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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Surgical Equipment

Carefusion 2200 Inc: Snowden-Pencer Endoscopic Surgical Devices Recalled for Breaking Knobs

Agency Publication Date: September 30, 2024
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Summary

Carefusion 2200 Inc. has recalled 92 units of various Snowden-Pencer MIS Diamond-Touch endoscopic surgical instruments, including graspers, dissectors, and clamps. These medical devices are being recalled because the rotation knob can crack or break during surgery due to the use of an incorrect adhesive during manufacturing. If the knob breaks while being used in a procedure, it could lead to surgical delays or leave the device in an unusable state while inside a patient.

Risk

A broken rotation knob on a surgical grasper or clamp can prevent a surgeon from properly controlling the instrument during a procedure, potentially causing internal tissue damage or requiring additional medical intervention to complete the surgery safely.

What You Should Do

  1. Identify if you have the affected Snowden-Pencer MIS Diamond-Touch devices by checking the Model (REF) and Lot numbers on the product packaging or device.
  2. Affected models include REF SP90-7012, SP90-7018, SP90-7020, SP90-7036, SP90-7043, SP90-7044, SP90-7045, SP90-7046, SP90-7048, SP90-7066, SP90-7071, SP90-7220, SP90-7243, SP90-7266, and SP90-7271.
  3. Check for specific lot numbers: B23, C23, and L22; verify these against the UDI/DI numbers provided in the product list.
  4. If you have an affected device, stop using it immediately and contact your healthcare facility's risk management department or the manufacturer for instructions on returning the product.
  5. Contact Carefusion 2200 Inc. or your healthcare provider to discuss replacement options or further technical instructions regarding these surgical instruments.
  6. For additional questions or to report issues, contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Manufacturer communication regarding manufacturing defect

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: Snowden-Pencer MIS DIAMOND-TOUCH GRASPER MCKERNAN FUNDUS 5MM, 32CM, RATCHETED
Model / REF:
SP90-7012
UPC Codes:
10885403159671
Lot Numbers:
B23
Product: Snowden-Pencer MIS DIAMOND-TOUCH GRASPER DIAMOND JAW BABCOCK 5MM, 32CM, RATCHETED
Model / REF:
SP90-7018
UPC Codes:
10885403159701
Lot Numbers:
B23
Product: Snowden-Pencer MIS DIAMOND-TOUCH ATRAUMATIC GRASPER DIAMOND JAW 5MM, 32CM, RATCHETED
Model / REF:
SP90-7020
UPC Codes:
10885403159725
Lot Numbers:
B23
Product: Snowden-Pencer MIS DIAMOND-TOUCH DISSECTOR FENESTRATED 16MM JAW 5MM, 32CM, NON RATCHETED
Model / REF:
SP90-7036
UPC Codes:
10885403159862
Lot Numbers:
B23
Product: Snowden-Pencer MIS DIAMOND-TOUCH CLAMP DEBAKEY 25 MM JAW 5MM, 32CM, RATCHETED
Model / REF:
SP90-7043
UPC Codes:
10885403160547
Lot Numbers:
L22
B23
C23
Product: Snowden-Pencer MIS DIAMOND-TOUCH CLAMP DEBAKEY 35 MM JAW 5MM, 32CM, RATCHETED
Model / REF:
SP90-7044
UPC Codes:
10885403160554
Lot Numbers:
B23
C23
Product: Snowden-Pencer MIS DIAMOND-TOUCH CLAMP BOWEL 50 MM JAW 5MM, 32CM, RATCHETED
Model / REF:
SP90-7045
UPC Codes:
10885403160561
Lot Numbers:
B23
Product: Snowden-Pencer MIS DIAMOND-TOUCH CLAMP BOWEL 60 MM JAW 5MM, 32CM, RATCHETED
Model / REF:
SP90-7046
UPC Codes:
10885403160578
Lot Numbers:
C23
L22
Product: Snowden-Pencer MIS DIAMOND-TOUCH GRASPER CRILE CURVED JAW 5MM, 32CM, RATCHETED
Model / REF:
SP90-7048
UPC Codes:
10885403160592
Lot Numbers:
B23
Product: Snowden-Pencer MIS DIAMOND-TOUCH GRASPERS CROCODILE GRASPER, DOUBLE ACTI 5MM, 32CM, RATCHETED HANDLE
Model / REF:
SP90-7066
UPC Codes:
10885403160769
Lot Numbers:
B23
Product: Snowden-Pencer MIS DIAMOND-TOUCH DISSECTOR DIAMOND JAW 5MM, 32CM, RATCHETED
Model / REF:
SP90-7071
UPC Codes:
10885403160790
Lot Numbers:
L22
B23
C23
Product: Snowden-Pencer MIS DIAMOND-TOUCH ATRAUMATIC GRASPER DIAMOND JAW 5MM, 45CM, RATCHETED
Model / REF:
SP90-7220
UPC Codes:
10885403161278
Lot Numbers:
B23
C23
Product: Snowden-Pencer MIS DIAMOND-TOUCH CLAMP DEBAKEY 25 MM JAW 5MM, 45CM, RATCHETED
Model / REF:
SP90-7243
UPC Codes:
10885403161384
Lot Numbers:
B23
Product: Snowden-Pencer MIS DIAMOND-TOUCH GRASPERS CROCODILE GRASPER, DOUBLE ACTI 5MM, 45CM, RATCHETED HANDLE
Model / REF:
SP90-7266
UPC Codes:
10885403161513
Lot Numbers:
B23
C23
Product: Snowden-Pencer MIS DIAMOND-TOUCH DISSECTOR DIAMOND JAW 5MM, 45CM, RATCHETED
Model / REF:
SP90-7271
UPC Codes:
10885403161544
Lot Numbers:
B23
C23

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 92561
Status: Active
Manufacturer: Carefusion 2200 Inc
Sold By: Hospitals; Surgical Centers; Medical Supply Distributors
Manufactured In: United States
Units Affected: 15 products (3 units; 3 units; 1 unit; 0 units; 8 units; 0 units; 2 units; 4 units; 0 units; 1 unit; 42 units; 0 units; 7 units; 1 unit; 20 units)
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.