PlainRecalls
ModerateClass IITerminated

FDA Devices recall · Reported August 4, 2021

Zippie Voyage, early intervention stroller - Product Usage: is manually operated by a caregiver for purposes of assisting a disabled person while providing supportive elements for assisted transportation and seating for a child or small adult not to exceed 75 pounds.

The seating system unexpectedly detached, which resulted in the seating system falling to the ground, causing injury.

Recall #
Z-2157-2021
Affected scope
9,865 devices
Initiated
July 8, 2021
Verify with FDA Devices →
View my saved recalls

Sunrise Medical (US) LLC recalled Zippie Voyage, early intervention stroller - Product Usage: is manually operated by a car… - a moderate-severity action.

Zippie Voyage, early intervention stroller - Product Usage: is manually operated by a car… was recalled by Sunrise Medical (US) LLC in August 4, 2021. Reason: The seating system unexpectedly detached, which resulted in the seating system falling to the ground, causing…. Check the official notice for the remedy. Verify recall #Z-2157-2021 with the FDA Devices before acting.

The recall

Sunrise Medical (US) LLC issued this moderate-severity FDA Devices recall-The seating system unexpectedly detached, which resulted in the seating system falling to the ground, causing….

Moderate
severity level
10K units
affected scope
Class II
classification
August 4, 2021
reported

Sourced from official FDA Devices enforcement records. Verify recall #Z-2157-2021 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.

Medical Devices recalls over time

Where this recall sits in its category - 41,021 medical devices recalls on record

01,0002,0003,0004,000 20052008201120142017202020232026 1,947
Severity1906864652High severity (most serious)Moderate severityLow severity
Where this agency-classified recall sits among FDA Class I/II/III notices

Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.

Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.

Product description

Zippie Voyage, early intervention stroller - Product Usage: is manually operated by a caregiver for purposes of assisting a disabled person while providing supportive elements for assisted transportation and seating for a child or small adult not to exceed 75 pounds.

Reason for recall

The seating system unexpectedly detached, which resulted in the seating system falling to the ground, causing injury.

Recall Profile

Structured summary of the FDA Devices recall record
Attribute Value
Agency U.S. Food and Drug Administration
Severity class Moderate (Class II)
Status Terminated
Recall number Z-2157-2021
Date reported August 4, 2021
Date initiated July 8, 2021
Recalling firm Sunrise Medical (US) LLC
Firm location Fresno, CA
Affected scope 9,865 devices
Distribution Worldwide distribution - U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto…

Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.

Scale of Impact

9,865 devices units affected - limited or regional distribution scale.

Regional (<10K units) ✓ This recall
Multi-state (10K – 100K units) -
Large-scale (100K – 1M units) -
Massive (≥1M units) -

Bracket cutoffs follow federal recall-disclosure conventions; bar widths scale linearly within each bracket. Source: PlainRecalls analysis of U.S. Food and Drug Administration filings.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

  • Check the recall number (Z-2157-2021) and product description against the item you own. Search the archive
  • Confirm the current status with FDA Devices before acting, recall details can be updated.
  • Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next

This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.

Frequently Asked Questions

What product was recalled?
Zippie Voyage, early intervention stroller - Product Usage: is manually operated by a caregiver for purposes of assisting a disabled person while providing supportive elements for assisted transportation and seating for a child or small adult not to exceed 75 pounds.. Recalled by Sunrise Medical (US) LLC. Units affected: 9,865 devices.
Why was this product recalled?
The seating system unexpectedly detached, which resulted in the seating system falling to the ground, causing injury.
Which agency issued this recall?
This recall was issued by the FDA Devices on August 4, 2021. Severity: Moderate. Recall number: Z-2157-2021.
Where was the recalled product distributed?
Distribution: Worldwide distribution - U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY. The countries of United Kingdom, Germany, France, Canada, Italy, Netherlands, Poland, Czech Republic, Australia, Hong Kong, Japan, Qatar, Norway, United Arab Emirates, China, Saudi Arabia, Sweden, Switzerland, Spain, Indonesia, India, Singapore, Bahrain and Israel..
Should I stop using a recalled medication or medical device?
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

Nationwide recalls with similar severity or category timing

Drug and device notices outside this firm and state, matched by severity timing and product category.

Compare this recall with GORE VIABIL Short Wire Biliary Endoprosthesis, Model No. VS… → · All Medical Devices recalls

This recall: FDA Devices, reported August 4, 2021. Severity classes follow each agency's own taxonomy; related-recall context is computed across the full archive.

Methodology · Corrections · Archive as of August 2026