Device recall: Transport Stretcher 747 - a non-powered, wheeled device designed to support patients in a horizontal position, Part…
Class II FDA enforcement event 88199. Recall start date: . Status in the FDA record: Ongoing.
Reason for recall, in the words of FDA
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
Class II, in the words of FDA
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Stryker Medical Division of Stryker Corporation started this device recall on 12 May 2021. The firm address in the FDA record is in Portage, MI. FDA put the recall in Class II. FDA event 88199 has 19 product records. The first FDA enforcement report date is 18 Aug 2021. The record gives the status Ongoing.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
Worldwide distribution - US Nationwide distribution and the countries of Argentina, Brazil, Canada, Chile, Colombia, India, Mexico, Thailand.
Recalling firm
Stryker Medical Division of Stryker Corporation, Portage, MI.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
19 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2205-2021 | Transport Stretcher 747 - a non-powered, wheeled device designed to support patients in a horizontal position, Part Number 0747000000 | 3 units | Class II | Ongoing | 18 Aug 2021 |
| Z-2206-2021 | Surgistool-intended to support a healthcare professional during surgical procedures Model 830, Part Number 0830000000 | 4 units | Class II | Ongoing | 18 Aug 2021 |
| Z-2207-2021 | 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 | 3 units | Class II | Ongoing | 18 Aug 2021 |
| Z-2208-2021 | 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 | 1 unit | Class II | Ongoing | 18 Aug 2021 |
| Z-2209-2021 | 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 | 2 units | Class II | Ongoing | 18 Aug 2021 |
| Z-2210-2021 | InTouch 2131-intended to support a human patient in an acute care setting, Model Number: 2131000000, Part #1460000000 | 2 units | Class II | Ongoing | 18 Aug 2021 |
| Z-2211-2021 | Proform- support surface is used to assist in the prevention and treatment of all categories/stages of pressure ulcers, Model Number: 2710, Part #2710000027 | 1 unit | Class II | Ongoing | 18 Aug 2021 |
| Z-2212-2021 | ComfortGel - assists in the prevention and treatment of all pressure injury stages, Model Number 2850, Part # 2850000999, 2850000001, 2850000009 | 3 units | Class II | Ongoing | 18 Aug 2021 |
| Z-2213-2021 | IsoGel Air - support surface assists in the prevention and treatment of all pressure ulcers stages, Model Number 2860, Part 2860000999 | 3 units | Class II | Ongoing | 18 Aug 2021 |
| Z-2214-2021 | 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 | 21 units | Class II | Ongoing | 18 Aug 2021 |
| Z-2215-2021 | 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 | 1 unit | Class II | Ongoing | 18 Aug 2021 |
| Z-2216-2021 | S3 MedSurg Bed - intended to support and transport patients within the Med/Surg and Critical Care hospital environments, Model Number: 3005, Part # 3005S3EX | 4 units | Class II | Ongoing | 18 Aug 2021 |
| Z-2217-2021 | TruRize Clinical Chair - support structure that places human occupants in upright, seated, recline, supine, and trend positions, Model Number: 3333, Part #3333000000 | 1 unit | Class II | Ongoing | 18 Aug 2021 |
| Z-2218-2021 | Symmetry Plus Treatment Recliner - general hospital use as a convenient seating surface for patients or guests to sit, Model Number 3500, Part # 3500000710 | 3 units | Class II | Ongoing | 18 Aug 2021 |
| Z-2219-2021 | 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 | 1 unit | Class II | Ongoing | 18 Aug 2021 |
| Z-2220-2021 | Stretcher Chair-for use in all acute care hospitals and medical outpatient services Model Number: 5050 Part # 5050000000 | 1 unit | Class II | Ongoing | 18 Aug 2021 |
| Z-2221-2021 | 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 | 2 units | Class II | Ongoing | 18 Aug 2021 |
| Z-2222-2021 | 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 | 9 units | Class II | Ongoing | 18 Aug 2021 |
| Z-2223-2021 | GoBed II MedSurg Bed, Model Number FL28, Part #FL28EX | 33 units | Class II | Ongoing | 18 Aug 2021 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2021
- 900
- Share of these events in Class II
- 89%
- Product records in this event
- 19Median of the firm: 1
- Events of the firm on the register
- 37
Other events of the firm
Stryker Medical Division of Stryker Corporation: all 37 events
Official channels
- FDA enforcement report Z-2205-2021The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
Follow by RSS:Food, drug and device recallsFDA Class I recalls
Cite this page
Recall Register. FDA enforcement event 88199. https://recallregister.com/fda/ii/88199/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
Worldwide distribution - US Nationwide distribution and the countries of Argentina, Brazil, Canada, Chile, Colombia, India, Mexico, Thailand.
- What quantity of product is in FDA event 88199?
- The event has 19 product records. The first record gives this quantity:
3 units
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2021 have the same class?
- 89% of the 900 device events that started in 2021 are in Class II.