Medical DeviceAug 16, 2017
Valorem Surgical PALLAS M/MAXIMIS Rod Pusher Angled recall — FDA Z-3001-2017
Devices are not consistent with Quality System Requirements.
Class IIFDA: TerminatedValorem Surgical LLC
28,065medical device recall records
2,353FDA Class I records
8firms with 5+ records
Zimmer Biomet, Inc.784 records
Database records
Records — page 926
28,065 detailed records are currently available in this category.
Medical DeviceAug 16, 2017
Valorem Surgical PALLAS M/MAXIMIS S recall — FDA Z-3009-2017
Devices are not consistent with Quality System Requirements.
Class IIFDA: TerminatedValorem Surgical LLC
Medical DeviceAug 16, 2017
Valorem Surgical PALLAS M/MAXIMIS 250mm Straight Rod recall — FDA Z-2954-2017
Devices are not consistent with Quality System Requirements.
Class IIFDA: TerminatedValorem Surgical LLC
Medical DeviceAug 16, 2017
Valorem Surgical PALLAS M/MAXIMIS Reduction A recall — FDA Z-2975-2017
Devices are not consistent with Quality System Requirements.
Class IIFDA: TerminatedValorem Surgical LLC
Medical DeviceAug 16, 2017
International Medsurg Connection Hypodermic Needle, 23 G X 1.0 in REG BEVEL, 100 per box, 50 recall — FDA Z-2816-2017
Insufficient documentation to support product sterility claims.
Class IIFDA: TerminatedInternational Medsurg Connection, Inc.
Medical DeviceAug 9, 2017
SORIN GROUP, SMART PERFUSION PACK, SMART 1/4" PEDS PACK, REF 627262502, STERILE EO, Rx Only recall — FDA Z-2795-2017
Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged in pouches which may have small pinholes (approximately 1mm or less in diameter). The result…
Class IIFDA: TerminatedSorin Group USA, Inc.
Medical DeviceAug 9, 2017
Stryker Neurovascular Stroke Fast Pack(TM) Trevo XP ProVue Retriever 4 x 20, Trevo Pro 18 recall — FDA Z-2800-2017
Stryker Neurovascular has become aware that some 3-Pack Stroke Fast Packs were manufactured using a carton sleeve where the pre-printed contents on the back of the sleeve did not match the…
Class IIFDA: TerminatedStryker Neurovascular
Medical DeviceAug 9, 2017
SORIN GROUP, SMART PERFUSION PACK, SMART CIRCULATORY ASSIST PACK, REF 627255003, STERILE EO recall — FDA Z-2784-2017
Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged in pouches which may have small pinholes (approximately 1mm or less in diameter). The result…
Class IIFDA: TerminatedSorin Group USA, Inc.
Medical DeviceAug 9, 2017
Hologic Tomcat Instrument, REF ASY-07379, Hologic Incorporated, automated laboratory sample recall — FDA Z-2864-2017
A Tomcat Instrument software anomaly that causes the pipettor arm to make physical contact with the mucous shelf which could potentially lead to incorrect patient results.
Class IIFDA: TerminatedHologic, Inc.
Medical DeviceAug 9, 2017
Zimmer Biomet ROSA Brain, 3.0.0 The device is intended for the spatial positioning and recall — FDA Z-2868-2017
Complaint of the head holder connector locking up mechanically when tightened.
Class IIFDA: TerminatedZimmer Biomet, Inc.
Medical DeviceAug 9, 2017
Sorin Group USA NON-STERILE SAMPLE, SORIN GROUP, SMART PERFUSION PACK, REF 627376401, 1 EA recall — FDA Z-2798-2017
Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged in pouches which may have small pinholes (approximately 1mm or less in diameter). The result…
Class IIFDA: TerminatedSorin Group USA, Inc.
Medical DeviceAug 9, 2017
Ortho Solutions Oxford/Oxbridge AFN End Cap 10 mm x 5 mm tp 12 mm x10 mm The end caps are a recall — FDA Z-2780-2017
There is a material mislabeling of the AFN End Cap.
Class IIFDA: TerminatedOrtho Solutions Inc.
Medical DeviceAug 9, 2017
Stryker Neurovascular Stroke Fast Pack(TM) Trevo XP ProVue Retriever 4 x 30, Trevo Pro 18 recall — FDA Z-2801-2017
Stryker Neurovascular has become aware that some 3-Pack Stroke Fast Packs were manufactured using a carton sleeve where the pre-printed contents on the back of the sleeve did not match the…
Class IIFDA: TerminatedStryker Neurovascular
Medical DeviceAug 9, 2017
Stryker Neurovascular Stroke Fast Pack(TM) Trevo XP ProVue Retriever 3 x 20, Trevo Pro 14 recall — FDA Z-2799-2017
Stryker Neurovascular has become aware that some 3-Pack Stroke Fast Packs were manufactured using a carton sleeve where the pre-printed contents on the back of the sleeve did not match the…
Class IIFDA: TerminatedStryker Neurovascular
Medical DeviceAug 9, 2017
SORIN GROUP, SMART PERFUSION PACK, INSPIRE 8FS S5 PACK W/CARDIOPLEGIA-3D, (a) REF 044042600 recall — FDA Z-2788-2017
Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged in pouches which may have small pinholes (approximately 1mm or less in diameter). The result…
Class IIFDA: TerminatedSorin Group USA, Inc.
Medical DeviceAug 9, 2017
In2Bones, SAS Non-Locking screws in the following lengths: (a) NEO(R) 0.27 - 10 mm, REF W27 recall — FDA Z-2869-2017
The firm received several customer complaints reporting some perioperative breakages of NE0411 Non-Locking screws when inserting the screw into the radius diaphysis
Class IIFDA: TerminatedIn2Bones, SAS
Medical DeviceAug 9, 2017
Quidel InflammaDry(R) AN RPS DIAGNOSTIC SOLUTION, Sample Collectors InflammaDry(R) is a recall — FDA Z-2803-2017
In-house testing revealed the presence of plastic spurs at the tips of some Sample Collectors.
Class IIFDA: TerminatedQuidel Corporation
Medical DeviceAug 9, 2017
SORIN GROUP, SMART PERFUSION PACK, INSPIRE 6FS, REF 044008204, STERILE EO, Rx Only, 1 EA recall — FDA Z-2786-2017
Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged in pouches which may have small pinholes (approximately 1mm or less in diameter). The result…
Class IIFDA: TerminatedSorin Group USA, Inc.
Medical DeviceAug 9, 2017
SORIN GROUP, SMART PERFUSION PACK, SMA PRIMO2X OPTI PACK, REF 088512900, STERILE EO, Rx recall — FDA Z-2785-2017
Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged in pouches which may have small pinholes (approximately 1mm or less in diameter). The result…
Class IIFDA: TerminatedSorin Group USA, Inc.
Medical DeviceAug 9, 2017
SORIN GROUP, SMART PERFUSION PACK, INSPIRE 8S, REF 044036101, STERILE EO, Rx Only, 1 EA recall — FDA Z-2794-2017
Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged in pouches which may have small pinholes (approximately 1mm or less in diameter). The result…
Class IIFDA: TerminatedSorin Group USA, Inc.
Medical DeviceAug 9, 2017
Sentinel CH SPA MULTIGENT Creatinine (Enzymatic), Catalog Numbers 8L24-31 and 8L24-41 recall — FDA Z-2867-2017
Reagent 1 component may result in Quality Control values shifting out of acceptable range, which is not resolved by recalibration.
Class IIFDA: TerminatedSentinel CH SPA
Medical DeviceAug 9, 2017
SORIN GROUP, SMART PERFUSION PACK, TOTAL VISION SYSTEM-SMA, REF 084510101, STERILE EO, Rx recall — FDA Z-2793-2017
Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged in pouches which may have small pinholes (approximately 1mm or less in diameter). The result…
Class IIFDA: TerminatedSorin Group USA, Inc.
Medical DeviceAug 9, 2017
Myelotec Video Guided Catheters, REF 2010 3.0 mm OD x 30 Cm Working Length, Two 1.3mm recall — FDA Z-2779-2017
Obstructed/blocked port from defective VGC Access Port Body component.
Class IIFDA: OngoingMyelotec, Inc.
Medical DeviceAug 9, 2017
GE Inspection Technologies Blade|line Industrial Cabinet X-ray system recall — FDA Z-2777-2017
GE Inspection Technologies, LP determined that the Blade|line cabinet x-ray system fails to comply with the cabinet x-ray performance standards emission limit of 0.5 milliRoentgen in one…
Class IIFDA: TerminatedGE Inspection Technologies, LP
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.