Medical DeviceAug 10, 2016
Zimmer Air Dermatome II Width Plate, 3 inch recall — FDA Z-2339-2016
The surface coating applied to the device is blistering, peeling and discoloring after usage over time
Class IIFDA: TerminatedZimmer Surgical Inc.
28,992medical device recall records
2,381FDA Class I records
8firms with 5+ records
Zimmer Biomet, Inc.784 records
Database records
Records — page 1052
28,992 detailed records are currently available in this category.
Medical DeviceAug 10, 2016
Philips Electronics IntelliVue Patient Monitor Product Usage: The monitors are indicated for recall — FDA Z-2328-2016
If an affected Patient Monitor has been powered on continuously for several months, any displayed waveforms will contain outdated data and therefore fail to reflect the patients current…
Class IIFDA: TerminatedPhilips Electronics North America Corporation
Medical DeviceAug 10, 2016
Beckman Coulter AU5800 Chemistry Analyzers, Reference No recall — FDA Z-2310-2016
Beckman coulter has received complaints regarding leaking and cracked C cups. When the cup cracks, coolant can leak onto the connectors of the Printed Circuit Boards (PCB) in the analyzer,…
Class IIFDA: TerminatedBeckman Coulter Inc.
Medical DeviceAug 10, 2016
CHG Hospital Beds Spirit Plus Bed, A-C Powered Hospital Bed recall — FDA Z-2331-2016
Stryker Medical is initiating a voluntary recall of the Spirit Select and Spirit Plus A-C powered hospital beds due to reports of hi-lo actuators broken at the mount ends, which could cause…
Class IIFDA: TerminatedCHG Hospital Beds Inc.
Medical DeviceAug 10, 2016
Beckman Coulter AU480 Chemistry Analyzers, Reference No recall — FDA Z-2308-2016
Beckman coulter has received complaints regarding leaking and cracked C cups. When the cup cracks, coolant can leak onto the connectors of the Printed Circuit Boards (PCB) in the analyzer,…
Class IIFDA: TerminatedBeckman Coulter Inc.
Medical DeviceAug 10, 2016
Zimmer Gmbh V-TEK TWIST D 40X90MM 30MM Cann 12MM Rnd recall — FDA Z-2324-2016
Zimmer Biomet initiated a voluntary recall of the Twist Drill & V-Tek Twist Drill due to to a potential tolerance stack up identified between the twist drill and the mating Kirschner Wire…
Class IIFDA: TerminatedZimmer Gmbh
Medical DeviceAug 10, 2016
Philips Electronics MultiDiagnost Eleva recall — FDA Z-2307-2016
The two bolts that attach the clamping plate to the lateral shaft may break, which could cause the c-arm to move laterally forward, slide out of its bearings, and sag
Class IIFDA: TerminatedPhilips Electronics North America Corporation
Medical DeviceAug 10, 2016
Zimmer Air Dermatome II Handpiece, item number 00-8851-001-00 recall — FDA Z-2334-2016
The surface coating applied to the device is blistering, peeling and discoloring after usage over time
Class IIFDA: TerminatedZimmer Surgical Inc.
Medical DeviceAug 10, 2016
Zimmer Air Dermatome II Width Plate, 4 inch recall — FDA Z-2340-2016
The surface coating applied to the device is blistering, peeling and discoloring after usage over time
Class IIFDA: TerminatedZimmer Surgical Inc.
Medical DeviceAug 10, 2016
Dako Denmark A/S EnVision FLEX+, Mouse, High pH (Link), Product No recall — FDA Z-2330-2016
The pH of Target Retrieval Solution in the kit measures 4-5 instead of the correct pH of 9.1.
Class IIFDA: TerminatedDako Denmark A/S
Medical DeviceAug 10, 2016
Mentor MemoryGel Breast Implant recall — FDA Z-2326-2016
The box of 300cc MemoryGel Breast Implant was labeled with null manufacturing and expiration dates.
Class IIFDA: TerminatedMentor Texas, LP.
Medical DeviceAug 10, 2016
Medtronic Navigation Fusion ENT Application recall — FDA Z-2317-2016
Medtronic Navigation, Inc. announces a voluntary field action for the Medtronic Navigation StealthStation Software applications affected by Neurologica BodyTom/CereTom floor-based scanners.
Class IIFDA: TerminatedMedtronic Navigation, Inc.
Medical DeviceAug 10, 2016
Merge PACS software recall — FDA Z-2303-2016
A migrated study that has annotations will display the annotations, but when a prior study is loaded that should have annotations, the second study will not display annotations.
Class IIFDA: TerminatedMerge Healthcare, Inc.
Medical DeviceAug 10, 2016
Zimmer Air Dermatome II Width Plate, 1 in., item number 00-8851-201-00 recall — FDA Z-2336-2016
The surface coating applied to the device is blistering, peeling and discoloring after usage over time
Class IIFDA: TerminatedZimmer Surgical Inc.
Medical DeviceAug 10, 2016
Zimmer Gmbh TWIST DR 25X95MM Cann 12MM Thd 30MM AO recall — FDA Z-2321-2016
Zimmer Biomet initiated a voluntary recall of the Twist Drill & V-Tek Twist Drill due to to a potential tolerance stack up identified between the twist drill and the mating Kirschner Wire…
Class IIFDA: TerminatedZimmer Gmbh
Medical DeviceAug 10, 2016
NeoCoil 3T 16ch Flex SPEEDER Coil, Large, NeoCoil Part Number NC046200, Toshiba Medical recall — FDA Z-2312-2016
There is a potential for higher than specified surface temperatures involving the 3T 16ch Flex SPEEDER Large Coil.
Class IIFDA: TerminatedNeoCoil, LLC
Medical DeviceAug 10, 2016
Medtronic Navigation Synergy Spine. The software application is sent in CD format with an recall — FDA Z-2316-2016
Medtronic Navigation, Inc. announces a voluntary field action for the Medtronic Navigation StealthStation Software applications affected by Neurologica BodyTom/CereTom floor-based scanners.
Class IIFDA: TerminatedMedtronic Navigation, Inc.
Medical DeviceAug 10, 2016
Zimmer Gmbh TWIST D 28X150MM CBS 45 Cann 14 MM AO recall — FDA Z-2322-2016
Zimmer Biomet initiated a voluntary recall of the Twist Drill & V-Tek Twist Drill due to to a potential tolerance stack up identified between the twist drill and the mating Kirschner Wire…
Class IIFDA: TerminatedZimmer Gmbh
Medical DeviceAug 10, 2016
Philips Electronics UroDiagnost; x-ray system. Product Code: 708033 recall — FDA Z-2306-2016
The two bolts that attach the clamping plate to the lateral shaft may break, which could cause the c-arm to move laterally forward, slide out of its bearings, and sag
Class IIFDA: TerminatedPhilips Electronics North America Corporation
Medical DeviceAug 10, 2016
ORTHO-CLINICAL DIAGNOSTICS VITROS Immunodiagnostic Products Total T4 Reagent Pack recall — FDA Z-2302-2016
Ortho-Clinical Diagnostics confirmed that sample results generated from VITROS Immunodiagnostic Products Total T4 Reagent Packs may show a negative bias prior to the open pack storage limit…
Class IIFDA: TerminatedORTHO-CLINICAL DIAGNOSTICS
Medical DeviceAug 10, 2016
C.R. Bard SureStep Tray, with Add-a-Foley, COMPLETE CARE, Drainage Bag, and STATLOCK recall — FDA Z-2333-2016
Labeling problem
Class IIIFDA: TerminatedC.R. Bard, Inc.
Medical DeviceAug 10, 2016
B-K Medical A/S BK Medical ApS Ultrasound System Scanner bk2300 - Model #: bk3500 with recall — FDA Z-2325-2016
In the system (bk3500) software generic volume measurement (HxWxLxl) function the user may be unaware of the calculation factor (1) and assume the generic volume calculation factor is…
Class IIFDA: TerminatedB-K Medical A/S
Medical DeviceAug 10, 2016
CHG Hospital Beds Spirit Select Bed, A-C Powered Hospital Bed recall — FDA Z-2332-2016
Stryker Medical is initiating a voluntary recall of the Spirit Select and Spirit Plus A-C powered hospital beds due to reports of hi-lo actuators broken at the mount ends, which could cause…
Class IIFDA: TerminatedCHG Hospital Beds Inc.
Medical DeviceAug 10, 2016
Medtronic Navigation MACH AxiEM Cranial Treon recall — FDA Z-2319-2016
Medtronic Navigation, Inc. announces a voluntary field action for the Medtronic Navigation StealthStation Software applications affected by Neurologica BodyTom/CereTom floor-based scanners.
Class IIFDA: TerminatedMedtronic Navigation, Inc.
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.