Restraint, Protective
FDA adverse event reports and recall history for restraint, protective (product code FMQ), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 1,023
- Deaths
- 221
- Injuries
- 152
- Malfunctions
- 613
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2015-09-14TerminatedVendor change control
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.
The wrist straps used for positioning the patient are too long
- 2015-01-15TerminatedComponent design/selection
Civco, MTSR02 Shoulder Retractor with Sherpa Wrist Loops Kit with Base, Non-sterile re-usable wool wrist strap, REF: 20SR02SUB2, Rx Only, The devise is intended to pull patients shoulders down for clearance when treating lateral fields to the neck.
The product (wool wrist loop) was manufactured 7cm shorter than product specifications.
- 2015-01-15TerminatedComponent design/selection
Civco, MTSR03 Shoulder Retractor with Wrist Loops Kit with Base, plus two pairs of wrist loops (nylon and sherpa), Non-sterile re-usable wool wrist strap, REF: 20SR03, Rx The devise is intended to pull patients shoulders down for clearance when treating lateral fields to the neck.
The product (wool wrist loop) was manufactured 7cm shorter than product specifications.
- 2014-03-14TerminatedPackaging
DeRoyal(R) LIMB HOLDERS, COTTON ADJUSTABLE, UNIVERSAL, REF M2017 Product Usage: Limb holders are intended for mildly to moderate agitated or disoriented patients who disrupt medical treatment and/or cause harm to themselves and/or others
Moldy smell in product
- 2013-04-09TerminatedProcess design
Posey Biothane Restraint Cuffs, Catalog Number 2900. The device is intended to limit a patient's movement to the extent necessary for treatment or protection of the patient or others.
The firm voluntarily recalled Biothane Restraint Cuffs, Catalog No. 2900, that did not meet the required specifications for tensile strength. Failure of these rivets could allow the cuff to become disconnected from the connecting strap and allow patients to regain free use of the limb.
- 2009-09-22TerminatedEmployee error
Posey Key Lock Belt (1334). Intended for medical purposes to limit a patient's movement to the extent necessary for treatment, examination or protection of the patient or others..
Posey has initiated a recall on certain Posey product units which were manufactured using an incorrect key lock buckle. The intended use of these products is to limit a patient's movement to the extent necessary for treatment, examination or protection of the patient or others.
- 2009-09-22TerminatedEmployee error
Posey Fifth Point Restraint, Locking (2219L). Intended for medical purposes to limit a patient's movement to the extent necessary for treatment, examination or protection of the patient or others.
Posey has initiated a recall on certain Posey product units which were manufactured using an incorrect key lock buckle. The intended use of these products is to limit a patient's movement to the extent necessary for treatment, examination or protection of the patient or others.
- 2009-09-22TerminatedEmployee error
Posey Connecting Strap/Belt, Cotton, 36" (232036). Intended for medical purposes to limit a patient's movement to the extent necessary for treatment, examination or protection of the patient or others.
Posey has initiated a recall on certain Posey product units which were manufactured using an incorrect key lock buckle. The intended use of these products is to limit a patient's movement to the extent necessary for treatment, examination or protection of the patient or others.
- 2009-09-22TerminatedEmployee error
Posey Connecting Strap/Belt, Cotton, 48" (232048). Intended for medical purposes to limit a patient's movement to the extent necessary for treatment, examination or protection of the patient or others.
Posey has initiated a recall on certain Posey product units which were manufactured using an incorrect key lock buckle. The intended use of these products is to limit a patient's movement to the extent necessary for treatment, examination or protection of the patient or others.
- 2009-09-22TerminatedEmployee error
Posey Connecting Strap/Belt, Cotton, 60" (232060). Intended for medical purposes to limit a patient's movement to the extent necessary for treatment, examination or protection of the patient or others.
Posey has initiated a recall on certain Posey product units which were manufactured using an incorrect key lock buckle. The intended use of these products is to limit a patient's movement to the extent necessary for treatment, examination or protection of the patient or others.
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