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Use caution Medical device recall · FDA · Published May 12, 2021

Stryker Prime Fifth Wheel Stretcher Recall: Home Use Risk

Stryker recalls Prime Fifth Wheel Stretcher model 1105 for home use. The device is intended for healthcare facilities but may be used at home without proper training, risking injury.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-2207-2021Medical deviceStryker ›
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Contact the company

Recalling firmStryker Medical Division of Stryker Corporation3800 E Centre Ave · Portage, MI 49002-5826
✎ GovInfoNow plain-language explainer

Stryker is recalling its Prime Fifth Wheel Stretcher model 1105 because it was distributed to residential customers instead of healthcare facilities. Home users may not understand the proper use instructions intended for healthcare professionals, which could lead to injury. Read more at govinfonow.com/recall/62548-stryker-prime-fifth-wheel-stretcher-recall-home-use-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/62548-stryker-prime-fifth-wheel-stretcher-recall-home-use-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2207-2021

Cite this page

“Stryker Prime Fifth Wheel Stretcher Recall: Home Use Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62548-stryker-prime-fifth-wheel-stretcher-recall-home-use-risk. Based on FDA recall #Z-2207-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2207-2021%22&limit=1).

The FDA announced on May 12, 2021, that Stryker Medical Division of Stryker Corporation is recalling Prime Fifth Wheel Stretchers because they were distributed to residential customers. The agency stated home users may not understand the labeling intended for healthcare professionals.

How to tell if you have it

  • Brand: Stryker
  • Product: Prime Fifth Wheel Stretcher
  • Model: 1105
  • Part Numbers: 1105000026, 1105000000X
  • UDI (DI#): 07613327278149, 07613327278194
  • Quantity: 3 units

The hazard

The FDA said the medical devices were distributed to residential customers and may be in use in a home environment. The agency noted that home users may not be aware of or fully understand the instructions intended for healthcare professionals.

Context

GovInfoNow's records show Stryker Medical Division of Stryker Corporation has had 17 other recalls on record since July 21, 2017. Recent brand recalls include a Feb. 18, 2026, notice for Cub Pediatric Cribs missing warning labels and an Oct. 31, 2025, recall of Arise 1000EX Mattresses for incompatible use with MV3 Beds. Other recent recalls of similar products include a Daig Livewire Steerable Catheter recall for incomplete sterile seals (April 10, 2026) and an XCEL Bladeless Trocar recall for cracking risk (Aug. 19, 2026).

How to tell if you have this one

Check for model number 1105 and part numbers 1105000026 or 1105000000X. The device was sold to residential customers, not healthcare facilities.

  • Brand
    Stryker
  • Category
    Medical device
FDA recall event · 19 products

All 19 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Ongoing
  • Distribution
    Worldwide distribution - US Nationwide distribution and the countries of Argentina, Brazil, Canada, Chile, Colombia, India, Mexico, Thailand.
Recall numberProduct, codes & lotsQuantity
Z-2205-2021Transport Stretcher 747 - a non-powered, wheeled device designed to support patients in a horizontal position, Part Number 0747000000; UDI (DI#): 076133272781873 units
Z-2206-2021Surgistool-intended to support a healthcare professional during surgical procedures Model 830, Part Number 0830000000; Serial Numbers: 1202033898 1206032470 1406034563 1607037109 UDI (DI#): 076133272825664 units
Z-2207-2021Prime Fifth Wheel Stretcher-stretcher may be used for minor procedures and short-term stay (treatment and recovery, Model 1105, Part Numbers 1105000026 and 1105000000X; UDI (DI#) 07613327278149 07613327278149 076133272781943 units
Z-2208-2021Prime 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; UDI (DI#): 076133272783301 unit
Z-2209-2021Prime 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¿¿¿¿¿¿¿; Serial Numbers: 1911040132 1911040133 UDI: 076133272826652 units
Z-2210-2021InTouch 2131-intended to support a human patient in an acute care setting, Model Number: 2131000000, Part #1460000000¿¿¿¿¿¿¿; Serial Numbers: U54274 U71491 UDI:076133271692942 units
Z-2211-2021Proform- support surface is used to assist in the prevention and treatment of all categories/stages of pressure ulcers, Model Number: 2710, Part #¿2710000027¿¿¿¿; Serial Numbers: 111427102713678 UDI:N/A1 unit
Z-2212-2021ComfortGel - assists in the prevention and treatment of all pressure injury stages, Model Number 2850, Part # 2850000999, 2850000001, 2850000009; Serial Numbers: 20170928500311838 UDI: 07613327277852 076133272779373 units
Z-2213-2021IsoGel Air - support surface assists in the prevention and treatment of all pressure ulcers stages, Model Number 2860, Part 2860000999; Serial Numbers: 031528600216109 051428600212599 081328600206460 UDI: 076133272985123 units
Z-2214-2021S3 MedSurg Bed - intended to support and transport patients within the Med/Surg and Critical Care hospital environments, Model Number 3002, Part 3002S3CUSTOM, 3002S3EX, 3002S3PATRIOT; Serial Numbers: 110715076 110915596 110915597 111015378 111015411 110515348 110515556 110517101 110915707 110915708 110915743 111118747 111215214 111216659 111216660 111216671 110717082 110717084 140915228 150615371 100215401 UDI: 0761332727840821 units
Z-2215-2021Isolibrium 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; Serial Numbers: 219009000417 UDI: 076133272784531 unit
Z-2216-2021S3 MedSurg Bed - intended to support and transport patients within the Med/Surg and Critical Care hospital environments, Model Number: 3005, Part # 3005S3EX; Serial Numbers: 120916611 121016000 130115957 130815166 UDI: 076133272783094 units
Z-2217-2021TruRize Clinical Chair - support structure that places human occupants in upright, seated, recline, supine, and trend positions, Model Number: 3333, Part #¿3333000000; Serial Numbers: 2017000300284 UDI: 076133273225691 unit
Z-2218-2021Symmetry Plus Treatment Recliner - general hospital use as a convenient seating surface for patients or guests to sit, Model Number 3500, Part # 3500000710; Serial Numbers: G201170298 G201181816 G201318385 UDI: 076133272824363 units
Z-2219-2021Michael 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 ¿; Serial Numbers: G201179538 UDI: 076133275061291 unit
Z-2220-2021Stretcher Chair-for use in all acute care hospitals and medical outpatient services Model Number: 5050¿¿¿¿ Part # 5050000000; Serial Numbers: N/A UDI: 076133272825111 unit
Z-2221-2021CUB 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; Serial Numbers: F09519 F50699 UDI:076133271693482 units
Z-2222-2021Electric 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; Serial Numbers: FL23J50576 FL23J50577 FL23J60424 FL23J60627 J32346 J32347 J32348 J32350 J29770 UDI: N/A9 units
Z-2223-2021GoBed II MedSurg Bed, Model Number FL28, Part #FL28EX; Serial Numbers: R52495 R53376 R55047 R56034 M14805 M14885 M14886 M14931 M14936 M14938 M14939 M50074 M50425 M50951 M50956 M54387 R63407 R54523 R54610 R54696 R54698 R60775 R32649 R25384 R35631 R35734 R58735 M15330 R58474 UDI: 07613327169355 0761332716938633 units
Based on the official FDA remedy

What to do — step by step

  1. Check Product Details

    Identify the model number and part numbers to confirm if your stretcher is affected.

  2. Contact Stryker

    Reach out to Stryker for guidance on next steps if you have the affected model.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “Worldwide distribution - US Nationwide distribution and the countries of Argentina, Brazil, Canada, Chile, Colombia, India, Mexico, Thailand.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA published this recall 3 months after the firm started it.

1. Firm started the recall: May 12, 202112. FDA classified it Class II: Aug 6, 202123. Published in FDA’s Enforcement Report: Aug 18, 202132021
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-2207-2021 (May 12, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2207-2021 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA