Z-2376-2016Class II

Volker 2080, 2082, S 280 and S 282 series beds with lateral release button. A/C Powered Adjustable Hospital...

Name: Z-2376-2016 Volker 2080, 2082, S 280 and S 282 series beds with lateral release button. A/C Powered Adjustable Hospital...
Creator: Hill-Rom, Inc.
Published: 2016-06-14
License: https://open.fda.gov/license/

Hill-Rom Inc. / initiated 2016-06-14 / Terminated / root cause: design

FDA source

Hill-Rom, Inc. began a recall of Volker 2080, 2082, S 280 and S 282 series beds with lateral release button. A/C Powered Adjustable Hospital Bed Product Usage: Volker model 2080/3010/3080... on 2016-06-14. FDA classified it as Class II and gives the reason as "The current construction of the side rail latch may not be able to support the full patient weight and may give way allowing the side rail to abruptly lower and the patient to fall, potentially resulting in harm. To...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2376-2016
Classification: Class II
Status: Terminated
Initiated: 2016-06-14
Posted: 2016-08-09
Terminated: 2017-05-15
Recalling firm: Hill-Rom Inc.
Product: Volker 2080, 2082, S 280 and S 282 series beds with lateral release button. A/C Powered Adjustable Hospital Bed Product Usage: Volker model 2080/3010/3080 nursing beds are intended for the care of residents in rooms in nursing homes, in residential homes for the elderly and in suitable rooms in private residences. They may not, however, be used for transportation purposes. Any deviation from this use is expressly excluded from possible liability claims.
Product code: FNL Bed, Ac-Powered Adjustable Hospital
Reason for recall: The current construction of the side rail latch may not be able to support the full patient weight and may give way allowing the side rail to abruptly lower and the patient to fall, potentially resulting in harm. To date there has been one report of a related injury.
Root cause tag: design
FDA root cause: Device Design
Action: Hill-Rom sent an URGENT: MEDICAL DEVICE CORRECTION letter dated June 14, 2016 to the affected US and Canadian customers via email and courier, international customers. The letter included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. The letter requests the number of beds in the consignees possession so that repair kits can be provided. If you have any questions regarding this safety notice, contact Hill-Rom Technical Support at 1-800-445-3720, your distributor, your Hill-Rom representative or contact us on www.hill-rom.com.
Quantity in commerce: 24262
Distribution: Worldwide Distribution - US Nationwide and the countries of: Canada, AUSTRALIA, CHINA, HONG KONG, THAILAND, POLAND, RUSSIAN FEDERATION, SLOVENIA, UNITED ARAB EMIRATES, AUSTRIA, BELGIUM, DENMARK, FINLAND, FRANCE, GERMANY, ICELAND, IRELAND, ISRAEL, ITALY, LUXEMBOURG, NETHERLANDS, NORWAY, SPAIN, SWITZERLAND, and UNITED KINGDOM.
Product codes and lots: All beds (serial numbers) in the 2080, 2082, S 280 and S 282 series are affected by this field action except for those without siderails. The models are as follows: 2080, 2082, 2080 C, 2080 E, 2080 FS, 2080 K, 2080 LP, 2080 MA, 2080 MB, 2080 S, 2080 SL, 2080 SONDER, 2082 SONDER, S280, S280 SONDER, S282, S282 SONDER.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2376-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2376-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-17	2016-08-09

Product code FNL

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)