FDA (Devices) recall action 88199

Stryker Medical Division of Stryker Corporation recalled 19 products on 2021-08-18

The FDA (Devices) publishes a recall like this one as 19 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 19 pages.

Products: 19
Announced: 2021-08-18
Critical: 0
Units: 98

Why these products were recalled

Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The product s labeling accurately identifies the correct use environment, but home users may not be aware of or fully understand these instructions intended for healthcare professionals

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–19 of 19

HighFDA (Devices)··2021-08-18
Stryker Prime Big Wheel Stretcher distributed to home users may lack professional-only guidance
The Prime Big Wheel Stretcher was distributed to home users, but is intended for professional healthcare facility use only. Home users may not understand the professional-only instructions, creating safety risks.
Product
Prime Big Wheel Stretcher-used as a short-term outpatient clinical evaluation, treatment, minor procedure, and short-term outpatient recovery platform, Model Number 1115, Part Number 1115000030
Category
Distribution
0 states
HighFDA (Devices)··2021-08-18
Michael Graves Stryker Highback Chair distributed to home users instead of healthcare facilities
Stryker Medical Division recalled its Michael Graves Highback Chair (Model 4853) after it was distributed to residential customers instead of healthcare facilities. Home users may not understand safety instructions written for trained medical professionals.
Product
Michael Graves with Stryker Highback Chair-intended for pediatric and adult person guest and patient seating use in an indoor medical setting, Model Number 4853, Part #4853000000 ¿
Category
Distribution
0 states
HighFDA (Devices)··2021-08-18
Stryker Electric Hospital Beds Recalled for Unintended Home Use
Stryker recalled 9 Electric MedSurg Bed FL23 units intended for healthcare facilities but distributed to residential customers. Professional-level instructions may not be understood by untrained home users.
Product
Electric MedSurg Bed FL23 - AC-powered adjustable hospital bed with four built-in electric DC motors and remote controls that is intended for medical purposes, Model Number: FL23, Part #FL23SE
Category
Distribution
0 states
ModerateFDA (Devices)··2021-08-18
InTouch 2131 Medical Device Recalled for Distribution to Residential Users
Stryker's InTouch 2131 medical device, intended for healthcare facilities, was distributed to residential customers. Home users may not understand healthcare-specific instructions, creating a risk of improper use.
Product
InTouch 2131-intended to support a human patient in an acute care setting, Model Number: 2131000000, Part #1460000000¿¿¿¿¿¿¿
Category
Distribution
0 states
HighFDA (Devices)··2021-08-18
S3 MedSurg hospital beds recalled from residential sale due to misuse risk
Stryker's S3 MedSurg hospital beds designed for healthcare facilities were distributed to home customers. The device labeling is correct but home users may not understand professional-use instructions, posing a risk of improper operation.
Product
S3 MedSurg Bed - intended to support and transport patients within the Med/Surg and Critical Care hospital environments, Model Number 3002, Part 3002S3CUSTOM, 3002S3EX, 3002S3PATRIOT
Category
Distribution
0 states
HighFDA (Devices)··2021-08-18
Transport Stretcher 747 distributed to home users without professional training
Stryker's Transport Stretcher 747, designed for healthcare facilities, was distributed to home users who may not understand its intended-use instructions. The recall addresses risks from improper use by untrained consumers.
Product
Transport Stretcher 747 - a non-powered, wheeled device designed to support patients in a horizontal position, Part Number 0747000000
Category
Distribution
0 states
HighFDA (Devices)··2021-08-18
Stryker CUB Pediatric Crib distributed to home users instead of healthcare facilities
Stryker's CUB Pediatric Crib, designed for hospital use by healthcare professionals, was distributed to home users who may not understand the complex instructions and safety procedures required to operate pediatric medical equipment safely.
Product
CUB Pediatric Crib- intended to provide a pediatric patient support surface for medical purposes and to provide a method of transporting pediatric patients within a healthcare facility Model Number: FL19 Part #5050000000
Category
Distribution
0 states
HighFDA (Devices)··2021-08-18
Stretcher Chair Model 5050 Incorrectly Distributed to Residential Customers
Stryker's Model 5050 stretcher chair was distributed to residential customers despite being designed for healthcare professionals. Home users may not understand instructions intended for trained medical staff, creating a risk of misuse.
Product
Stretcher Chair-for use in all acute care hospitals and medical outpatient services Model Number: 5050¿¿¿¿ Part # 5050000000
Category
Distribution
0 states
ModerateFDA (Devices)··2021-08-18
Prime TC Transport Chair Recalled for Improper Residential Distribution
The Prime TC-transport chair, designed for healthcare facility use, was distributed to residential customers who may not understand the professional-level operating instructions. The recall addresses potential risk of improper use by home users.
Product
Prime TC-transport chair intended for medical purposes to assist a person in performing an activity that the person would find difficult to do or be unable to do Model Number: 1460, Part #1460000000¿¿¿¿¿¿¿
Category
Distribution
0 states
HighFDA (Devices)··2021-08-18
TruRize Clinical Chair distributed to home users who may misuse it
Stryker's TruRize Clinical Chair was distributed to residential customers despite being designed for healthcare facility use only. Home users may not understand safety instructions intended for trained professionals.
Product
TruRize Clinical Chair - support structure that places human occupants in upright, seated, recline, supine, and trend positions, Model Number: 3333, Part #¿3333000000
Category
Distribution
0 states
HighFDA (Devices)··2021-08-18
Stryker Prime Fifth Wheel Stretcher distributed to residential customers instead of healthcare facilities
A medical stretcher designed for healthcare professionals was distributed to residential customers. The device labeling is appropriate for healthcare settings, but home users may not understand or follow the professional-use instructions.
Product
Prime Fifth Wheel Stretcher-stretcher may be used for minor procedures and short-term stay (treatment and recovery, Model 1105, Part Numbers 1105000026 and 1105000000X
Category
Distribution
0 states
HighFDA (Devices)··2021-08-18
Hospital Bed Model 3005 Recalled for Distribution to Home Residents
Stryker's S3 MedSurg hospital bed was distributed to home residents instead of healthcare facilities. The devices are designed for professional operation, and untrained home users may not understand safety instructions.
Product
S3 MedSurg Bed - intended to support and transport patients within the Med/Surg and Critical Care hospital environments, Model Number: 3005, Part # 3005S3EX
Category
Distribution
0 states
HighFDA (Devices)··2021-08-18
Symmetry Plus Treatment Recliner distributed to home users instead of healthcare facilities
A medical treatment recliner designed for healthcare facilities was distributed to home consumers. Home users may not understand the specialized instructions intended for healthcare professionals, creating a potential safety risk.
Product
Symmetry Plus Treatment Recliner - general hospital use as a convenient seating surface for patients or guests to sit, Model Number 3500, Part # 3500000710
Category
Distribution
0 states
HighFDA (Devices)··2021-08-18
Stryker Proform pressure ulcer support surface distributed to home users
Stryker Proform pressure ulcer support surfaces designed for healthcare facility use were distributed to residential customers. The device labeling is correct but home users may not understand professional-level instructions.
Product
Proform- support surface is used to assist in the prevention and treatment of all categories/stages of pressure ulcers, Model Number: 2710, Part #¿2710000027¿¿¿¿
Category
Distribution
0 states
HighFDA (Devices)··2021-08-18
Medical device designed for healthcare professionals distributed to untrained home users
Stryker's ComfortGel pressure injury treatment device was distributed to residential customers for home use, though it was designed for trained healthcare professionals. Home users may not understand the complex instructions intended for professional use.
Product
ComfortGel - assists in the prevention and treatment of all pressure injury stages, Model Number 2850, Part # 2850000999, 2850000001, 2850000009
Category
Distribution
0 states
ModerateFDA (Devices)··2021-08-18
Support Surface Device Distributed to Home Patients Without Healthcare Professional Instructions
An Isolibrium Support Surface intended for healthcare facilities was distributed to home customers. While the labeling is correct, home users may not understand instructions intended for healthcare professionals.
Product
Isolibrium Support Surface - support surface assists in the prevention and treatment of all pressure injury stages (including stages 1, 2, 3, 4, Unstageable and Deep Tissue Pressure Injury, Model Number: 2972, Part # 2972000000
Category
Distribution
0 states
HighFDA (Devices)··2021-08-18
Stryker GoBed II Medical Bed Recalled for Improper Home Distribution
Stryker's GoBed II MedSurg Bed was distributed to residential customers but is intended for healthcare facility use. Home users may not understand professional-level safety instructions, creating a risk of misuse.
Product
GoBed II MedSurg Bed, Model Number FL28, Part #FL28EX
Category
Distribution
0 states
HighFDA (Devices)··2021-08-18
Stryker IsoGel Air Medical Device Distributed to Home Users Instead of Healthcare Facilities
Stryker has recalled 3 IsoGel Air pressure ulcer support surfaces that were distributed to home users when designed for use only in healthcare facilities. Home users may not understand the professional healthcare instructions required for proper use.
Product
IsoGel Air - support surface assists in the prevention and treatment of all pressure ulcers stages, Model Number 2860, Part 2860000999
Category
Distribution
0 states
HighFDA (Devices)··2021-08-18
Stryker Surgistool Model 830 distributed to home users instead of healthcare professionals
Stryker Medical recalls a surgical support tool that was distributed to home consumers but is intended only for healthcare professionals. The device labeling is correct, but home users may lack training to use it safely.
Product
Surgistool-intended to support a healthcare professional during surgical procedures Model 830, Part Number 0830000000
Category
Distribution
0 states