FDA Device recall Z-0076-2027

Brand Name: ADAPTABLE Beach Chair Product Name: Beach Chair surgical patient positioner Model/Catalog Number: 804-33-300 (Enovis)

FDA Device
Class II
ongoing
Published 2026-10-14

On 2026-10-14 the FDA classified a Class II recall of Brand Name: ADAPTABLE Beach Chair Product Name: Beach Chair surgical patient positioner Model/Catalog Number: 804-33-300 (Enovis) by Quantum Ops, citing due to a manufacturing issue (inadequate weld) for patient head positioning system.

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-0076-2027
Classification	Class II
Status	ongoing
Initiated	2026-07-24
Published	2026-10-14
Last updated	2026-10-21 05:30 UTC
Company	Quantum Ops
Distribution	US

Product

Brand Name: ADAPTABLE Beach Chair Product Name: Beach Chair surgical patient positioner Model/Catalog Number: 804-33-300 (Enovis); 3105-400-030 (Stryker); internal BC-0001 / BC-0220 Software Version: N/A Product Description: Surgical beach-chair positioner that mounts to the accessory rails of the OR table leg section to elevate and support the patient's upper body in the upright (beach chair) position during surgical procedures. Component: No, finished device. The failure is in the BC-0105, subcomponent.

Reason

Due to a manufacturing issue (inadequate weld) for patient head positioning system.

Identifiers

code_info	Lot Code: GTIN / UDI-DI: 00190446667278 Affected lots / serials: Product Number: 3105-400-030 Lots: 2021110101 Serial… Lot Code: GTIN / UDI-DI: 00190446667278 Affected lots / serials: Product Number: 3105-400-030 Lots: 2021110101 Serial Numbers: A-026 A-027 A-028 A-029 A-030 A-031 A-032 A-033 A-034 A-035 A-036 A-037 A-038 A-039 A-040 Lot Number: 2021120201 Serial Numbers: A-041 A-042 A-043 A-044 A-045 A-046 A-047 A-048 A-049 A-050 A-051 A-052 A-053 A-054 A-056 A-057 A-058 A-059 A-060 A-061 A-062 A-063 A-064 A-065 A-066 A-067 A-068 A-069 A-070 Lot Number: 2022010601 Serial Numbers: A-071 A-072 A-073 A-074 A-075 A-076 A-077 A-078 A-079 A-082 A-083 A-084 A-087 A-090 A-091 A-092 A-093 A-094 A-095 A-099 Lot Number: 2023012501 Serial Numbers: C-051 C-052 C-053 C-054 C-055 C-056 C-057 C-058 C-059 C-060 C-061 C-062 C-063 C-064 C-065 C-066 C-067 Lot Number: 2023020201 Serial Numbers: C-001 C-002 C-003 C-004 C-005 C-006 C-007 C-008 C-009 C-010 C-011 C-012 C-013 C-014 C-015 C-016 C-017 C-018 C-019 C-020 C-021 C-022 C-023 C-024 C-025 C-026 C-027 C-028 C-029 C-030 C-031 Lot Number: 2023060101 Serial Numbers:

code_info

Lot Code: GTIN / UDI-DI: 00190446667278 Affected lots / serials: Product Number: 3105-400-030 Lots: 2021110101 Serial…

Lot Code: GTIN / UDI-DI: 00190446667278 Affected lots / serials: Product Number: 3105-400-030 Lots: 2021110101 Serial Numbers: A-026 A-027 A-028 A-029 A-030 A-031 A-032 A-033 A-034 A-035 A-036 A-037 A-038 A-039 A-040 Lot Number: 2021120201 Serial Numbers: A-041 A-042 A-043 A-044 A-045 A-046 A-047 A-048 A-049 A-050 A-051 A-052 A-053 A-054 A-056 A-057 A-058 A-059 A-060 A-061 A-062 A-063 A-064 A-065 A-066 A-067 A-068 A-069 A-070 Lot Number: 2022010601 Serial Numbers: A-071 A-072 A-073 A-074 A-075 A-076 A-077 A-078 A-079 A-082 A-083 A-084 A-087 A-090 A-091 A-092 A-093 A-094 A-095 A-099 Lot Number: 2023012501 Serial Numbers: C-051 C-052 C-053 C-054 C-055 C-056 C-057 C-058 C-059 C-060 C-061 C-062 C-063 C-064 C-065 C-066 C-067 Lot Number: 2023020201 Serial Numbers: C-001 C-002 C-003 C-004 C-005 C-006 C-007 C-008 C-009 C-010 C-011 C-012 C-013 C-014 C-015 C-016 C-017 C-018 C-019 C-020 C-021 C-022 C-023 C-024 C-025 C-026 C-027 C-028 C-029 C-030 C-031 Lot Number: 2023060101 Serial Numbers:

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-10-21 05:30 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0076-2027%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.