510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR

Device recalls

Recall records from FDA, newest initiation date first.

Every device recall MDM has ingested. The recall record supplies the product, the reason and the product code; the matching enforcement report supplies the Class I, II or III classification. Where the two have not been joined, the class is left blank rather than assumed.

Data as of , the FDA export date. FDA medical device recall database

59,544 records, page 589 of 1191
FDA device recalls, page 589 of 1191
Recall numberClassProductRecalling firmProduct codeInitiated
Z-1806-2016Class IIAmerican Surgical Telfa 1" x 3" Ref Number: 80-13 Product Usage: Neurosurgical and...American Surgical Company, LLCHBA
Z-1805-2016Class IIAmerican Surgical Telfa 1" x 1" Ref Number: 80-12 Product Usage: Neurosurgical and...American Surgical Company, LLCHBA
Z-1804-2016Class IIAmerican Surgical Telfa 3/4" x 3" Ref Number: 80-11 Product Usage: Neurosurgical and...American Surgical Company, LLCHBA
Z-1803-2016Class IIAmerican Surgical Telfa 1/2" x 3" Ref Number: 80-09 Product Usage: Neurosurgical and...American Surgical Company, LLCHBA
Z-1802-2016Class IIAmerican Surgical Telfa 1/2" x 1.5" Ref Number: 80-08 Product Usage: Neurosurgical and...American Surgical Company, LLCHBA
Z-1801-2016Class IIAmerican Surgical Telfa 1/2" x 1/2" Ref Number: 80-06 Product Usage: Neurosurgical and...American Surgical Company, LLCHBA
Z-1800-2016Class IIAmerican Surgical Telfa 3/8" x 3" Ref Number: 80-05 Product Usage: Neurosurgical and...American Surgical Company, LLCHBA
Z-1799-2016Class IIAmerican Surgical Cylindrical Sponges-Strung 1/2" x 1.5" Ref Number: 70-02 Product...American Surgical Company, LLCEFN
Z-1798-2016Class IIAmerican Surgical Uniqcot 1/2" x 2" Ref Number: 67-29 Product Usage: Neurosurgical and...American Surgical Company, LLCHBA
Z-1797-2016Class IIAmerican Surgical Uniqcot 1/2" x 3" Ref Number: 67-09 Product Usage: Neurosurgical and...American Surgical Company, LLCHBA
Z-1796-2016Class IIAmerican Surgical Uniqcot 1/2" x 1.5" Ref Number: 67-08 Product Usage: Neurosurgical and...American Surgical Company, LLCHBA
Z-1795-2016Class IIAmerican Surgical Uniqcot 1/2" x 1/2" Ref Number: 67-06 Product Usage: Neurosurgical and...American Surgical Company, LLCHBA
Z-1794-2016Class IIAmerican Surgical Uniqcot 1/4" x 1/4" Ref Number: 67-02 Product Usage: Neurosurgical and...American Surgical Company, LLCHBA
Z-1793-2016Class IIAmerican Surgical Delicot X 9 mm x 50 mm Ref Number: 63x07 Product Usage: Neurosurgical...American Surgical Company, LLCHBA
Z-1792-2016Class IIAmerican Surgical Delicot X 6 mm x 50 mm Ref Number: 63x06 Product Usage: Neurosurgical...American Surgical Company, LLCHBA
Z-1791-2016Class IIAmerican Surgical Delicot-J 30 mm x 70 mm Ref Number: 63-10J (Japan Only) Product...American Surgical Company, LLCHBA
Z-1790-2016Class IIAmerican Surgical Delicot 30 mm x 70 mm Ref Number: 63-10 Product Usage: Neurosurgical...American Surgical Company, LLCHBA
Z-1789-2016Class IIAmerican Surgical Delicot 20 mm x 60 mm Ref Number: 63-09 Product Usage: Neurosurgical...American Surgical Company, LLCHBA
Z-1788-2016Class IIAmerican Surgical Delicot-J 13 mm x 60 mm Ref Number: 63-08J (Japan only) Product...American Surgical Company, LLCHBA
Z-1787-2016Class IIAmerican Surgical Delicot 13 mm x 60 mm Ref Number: 63-08 Product Usage: Neurosurgical...American Surgical Company, LLCHBA
Z-1786-2016Class IIAmerican Surgical Delicot 9 mm x 50 mm Ref Number: 63-07 Product Usage: Neurosurgical...American Surgical Company, LLCHBA
Z-1785-2016Class IIAmerican Surgical Delicot 6 mm x 50 mm Ref Number: 63-06 Product Usage: Neurosurgical and...American Surgical Company, LLCHBA
Z-1784-2016Class IIAmerican Surgical Delicot 4 mm x 50 mm Ref Number: 63-05 Product Usage: Neurosurgical and...American Surgical Company, LLCHBA
Z-1783-2016Class IIAmerican Surgical Delicot-J 15 mm x 20 mm Ref Number: 63-04J (Japan Only) Product...American Surgical Company, LLCHBA
Z-1782-2016Class IIAmerican Surgical Delicot 4 mm x 50 mm Ref Number: 63-05 Product Usage: Neurosurgical...American Surgical Company, LLCHBA
Z-1781-2016Class IIAmerican Surgical Delicot non-xray 10 mm x 13 mm Ref Number: 63-03 non-xray Product...American Surgical Company, LLCHBA
Z-1780-2016Class IIAmerican Surgical Delicot 10 mm x 13 mm Ref Number: 63-03 Product Usage: Neurosurgical...American Surgical Company, LLCHBA
Z-1779-2016Class IIAmerican Surgical Delicot non-xray 5 mm x 13 mm Ref Number: 63-02 non-xray Product...American Surgical Company, LLCHBA
Z-1778-2016Class IIAmerican Surgical Delicot 5 mm x 13 mm Ref Number: 63-02 Product Usage: Neurosurgical...American Surgical Company, LLCHBA
Z-1777-2016Class IIAmerican Surgical Delicot-J 5 mm x 8 mm Ref Number: 63-01J (Japan Only) Product...American Surgical Company, LLCHBA
Z-1776-2016Class IIAmerican Surgical Delicot non-xray 5 mm x 8 mm Ref Number: 63-01 Non X-Ray Product...American Surgical Company, LLCHBA
Z-1775-2016Class IIAmerican Surgical Delicot 5 mm x 8 mm Ref Number: 63-01 Product Usage: Neurosurgical and...American Surgical Company, LLCHBA
Z-1774-2016Class IIAmerican Surgical Ray-Cot 1/2" x 2" Ref Number: 60-29 Product Usage: Neurosurgical and...American Surgical Company, LLCHBA
Z-1773-2016Class IIAmerican Surgical Ray-Cot 1.5" x 3" Ref Number: 60-22 Product Usage: Neurosurgical and...American Surgical Company, LLCHBA
Z-1772-2016Class IIAmerican Surgical Ray-Cot 3" x 3" Ref Number: 60-15 Product Usage: Neurosurgical and...American Surgical Company, LLCHBA
Z-1771-2016Class IIAmerican Surgical Ray-Cot 1" x 3" Ref Number: 60-13 Product Usage: Neurosurgical and...American Surgical Company, LLCHBA
Z-1770-2016Class IIAmerican Surgical Ray-Cot 1" x 1" Ref Number: 60-12 Product Usage: Neurosurgical and...American Surgical Company, LLCHBA
Z-1769-2016Class IIAmerican Surgical Ray-Cot 1/2" x 3" Ref Number: 60-09 Product Usage: Neurosurgical and...American Surgical Company, LLCHBA
Z-1768-2016Class IIAmerican Surgical Ray-Cot 1/2" x 1.5" Ref Number: 60-08 Product Usage: Neurosurgical and...American Surgical Company, LLCHBA
Z-1767-2016Class IIAmerican Surgical Ray-Cot 1/2" x 1" Ref Number: 60-07 Product Usage: Neurosurgical and...American Surgical Company, LLCHBA
Z-1766-2016Class IIAmerican Surgical Ray-Cot 1/2" x 1/2" Ref Number: 60-06 Product Usage: Neurosurgical and...American Surgical Company, LLCHBA
Z-1765-2016Class IIAmerican Surgical Ray-Cot 1/4" x 3" Ref Number: 60-04 Product Usage: Neurosurgical and...American Surgical Company, LLCHBA
Z-1764-2016Class IIAmerican Surgical Ray-Cot 1/4" x 1/4" Ref Number: 60-02 Product Usage: Neurosurgical and...American Surgical Company, LLCHBA
Z-1763-2016Class IIAmerican Surgical Tonsil Sponges 1" Large Ref Number: 50-01 Product Usage: Neurosurgical...American Surgical Company, LLCEFQ
Z-1762-2016Class IIAmerican Surgical Cotton Balls-Non-Strung 1/8" Ref Number: 31-07 Product...American Surgical Company, LLCFRL
Z-1761-2016Class IIAmerican Surgical Cotton Balls-Non-Strung 1" Ref Number: 31-04 Product...American Surgical Company, LLCFRL
Z-1760-2016Class IIAmerican Surgical Cotton Balls-Non-Strung 3/4" Ref Number: 31-03 Product...American Surgical Company, LLCGDY
Z-1759-2016Class IIAmerican Surgical Cotton Balls-Strung 1/8" Ref Number: 30-07 Product Usage: Neurosurgical...American Surgical Company, LLCGDY
Z-1758-2016Class IIAmerican Surgical Cotton Balls-Strung 1.25" Ref Number: 30-05 Product...American Surgical Company, LLCGDY
Z-1757-2016Class IIAmerican Surgical Cotton Balls-Strung 1" Ref Number: 30-04 Product Usage: Neurosurgical...American Surgical Company, LLCGDY