Recall category
Devices a patient or caregiver can identify as used, worn, implanted, or supplied for their care.
Due to catheter separation
Missing from associated official evidence: action, consumer scope.
There have been reports of air and medication leakage from the nebulizer cup during therapy of Volara system patient circuits. The leakage can lead to an oxygen level drop in the patient and ineffective nebulization, which may affect the delivery of the pre...
Missing from associated official evidence: action.
Due to reported complaints, the cuff device may alarm with a "Cuff System Leakage" error. As a result, the motor may pump continuously and fail to maintain the cuff pressure set by the user.
Missing from associated official evidence: action, consumer scope.
Due to engineering sample labeled "Not for Human Use" being inadvertently shipped it the U.S. market.
Missing from associated official evidence: action, consumer scope.
Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of leaks/breakage involving failures of the (blue) proximal injectate lumen hub on these catheters. This has led to instances of leakage, lumen damage, and breaka...
Missing from associated official evidence: action, consumer scope.
The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to quality issues identified during a recent FDA manufacturing inspection of its d...
Missing from associated official evidence: action.
Devices containing inner shaft assemblies from specific manufacturing lots may have an increased potential for distal tip detachment from the delivery system under certain procedural or anatomical conditions due to a manufacturing issue.
Missing from associated official evidence: action.
External soft cannula damage during manufacturing that results in insulin leaking around the Pod instead of being delivered to the user regardless of basal or bolus delivery. The primary failure mode is pump under-delivery due to loss of insulin to an exter...
Missing from associated official evidence: action, consumer scope.
Two devices recalled: 1) Electrocardiogram (ECG) electrode assembly ECG feature may incorrectly detect extreme bradycardia, tachycardia and trigger alarms on normal heart rate patients, which may distract clinicians away from management of true positive ala...
Missing from associated official evidence: action, consumer scope.
Beam set delivery note issues in which there is potential data loss if the beam set delivery note is modified simultaneously and/or if a note is updated during a treatment session, the user is not notified of the change.
Missing from associated official evidence: action, consumer scope.
Expansion of RES 98277. Specific lots of reprocessed catheters may contain small particles of residual material. If devices with residual particulates on patient-contacting surfaces are used, there is a potential risk of an inflammatory response or systemic...
Missing from associated official evidence: action.
Surgical instruments used during shoulder arthroplasty procedures does not progressively translate to replicate implant geometry, so the reaming guide and the stem reamer are positioned approximately 0.2 mm per size more laterally than intended, which may i...
Missing from associated official evidence: action, consumer scope.
Under extended clinical use conditions (e.g., long duration studies), moisture generated within the pneumatic circuit may accumulate inside the system's internal tubing or at the hydrophobic filter and waterproof pressure sensors. Accumulated moisture may a...
Missing from associated official evidence: action, consumer scope.
A single lot of expired syringes were distributed due to a distribution system control failure.
Missing from associated official evidence: action, consumer scope.
Spherical applicators (radiation therapy accessory) failed to meet manufacturing specifications.
Missing from associated official evidence: action, consumer scope.
Potential for thrombus formation during prolonged use of the introducer.
Missing from associated official evidence: action, consumer scope.
Due to manufacturing error, hexalobe screws used with wrist fixation system may break during use.
Missing from associated official evidence: action, consumer scope.
Certain lots of Dexcom G7 sensors originally designated as scrap and intended for destruction were stolen during the destruction process. The sensors were later sold to pharmacies and distributors by Pharmsource, LLC. Lot 1725204004 were designated for dest...
Missing from associated official evidence: action, consumer scope.
Firm received a complaint with no clinical impact in which a posterior augment was found within the distal augment package.
Missing from associated official evidence: action, consumer scope.
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.
Missing from associated official evidence: action, consumer scope.
Operative components of surgical systems potentially distributed with E-brake retainer pin, so in event of a structural column failure, the E-brake pin would prevent E-brake engagement and may result in uncontrolled motion. In addition, if it moves/backs ou...
Missing from associated official evidence: action, consumer scope.
GE HealthCare has become aware of a context synchronization issue in AW Server 3.2 ext. 6.5. When a user selects a patient or exam in the AW Server Web Client worklist and launches an interactive application (e.g. Volume Viewer), the application may open th...
Missing from associated official evidence: action, consumer scope.
There is the potential for leakage along the drug pathway from the pump through the end of the catheter.
Missing from associated official evidence: action.
Embolization coil detachment system devices may experience premature battery drain causing devices to: 1) Not power on; 2) Power on with faint audible and visual indicators; 3) Be unable to detach a coil as intended, which may necessitate medical interventi...
Missing from associated official evidence: action, consumer scope.
