Instrumed International, Inc. A zipser clamp is an instrument used to compress reduce blood flow to the penis and reduce pain and is sold under the Medline Industries, Boss Instruments, Millennium Surgical, Medetz Surgical, Surgical Direct, and Surgipro brand names. Recall
Class II: 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
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
A zipser clamp is an instrument used to compress reduce blood flow to the penis and reduce pain and is sold under the Medline Industries, Boss Instruments, Millennium Surgical, Medetz Surgical, Surgical Direct, and Surgipro brand names.
Brand
Instrumed International, Inc.
Lot Codes / Batch Numbers
1) Instrumed Product Name: Zipser Meatus Clamp 4 1/4", Instrumed Product Number: 330-86112, Trade Name: Medline Industries, Medline Industries Product Name: CLAMP, ZIPSER MEATUS, OVERALL LGTH 4-1/4, Medline Industries Item Number: MDG5597111, Lot Numbers: 051208, 060810. 2) Instrumed Product Name: Zipser Meatus Clamp 4 1/4", Instrumed Product Number: 330-86112, Trade Name: Boss Instruments, Boss Instruments Product Name: Zipser Meatus Clamp 4 1/4", Boss Instruments Item Number: 46-5195, Lot Number: 060810. 3) Instrumed Product Name: Zipser Meatus Clamp 4 1/4", Instrumed Product Number: 330-86112, Trade Name: Millennium Surgical, Millennium Surgical Product Name: Zipser Meatus Clamp 4 1/4", Millennium Surgical Item Number: 9-124570, Lot Number: 060810. 4) Instrumed Product Name: Zipser Meatus Clamp 4 1/4", Instrumed Product Number: 330-86112, Trade Name: Medetz Surgical Instruments, Medetz Surgical Instruments Product Name: Zipser Meatus Clamp 4 1/4", Medetz Surgical Instruments Item Number: 9-124570, Lot Number: 060810. 5) Instrumed Product Name: Zipser Meatus Clamp 4 1/4", Instrumed Product Number: 330-86112, Trade Name: Medetz Surgical Instruments, Medetz Surgical Instruments Product Name: Zipser Meatus Clamp 4 1/4", Medetz Surgical Instruments Item Number: 9-124570, Lot Number: 060810. 6) Instrumed Product Name: Zipser Meatus Clamp 4 1/4", Instrumed Product Number: 330-86112, Trade Name: Millennium Surgical, Millennium Surgical Product Name: Zipser Meatus Clamp 4 1/4", Millennium Surgical Item Number: 9-124570, Lot Numbers: 060810, 080713, 082213. 7) Instrumed Product Name: Zipser Meatus Clamp 4 1/4", Instrumed Product Number: 330-86112, Trade Name: Surgical Direct, Surgical Direct Product Name: Zipser Meatus Clamp 4 1/4", Surgical Direct Item Number: SD16450.100, Lot Number: 060810. 8) Instrumed Product Name: Zipser Meatus Clamp 4 1/4", Instrumed Product Number: 330-86112, Trade Name: Surgipro, Surgipro Product Name: Zipser Meatus Clamp 4 1/4", Surgipro Item Number: SPGU-4570, Lot Number: 060810.
Products Sold
1) Instrumed Product Name: Zipser Meatus Clamp 4 1/4"; Instrumed Product Number: 330-86112; Trade Name: Medline Industries; Medline Industries Product Name: CLAMP, ZIPSER MEATUS, OVERALL LGTH 4-1/4; Medline Industries Item Number: MDG5597111; Lot Numbers: 051208, 060810. 2) Instrumed Product Name: Zipser Meatus Clamp 4 1/4"; Instrumed Product Number: 330-86112; Trade Name: Boss Instruments; Boss Instruments Product Name: Zipser Meatus Clamp 4 1/4"; Boss Instruments Item Number: 46-5195; Lot Number: 060810. 3) Instrumed Product Name: Zipser Meatus Clamp 4 1/4"; Instrumed Product Number: 330-86112; Trade Name: Millennium Surgical; Millennium Surgical Product Name: Zipser Meatus Clamp 4 1/4"; Millennium Surgical Item Number: 9-124570; Lot Number: 060810. 4) Instrumed Product Name: Zipser Meatus Clamp 4 1/4"; Instrumed Product Number: 330-86112; Trade Name: Medetz Surgical Instruments; Medetz Surgical Instruments Product Name: Zipser Meatus Clamp 4 1/4"; Medetz Surgical Instruments Item Number: 9-124570; Lot Number: 060810. 5) Instrumed Product Name: Zipser Meatus Clamp 4 1/4"; Instrumed Product Number: 330-86112; Trade Name: Medetz Surgical Instruments; Medetz Surgical Instruments Product Name: Zipser Meatus Clamp 4 1/4"; Medetz Surgical Instruments Item Number: 9-124570; Lot Number: 060810. 6) Instrumed Product Name: Zipser Meatus Clamp 4 1/4"; Instrumed Product Number: 330-86112; Trade Name: Millennium Surgical; Millennium Surgical Product Name: Zipser Meatus Clamp 4 1/4"; Millennium Surgical Item Number: 9-124570; Lot Numbers: 060810, 080713, 082213. 7) Instrumed Product Name: Zipser Meatus Clamp 4 1/4"; Instrumed Product Number: 330-86112; Trade Name: Surgical Direct; Surgical Direct Product Name: Zipser Meatus Clamp 4 1/4"; Surgical Direct Item Number: SD16450.100; Lot Number: 060810. 8) Instrumed Product Name: Zipser Meatus Clamp 4 1/4"; Instrumed Product Number: 330-86112; Trade Name: Surgipro; Surgipro Product Name: Zipser Meatus Clamp 4 1/4"; Surgipro Item Number: SPGU-4570; Lot Number: 060810.
Instrumed International, Inc. is recalling A zipser clamp is an instrument used to compress reduce blood flow to the penis and reduce pain and due to The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, . This is a Class I recall, indicating a high risk of serious health consequences or death. Based on FDA medical device enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to market the devices as "Pre-Amendment" devices.
Recommended Action
Per FDA guidance
Healthcare providers and patients should stop using the device and contact the manufacturer for further instructions. Report problems to FDA MedWatch.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026