ICU Medical 14 cm (5.5") Appx 0.27 ml, Smallbore Ext Set w/SURPLUG Nano T-Connector, Clamp recall — FDA Z-1347-2018
The infusion sets were manufactured with an incorrect spin collar.
Complete FDA and NHTSA recall records dated in 2018, organized for browsing by month, category and recalling company.
Select a month to review the recall records reported during that period.
Records are ordered by the best available source date.
The infusion sets were manufactured with an incorrect spin collar.
The NBP measurement of Intellivue X3 Patient Monitor shows intermittently only mean values instead of the diastolic and systolic blood pressure values. This is caused by a falsely detected…
Three (3) lots were distributed with the incorrect expiry date on the label. The lots were labeled with an expiry date of five (5) years from date of manufacture instead of the correct…
Three (3) lots were distributed with the incorrect expiry date on the label. The lots were labeled with an expiry date of five (5) years from date of manufacture instead of the correct…
Orthofix is conducting a voluntary recall of the Connector System Large Set Screw (PN: 79-2002) with affected Lot Numbers 001 and 002, and Small Set Screw (PN: 79-2003) with affected Lot…
One lot of D-RAD Self-Taping Locking Screws used with the Distal Radius Fracture Kit were machined out of specification. Screws measured over tolerance within the head thread form by…
VITROS TSH reagent lots have been found to generate higher than expected Calibrator level 2 signals on some customer systems. These Calibrator Level 2 responses cause a higher than expected…
Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed.
During continuous postmarket surveillance activities, we have noticed a potential malfunction of individual foot controls of the type S-N1/S-N2. In case the error occurs, the foot control…
The infusion sets were manufactured with an incorrect spin collar.
Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed.
BMD has identified that the product code/lot number combination identified above may have ineffectively fused tubing and ENFit(TM) connector.
These products contain latex, but the following statement is not included on any level of product packaging: Caution: This Product Contains Natural Rubber Latex Which May Cause Allergic…
Certain lots of M-30D diluent used with BC-3200 and BC-3600 Hematology Analyzers and M-53D diluent used with BC-5390 Hematology Analyzers may cause the system to produce an elevated…
All American Seasonings is recalling Lost Cajun Gumbo Base because an ingredient was contaminated with Salmonella.
Original Smoked Oysters, packaged in vacuum pouches, are recalled because the product is not intended to be packaged in a vacuum pouch. This product is cold smoked and low salt and will not…
A packaging revision and lack of revision to the corresponding packaging batch record caused the labeling for the firm's Signature Care brand Calcium Chews dietary supplement to declare a…
Case labeling (shrink-wrap labeling) for Diet Pepsi 6 packs (6-16oz bottles) may indicate that the product is "Now Aspartame Free" when the product actually contains aspartame. The…
A sample was collected by the Florida Department of Agriculture and Consumer Services and the analysis revealed that the product contains undeclared sulfites.
The firm recalled cheese after a sample tested positive for Listeria monocytogenes by the State of New York.
Amaranth Flour is recalled due to potential for contamination with Salmonella.
Bruschetta Dip and Bruschetta Mix are recalled because they contain undeclared Milk & Soy.
Smoked Scallops, packaged and frozen in vacuum pouches, are recalled because product did not meet minimum Water Phase Salt (WPS) percentage of 3.5%.
Failed impurities/degradation specifications: Failure to water content and impurity
This archive groups records by their reported or recall date. It does not imply that every recall was initiated, announced and resolved during the same calendar year. Open the individual record for the exact dates and source details supplied by FDA or NHTSA.