Medical DeviceApr 8, 2020
Gentell Hydrogel Ag 4x4, model no recall — FDA Z-1624-2020
During an FDA audit, it was discovered that the product was not properly registered with FDA.
Class IIFDA: OngoingGentell, Inc.
25,676medical device recall records
2,265FDA Class I records
8firms with 5+ records
Zimmer Biomet, Inc.759 records
Database records
Records — page 624
25,676 detailed records are currently available in this category.
Medical DeviceApr 8, 2020
Respironics California Philips V60 Ventilators with Power Management PCBA part number recall — FDA Z-1622-2020
Solder connection failure on Power Management printed circuit board assembly of ventilators may cause 1) Blower to lose power, spool down, and trigger visual and audible High Priority Check…
Class IIFDA: OngoingRespironics California, LLC
Medical DeviceApr 8, 2020
Maquet Cardiovascular Us Sales Avalon Elite Vascular Access Kit, Model No. 70106.3540, UDI recall — FDA Z-1603-2020
A lot of Avalon Elite Vascular Access Kits (VAK) are being recalled due to a material mix-up with the needle portion of the kit; 81 of 255 kits were assembled with an incorrect Arterial…
Class IIFDA: TerminatedMaquet Cardiovascular Us Sales, LLC
Medical DeviceApr 8, 2020
Trilliant Surgical Instructions for Use and Surgical Cleaning and Sterilization Protocol recall — FDA Z-1605-2020
Instructions for Use (IFU) and Surgical Cleaning and Sterilization Protocols updated with revised dry time parameters. This recall of IFU occurred in 2018.
Class IIFDA: TerminatedTrilliant Surgical, LLC
Medical DeviceApr 8, 2020
Butterfly iQ Ultrasound System Auto Bladder Volume Tool-The Auto Bladder Volume Tool is a recall — FDA Z-1600-2020
Distributed without an approved 510(k)
Class IIFDA: TerminatedButterfly Network, Inc.
Medical DeviceApr 8, 2020
Trilliant Surgical Instructions for Use and Surgical Cleaning and Sterilization Protocol for recall — FDA Z-1609-2020
Instructions for Use (IFU) and Surgical Cleaning and Sterilization Protocols updated with revised dry time parameters. This recall of IFU occurred in 2018.
Class IIFDA: TerminatedTrilliant Surgical, LLC
Medical DeviceApr 8, 2020
Philips Expression MR400 MRI Patient Monitoring System recall — FDA Z-1616-2020
Menu selections for users to access the oxygen (O2) sensor calibration were changed and not incorporated into the device s Instructions for Use. As a result, the instructions for performing…
Class IIFDA: TerminatedPhilips North America, LLC
Medical DeviceApr 8, 2020
Gentell Hydrogel Ag 4oz recall — FDA Z-1626-2020
During an FDA audit, it was discovered that the product was not properly registered with FDA.
Class IIFDA: OngoingGentell, Inc.
Medical DeviceApr 8, 2020
Karl Storz SE & Co recall — FDA Z-1618-2020
The firm has become aware that there is a potential that the glass cover at the distal end of the camera/led lighting on the video laryngoscope could become loose during reprocessing or…
Class IIFDA: TerminatedKarl Storz Endoscopy
Medical DeviceApr 8, 2020
Physio-Control LifePAK 500 Automated External Defibrillator, model numbers: 3005400-XXX recall — FDA Z-1633-2020
Automated External Defibrillators may not detect a patient connection due to mechanical wear-through of the contact plating on the therapy connector. The wear-through could result in the…
Class IIFDA: TerminatedPhysio-Control, Inc.
Medical DeviceApr 8, 2020
Trilliant Surgical Instructions for Use and Surgical Cleaning and Sterilization Protocol for recall — FDA Z-1608-2020
Instructions for Use (IFU) and Surgical Cleaning and Sterilization Protocols updated with revised dry time parameters. This recall of IFU occurred in 2018.
Class IIFDA: TerminatedTrilliant Surgical, LLC
Medical DeviceApr 8, 2020
Smith & Nephew NAVIO Soft Tissue Protector, included in instrument kits recall — FDA Z-1634-2020
Potential for the NAVIO Soft Tissue Protector to become stuck or bound to the bone pin intraoperatively when inserting the NAVIO bone pins.
Class IIFDA: TerminatedSmith & Nephew, Inc.
Medical DeviceApr 8, 2020
XLTEK natus newborn care Olympic Brainz Monitor, REF OBM00002. electroencephalograph recall — FDA Z-1630-2020
The OBM system functional test (impedance and noise) was not carried out on the affected items prior to release to the customer. The manufacturer cannot attest to the system functionality…
Class IIFDA: TerminatedNatus Neurology DBA Excel Tech., Ltd. (XLTEK)
Medical DeviceApr 8, 2020
Gentell Hydrogel Ag 2x2, model no GEN-11220 - Product Usage: Under the care of a healthcare recall — FDA Z-1623-2020
During an FDA audit, it was discovered that the product was not properly registered with FDA.
Class IIFDA: OngoingGentell, Inc.
Medical DeviceApr 8, 2020
Stryker Neurovascular, AXS Vecta 71 Aspiration Catheter, Ref recall — FDA Z-1620-2020
The firm has become aware of a potential problem that their Catheters may break/fracture and/or kink/bend if improperly removed from the packaging/dispenser hoop or during catheter use.
Class IIFDA: TerminatedStryker Neurovascular
Medical DeviceApr 8, 2020
Bard Peripheral Vascular BD WAVELINQ 4F EndoAVF System, Arterial Catheter 50 cm, Venous recall — FDA Z-1637-2020
The firm has become aware of a potential problem with their venous and arterial magnetic catheters may be at risk of experiencing a magnetic deficiency, which may result in the magnets…
Class IIFDA: TerminatedBard Peripheral Vascular Inc.
Medical DeviceApr 8, 2020
Biomet Comprehensive Reverse Shoulder Glenosphere Mini Baseplate With Taper recall — FDA Z-1615-2020
Package is intended to contain one (1) baseplate and one (1) taper adapter; however, devices may be packaged with two (2) baseplates and no (0) adapters.
Class IIFDA: TerminatedBiomet, Inc.
Medical DeviceApr 8, 2020
Trilliant Surgical Instructions for Use and Surgical Cleaning Sterilization Protocol for recall — FDA Z-1607-2020
Instructions for Use (IFU) and Surgical Cleaning and Sterilization Protocols updated with revised dry time parameters. This recall of IFU occurred in 2018.
Class IIFDA: TerminatedTrilliant Surgical, LLC
Medical DeviceApr 8, 2020
Trilliant Surgical Instructions for Use and Surgical Cleaning and Sterilization Protocol recall — FDA Z-1612-2020
Instructions for Use (IFU) and Surgical Cleaning and Sterilization Protocols updated with revised dry time parameters. This recall of IFU occurred in 2018.
Class IIFDA: TerminatedTrilliant Surgical, LLC
Medical DeviceApr 8, 2020
Merits E604 Pilot Navigator Stairlift - Product Usage: To transport patients up stairs recall — FDA Z-1632-2020
Pinion gear may disengage from track allowing lift to slip or jolt.
Class IIFDA: TerminatedMerits Holdings Co. dba Merits Health Products, Inc.
Medical DeviceApr 8, 2020
Stryker Neurovascular, AXS Vecta 74 Aspiration Catheter, Ref recall — FDA Z-1621-2020
The firm has become aware of a potential problem that their Catheters may break/fracture and/or kink/bend if improperly removed from the packaging/dispenser hoop or during catheter use.
Class IIFDA: TerminatedStryker Neurovascular
Medical DeviceApr 8, 2020
Butterfly iQ Ultrasound System containing the Auto EF(Ejection Fraction) Tool REF/Model recall — FDA Z-1601-2020
Distributed without an approved 510(k)
Class IIFDA: TerminatedButterfly Network, Inc.
Medical DeviceApr 8, 2020
Gentell Hydrogel Ag 4x8, model no recall — FDA Z-1625-2020
During an FDA audit, it was discovered that the product was not properly registered with FDA.
Class IIFDA: OngoingGentell, Inc.
Medical DeviceApr 8, 2020
Haemonetics TEG Manager software versions used in conjunction with TEG 5000 are 1.1.0 recall — FDA Z-1617-2020
Software defect in TEG Manager impacts the displayed alert for out of range test results. Due to this defect, reference range values received from TEG 5000 and displayed on the TEG Manager…
Class IIFDA: TerminatedHaemonetics Corporation
How to use this medical device recall index
Medical device recall records can change as the FDA receives additional information. Check the official record identifier and current FDA information before making health or product-use decisions.
Recall Lookup USA keeps the last complete source record available when an official data service is temporarily unavailable. When a source provides only a few fields, we show only those known facts rather than padding the page with generic text.
What the database can and cannot tell you
This database is designed for discovery and reference. It can help you locate a relevant recall record, identify the recalling firm or NHTSA campaign, compare dates and classifications, and follow the official source. It is not a substitute for a VIN-specific NHTSA check, a manufacturer notice, medical advice or instructions issued by the recalling company.