Failed Impurities/Degradation Specifications: High Out Of Specification degradation results.
All Recalls
95,018 total recalls in our database
Ohm Sanitizer Spray (alcohol (ethyl alcohol) 80% v/v, 8 FL OZ (237 ML) bottles.
Urban Electric Power
CGMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification limits.
CGMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification limits.
Failed Stability Specifications: Out of specification test results for viscosity was identified at the 12M stability timepoint.
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
Precision Delivery Set with Filter, REF: PD06F; and Precision Delivery Set with Trifurcated Luer, REF: PDT05CV2
Quest Medical
Delivery Sets may have tubing that could become detached that could result in patient infection.
UNIVERSAL CORE DR RUNNELS PACK. Sterile Procedural Tray
MEDLINE INDUSTRIES, LP - Northfield
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
Sterile Procedural Trays, labeled as the following: AMBULATORY MINI PACK
MEDLINE INDUSTRIES, LP - Northfield
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
HIGH V+ Spinal Cement System REF T040321K
TEKNIMED SAS
Incorrect expiry date. Product is labeled with expiry date 2027-02-28. The correct expiration date is 2025-02-28.
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
LOCAL PACK. Sterile Procedural Tray.
MEDLINE INDUSTRIES, LP - Northfield
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
Sterile Procedural Trays, labeled as the following: a. RHINOPLASTY PACK b. OSC OTOLOGY PACK-LF c. RHYZOTOMY
MEDLINE INDUSTRIES, LP - Northfield
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
Firm identified that user may be unable to adjust the length of the Smart Correction Dual Joint Express Struts due to the collar release pin backing out. This may lead to a delay in correction.
FEMORAL ARTERY PACK-LF. Sterile Procedural Tray
MEDLINE INDUSTRIES, LP - Northfield
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
Sterile Procedural Trays, labeled as the following: a. UNIVERSAL PLASTIC b. KNEE ARTHROSCOPY PACK
MEDLINE INDUSTRIES, LP - Northfield
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.