Recall archive
37 recalls · page 2 of 2
Reported Dec 21, 2016
Reprocessed Xcel Bladeless Trocar (H12LP) Model # H12LP Reprocessed Endoscopic Trocars are indicated for use to…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Sustainability Solutions
Matched: Brand — An increase in reports indicating that the reprocessed H12LP Trocar adjustable plug may break in the packaging or during use.
FDA (openFDA device enforcement)
Reported Nov 16, 2016
Reprocessed Daig Steerable and Daig Supreme Fixed Curve Diagnostic Electrophysiology Catheters Model Numbers: 401940,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Sustainability Solutions
Matched: Brand — The EP Catheters may be mislabeled for French size during reprocessing.
FDA (openFDA device enforcement)
Reported Nov 9, 2016
Reprocessed Pressure Tourniquet Cuff (PTC) Tourniquet cuffs are single- or dual-bladder inflatable cuffs connected to a…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Sustainability Solutions
Matched: Brand — Issue with the process for detection of leaking Pressure Tourniquet Cuffs (PTC). Leaking PTC devices may result in excessive blood loss requiring…
FDA (openFDA device enforcement)
Reported Jul 27, 2016
AngioDynamics Soft Vu Omni Flush Angiographic Catheter Model Number: 10732203
High riskUsing this product could cause serious injury, illness or death — stop using it now.Stryker Sustainability Solutions
Matched: Brand — Product defect; tip of two (2) Angiographic Catheters model # 10732203 broke off, prior to being used on the patient.
FDA (openFDA device enforcement)
Reported Jun 1, 2016
Reprocessed Daig Supreme Fixed Curve Diagnostic Electrophysiology Catheters; Model #: 401450, 401877. Indicated for…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Sustainability Solutions
Matched: Brand — Mislabeled for size
FDA (openFDA device enforcement)
Reported May 18, 2016
Mallinckrodt Evac Tracheal Tubes Model #124170-MALLINCKRODT & 124175
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Sustainability Solutions
Matched: Brand — Device packaging may not be sealed.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jan 20, 2016
Reprocessed Stryker Color Cuff and Color Cuff II Adult Tourniquet Cuffs Model Numbers: 5921-218-135, 5921-044-135,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Sustainability Solutions
Matched: Brand · Product · Product details · Reason for recall — Reprocessed Stryker Pressure Tourniquet Cuffs were mislabeled, including some labeled as single port when they contained dual port, and vice versa.
FDA (openFDA device enforcement)
Reported Jan 13, 2016
The Fuhrman Pleural/Pneumopericardial Drainage Set The Fuhrman Pleural/Pneumopericardial Drainage Set consists of…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Stryker Sustainability Solutions
Matched: Brand · Reason for recall — Stryker Sustainability Solutions is recalling the Fuhrman Pleural & Pneumopericardial Drainage Set due to receiving complaints that it broke off in…
FDA (openFDA device enforcement)
Reported Nov 18, 2015
SSS Reprocessed Zimmer, Synthes, Stryker and Linvatec Drill Bits and Blades Surgical drill bits, blades, burs, chisels,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Sustainability Solutions
Matched: Brand · Product · Product details — It was reported that packaging was not properly sealed.
FDA (openFDA device enforcement)
Reported Sep 2, 2015
Stryker Sustainability Solutions CB5LT Ethicon Endo-Surgery, Inc. Excel Trocar Sleeve w/Stability Sleeve 5mm x 100mm…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Sustainability Solutions
Matched: Brand · Product · Product details · Reason for recall — Stryker Sustainability Solutions has received reports indicating that devices from one lot (lot# 3574704) were labeled as 100mm models (CB5LT) while…
FDA (openFDA device enforcement)
Reported Jul 1, 2015
Fios First Entry; 5mm x 100mm and 12mm x 100mm; Model #:CTF03 and CTF73. Indicated for use to establish a port of entry…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Sustainability Solutions
Matched: Brand · Reason for recall — Stryker Sustainability Solutions is recalling Trocars because they have received reports indicating that some may fracture at the distal tip…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 27, 2013
Reprocessed Diagnostic Electrophysiology (EP) Catheters and Diagnostic EP Catheter Cables, Model Numbers: D6-DR-252-RT,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Sustainability Solutions
Matched: Brand · Reason for recall — Stryker Sustainability Solutions is recalling the Reprocessed Diagnostic Electrophysiology (EP) Catheters Cables due to a potential sterility breach…
FDA (openFDA device enforcement)
Reported Feb 27, 2013
STRYKER Sustainability Solutions, AC Power Adaptor for Restep Deep Vein Thrombosis (DVT) System, an external…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Sustainability Solutions
Matched: Brand · Product · Product details — Reports that the AC Power Adaptor may not operate due to wires coming loose in the unit.
FDA (openFDA device enforcement)
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