CLASS II Device recall · Reported 10 Jul 2013 · FDA Enforcement Report
Calf Garment Standard recalled by Surgical Instrument Service
Surgical Instrument Service And Savings is recalling Calf Garment Standard, distributed nationwide in the US. The recall was initiated on 3 May 2013 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1638-2013
- FDA event ID
- 65205
- Recalling firm
- Surgical Instrument Service And Savings, Redmond, OR
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 3 May 2013
- FDA classified
- 1 Jul 2013
- Reported
- 10 Jul 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Hip & Knee Implants
Timeline
| 3 May 2013 | Recall initiated by company | |
| 1 Jul 2013 | Classified by FDA | +59 days |
| 10 Jul 2013 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
- 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
Where it was distributed
Nationwide Distribution.
Questions about this recall
Why was it 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.
Which lots are affected?
122692, 122982, 122986, 122984, 122549, 122985, 122570, 122546, 122547, 122574, 122715.
Where was it sold?
Nationwide Distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
21 other products · FDA event 65205This product is part of a recall event; the main page for the event is Relieva Flex Sinus Guide Catheter (Green) Tip Shape: F recalled.
More recalls from Surgical Instrument Service And Savings
All 22| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Cannulated Drill Bit for Mini TightRope recalled | Surgical Instrument Service And Savings | Sterility | Nationwide |
| Device | CLASS II | Average Medium Blade x recalled by Surgical Instrument Service | Surgical Instrument Service And Savings | Sterility | Nationwide |
| Device | CLASS II | GII QuickAnchor Plus, Ethibond Polyester Suture, 36" recalled | Surgical Instrument Service And Savings | Sterility | Nationwide |
| Device | CLASS II | Harmonic ACE Ergonomically-Enhanced Curved Shear recalled | Surgical Instrument Service And Savings | Sterility | Nationwide |
| Device | CLASS II | ConMed Linvatec Spectrum II Suture Hook Crescent, Medium (Teal) recalled | Surgical Instrument Service And Savings | Sterility | Nationwide |
Other Hip & Knee Implants recalls
All 3,097| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline convenience kits labeled as: Femoral Pack, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Arvis Surgical Navigation System Gen recalled by Kico Knee Innovation | Kico Knee Innovation | Device Malfunction | 19 states |
| Device | CLASS II | Veritas Standard Reverse Total Shoulder Veritas Standard recalled | restor3d | Device Malfunction | Nationwide |
| Device | CLASS II | Endo-Model, Replacement Set, Tibial Plateau, right/left, L, Uhmwpe recalled | Waldemar Link GmbH & Co. KG (Mfg Site) | Other | IN |
| Device | CLASS II | U2 Total Knee System Femoral offset bushing recalled | United Orthopedic | Device Malfunction | Nationwide |