| | Class 2 Device Recall Liko CeilingMounted Overhead Patient Lift System |  |
| Date Initiated by Firm | September 14, 2026 |
| Date Posted | October 13, 2026 |
| Recall Status1 |
Open3, Classified |
| Recall Number | Z-0151-2027 |
| Recall Event ID |
99802 |
| Product Classification |
Lift, patient, non-ac-powered - Product Code FSA
|
| Product | Likorall Overhead Lifts
Product Code: 3121001
Product Description: LIKORALL 200
Product Code: 3122005
Product Description: LIKORALL 242 ES, NATURAL
Product Code: 3122005NA
Product Description: LIKORALL 242 ES, NATURAL
Product Code: 3122006
Product Description: LIKORALL 242 ES, WHITE
Product Code: 3122006NA
Product Description: LIKORALL 242 ES, WHITE
Product Code: 3122007
Product Description: LIKORALL 242 ES R2R, NATURAL
Product Code: 3122007NA
Product Description: LIKORALL 242 ES R2R, NATURAL
Product Code: 3122008
Product Description: LIKORALL 242 ES R2R, WHITE
Product Code: 3122008NA
Product Description: LIKORALL 242 ES R2R, WHITE
Product Code: 3122009
Product Description: LIKORALL 242 S, NATURAL
Product Code: 3122009NA
Product Description: LIKORALL 242 S, NATURAL
Product Code: 3122010
Product Description: LIKORALL 242 S, WHITE
Product Code: 3122011
Product Description: LIKORALL 242 S R2R, NATURAL
Product Code: 3122011NA
Product Description: LIKORALL 242 S R2R, NATURAL
Product Code: 3122012
Product Description: LIKORALL 242 S R2R, WHITE
Product Code: 3122012NA
Product Description: LIKORALL 242 S R2R, WHITE
Product Code: 3122501
Product Description: LIKORALL 250 ES, NATURAL
Product Code: 3122501NA
Product Description: LIKORALL 250 ES, NATURAL
Product Code: 3122502
Product Description: LIKORALL 250 ES, WHITE
Product Code: 3122502NA
Product Description: LIKORALL 250 ES, WHITE
Product Code: 3123001
Product Description: LIKORALL 243 ES
Product Code: 3123001NA
Product Description: LIKORALL 243 ES
Product Code: 3123002
Product Description: LIKORALL 243 ES, WHITE
Product Code: 3123002NA
Product Description: LIKORALL 243 ES, WHITE
Product Code: 3124050
Product Description: LIKORALL 250 S, IRC |
| Code Information |
Product Code: 3121001
Product Description: LIKORALL 200
Lot/Serial Number: Intervals: 8400054-8450499 and 9000000-9000999
UDI-DI Number: 00887761981911
Product Code: 3122005
Product Description: LIKORALL 242 ES, NATURAL
Lot/Serial Number: Greater than or equal to 8104548
UDI-DI Number: 00887761979710
Product Code: 3122005NA
Product Description: LIKORALL 242 ES, NATURAL
Lot/Serial Number: Interval: 429087-431032
UDI-DI Number: 00887761979727
Product Code: 3122006
Product Description: LIKORALL 242 ES, WHITE
Lot/Serial Number: Greater than or equal to: 8101715
UDI-DI Number: 00887761979734
Product Code: 3122006NA
Product Description: LIKORALL 242 ES, WHITE
Lot/Serial Number: Interval: 429186-431035
UDI-DI Number: 00887761979741
Product Code: 3122007
Product Description: LIKORALL 242 ES R2R, NATURAL
Lot/Serial Number: Greater than or equal to: 8104481
UDI-DI Number: 00887761979758
Product Code: 3122007NA
Product Description: LIKORALL 242 ES R2R, NATURAL
Lot/Serial Number: Interval: 429041-430984
UDI-DI Number: 00887761979765
Product Code: 3122008
Product Description: LIKORALL 242 ES R2R, WHITE
Lot/Serial Number: Greater than or equal to: 8100815
UDI-DI Number: 00887761979772
Product Code: 3122008NA
Product Description: LIKORALL 242 ES R2R, WHITE
Lot/Serial Number: Interval: 429081-431018
UDI-DI Number: 00887761979789
Product Code: 3122009
Product Description: LIKORALL 242 S, NATURAL
Lot/Serial Number: Greater than or equal to: 8000235
UDI-DI Number: 00887761979796
Product Code: 3122009NA
Product Description: LIKORALL 242 S, NATURAL
Lot/Serial Number: Interval: 286125-289686
UDI-DI Number: 00887761979802
Product Code: 3122010
Product Description: LIKORALL 242 S, WHITE
Lot/Serial Number: Greater than or equal to: 8000114
UDI-DI Number: 00887761979819
Product Code: 3122011
Product Description: LIKORALL 242 S R2R, NATURAL
Lot/Serial Number: Greater than or equal to: 8001716
UDI-DI Number: 00887761979444
Product Code: 3122011NA
Product Description: LIKORALL 242 S R2R, NATURAL
Lot/Serial Number: Interval: 286040-289602
UDI-DI Number: 00887761979451
Product Code: 3122012
Product Description: LIKORALL 242 S R2R, WHITE
Lot/Serial Number: Greater than or equal to: 8014169
UDI-DI Number: 00887761979468
Product Code: 3122012NA
Product Description: LIKORALL 242 S R2R, WHITE
Lot/Serial Number: Interval: 286047-289640
UDI-DI Number: 00887761979475
Product Code: 3122501
Product Description: LIKORALL 250 ES, NATURAL
Lot/Serial Number: Greater than or equal to: 8300562
UDI-DI Number: 00887761979482
Product Code: 3122501NA
Product Description: LIKORALL 250 ES, NATURAL
Lot/Serial Number: Interval: 6604187-6606919
UDI-DI Number: 00887761979499
Product Code: 3122502
Product Description: LIKORALL 250 ES, WHITE
Lot/Serial Number: Greater than or equal to: 8300004
UDI-DI Number: 00887761979505
Product Code: 3122502NA
Product Description: LIKORALL 250 ES, WHITE
Lot/Serial Number: Interval: 6604051-6606836
UDI-DI Number: 00887761979512
Product Code: 3123001
Product Description: LIKORALL 243 ES
Lot/Serial Number: Greater than or equal to: 8200065
UDI-DI Number: 00887761979529
Product Code: 3123001NA
Product Description: LIKORALL 243 ES
Lot/Serial Number: Interval: 362939-368654
UDI-DI Number: 00887761979536
Product Code: 3123002
Product Description: LIKORALL 243 ES, WHITE
Lot/Serial Number: Greater than or equal to: 8206060
UDI-DI Number: 00887761979543
Product Code: 3123002NA
Product Description: LIKORALL 243 ES, WHITE
Lot/Serial Number: Interval: 368113-368658
UDI-DI Number: 00887761979550
Product Code: 3124050
Product Description: LIKORALL 250 S, IRC
Lot/Serial Number: Interval: 2108-24074
UDI-DI Number: 00887761979567
|
| FEI Number |
1417572
|
Recalling Firm/ Manufacturer |
Baxter Healthcare Corporation
1 Baxter Pkwy
Deerfield
IL
60015-4625
|
| For Additional Information Contact | Center for One Baxter 1-847-9484770 |
Manufacturer Reason for Recall | Potential issue involving motor shaft breakage combined with reduced performance of the Single Fault Safety (SFS) system may lead to instances where the lift strap lowers more quickly than expected during use. Patients are at some risk for injury if a significant fall/drop were to occur due to this issue. |
FDA Determined Cause 2 | Process control |
| Action | The firm began mailing Urgent Medical Device Correction letters to facilities on September 14, 2026. Home patient communication was sent on September 15, 2026.
Customers were informed that Baxter has developed procedures to inspect devices and correct them as needed. A Baxter representative will contact customer facilities to provide instructions or to coordinate onsite completion of these activities.
The firm recommends that a Mobile Lift be used as an alternative until the correction can be made. Additional safety precautions were given in case the customer chooses to continue to use potentially affected product prior to the correction. |
| Distribution | Worldwide - US Nationwide distribution including in the states of Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, Wisconsin, and Wyoming. International distribution in pending. |
| Total Product Life Cycle | TPLC Device Report |
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
|
|
|
|