FDAAugust 19, 2015device
CIVCO Shoulder Retractors, Reusable non-sterile hand grip, REF 302070, packaged 1 set per box, RX. For use in patient positioning. The grips are used for pulling down the shoulders during radiotherapy simulation and treatment sessions where opposed lateral fields are used in the neck area.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
The wrist straps used for positioning the patient are too long
What to do
FDA enforcement status: Terminated
Brands named
med tecmed
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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- FDADORO¿ Easy-Connect Navigation Adaptor; BRAINLAB (item No. 1204.002)2025-03-14
- FDASUC-4300S, Rigid Intracardiac Sucker Fluted Tip; 1/4" (6.4mm) connector 13" (33cm) length. Indicated for handheld use only to remove excess fluid from the surgical field.2024-11-19
- FDAhuman med Biofill Infiltration Cannula, diameter 2.5mm, 15cm, REF 2024-012, REF 1580107, sterile, single use.2024-10-18
- FDABrand Name: NOVA ORTHO-MED INC. Product Name: MONARCH ROLLATOR BLUE Model/Catalog Number: 4329BL Product Description: ROLLING WALKER MOBILITY AID2024-08-26
- FDABrand Name: NOVA ORTHO-MED INC. Product Name: MONARCH ROLLATOR RED Model/Catalog Number: 4329RD Product Description: ROLLING WALKER MOBILITY AID2024-08-26
- FDABrand Name: NOVA ORTHO-MED INC. Product Name: MONARCH ROLLATOR PURPLE Model/Catalog Number: 4329PL Product Description: ROLLING WALKER MOBILITY AID2024-08-26
- FDAMi1250 SYNCHRONY 2, Item Numbers: a) 39541, FLEXSOFT S-Vector; b) 39545, FLEX28 S-Vector; c) 39547, FLEX26 S-Vector; Cochlear Implant2024-04-18
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