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.
Injection solutions would not flow as intended through the tip of 25ga-sized needles. Investigations that some units contained debris from the manufacturing process within the inner sheath that blocked the ID of the needle.
These labels are deterministic app interpretations, not FDA categories.
Injection solutions would not flow as intended through the tip of 25ga-sized needles. Investigations that some units contained debris from the manufacturing process within the inner sheath that blocked the ID of the needle.
Injection solutions would not flow as intended through the tip of 25ga-sized needles. Investigations that some units contained debris from the manufacturing process within the inner sheath that blocked the ID of the needle.
These labels are deterministic app interpretations, not FDA categories.
Injection solutions would not flow as intended through the tip of 25ga-sized needles. Investigations that some units contained debris from the manufacturing process within the inner sheath that blocked the ID of the needle.
Code information
Catalog Number: 4702; UDI-DI: M84947020; Lot Numbers: H08-23-263, H01-24-114.
Distribution pattern
Worldwide - US Nationwide distribution in the states of CT, GA, IN, MI, MN, MS, NH, NJ, NY, OH, TN, VT, WA, WI, WV and the country of Canada.
Injection solutions would not flow as intended through the tip of 25ga-sized needles. Investigations that some units contained debris from the manufacturing process within the inner sheath that blocked the ID of the needle.
These labels are deterministic app interpretations, not FDA categories.
Injection solutions would not flow as intended through the tip of 25ga-sized needles. Investigations that some units contained debris from the manufacturing process within the inner sheath that blocked the ID of the needle.
Code information
Catalog Number: 4706; UDI-DI: M84947060; Lot Number: SD09-23-089.
Distribution pattern
Worldwide - US Nationwide distribution in the states of CT, GA, IN, MI, MN, MS, NH, NJ, NY, OH, TN, VT, WA, WI, WV and the country of Canada.
Injection solutions would not flow as intended through the tip of 25ga-sized needles. Investigations that some units contained debris from the manufacturing process within the inner sheath that blocked the ID of the needle.
These labels are deterministic app interpretations, not FDA categories.
Injection solutions would not flow as intended through the tip of 25ga-sized needles. Investigations that some units contained debris from the manufacturing process within the inner sheath that blocked the ID of the needle.
Code information
Catalog Number: 4716; UDI-DI: M84947160; Lot Number: H01-24-076.
Distribution pattern
Worldwide - US Nationwide distribution in the states of CT, GA, IN, MI, MN, MS, NH, NJ, NY, OH, TN, VT, WA, WI, WV and the country of Canada.
Injection solutions would not flow as intended through the tip of 25ga-sized needles. Investigations that some units contained debris from the manufacturing process within the inner sheath that blocked the ID of the needle.
These labels are deterministic app interpretations, not FDA categories.
Injection solutions would not flow as intended through the tip of 25ga-sized needles. Investigations that some units contained debris from the manufacturing process within the inner sheath that blocked the ID of the needle.
Code information
Catalog Number: 4721; UDI-DI: M84947210; Lot Number: H11-23-057.
Distribution pattern
Worldwide - US Nationwide distribution in the states of CT, GA, IN, MI, MN, MS, NH, NJ, NY, OH, TN, VT, WA, WI, WV and the country of Canada.
Injection solutions would not flow as intended through the tip of 25ga-sized needles. Investigations that some units contained debris from the manufacturing process within the inner sheath that blocked the ID of the needle.
These labels are deterministic app interpretations, not FDA categories.
Injection solutions would not flow as intended through the tip of 25ga-sized needles. Investigations that some units contained debris from the manufacturing process within the inner sheath that blocked the ID of the needle.
Code information
Catalog Number: 4704; UDI-DI: M84947040; Lot Numbers: H10-23-106, H11-23-059.
Distribution pattern
Worldwide - US Nationwide distribution in the states of CT, GA, IN, MI, MN, MS, NH, NJ, NY, OH, TN, VT, WA, WI, WV and the country of Canada.
Injection solutions would not flow as intended through the tip of 25ga-sized needles. Investigations that some units contained debris from the manufacturing process within the inner sheath that blocked the ID of the needle.
These labels are deterministic app interpretations, not FDA categories.
Injection solutions would not flow as intended through the tip of 25ga-sized needles. Investigations that some units contained debris from the manufacturing process within the inner sheath that blocked the ID of the needle.
Code information
Catalog Number: 4718; UDI-DI: M84947180; Lot Numbers: H08-23-264, H09-23-112.
Distribution pattern
Worldwide - US Nationwide distribution in the states of CT, GA, IN, MI, MN, MS, NH, NJ, NY, OH, TN, VT, WA, WI, WV and the country of Canada.
Injection solutions would not flow as intended through the tip of 25ga-sized needles. Investigations that some units contained debris from the manufacturing process within the inner sheath that blocked the ID of the needle.
These labels are deterministic app interpretations, not FDA categories.
Injection solutions would not flow as intended through the tip of 25ga-sized needles. Investigations that some units contained debris from the manufacturing process within the inner sheath that blocked the ID of the needle.
Injection solutions would not flow as intended through the tip of 25ga-sized needles. Investigations that some units contained debris from the manufacturing process within the inner sheath that blocked the ID of the needle.
These labels are deterministic app interpretations, not FDA categories.
Injection solutions would not flow as intended through the tip of 25ga-sized needles. Investigations that some units contained debris from the manufacturing process within the inner sheath that blocked the ID of the needle.
Code information
Catalog Number: 4723; UDI-DI: M84947230; Lot Numbers: H07-23-107, H08-23-034.
Distribution pattern
Worldwide - US Nationwide distribution in the states of CT, GA, IN, MI, MN, MS, NH, NJ, NY, OH, TN, VT, WA, WI, WV and the country of Canada.
