Instrumed International, Inc. A circumcision clamp is an instrument used to compress the foreskin of the penis during circumcision of a male infant sold under the Medline Industries, Boss Instruments, Millennium Surgical, Medetz Surgical, Surgical Direct, Surgipro, Teleflex Medical, Boss Instruments, Symmetry Surgical, Phoenix Instruments, GICAL, and CareFusion 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 circumcision clamp is an instrument used to compress the foreskin of the penis during circumcision of a male infant sold under the Medline Industries, Boss Instruments, Millennium Surgical, Medetz Surgical, Surgical Direct, Surgipro, Teleflex Medical, Boss Instruments, Symmetry Surgical, Phoenix Instruments, GICAL, and CareFusion brand names.
Brand
Instrumed International, Inc.
Lot Codes / Batch Numbers
1) Instrumed Product Name: Mogen Circumcision Clamp, Instrumed Product Number: 330-86212, Trade Name: Teleflex Medical, Teleflex Medical Product Name: CLAMP MOGEN, Teleflex Medical Item Number: P-16310, Lot Numbers: 010214, 030113, 050114, 060313, 100112. 2) Instrumed Product Name: Mogen Circumcision Clamp, Instrumed Product Number: 330-86212, Trade Name: Boss Instruments, Boss Instruments Product Name: Mogan Circumcision Clamp, infant, Boss Instruments Item Number: 46-5190, Lot Numbers: 030113, 100112. 3) Instrumed Product Name: Mogen Circumcision Clamp, Instrumed Product Number: 330-86212, Trade Name: Millennium Surgical, Millennium Surgical Product Name: Mogan Circumcision Clamp, infant, Millennium Surgical Item Number: 0-64227, Lot Numbers: 010214, 030112, 030113, 100112, 120413. 4) Instrumed Product Name: Mogen Circumcision Clamp, Instrumed Product Number: 330-86212, Trade Name: Phoenix Instruments, Phoenix Instruments Product Name: Mogan Circumcision Clamp, infant, Phoenix Instruments Item Number: 185-6550, Lot Number: 080111. 5) Instrumed Product Name: Mogen Circumcision Clamp, Instrumed Product Number: 330-86212, Trade Name: Symmetry Surgical, Symmetry Surgical Product Name: Mogan Circumcision Clamp, infant, Symmetry Surgical Item Number: 85-6550, Lot Numbers: 010214, 020411, 030112, 030113, 050114, 060313, 100112, 120111, 120413. 6) Instrumed Product Name: Mogen Circumcision Clamp, Instrumed Product Number: 330-86212, Trade Name: GICAL, GICAL Product Name: Mogan Circumcision Clamp, infant, GICAL Item Number: H156-7312, Lot Numbers: 010214, 030113. 7) Instrumed Product Name: Mogen Circumcision Clamp, Instrumed Product Number: 330-86212, Trade Name: CareFusion, CareFusion Product Name: Mogan Circumcision Clamp, infant, CareFusion Item Number: VM57-6201, Lot Numbers: 010214, 030113, 050114, 080111, 100112. 8) Instrumed Product Name: Mogen Circumcision Clamp, Instrumed Product Number: 330-86212, Trade Name: Teleflex Medical, Teleflex MedicalProduct Name: Mogan Circumcision Clamp, infant, Teleflex MedicalItem Number: P-16310, Lot Number: 120111.
Products Sold
1) Instrumed Product Name: Mogen Circumcision Clamp; Instrumed Product Number: 330-86212; Trade Name: Teleflex Medical; Teleflex Medical Product Name: CLAMP MOGEN; Teleflex Medical Item Number: P-16310; Lot Numbers: 010214, 030113, 050114, 060313, 100112. 2) Instrumed Product Name: Mogen Circumcision Clamp; Instrumed Product Number: 330-86212; Trade Name: Boss Instruments; Boss Instruments Product Name: Mogan Circumcision Clamp, infant; Boss Instruments Item Number: 46-5190; Lot Numbers: 030113, 100112. 3) Instrumed Product Name: Mogen Circumcision Clamp; Instrumed Product Number: 330-86212; Trade Name: Millennium Surgical; Millennium Surgical Product Name: Mogan Circumcision Clamp, infant; Millennium Surgical Item Number: 0-64227; Lot Numbers: 010214, 030112, 030113, 100112, 120413. 4) Instrumed Product Name: Mogen Circumcision Clamp; Instrumed Product Number: 330-86212; Trade Name: Phoenix Instruments; Phoenix Instruments Product Name: Mogan Circumcision Clamp, infant; Phoenix Instruments Item Number: 185-6550; Lot Number: 080111. 5) Instrumed Product Name: Mogen Circumcision Clamp; Instrumed Product Number: 330-86212; Trade Name: Symmetry Surgical; Symmetry Surgical Product Name: Mogan Circumcision Clamp, infant; Symmetry Surgical Item Number: 85-6550; Lot Numbers: 010214, 020411, 030112, 030113, 050114, 060313, 100112, 120111, 120413. 6) Instrumed Product Name: Mogen Circumcision Clamp; Instrumed Product Number: 330-86212; Trade Name: GICAL; GICAL Product Name: Mogan Circumcision Clamp, infant; GICAL Item Number: H156-7312; Lot Numbers: 010214, 030113. 7) Instrumed Product Name: Mogen Circumcision Clamp; Instrumed Product Number: 330-86212; Trade Name: CareFusion; CareFusion Product Name: Mogan Circumcision Clamp, infant; CareFusion Item Number: VM57-6201; Lot Numbers: 010214, 030113, 050114, 080111, 100112. 8) Instrumed Product Name: Mogen Circumcision Clamp; Instrumed Product Number: 330-86212; Trade Name: Teleflex Medical; Teleflex MedicalProduct Name: Mogan Circumcision Clamp, infant; Teleflex MedicalItem Number: P-16310; Lot Number: 120111.
Instrumed International, Inc. is recalling A circumcision clamp is an instrument used to compress the foreskin of the penis during circumcision 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