Concerto & Basic Shower Trolly — Class II medical device recall Z-1452-2020
Terminated recall by ARJOHUNTLEIGH POLSKA Sp. z.o.o., reported 2020-03-18, distributed in CA, CO, CT, GA, MA, MD, MI, NC…. The firm has become aware that any of the 4 safety catches may exhibit a mechanical failure (break in one of t
| Recall number | Z-1452-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | ARJOHUNTLEIGH POLSKA Sp. z.o.o., Komorniki, Poland |
| Recall initiated | 2019-08-22 |
| Classified | 2020-03-06 |
| Reported by FDA | 2020-03-18 |
| Terminated | 2022-02-15 |
| Distributed | CA, CO, CT, GA, MA, MD, MI, NC, NJ, NY, OH, OK, TX, VA, WI |
| Countries outside the US | AE, AT, AU, BD, BE, CA, CH, CN, CZ, DE, DK, ES, FI, FR, GB, HK, IE, IN, IS, IT, JP, KR, LU, NL, NO, NZ, PH, PL, SE, SG, SI, TW, ZA |
| Quantity | 669 trollys |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 05055982787949, 05055982788007, 05055982788021, 05055982788083, 05055982788106, 05055982788120, 05055982788144, 05055982796156, 05055982796163, 05055982796187, 05055982796194, 05055982796248, 05055982796255, 05056097364483 |
| Serial numbers | 1106000338, P0232526, P0249502, P0279164, P0422951, P0512263, P0551621, SEE0348065, SEE045073, SEE0520032, SEE0605124, SEE0643339 |
| Model numbers | 8451622, 8546608, BAB1000-01, S8523559-031, S8533570-031, S8533571-031, S8533572-031, S8542201-014 |
Product
Concerto & Basic Shower Trolly, Model Numbers BAB1000-01 (UDI: (01)05055982788083), BAB1000CON6102 [(01)05056097364483], BAB1007-01 [(01)05055982796255], BAB1101-01 [(01)05055982787949], BAB1102-01 [(01)05055982796156], BAB1103-01 [UDI: (01)05055982796163], BAB1107-01 [(01)05055982796187], BAB2000-01 [UDI: (01)05055982788106], BAB2101-01 [(01)05055982788007], BAB2102-01 [01)05055982796194], BAB3000-01 [(01)05055982788120], BAB3101-01 [(01)05055982788021], BAB3107-01[ (01)05055982796248], BAB5000-01 [UDI: (01)05055982788144]. and Concerto & Basic Shower Trolley Spare parts (safety catch) part no. 8451622, 8546608, S8533571-031, S8533572-031, S8533570-031 S8542201-014, S8523559-031,
Reason for recall
The firm has become aware that any of the 4 safety catches may exhibit a mechanical failure (break in one of the arms of safety catch), which in certain circumstances may contribute to the side support unintentionally opening and may lead to a potential risk of a patient fall. The patient falling could lead to various types of injuries.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1452-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.