STERILEEO, Rx Only recall — FDA Z-1694-2024
Their is a potential that breast implants lack the lubricious coating that allows them to slide through the funnels during the implantation procedure.
Class IIFDA: OngoingAllergan Sales, LLC
Medical DeviceMay 8, 2024
SEDECAL SA Battery Mobile X-ray Unit EASY MOVING Model with telescopic column 3.1, model recall — FDA Z-1754-2024
Potential interference with the anti-fall system.
Class IIFDA: OngoingSEDECAL SA
Medical DeviceMay 8, 2024
Zimmer ZPLP recall — FDA Z-1709-2024
Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be readily recognizable by the user since the…
Class IIFDA: OngoingZimmer, Inc.
Medical DeviceMay 8, 2024
Stryker Neurovascular The Distal Access Catheter is a single-lumen, braided shaft, variable recall — FDA Z-1740-2024
Stryker Neurovascular is recalling their DAC- Distal Access Catheter -038 136cm, a Distal Access Catheter by removal. The reason for the recall is: the DAC Lot #0000486382 was released with…
Class IIFDA: OngoingStryker Neurovascular
Medical DeviceMay 8, 2024
Zimmer ZPLP recall — FDA Z-1713-2024
Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be readily recognizable by the user since the…
Class IIFDA: OngoingZimmer, Inc.
Medical DeviceMay 8, 2024
Zimmer ZPLP recall — FDA Z-1717-2024
Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be readily recognizable by the user since the…
Class IIFDA: OngoingZimmer, Inc.
Medical DeviceMay 8, 2024
Zimmer ZPLP Distal Lateral Fibular Plate, Left, 6 Holes, 106 MM, Nonsterile- Indicated for recall — FDA Z-1727-2024
Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be readily recognizable by the user since the…
Class IIFDA: OngoingZimmer, Inc.
Medical DeviceMay 8, 2024
Philips The Oncology Essentials Package of the Spectral CT imaging system recall — FDA Z-1756-2024
Potential for third party oncology marking laser to be reflected off the gantry cover surface, which can potentially lead to misdiagnosis and subsequent incorrect treatment.
Class IIFDA: OngoingPhilips North America LLC
Medical DeviceMay 8, 2024
Advanced Instruments OsmoPRO MAX Automated Osmometer- IVD Osmometer for Clinical Use recall — FDA Z-1696-2024
System error messages may delay the ability to test patient samples and the need for frequent calibration due to results outside the expected range when testing controls.
Class IIFDA: OngoingAdvanced Instruments, LLC
Medical DeviceMay 8, 2024
IVOCLAR VIVADENT AG IPS e.max ZirCAD CER/in recall — FDA Z-1706-2024
Defective blocks may show cracks after sintering If cracks are unnoticed, restorations may fracture in the patient's mouth and require restoration
Class IIFDA: OngoingIVOCLAR VIVADENT AG
Medical DeviceMay 8, 2024
Cardinal Health 200 Jackson-Pratt 3-Spring Reservoir with Silicone Adapters, 400mL, REF recall — FDA Z-1739-2024
Cardinal Health is issuing a lot number specific voluntary removal of Jackson-Pratt 3-Spring Reservoir kits due to specific products being shipped to users before undergoing sterilization.
Class IIFDA: OngoingCardinal Health 200, LLC
Medical DeviceMay 8, 2024
Zimmer ZPLP Distal Lateral Fibular Plate, Right, 8 Holes, 132 MM, Nonsterile- Indicated for recall — FDA Z-1724-2024
Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be readily recognizable by the user since the…
Class IIFDA: OngoingZimmer, Inc.
Medical DeviceMay 8, 2024
Zimmer ZPLP recall — FDA Z-1710-2024
Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be readily recognizable by the user since the…
Class IIFDA: OngoingZimmer, Inc.
Medical DeviceMay 8, 2024
RAYSEARCH LABORATORIES AB RayStation 11.0.0.951, 11.0.1.29, 11.0.3.116 & 11.0.4.15 recall — FDA Z-1748-2024
Potential for reported SSD to be too high.
Class IIFDA: OngoingRAYSEARCH LABORATORIES AB
Medical DeviceMay 8, 2024
Zimmer ZPLP Distal Lateral Fibular Plate, Left, 14 Holes, 210 MM, Sterile- Indicated for recall — FDA Z-1720-2024
Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be readily recognizable by the user since the…
Class IIFDA: OngoingZimmer, Inc.
Medical DeviceMay 8, 2024
Zimmer ZPLP recall — FDA Z-1721-2024
Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be readily recognizable by the user since the…
Class IIFDA: OngoingZimmer, Inc.
Medical DeviceMay 8, 2024
Zimmer ZPLP Distal Lateral Fibular Plate, Right, 6 Holes, 106 MM, Nonsterile- Indicated for recall — FDA Z-1723-2024
Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be readily recognizable by the user since the…
Class IIFDA: OngoingZimmer, Inc.
Medical DeviceMay 8, 2024
Noah Medical Galaxy System REF GAL-001 recall — FDA Z-1734-2024
Due to a misaligned calibration of the wired controller that may result in unintended motion of the scope.
Class IIFDA: OngoingNoah Medical
Medical DeviceMay 8, 2024
Cardinal Health 200 Jackson-Pratt 3-Spring Reservoir Kit with PVC Round Drain, 400mL, 10Fr. recall — FDA Z-1736-2024
Cardinal Health is issuing a lot number specific voluntary removal of Jackson-Pratt 3-Spring Reservoir kits due to specific products being shipped to users before undergoing sterilization.
Class IIFDA: OngoingCardinal Health 200, LLC
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Recent recall archives
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