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.
The povidone iodine prep pads included in certain kits and trays do not meet the requirements for a 36-month shelf life and should be labeled with a 24-month shelf life.
These labels are deterministic app interpretations, not FDA categories.
The povidone iodine prep pads included in certain kits and trays do not meet the requirements for a 36-month shelf life and should be labeled with a 24-month shelf life.
Code information
Lots: 13F16H0183, 13F17E0728, 13F17F0525, 23F16E1188, 23F16H0911; Expiration dates: October 2018 through March 2020
Distribution pattern
US nationwide distribution, including Puerto Rico.
The povidone iodine prep pads included in certain kits and trays do not meet the requirements for a 36-month shelf life and should be labeled with a 24-month shelf life.
These labels are deterministic app interpretations, not FDA categories.
The povidone iodine prep pads included in certain kits and trays do not meet the requirements for a 36-month shelf life and should be labeled with a 24-month shelf life.
Code information
Lots: 13F16H0263, 13F16J0335, 13F16K0145, 13F16M0246, 13F17C0500, 13F17F0199, 13F17F0473, 13F17F0530, 13F17G0325, 23F16E1189, 23F16E1190, 23F16F0474, 23F16F1041, 23F16H0164; Expiration dates: October 2018 through March 2020
Distribution pattern
US nationwide distribution, including Puerto Rico.
The povidone iodine prep pads included in certain kits and trays do not meet the requirements for a 36-month shelf life and should be labeled with a 24-month shelf life.
These labels are deterministic app interpretations, not FDA categories.
The povidone iodine prep pads included in certain kits and trays do not meet the requirements for a 36-month shelf life and should be labeled with a 24-month shelf life.
Code information
Lots: 13F16H0430, 13F16M0224, 13F16M0242, 13F17F0150, 13F17F0475, 13F17G0240, 23F16E1193, 23F16F0476, 23F16G0085, 23F16H0013, 23F16H0680; Expiration dates: October 2018 through March 2020
Distribution pattern
US nationwide distribution, including Puerto Rico.
The povidone iodine prep pads included in certain kits and trays do not meet the requirements for a 36-month shelf life and should be labeled with a 24-month shelf life.
These labels are deterministic app interpretations, not FDA categories.
The povidone iodine prep pads included in certain kits and trays do not meet the requirements for a 36-month shelf life and should be labeled with a 24-month shelf life.
Code information
Lots: 13F16H0289, 13F16M0161, 13F17E0858, 13F17G0178, 23F16E1191, 23F16H0163; Expiration dates: October 2018 through March 2020
Distribution pattern
US nationwide distribution, including Puerto Rico.
The povidone iodine prep pads included in certain kits and trays do not meet the requirements for a 36-month shelf life and should be labeled with a 24-month shelf life.
These labels are deterministic app interpretations, not FDA categories.
The povidone iodine prep pads included in certain kits and trays do not meet the requirements for a 36-month shelf life and should be labeled with a 24-month shelf life.
Code information
Lots: 13F16H0329, 13F17F0074, 13F17G0237; Expiration dates: October 2018 through March 2020
Distribution pattern
US nationwide distribution, including Puerto Rico.
The povidone iodine prep pads included in certain kits and trays do not meet the requirements for a 36-month shelf life and should be labeled with a 24-month shelf life.
These labels are deterministic app interpretations, not FDA categories.
The povidone iodine prep pads included in certain kits and trays do not meet the requirements for a 36-month shelf life and should be labeled with a 24-month shelf life.
Code information
Lots: 13F16H0429, 13F16M0214, 13F17F0281, 23F16H0161, 23F16J0018; Expiration dates: October 2018 through March 2020
Distribution pattern
US nationwide distribution, including Puerto Rico.
The povidone iodine prep pads included in certain kits and trays do not meet the requirements for a 36-month shelf life and should be labeled with a 24-month shelf life.
These labels are deterministic app interpretations, not FDA categories.
The povidone iodine prep pads included in certain kits and trays do not meet the requirements for a 36-month shelf life and should be labeled with a 24-month shelf life.
Code information
Lots: 13F17A0292, 13F17C0309, 13F17E0359, 13F17G0300, 13F17J0242, 23F16F0623, 23F16G0675; Expiration dates: October 2018 through March 2020
Distribution pattern
US nationwide distribution, including Puerto Rico.