CLASS II ONGOING Device recall · Reported 14 Oct 2026 · FDA Enforcement Report
Adaptable Beach Chair Beach Chair surgical patient positioner recalled
Quantum OPS is recalling Adaptable Beach Chair Beach Chair surgical patient positioner, distributed nationwide in the US. The recall was initiated on 24 Jul 2026 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0076-2027
- FDA event ID
- 99384
- Recalling firm
- Quantum OPS, Chattanooga, TN
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 24 Jul 2026
- FDA classified
- 2 Oct 2026
- Reported
- 14 Oct 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Surgical Instruments
Timeline
| 24 Jul 2026 | Recall initiated by company | |
| 2 Oct 2026 | Classified by FDA | +70 days |
| 14 Oct 2026 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Due to a manufacturing issue (inadequate weld) for patient head positioning system.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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.
Where it was distributed
U.S. Nationwide distribution in the states of CA and TX.
Questions about this recall
Why was it recalled?
Due to a manufacturing issue (inadequate weld) for patient head positioning system.
Which lots are affected?
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: C-081 C-082 C-083 C-084 C-085 C-086 C-087 C-088 C-089 C-090 C-091 C-092 C-093 C-094 C-095 Lot Number: 2023071801 Serial Numbers: C-096 C-097 C-098 C-099 C-100 C-101 C-102 C-103 C-104 C-105 C-106 C-107 C-108 C-109 C-110 C-111 C-112 C-113 C-114 C-115 C-116 C-117 C-118 C-119 C-120 C-121 C-122 Lot Number: 2024081401 Serial Numbers: C-123 C-124 C-125 C-126 C-127 C-128 C-129 C-130 C-131 C-132 Lot Number: 2024091001 Serial Numbers: C-133 C-134 C-135 C-136 C-137 C-138 C-139 C-140 C-141 C-142 C-143 C-144 C-145 C-146 C-147 Lot Number: 2024100301 Serial Numbers: C-148 C-149 C-150 C-151 C-152 C-153 C-154 C-155 C-156 C-157 Lot Number: 2024110401 Serial Numbers: C-158 C-159 C-160 C-161 C-162 C-163 C-164 C-165 C-166 C-167 C-168 C-169 C-170 C-171 C-172 Product Number: 804-33-300 Lot Number: 2020102701 Serial Numbers: A-001 A-002 A-003 A-004 A-005 A-006 A-007 A-010 A-011 A-012 Lot Number: 2021050601 Serial Numbers: A-014 A-015 A-016 A-017 A-018 A-019 A-020 A-021 A-023 A-024 Lot Number: 2022031701 Serial Numbers: A-0131 A-0132 A-0133 A-0134 A-0135 A-0136 A-0138 A-0139 A-0140 Lot Number: 2023020101 Serial Numbers: C-068 C-069 C-070 C-073 C-071 C-072 C-074 C-075 C-076 C-077 C-078 C-079 C-080 Lot Number: 2023032001 Serial Numbers: C-032 C-033 C-034 C-035 C-036 C-037 C-038 C-039 C-040 C-041 C-042 C-043 C-044 C-045 C-046 C-047 C-048 C-049 C-050 2020101201. Excluded (demo/undelivered): A-008, A-009, A-013, A-022, A-025, A-0137.
Where was it sold?
U.S. Nationwide distribution in the states of CA and TX.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Oct 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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