Z-0231-2023Class II

Hill-Rom Progressa Bed System

Name: Z-0231-2023 Hill-Rom Progressa Bed System
Creator: Baxter Healthcare Corporation
Published: 2022-10-18
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2022-10-18 / Open, Classified / root cause: labeling and UDI

FDA source

Baxter Healthcare Corporation began a recall of Hill-Rom Progressa Bed System on 2022-10-18. FDA classified it as Class II and gives the reason as "The compression links on impacted Progressa beds, listed in Appendix A, may bend when raising the head section. The labeling for these beds list a maximum patient weight of 500 lbs., however the bending may still occur...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0231-2023
Classification: Class II
Status: Open, Classified
Initiated: 2022-10-18
Posted: 2022-11-14
Recalling firm: Baxter Healthcare Corporation
Product: Hill-Rom Progressa Bed System
Product code: FNL Bed, Ac-Powered Adjustable Hospital
Reason for recall: The compression links on impacted Progressa beds, listed in Appendix A, may bend when raising the head section. The labeling for these beds list a maximum patient weight of 500 lbs., however the bending may still occur with a patient weight of less than 500 lbs. depending on the patient 's position on the bed.
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: Baxter/Hill-Rom disseminated an URGENT MEDICAL DEVICE CORRECTION NOTICE to its consignees on 10/18/2022 by UPS Ground Service. The notice explained the issue and potential risk and requested the following: "Actions to be taken by Customer: " Please identify if you have the impacted beds per Appendix A in your facility and remove from service immediately. Serial number can be found on the patient right side of the bed under the head rail. Return the enclosed response form within two weeks, confirming serial numbers of impacted beds in your facility. Action to be taken by the Distributor: " Please share this Medical Device Correction Notice with your end users. " Complete response form and return to [email protected] within two weeks, identifying serial numbers of beds to be reworked. Hillrom will arrange shipment of replacement kit and associated instructions." "If you have any questions regarding this Urgent Medical Device Correction, please contact Hillrom Technical Support at 800-445-3720 or [email protected]" Update: On 11/22/2022 (and some on 12/12/2022), the firm issued an URGENT MEDICAL DEVICE CORRECTION NOTICE to additional consignees via UPS Ground Service which provided the same instructions as the initial notification but added 59 additional serial numbers in the Appendix of the notification.
Quantity in commerce: 248 beds (Updated)
Distribution: Worldwide - US Nationwide distribution in the states of AZ, CA, CO, FL, HI, IN, LA, MA, MO, NC, NM, NV, NY, OK, OR, PA, SC. TN, TX, WA, and WI. (UPDATED: States of PA and SC and there was government distribution.) There was no military distribution. Foreign distribution was made to Canada, Qatar, Singapore, and UAE. UPDATE: Saudi Arabia now included.
Product codes and lots: UDI/DI 00887761000100, Serial Numbers: X157AW7312, X206AW8017, X154AW7292, X166AW7416, X207AW8041, X158AW7351, X157AW7326, X157AW7313, X206AW8018, X154AW7293, X166AW7418, X167AW7449, X158AW7352, X157AW7328, X174AW7575, X206AW8019, X154AW7296, X167AW7428, X167AW7450, X158AW7353, X157AW7329, X174AW7579, X206AW8021, X154AW7297, X167AW7429, X167AW7451, X158AW7354, X157AW7330, X181AW7722, X206AW8022, X154AW7298, X157AW7308, X166AW7419, X158AW7355, X157AW7332, X181AW7728, X206AW8023, X154AW7300, X157AW7309, X167AW7425, X206AW8010, X158AW7340, X182AW7736, X206AW8024, X168AW7456, X178AW7622, X167AW7427, X206AW8011, X158AW7341, X182AW7737, X206AW8025, X168AW7478, X178AW7623, X159AW7375, X206AW8012, X158AW7342, X207AW8060, X158AW7344, X171AW7495, X178AW7625, X159AW7378, X206AW8020, X158AW7343, X208AW8079, X206AW8026, X171AW7496, X178AW7626, X159AW7380, X158AW7333, X158AW7349, X208AW8082, X206AW8027, X171AW7497, X178AW7627, X216AW8193, X158AW7334, X158AW7359, X208AW8084, X206AW8028, X171AW7498, X178AW7628, X216AW8194, X158AW7336, X159AW7360, X157AW7305, X206AW8029, X172AW7521, X178AW7629, X168AW7468, X158AW7337, X159AW7361, X158AW7348, X206AW8030, X172AW7522, X154AW7288, X168AW7474, X158AW7338, X159AW7364, X164AW7390, X207AW8038, X172AW7531, X154AW7295, X171AW7481, X158AW7356, X159AW7367, X166AW7403, X207AW8039, X172AW7533, X159AW7370, X206AW8032, X158AW7358, X159AW7374, X167AW7433, X207AW8040, X172AW7534, X159AW7371, X207AW8036, X159AW7363, X159AW7383, X167AW7434, X180AW7693, X173AW7536, X174AW7565, X167AW7447, X154AW7302, X159AW7384, X167AW7435, X181AW7714, X173AW7537, X174AW7567, X172AW7528, X157AW7304, X159AW7385, X201AW7935, X181AW7720, X159AW7382, X199AW7872, X172AW7529, X157AW7316, X159AW7386, X201AW7940, X154AW7289, X166AW7405, X158AW7345, X173AW7539, X157AW7317, X159AW7387, X203AW8005, X154AW7294, X166AW7406, X158AW7346, X173AW7540, X157AW7318, X164AW7395, X203AW8006, X164AW7391, X166AW7407, X158AW7347, X173AW7542, X157AW7320, X166AW7396, X207AW8042, X164AW7392, X166AW7411, X154AW7301, X173AW7543, X157AW7321, X166AW7398, X207AW8043, X164AW7388, X166AW7412, X157AW7311, X173AW7545, X157AW7322, X166AW7399, X207AW8044, X164AW7393, X166AW7414, X159AW7365, X173AW7546, X157AW7324, X166AW7410, X207AW8045, X154AW7291, X166AW7415, X159AW7366, X158AW7350, X157AW7325, X154AW7290 ADDITIONAL SERIAL NUMBERS UPDATED 2/14/2023: X140AW7268, X140AW7269, X140AW7270, X140AW7271, X140AW7272, X140AW7253, X140AW7254, X140AW7255, X140AW7256, X140AW7257, X140AW7258, X140AW7259, X140AW7260, X140AW7262, X140AW7263, X139AW7226, X139AW7227, X139AW7228, X139AW7229, X139AW7230, X103AW6603, X103AW6604, X103AW6605, X103AW6606, X103AW6607, X103AW6608, X103AW6609, X103AW6610, X103AW6611, X103AW6612, X103AW6613, X139AW7232, X139AW7234, X139AW7236, X139AW7237, X139AW7238, X139AW7239, X139AW7240, X139AW7241, X139AW7242, X139AW7243, X140AW7245, X140AW7246, X140AW7249, X140AW7250, X140AW7251, X140AW7252, X140AW7273, X140AW7274, X140AW7275, X154AW7280, X139AW7231, X139AW7235, X139AW7244, X140AW7261, X140AW7264, X140AW7265, X140AW7266, X140AW7267

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0231-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0231-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-11-23	2022-11-14

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)