Manufacturer

Stryker Instruments Div. of Stryker Corporation

161 recalls in our database name Stryker Instruments Div. of Stryker Corporation as the manufacturing or recalling firm.

What the numbers show

Total: 161
Critical: 4
Severe: 11
Most recent: 2022-07-27

Of the 161 recalls from Stryker Instruments Div. of Stryker Corporation we have scored against our rubric, 4 (2%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 11 (7%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

151–161 of 161

ModerateFDA (Devices)·Z-1503-2013·2013-06-12
Stryker T4 Toga Recall Due to Potential Sterile Barrier Breach
Stryker is recalling 2,000 units of T4 Toga surgical drapes due to potential sterile barrier breaches identified in accelerated aging tests.
Product
Stryker Instruments 0400-850-000S2 T4 Toga, XL, w/Inside Tie) Sterile, EO; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0455-2013·2012-12-12
Stryker Neptune 2 Rover Recall Due to Binding Casters
Stryker is recalling 154 Neptune 2 Rover units because a castor design defect can cause binding, leading to operator strain and back pain.
Product
Neptune¿ 2 Rover - ULTRA ~230V ~ 50 Hz 12A REF 0702-002-000, Rx Caution, consult accompanying documents Consult instructions for use, Max Vacuum; 21.0 in-Hg, 530 mm-Hg, The Neptune Waste Management System consists of a mobile rover unit used to suction and collect fluid wa
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0454-2013·2012-12-12
Stryker Neptune 2 Rover Recall Due to Castor Binding Defect
Stryker is recalling Neptune 2 Rover waste management systems because a castor design defect can cause the unit to bind, potentially leading to operator back pain.
Product
Neptune¿ 2 Rover - ULTRA ~120V ~ 60 Hz 12A REF 0702-001-000, Rx, Caution, consult accompanying documents Consult instructions for use, Max Vacuum; 21.0 in-Hg, 530 mm-Hg, The Neptune Waste Management System consists of a mobile rover unit used to suction and collect fluid was
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2064-2012·2012-08-22
Stryker Neptune Waste Management System Recalled Due to Tissue Injury and Fatality
Stryker is recalling Neptune waste management systems after reports of serious tissue injury and one fatality. The devices also lack FDA clearance.
Product
Neptune Rover Waste Management System, Neptune 2 Ultra Intended for use in the surgical environment or physician's office to collect and dispose of surgical fluid waste.
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2063-2012·2012-08-22
Stryker Neptune Waste Management System Recall Due to Tissue Injury and Fatality
Stryker is recalling Neptune waste management system instructions due to reports of serious injury and one fatality from improper use.
Product
Stryker Neptune Bronze Rover, Part 0700-007-000 Neptune Bronze Rover Waste Management System Instructions For Use. Intended for use in the surgical environment or physician's office to collect and dispose of surgical fluid waste.
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2061-2012·2012-08-22
Stryker Neptune 1 Silver Rover Recalled for Tissue Injury and Fatality
Stryker is recalling Neptune 1 Silver Rover devices due to reports of serious tissue injury and a fatality, as well as a lack of FDA clearance.
Product
Neptune 1 Silver Rover, Part 0700-003-000 Stryker Instruments Neptune Rover IFU part 0700-001-700
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2062-2012·2012-08-22
Stryker Neptune 1 Gold Rover Waste Management System Recalled for Injury Risk
Stryker is recalling Neptune 1 Gold Rover waste management systems due to reports of serious injury and a fatality associated with the Neptune 2 system.
Product
Neptune 1 Gold Rover (120 Vand 230V ) Waste Management System Part Number 0700-001-000, 0700-002-000(International) Instructions For Use 0700-001-700, 0700-002-707 Intended for use in the surgical environment or physician's office to collect and dispose of surgical fluid was
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2134-2012·2012-08-08
Stryker Recalls 210 RF Cannula Units Due to Packaging Error
Stryker is recalling 210 RF Cannula units because 5mm and 10mm needles were mistakenly packaged in the wrong boxes. This error could lead to thermal skin lesions if the larger tip is used in cervical procedures.
Product
RF Cannula, 100 mm,Curved 5 MM, 20 G, REF 0406-630-115 RX only, Disposable ( 10/pk) Product Usage: The Stryker RF Cannulae, in combination with the Stryker RF Generator/Multi- Gen and electrodes, are intended for coagulation of soft tissue in orthopedic, arthroscopic, spina
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2135-2012·2012-08-08
Stryker Recalls RF Cannulas Due to Packaging Error
Stryker is recalling 226 units of RF Cannulas because 5mm and 10mm needles were incorrectly packaged in each other's boxes, posing a risk of thermal skin lesions.
Product
RF Cannula, 100 mm,Curved 10 MM, 20 G, REF 0406-630-125 RX only, Disposable ( 10/pk) Product Usage: The Stryker RF Cannulae, in combination with the Stryker RF Generator/Multi- Gen and electrodes, are intended for coagulation of soft tissue in orthopedic, arthroscopic, spin
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1810-2012·2012-06-20
Stryker T4-Hytrel Zipper Toga Recall Due to Missing Tape
Stryker is recalling T4-Hytrel Zipper Togas because clear tape was not applied during manufacturing, allowing bodily fluids to bleed through the sleeve seam.
Product
T4-Hytrel Zipper Toga Product Usage - The togas are intended to provide a barrier between the operating room and the members of the surgical team in order to help protect against contamination and/or exposure of infectious body fluids and harmful microorganisms.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1809-2012·2012-06-20
Stryker T5 Hytrel Zipper Toga Recalled for Missing Protective Tape
Stryker is recalling T5 Hytrel Zipper Togas because clear tape was not applied during manufacturing, allowing bodily fluids to bleed through the sleeve seam.
Product
T5 Hytrel Zipper Toga. Product Usage: The togas are intended to provide a barrier between the operating room and the members of the surgical team in order to help protect against contamination and/or exposure of infectious body fluids and harmful microorganisms.
Category
Medical Device
Distribution
Distributed nationwide