Device recall: American Surgical Delicot 15mm x 20mm Ref: 63-04 Product Usage: Neurosurgical and Nonneurosurgical Sponges
Class II FDA enforcement event 73734. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
Product packaging defective compromising sterility
Class II, in the words of FDA
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
American Surgical Company started this device recall on 31 Mar 2016. The firm address in the FDA record is in Salem, MA. FDA put the recall in Class II. FDA event 73734 has 91 product records. The first FDA enforcement report date is 1 Jun 2016. The record gives the status Terminated, with the termination date 21 Oct 2016.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand,…
Recalling firm
American Surgical Company, Salem, MA.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
91 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1721-2016 | American Surgical Delicot 15mm x 20mm Ref: 63-04 Product Usage: Neurosurgical and Nonneurosurgical Sponges | 351 boxes | Class II | Terminated | 1 Jun 2016 |
| Z-1722-2016 | American Surgical Delicot 30mm x 70mm Ref: 63-10 Product Usage: Neurosurgical and Nonneurosurgical Sponges | 689 boxes | Class II | Terminated | 1 Jun 2016 |
| Z-1723-2016 | American Surgical Americot Blue 1/4" x 1/4" Ref Number: 20-01S Product Usage: Neurosurgical and Nonneurosurgical Sponges | 54 cases | Class II | Terminated | 1 Jun 2016 |
| Z-1724-2016 | American Surgical Americot Blue 1/2" x 1/2" Ref Number: 20-04S Product Usage: Neurosurgical and Nonneurosurgical Sponges | 262 boxes | Class II | Terminated | 1 Jun 2016 |
| Z-1725-2016 | American Surgical Americot Blue 1/2" x 1" Ref Number: 20-05S Product Usage: Neurosurgical and Nonneurosurgical Sponges Product Usage: Neurosurgical and Nonneurosurgical Sponges | 35 boxes | Class II | Terminated | 1 Jun 2016 |
| Z-1726-2016 | American Surgical Americot Blue 1/2" x 1.5" Ref Number: 20-06S Product Usage: Neurosurgical and Nonneurosurgical Sponges | 78 boxes | Class II | Terminated | 1 Jun 2016 |
| Z-1727-2016 | American Surgical Americot Blue 1/2" x 3" Ref Number: 20-07S Product Usage: Neurosurgical and Nonneurosurgical Sponges | 33 boxes | Class II | Terminated | 1 Jun 2016 |
| Z-1728-2016 | American Surgical Americot Blue 1" x 3" Ref Number: 20-10S Product Usage: Neurosurgical and Nonneurosurgical Sponges | 103 boxes | Class II | Terminated | 1 Jun 2016 |
| Z-1729-2016 | American Surgical Americot Blue 3/8" x 3/4" Ref Number: 20-14S Product Usage: Neurosurgical and Nonneurosurgical Sponges | 37 boxes | Class II | Terminated | 1 Jun 2016 |
| Z-1730-2016 | American Surgical Americot Blue 1/8" x 1/8" Ref Number: 20-19S Product Usage: Neurosurgical and Nonneurosurgical Sponges | 4 boxes | Class II | Terminated | 1 Jun 2016 |
| Z-1731-2016 | American Surgical Americot Blue 3/8" x 3/8" Ref Number: 20-22S Product Usage: Neurosurgical and Nonneurosurgical Sponges | 24 boxes | Class II | Terminated | 1 Jun 2016 |
| Z-1732-2016 | American Surgical Americot Blue 3/8" x 2" Ref Number: 20-26S Product Usage: Neurosurgical and Nonneurosurgical Sponges | 15 boxes | Class II | Terminated | 1 Jun 2016 |
| Z-1733-2016 | American Surgical Americot Blue 1/4" x 1.5" Ref Number: 20-30S Product Usage: Neurosurgical and Nonneurosurgical Sponges | 22 boxes | Class II | Terminated | 1 Jun 2016 |
| Z-1734-2016 | American Surgical Americot White 1.5 cm x 5.5 cm Ref Number: 20-31SW Product Usage: Neurosurgical and Nonneurosurgical Sponges | 35 boxes | Class II | Terminated | 1 Jun 2016 |
| Z-1735-2016 | American Surgical Americot Blue 1/2" x 2" Ref Number: 20-32S Product Usage: Neurosurgical and Nonneurosurgical Sponges | 37 boxes | Class II | Terminated | 1 Jun 2016 |
| Z-1736-2016 | American Surgical Ultracot 5 mm x 8 mm Ref Number: 23-01 Product Usage: Neurosurgical and Nonneurosurgical Sponges | 114 cases | Class II | Terminated | 1 Jun 2016 |
| Z-1737-2016 | American Surgical Ultracot 5 mm x 8 mm (Glassine) Ref Number: 23-01G Product Usage: Neurosurgical and Nonneurosurgical Sponges | 11 boxes | Class II | Terminated | 1 Jun 2016 |
| Z-1738-2016 | American Surgical Ultracot 5 mm x 13 mm (Glassine) Ref Number: 23-02G Product Usage: Neurosurgical and Nonneurosurgical Sponges | 15 boxes | Class II | Terminated | 1 Jun 2016 |
| Z-1739-2016 | American Surgical Ultracot 10 mm x 13 mm (Glassine) Ref Number: 23-03G Product Usage: Neurosurgical and Nonneurosurgical Sponges | 41 Boxes | Class II | Terminated | 1 Jun 2016 |
| Z-1740-2016 | American Surgical Ultracot 15 mm x 20 mm Ref Number: 23-04 Product Usage: Neurosurgical and Nonneurosurgical Sponges | 22 boxes | Class II | Terminated | 1 Jun 2016 |
| Z-1741-2016 | American Surgical Ultracot 15 mm x 20 mm (Glassine) Ref Number: 23-04G Product Usage: Neurosurgical and Nonneurosurgical Sponges | 39 boxes | Class II | Terminated | 1 Jun 2016 |
| Z-1742-2016 | American Surgical Ultracot 6 mm x 50 mm Ref Number: 23-06 Product Usage: Neurosurgical and Nonneurosurgical Sponges | 1 box | Class II | Terminated | 1 Jun 2016 |
| Z-1743-2016 | American Surgical Ultracot 9 mm x 50 mm (Glassine) Ref Number: 23-07G Product Usage: Neurosurgical and Nonneurosurgical Sponges | 32 boxes | Class II | Terminated | 1 Jun 2016 |
| Z-1744-2016 | American Surgical Ultracot 13 mm x 60 mm Ref Number: 23-08 Product Usage: Neurosurgical and Nonneurosurgical Sponges | 23 boxes | Class II | Terminated | 1 Jun 2016 |
| Z-1745-2016 | American Surgical Ultracot 13 mm x 60 mm (Glassine) Ref Number: 23-08G Product Usage: Neurosurgical and Nonneurosurgical Sponges | 45 boxes | Class II | Terminated | 1 Jun 2016 |
| Z-1746-2016 | American Surgical Ultracot 20 mm x 60 mm Ref Number: 23-09 Product Usage: Neurosurgical and Nonneurosurgical Sponges | 33 boxes | Class II | Terminated | 1 Jun 2016 |
| Z-1747-2016 | American Surgical Ultracot 20 mm x 60 mm (Glassine) Ref Number: 23-09G Product Usage: Neurosurgical and Nonneurosurgical Sponges | 155 boxes | Class II | Terminated | 1 Jun 2016 |
| Z-1748-2016 | American Surgical Ultracot 30 mm x 70 mm Ref Number: 23-10 Product Usage: Neurosurgical and Nonneurosurgical Sponges | 2 boxes | Class II | Terminated | 1 Jun 2016 |
| Z-1749-2016 | American Surgical Ultracot 30 mm x 70 mm (Glassine) Ref Number: 23-10G Product Usage: Neurosurgical and Nonneurosurgical Sponges | 23 boxes | Class II | Terminated | 1 Jun 2016 |
| Z-1750-2016 | American Surgical Ultracot 15 mm x 15 mm (Glassine) Ref Number: 23-12G Product Usage: Neurosurgical and Nonneurosurgical Sponges | 6 boxes | Class II | Terminated | 1 Jun 2016 |
| Z-1751-2016 | American Surgical Ultracot 30 mm x 90 mm (Glassine) Ref Number: 23-15G Product Usage: Neurosurgical and Nonneurosurgical Sponges | 33 boxes | Class II | Terminated | 1 Jun 2016 |
| Z-1752-2016 | American Surgical Ultracot 70 mm x 10090 mm Ref Number: 23-24 Product Usage: Neurosurgical and Nonneurosurgical Sponges | 27 boxes | Class II | Terminated | 1 Jun 2016 |
| Z-1753-2016 | American Surgical Cotton Balls-Strung 1/4" Ref Number: 30-00 Product Usage: Neurosurgical and Nonneurosurgical Sponges | 87 boxes | Class II | Terminated | 1 Jun 2016 |
| Z-1754-2016 | American Surgical Cotton Balls-Strung 3/8" Ref Number: 30-01 Product Usage: Neurosurgical and Nonneurosurgical Sponges | 13 boxes | Class II | Terminated | 1 Jun 2016 |
| Z-1755-2016 | American Surgical Cotton Balls-Strung 1/2" Ref Number: 30-02 Product Usage: Neurosurgical and Nonneurosurgical Sponges | 182 boxes | Class II | Terminated | 1 Jun 2016 |
| Z-1756-2016 | American Surgical Cotton Balls-Strung 3/4" Ref Number: 30-03 Product Usage: Neurosurgical and Nonneurosurgical Sponges | 70 units | Class II | Terminated | 1 Jun 2016 |
| Z-1757-2016 | American Surgical Cotton Balls-Strung 1" Ref Number: 30-04 Product Usage: Neurosurgical and Nonneurosurgical Sponges | 237 units | Class II | Terminated | 1 Jun 2016 |
| Z-1758-2016 | American Surgical Cotton Balls-Strung 1.25" Ref Number: 30-05 Product Usage: Neurosurgical and Nonneurosurgical Sponges | 25 units | Class II | Terminated | 1 Jun 2016 |
| Z-1759-2016 | American Surgical Cotton Balls-Strung 1/8" Ref Number: 30-07 Product Usage: Neurosurgical and Nonneurosurgical Sponges | 34 boxes | Class II | Terminated | 1 Jun 2016 |
| Z-1760-2016 | American Surgical Cotton Balls-Non-Strung 3/4" Ref Number: 31-03 Product Usage: Neurosurgical and Nonneurosurgical Sponges | 10 boxes | Class II | Terminated | 1 Jun 2016 |
| Z-1761-2016 | American Surgical Cotton Balls-Non-Strung 1" Ref Number: 31-04 Product Usage: Neurosurgical and Nonneurosurgical Sponges | 3 boxes | Class II | Terminated | 1 Jun 2016 |
| Z-1762-2016 | American Surgical Cotton Balls-Non-Strung 1/8" Ref Number: 31-07 Product Usage: Neurosurgical and Nonneurosurgical Sponges | 7 boxes | Class II | Terminated | 1 Jun 2016 |
| Z-1763-2016 | American Surgical Tonsil Sponges 1" Large Ref Number: 50-01 Product Usage: Neurosurgical and Nonneurosurgical Sponges | 4 boxes | Class II | Terminated | 1 Jun 2016 |
| Z-1764-2016 | American Surgical Ray-Cot 1/4" x 1/4" Ref Number: 60-02 Product Usage: Neurosurgical and Nonneurosurgical Sponges | 165 boxes | Class II | Terminated | 1 Jun 2016 |
| Z-1765-2016 | American Surgical Ray-Cot 1/4" x 3" Ref Number: 60-04 Product Usage: Neurosurgical and Nonneurosurgical Sponges | 3 boxes | Class II | Terminated | 1 Jun 2016 |
| Z-1766-2016 | American Surgical Ray-Cot 1/2" x 1/2" Ref Number: 60-06 Product Usage: Neurosurgical and Nonneurosurgical Sponges | 266 boxes | Class II | Terminated | 1 Jun 2016 |
| Z-1767-2016 | American Surgical Ray-Cot 1/2" x 1" Ref Number: 60-07 Product Usage: Neurosurgical and Nonneurosurgical Sponges | 165 boxes | Class II | Terminated | 1 Jun 2016 |
| Z-1768-2016 | American Surgical Ray-Cot 1/2" x 1.5" Ref Number: 60-08 Product Usage: Neurosurgical and Nonneurosurgical Sponges | 28 boxes | Class II | Terminated | 1 Jun 2016 |
| Z-1769-2016 | American Surgical Ray-Cot 1/2" x 3" Ref Number: 60-09 Product Usage: Neurosurgical and Nonneurosurgical Sponges | 449 boxes | Class II | Terminated | 1 Jun 2016 |
| Z-1770-2016 | American Surgical Ray-Cot 1" x 1" Ref Number: 60-12 Product Usage: Neurosurgical and Nonneurosurgical Sponges | 102 boxes | Class II | Terminated | 1 Jun 2016 |
| Z-1771-2016 | American Surgical Ray-Cot 1" x 3" Ref Number: 60-13 Product Usage: Neurosurgical and Nonneurosurgical Sponges | 209 boxes | Class II | Terminated | 1 Jun 2016 |
| Z-1772-2016 | American Surgical Ray-Cot 3" x 3" Ref Number: 60-15 Product Usage: Neurosurgical and Nonneurosurgical Sponges | 16 boxes | Class II | Terminated | 1 Jun 2016 |
| Z-1773-2016 | American Surgical Ray-Cot 1.5" x 3" Ref Number: 60-22 Product Usage: Neurosurgical and Nonneurosurgical Sponges | 27 boxes | Class II | Terminated | 1 Jun 2016 |
| Z-1774-2016 | American Surgical Ray-Cot 1/2" x 2" Ref Number: 60-29 Product Usage: Neurosurgical and Nonneurosurgical Sponges | 38 boxes | Class II | Terminated | 1 Jun 2016 |
| Z-1775-2016 | American Surgical Delicot 5 mm x 8 mm Ref Number: 63-01 Product Usage: Neurosurgical and Nonneurosurgical Sponges | 287 boxes | Class II | Terminated | 1 Jun 2016 |
| Z-1776-2016 | American Surgical Delicot non-xray 5 mm x 8 mm Ref Number: 63-01 Non X-Ray Product Usage: Neurosurgical and Nonneurosurgical Sponges | 24 boxes | Class II | Terminated | 1 Jun 2016 |
| Z-1777-2016 | American Surgical Delicot-J 5 mm x 8 mm Ref Number: 63-01J (Japan Only) Product Usage: Neurosurgical and Nonneurosurgical Sponges | 27 boxes | Class II | Terminated | 1 Jun 2016 |
| Z-1778-2016 | American Surgical Delicot 5 mm x 13 mm Ref Number: 63-02 Product Usage: Neurosurgical and Nonneurosurgical Sponges | 97 boxes | Class II | Terminated | 1 Jun 2016 |
| Z-1779-2016 | American Surgical Delicot non-xray 5 mm x 13 mm Ref Number: 63-02 non-xray Product Usage: Neurosurgical and Nonneurosurgical Sponges | 21 boxes | Class II | Terminated | 1 Jun 2016 |
| Z-1780-2016 | American Surgical Delicot 10 mm x 13 mm Ref Number: 63-03 Product Usage: Neurosurgical and Nonneurosurgical Sponges | 442 boxes | Class II | Terminated | 1 Jun 2016 |
The table shows 60 of 91 product records. The FDA enforcement report lists all the records.
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2016
- 1,232
- Share of these events in Class II
- 91%
- Product records in this event
- 91
- Events of the firm on the register
- 1
Official channels
- FDA enforcement report Z-1721-2016The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
Follow by RSS:Food, drug and device recallsFDA Class I recalls
Cite this page
Recall Register. FDA enforcement event 73734. https://recallregister.com/fda/ii/73734/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand,…
- What quantity of product is in FDA event 73734?
- The event has 91 product records. The first record gives this quantity:
351 boxes
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2016 have the same class?
- 91% of the 1,232 device events that started in 2016 are in Class II.