Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

- Calf Garment Standard Ref. L501-M Lot 122549 Recalled by Surgical Instrument Service And Savings, Inc. Due to The seal which maintains a sterile barrier for...

Date: May 3, 2013
Company: Surgical Instrument Service And Savings, Inc.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Surgical Instrument Service And Savings, Inc. directly.

Affected Products

- Calf Garment Standard Ref. L501-M Lot 122549, 122985 - Calf Garment, DVT10 Standard Ref. DVT10 Lot 122570, 12546 - Calf Garment, DVT20 Large Ref. DVT20 Lot 122549, 122570 - SCD Express Compression Sleeve, Knee Length, (White) Large Ref. 9789 Lot 122574 - SCD Express Compression Sleeve, Knee Length, (White) Medium Ref. 9529 Lot 122547, 122574 - SCD Express Compression Sleeve, Thigh Length, (White) Medium Ref. 9530 Lot 122574 Compressible limb sleeve. - Thigh Garment DVT30 Medium Ref. DVT30 Lot 122549, 122985 - Thigh Garment DVT40 Large Ref. DVT40 Lot 122549, 122985 - Vaso-Force Intermittent DVT Calf Garment, Large, Calf Sizes up to 24" 24" Ref. MDS601L Lot 122982, 122986 - Vaso-Force Intermittent DVT Calf Garment, Medium, Calf Sizes up to 18" 18" Ref. MDS601M Lot 122986, 122984 - VENAFLOW Calf Cuff, w/Foam (White) 19" Max. Calf Circumference Ref. 3010-PL Lot 122692, 122715

Quantity: 229

Why Was This Recalled?

The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Surgical Instrument Service And Savings, Inc.

Surgical Instrument Service And Savings, Inc. has 22 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report