PlainRecalls
FDA Devices Verify with FDA Devices → Moderate Class II Terminated

Enterprise 8000 Bed; an AC-powered adjustable hospital bed; ArjoHuntleigh AB, Eslov, Sweden; Models 8000, 8001, 8002, 8003, 8500, 8600, 8700 and 8800 General medicine, general and specialist surgery, care of the elderly, HDU, ITU, coronary care and oncology. The bed is appropriate for high dependency patients who pose a movement and handling risk and/or whose clinical condition requires that they are positioned with the minimal physical handling.

Reported: August 14, 2013 Initiated: November 16, 2012 #Z-0476-2013 94 beds in U.S., 31 beds in Canada, 26,010 beds in ROW units

Arjo, Inc. dba ArjoHuntleigh issued this FDA Devices recall on August 14, 2013. Classified as Moderate severity (Class II). Approximately 94 beds in U.S., 31 beds in Canada, 26,010 beds in ROW units are affected. The recall was issued because: ArjoHuntleigh has received reports of unintended movement where the backrest and/or thigh sections of the bed have move…. This recall notice is sourced from official FDA Devices enforcement records. Below you will find the complete product description, hazard information, remedy instructions, and related recalls from the same manufacturer or product category.

Recall Insight

This FDA Devices action (record #Z-0476-2013) was formally reported on August 14, 2013, with the manufacturer initiating the action on November 16, 2012. It is classified under Moderate severity (Class II), with a current status of Terminated. Arjo, Inc. dba ArjoHuntleigh is listed as the recalling firm, operating out of Addison, IL. Federal records indicate 94 beds in U.S., 31 beds in Canada, 26,010 beds in ROW units are affected, placing this recall in the million-unit bracket that typically triggers nationwide consumer alerts and retailer sweeps.

The documented reason for this recall is: ArjoHuntleigh has received reports of unintended movement where the backrest and/or thigh sections of the bed have moved without anyone consciously pressing the control button. These incidents have occurred in High Dep… Distribution data in the federal record shows the product reached: Worldwide Distribution-USA (nationwide, including Puerto Rico) and the countries of Algeria, Angola, Australia, Austria, Bahrain, Belgium, Bosnia and Herzegovia, Botswana, Brazil, Canada, Chile, China, Colombia, Costa R…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 13 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.

Recall Distribution by Severity Class

Severity1Class I (Critical)Class II (Moderate)Class III (Low)
Recall Distribution by Severity Class

Severity

Moderate

Units Affected

94 beds in U.S., 31 beds in Canada, 26,010 beds in ROW

Related Recalls

6

6 from same agency

Product Description

Enterprise 8000 Bed; an AC-powered adjustable hospital bed; ArjoHuntleigh AB, Eslov, Sweden; Models 8000, 8001, 8002, 8003, 8500, 8600, 8700 and 8800 General medicine, general and specialist surgery, care of the elderly, HDU, ITU, coronary care and oncology. The bed is appropriate for high dependency patients who pose a movement and handling risk and/or whose clinical condition requires that they are positioned with the minimal physical handling.

Reason for Recall

ArjoHuntleigh has received reports of unintended movement where the backrest and/or thigh sections of the bed have moved without anyone consciously pressing the control button. These incidents have occurred in High Dependency and Intensive Therapy environments where unintended movement of the patient may have serious consequences.

Details

Units Affected
94 beds in U.S., 31 beds in Canada, 26,010 beds in ROW
Distribution
Worldwide Distribution-USA (nationwide, including Puerto Rico) and the countries of Algeria, Angola, Australia, Austria, Bahrain, Belgium, Bosnia and Herzegovia, Botswana, Brazil, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cuba, Czech Republic, Denmark, Ecuador, Egypt, Falkland Islands, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Jordan, Kenya, Kuwait, Lebanon, Libyan Arab Jamahira, Lithuania, Malaysia, Malta, Mauritius, Mexico, Morocco, the Netherlands, New Zealand, Nigeria, Nordic, Norway, Oman, Panama, Poland, Qatar, Romania, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sri Lanka, Switzerland, Syrian Arab Republic, Thailand, Turkey, United Kingdom, United Arab Emirates, Uruguay, Venezuela and Yemen.
Location
Addison, IL

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-0476-2013
Date reported August 14, 2013
Date initiated November 16, 2012
Recalling firm Arjo, Inc. dba ArjoHuntleigh
Units affected 94 beds in U.S., 31 beds in Canada, 26,010 beds in ROW
Distribution Worldwide Distribution-USA (nationwide, including Puerto Rico) and the countries of Algeria, Angola, Australia, Austria, Bahrain, Belgium, Bosnia and Herzegovia, Botswana, Brazil, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cuba, …

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

Scale of Impact

94 beds in U.S., 31 beds in Canada, 26,010 beds in ROW units affected — million-unit bracket.

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

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.

Frequently Asked Questions

What product was recalled?
Enterprise 8000 Bed; an AC-powered adjustable hospital bed; ArjoHuntleigh AB, Eslov, Sweden; Models 8000, 8001, 8002, 8003, 8500, 8600, 8700 and 8800 General medicine, general and specialist surgery, care of the elderly, HDU, ITU, coronary care and oncology. The bed is appropriate for high dependency patients who pose a movement and handling risk and/or whose clinical condition requires that they are positioned with the minimal physical handling.. Recalled by Arjo, Inc. dba ArjoHuntleigh. Units affected: 94 beds in U.S., 31 beds in Canada, 26,010 beds in ROW.
Why was this product recalled?
ArjoHuntleigh has received reports of unintended movement where the backrest and/or thigh sections of the bed have moved without anyone consciously pressing the control button. These incidents have occurred in High Dependency and Intensive Therapy environments where unintended movement of the patient may have serious consequences.
Which agency issued this recall?
This recall was issued by the FDA Devices on August 14, 2013. Severity: Moderate. Recall number: Z-0476-2013.
Where was the recalled product distributed?
Distribution: Worldwide Distribution-USA (nationwide, including Puerto Rico) and the countries of Algeria, Angola, Australia, Austria, Bahrain, Belgium, Bosnia and Herzegovia, Botswana, Brazil, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cuba, Czech Republic, Denmark, Ecuador, Egypt, Falkland Islands, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Jordan, Kenya, Kuwait, Lebanon, Libyan Arab Jamahira, Lithuania, Malaysia, Malta, Mauritius, Mexico, Morocco, the Netherlands, New Zealand, Nigeria, Nordic, Norway, Oman, Panama, Poland, Qatar, Romania, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sri Lanka, Switzerland, Syrian Arab Republic, Thailand, Turkey, United Kingdom, United Arab Emirates, Uruguay, Venezuela and Yemen..
How do I check if my product is affected by a recall?
Check the product description and recall number (Z-0476-2013) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
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.

Recall Context

Product recalls are issued when a manufacturer, distributor, or federal agency determines that a product poses a safety risk to consumers. This recall is classified as moderate severity, indicating the product may cause temporary or medically reversible health consequences. Across PlainRecalls, we track 83,000+ recalls from FDA, CPSC, and NHTSA to help consumers stay informed and act quickly when safety issues arise.

Nearby Recalls in This Category

Other recalls in the same product category — useful for spotting patterns across the same defect class or manufacturer.

Compare this recall with Endo-Model Replacement Plateau; Item Number: 15-0027/11; →

Data Sources

Data as of 2025. Source: FDA, CPSC, NHTSA, USDA FSIS federal recall databases.

  • Source: FDA — Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
  • Source: CPSC — Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
  • Source: NHTSA — National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)
  • Source: USDA FSIS — Food Safety and Inspection Service (meat, poultry, and egg product recalls)

Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.

All federal data sources used on this page

Source: Federal recall agencies (FDA, CPSC, NHTSA, USDA FSIS) Aggregated multi-agency recall feeds · 2024 Recall data normalized across federal agency feeds; severity classifications follow each agency's own taxonomy (FDA Class I/II/III; CPSC, NHTSA, USDA FSIS).