Stryker Sustainability Solutions recalls
Stryker Sustainability Solutions appears in 71 official U.S. recall notices indexed by RecallRadar.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
- Stryker Sustainability Solutions Reprocessed BW Lasso 2515 NAV eco Variable Diagnostic EP Catheters, Ref D134301, Sterile, Rx. The Reproces…
FDA Device · Class II · 2018-03-14 · Stryker Sustainability Solutions
Reason: An EEPROM chip error code may occur when the catheters are used with CARTO EP Navigation Systems. - Stryker Sustainability Solutions Reprocessed BW Lasso 2515 NAV eco Variable Diagnostic EP Catheters, Ref D134302, Sterile, Rx. The Reproces…
FDA Device · Class II · 2018-03-14 · Stryker Sustainability Solutions
Reason: An EEPROM chip error code may occur when the catheters are used with CARTO EP Navigation Systems. - 3040-VenaFlow Calf Garment (Aircast) Quick Connect was mislabeled as 3010-PL Aircast Pos-Lock Connector
FDA Device · Class II · 2017-12-27 · Stryker Sustainability Solutions
Reason: 3040 compression sleeves being mislabeled as a 3010-PL compression sleeves. - Reprocessed Electrophysiology Catheter Cables Catalog Number: CB3434CT, D134401, CB3410CT, CB3412CT Electrophysiology catheter cables are d…
FDA Device · Class II · 2017-01-18 · Stryker Sustainability Solutions
Reason: A breach in the sterile packaging may have occurred resulting in potentially non-sterile product. - Reprocessed Ablation Catheter Cable Catalog Number: CR3425CT, CR3434CT Ablation catheter cables are designed as electrode cables with a mul…
FDA Device · Class II · 2017-01-18 · Stryker Sustainability Solutions
Reason: A breach in the sterile packaging may have occurred resulting in potentially non-sterile product. - Reprocessed Xcel Bladeless Trocar (H12LP) Model # H12LP Reprocessed Endoscopic Trocars are indicated for use to establish a port of entry f…
FDA Device · Class II · 2016-12-21 · Stryker Sustainability Solutions
Reason: An increase in reports indicating that the reprocessed H12LP Trocar adjustable plug may break in the packaging or during use. - Reprocessed Daig Steerable and Daig Supreme Fixed Curve Diagnostic Electrophysiology Catheters Model Numbers: 401940, 402004 UPC Code: 0088…
FDA Device · Class II · 2016-11-16 · Stryker Sustainability Solutions
Reason: The EP Catheters may be mislabeled for French size during reprocessing. - Reprocessed Pressure Tourniquet Cuff (PTC) Tourniquet cuffs are single- or dual-bladder inflatable cuffs connected to a tourniquet system v…
FDA Device · Class II · 2016-11-09 · Stryker Sustainability Solutions
Reason: Issue with the process for detection of leaking Pressure Tourniquet Cuffs (PTC). Leaking PTC devices may result in excessive blood loss requiring surgical or medical intervention or systemic leakage of local anesthetic… - AngioDynamics Soft Vu Omni Flush Angiographic Catheter Model Number: 10732203
FDA Device · Class I · 2016-07-27 · Stryker Sustainability Solutions
Reason: Product defect; tip of two (2) Angiographic Catheters model # 10732203 broke off, prior to being used on the patient. - Reprocessed Daig Supreme Fixed Curve Diagnostic Electrophysiology Catheters
FDA Device · Class II · 2016-06-01 · Stryker Sustainability Solutions
Reason: Mislabeled for size - Mallinckrodt Evac Tracheal Tubes Model #124170-MALLINCKRODT & 124175
FDA Device · Class II · 2016-05-18 · Stryker Sustainability Solutions
Reason: Device packaging may not be sealed. - Launcher Guiding Catheter Model #LA6EBU30
FDA Device · Class II · 2016-05-18 · Stryker Sustainability Solutions
Reason: Device packaging may not be sealed. - Reprocessed Stryker Color Cuff and Color Cuff II Adult Tourniquet Cuffs Model Numbers: 5921-218-135, 5921-044-135, 5921-034-135, 5921-034-2…
FDA Device · Class II · 2016-01-20 · Stryker Sustainability Solutions
Reason: Reprocessed Stryker Pressure Tourniquet Cuffs were mislabeled, including some labeled as single port when they contained dual port, and vice versa. - The Fuhrman Pleural/Pneumopericardial Drainage Set The Fuhrman Pleural/Pneumopericardial Drainage Set consists of pigtail catheter, access…
FDA Device · Class I · 2016-01-13 · Stryker Sustainability Solutions
Reason: Stryker Sustainability Solutions is recalling the Fuhrman Pleural & Pneumopericardial Drainage Set due to receiving complaints that it broke off in the pleural cavity while inserting the device into the patient. - SSS Reprocessed Zimmer, Synthes, Stryker and Linvatec Drill Bits and Blades Surgical drill bits, blades, burs, chisels, rasps, taps and rea…
FDA Device · Class II · 2015-11-18 · Stryker Sustainability Solutions
Reason: It was reported that packaging was not properly sealed. - Stryker Sustainability Solutions CB5LT Ethicon Endo-Surgery, Inc
FDA Device · Class II · 2015-09-02 · Stryker Sustainability Solutions
Reason: Stryker Sustainability Solutions has received reports indicating that devices from one lot (lot# 3574704) were labeled as 100mm models (CB5LT) while the devices inside of the packaging were 75mm models (CB5ST). - Cannula and Seal
FDA Device · Class II · 2015-07-01 · Stryker Sustainability Solutions
Reason: Stryker Sustainability Solutions is recalling Trocars because they have received reports indicating that some may fracture at the distal tip resulting in fragments at the surgical site. - Fios First Entry
FDA Device · Class II · 2015-07-01 · Stryker Sustainability Solutions
Reason: Stryker Sustainability Solutions is recalling Trocars because they have received reports indicating that some may fracture at the distal tip resulting in fragments at the surgical site. - Optical Access System
FDA Device · Class II · 2015-07-01 · Stryker Sustainability Solutions
Reason: Stryker Sustainability Solutions is recalling Trocars because they have received reports indicating that some may fracture at the distal tip resulting in fragments at the surgical site. - Reprocessed Diagnostic Electrophysiology (EP) Catheters and Diagnostic EP Catheter Cables, Model Numbers: D6-DR-252-RT, F6-QF-252RT, 201101…
FDA Device · Class II · 2013-11-27 · Stryker Sustainability Solutions
Reason: Stryker Sustainability Solutions is recalling the Reprocessed Diagnostic Electrophysiology (EP) Catheters Cables due to a potential sterility breach in the package seal. - STRYKER Sustainability Solutions, AC Power Adaptor for Restep Deep Vein Thrombosis (DVT) System, an external compression system
FDA Device · Class II · 2013-02-27 · Stryker Sustainability Solutions
Reason: Reports that the AC Power Adaptor may not operate due to wires coming loose in the unit.