💊 Drugs Class I - Dangerous
Lack Of Assurance Of Sterility.
All Recalls
95,075 total recalls in our database
💊 Drugs Class I - Dangerous
Lack Of Assurance Of Sterility.
💊 Drugs Class I - Dangerous
Lack Of Assurance Of Sterility.
Calcium GLUCOnate 2 g added to 0.9% Sodium Chloride 50 mL Bag, Each bag contains 9.3 mEq Ca++ Rx Only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205, NDC 70004-0510-30
SCA Pharmaceuticals
💊 Drugs Class I - Dangerous
Lack Of Assurance Of Sterility.
💊 Drugs Class I - Dangerous
Failed dissolution specifications; all lots within expiry are being recalled due to out of specification dissolution results.
💊 Drugs Class I - Dangerous
Lack Of Assurance Of Sterility.
ROCuronium Bromide 10 mg per mL, 5 mL Fill in single dose syringe, (50 mg / 5 mL Total Dose) Rx Only SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205, NDC 70004-850-09
SCA Pharmaceuticals
💊 Drugs Class I - Dangerous
Lack Of Assurance Of Sterility.
💊 Drugs Class I - Dangerous
Marketed Without An Approved NDA/ANDA: FDA analysis found this product to contain undeclared sibutramine, phenolphthalein, and n-desmethyl sibutramine, making this an unapproved drug for which safety and efficacy have not been established and therefore, subject to recall.
THERMOCOOL SF NAV Catheters Model Numbers - BNI35FJCT, BNI35DFCT, D-131503-S, D-131504-S
Biosense Webster
🏥 Medical Devices Class I - Dangerous
Biosense Webster, Inc. has recently received an increased number of complaints related to the display of Alert 402 on the CARTO 3 System for certain lots of THERMOCOOL brand catheters. Alert 402 implies a "Map: magnetic distortion" when connected to CARTO 3 System. This issue may subsequently lead the physician to ablate in an unintended area when delivering RF energy.
🏥 Medical Devices Class I - Dangerous
Smiths Medical became aware that certain Non Flow-Stop CADD(R) Medication Cassette Reservoirs may have been manufactured with an incorrect pressure plate.
THERMOCOOL SMARTTOUCH SF Uni-Directional Product Codes D-1347-01-S, D-1347-02-S, D-1347-03-S
Biosense Webster
🏥 Medical Devices Class I - Dangerous
Biosense Webster, Inc. has recently received an increased number of complaints related to the display of Alert 402 on the CARTO 3 System for certain lots of THERMOCOOL brand catheters. Alert 402 implies a "Map: magnetic distortion" when connected to CARTO 3 System. This issue may subsequently lead the physician to ablate in an unintended area when delivering RF energy.
Alcon Custom Pak
Alcon Research
🏥 Medical Devices Class I - Dangerous
Alcon is initiating a medical device recall, after receiving notification from a supplier of a recall for x-ray detectable sponges. The one product referenced in the supplier recall notification, is used within Alcon Custom Paks.
🏥 Medical Devices Class I - Dangerous
In some systems, the unit continues to emit RF energy after the PAUSE button is pressed.
🏥 Medical Devices Class I - Dangerous
Smiths Medical became aware that certain Non Flow-Stop CADD(R) Medication Cassette Reservoirs may have been manufactured with an incorrect pressure plate.
🏥 Medical Devices Class I - Dangerous
Smiths Medical became aware that certain Non Flow-Stop CADD(R) Medication Cassette Reservoirs may have been manufactured with an incorrect pressure plate.
THERMOCOOL SMARTTOUCH Uni-Directional Navigation Catheter (D133602S)
Biosense Webster
🏥 Medical Devices Class I - Dangerous
Biosense Webster, Inc. has recently received an increased number of complaints related to the display of Alert 402 on the CARTO 3 System for certain lots of THERMOCOOL brand catheters. Alert 402 implies a "Map: magnetic distortion" when connected to CARTO 3 System. This issue may subsequently lead the physician to ablate in an unintended area when delivering RF energy.
Teleflex is recalling these products because the jaws of the tool tip may break, causing a fragment of the tool tip to fall off during use.
THERMOCOOL SMARTTOUCH SF Bi-Directional Product Codes D-1348-01-S, D-1348-04-S, D-1348-05-S
Biosense Webster
🏥 Medical Devices Class I - Dangerous
Biosense Webster, Inc. has recently received an increased number of complaints related to the display of Alert 402 on the CARTO 3 System for certain lots of THERMOCOOL brand catheters. Alert 402 implies a "Map: magnetic distortion" when connected to CARTO 3 System. This issue may subsequently lead the physician to ablate in an unintended area when delivering RF energy.
🏥 Medical Devices Class I - Dangerous
Biosense Webster, Inc. has recently received an increased number of complaints related to the display of Alert 402 on the CARTO 3 System for certain lots of THERMOCOOL brand catheters. Alert 402 implies a "Map: magnetic distortion" when connected to CARTO 3 System. This issue may subsequently lead the physician to ablate in an unintended area when delivering RF energy.
Baby B'gosh quilted jackets
Unknown Manufacturer
🏠 Consumer Products Class II - Moderate
The snaps can detach, posing a choking hazard.