openFDA Device Enforcement
Report-date coverage
June 20, 2012–July 08, 2026
Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall
event_date_initiated coverage
June 01, 1997–June 30, 2026
Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.
Product dates, classifications, firms, and source wording remain attached to their individual rows.
Opening this dossier never hides products that did not match a prior timeline filter.
device · product 1 of 6
Allen Advance Table, RSP-ADVANCE TABLE: a) REF A-71100-US, #107003, b) A-71101-EU, #107003. operating room table
the adhesive, applied to screws and bolts as an additional holding force, may not cure correctly, and as a result, could result in a loss of holding and reduced mechanical integrity.
These labels are deterministic app interpretations, not FDA categories.
the adhesive, applied to screws and bolts as an additional holding force, may not cure correctly, and as a result, could result in a loss of holding and reduced mechanical integrity.
Code information
a) UDI/DI 00615521003012, Serial Number 122190000035, Lot Number 122220000528 b) UDI/DI 00615521003036, Serial Number 122230000655, Lot Number 122180001460
Distribution pattern
MI, BA, WI, WA, TX, and Germany, Japan, South Korea, Sweden, South Africa
device · product 2 of 6
C-Flex Polar Head Positnr-Device Only, SSP-NEUROSURGICAL HEADREST, REF A-70701, #103001,
the adhesive, applied to screws and bolts as an additional holding force, may not cure correctly, and as a result, could result in a loss of holding and reduced mechanical integrity.
These labels are deterministic app interpretations, not FDA categories.
the adhesive, applied to screws and bolts as an additional holding force, may not cure correctly, and as a result, could result in a loss of holding and reduced mechanical integrity.
Code information
UDI/DI 00615521002701, Lot Numbers: 122190000182, 122190001101
Distribution pattern
MI, BA, WI, WA, TX, and Germany, Japan, South Korea, Sweden, South Africa
device · product 3 of 6
Allen Standard Starburst, Mayfield/Doro, STANDARD SPINE POSITIONERS CMPT, REF A-70710, #800103. Component to position and support the patients head in surgical procedures.
the adhesive, applied to screws and bolts as an additional holding force, may not cure correctly, and as a result, could result in a loss of holding and reduced mechanical integrity.
These labels are deterministic app interpretations, not FDA categories.
the adhesive, applied to screws and bolts as an additional holding force, may not cure correctly, and as a result, could result in a loss of holding and reduced mechanical integrity.
Code information
UDI/DI 00615521002725, Lot Number: 22-123
Distribution pattern
MI, BA, WI, WA, TX, and Germany, Japan, South Korea, Sweden, South Africa
device · product 4 of 6
Beach Chair Clamp, BEACH CHAIR SHLDER POSITIONER CMPT, REF A-90013, #800104. Component to position and support the patients head in surgical procedures.
the adhesive, applied to screws and bolts as an additional holding force, may not cure correctly, and as a result, could result in a loss of holding and reduced mechanical integrity.
These labels are deterministic app interpretations, not FDA categories.
the adhesive, applied to screws and bolts as an additional holding force, may not cure correctly, and as a result, could result in a loss of holding and reduced mechanical integrity.
Code information
UDI/DI 00615521003920, Lot Number: 10-22-140
Distribution pattern
MI, BA, WI, WA, TX, and Germany, Japan, South Korea, Sweden, South Africa
device · product 5 of 6
Allen Life Assist Beach Chair, BCSSP-BEACH CHAIR , REF A-91501, #104002. For use with orthopaedic procedures using the Fowlers or beach chair position.
the adhesive, applied to screws and bolts as an additional holding force, may not cure correctly, and as a result, could result in a loss of holding and reduced mechanical integrity.
These labels are deterministic app interpretations, not FDA categories.
the adhesive, applied to screws and bolts as an additional holding force, may not cure correctly, and as a result, could result in a loss of holding and reduced mechanical integrity.
Code information
UDI/DI 00615521004125, Lot Number: 22-123
Distribution pattern
MI, BA, WI, WA, TX, and Germany, Japan, South Korea, Sweden, South Africa
device · product 6 of 6
Simple Clamp, US/EURO Rails, UPPER EXTREMITY DISTRACTION CMPT, REF F-40018, #800101. To position, support and/or distract the patients hand, wrist, forearm, arm, and shoulder in surgical procedures.
the adhesive, applied to screws and bolts as an additional holding force, may not cure correctly, and as a result, could result in a loss of holding and reduced mechanical integrity.
These labels are deterministic app interpretations, not FDA categories.
the adhesive, applied to screws and bolts as an additional holding force, may not cure correctly, and as a result, could result in a loss of holding and reduced mechanical integrity.
Code information
UDI/DI 00615521012731, Lot Number: 22-124
Distribution pattern
MI, BA, WI, WA, TX, and Germany, Japan, South Korea, Sweden, South Africa
