FoodDec 30, 2020
Shenandoah Growers Organic fresh cut basil packaged in plastic clamshell recall — FDA F-0186-2021
Possible contamination with Cyclospora
Class IIFDA: TerminatedShenandoah Growers, Inc.
December 2020 recalls — page 4
These records include useful source details for the selected month.
FoodDec 30, 2020
Maribel's Sweets CACAO MARKET MARIE BELLE NEW YORK recall — FDA F-0181-2021
Product contains undeclared milk.
Class IFDA: TerminatedMaribel's Sweets, Inc.
FoodDec 30, 2020
Flowers Foods CANYON BAKEHOUSE GLUTEN FREE BAGELS EVERYTHING NET WT recall — FDA F-0182-2021
The firm discovered that some of their products showed higher than acceptable levels of gluten. They placed the product on hold for destruction however, one shipper sent products into…
Class IIFDA: TerminatedFlowers Foods (Corporate Offices)
DrugDec 30, 2020
Morton Grove Pharmaceuticals Hydroxyzine Hydrochloride Oral Solution, USP (Syrup), 10 mg/5 recall — FDA D-0174-2021
Failed Impurities/Degradation Specification: OOS for the following - unknown degradant/impurity, 4-chorobenzophenone, and for total impurities.
Class IIFDA: TerminatedMorton Grove Pharmaceuticals, Inc.
DrugDec 30, 2020
Auryxia (ferric citrate) tablets, 210 mg, 200-count bottles recall — FDA D-0170-2021
CGMP Deviations
Class IIFDA: TerminatedAkebia Therapeutics dba Keryx Biopharmaceutials, Inc.
DrugDec 30, 2020
SENSORCAINE recall — FDA D-0172-2021
Subpotent Drug: Low out-of-specification assay results for the epinephrine component.
Class IIFDA: TerminatedFresenius Kabi USA, LLC
Medical DeviceDec 23, 2020
Synthes (USA) Products DePuy Synthes 14.0MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual recall — FDA Z-0579-2021
RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue reaction, soft tissue damage, and/or bone damage, when the recommended surgical techniques are…
Class IIFDA: TerminatedSynthes (USA) Products LLC
Medical DeviceDec 23, 2020
Synthes (USA) Products DePuy Synthes 18.0MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual recall — FDA Z-0587-2021
RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue reaction, soft tissue damage, and/or bone damage, when the recommended surgical techniques are…
Class IIFDA: TerminatedSynthes (USA) Products LLC
Medical DeviceDec 23, 2020
Zimmer Biomet Polaris 5.5 Spinal System and Polaris 5.5/Cypher Spinal System recall — FDA Z-0570-2021
Zimmer Biomet is conducting a medical device correction to update the Instructions for Use (IFU) and the Surgical Techniques for the Polaris Spinal System Translation Screw and Cypher MIS…
Class IIFDA: TerminatedZimmer Biomet, Inc.
Medical DeviceDec 23, 2020
Biomet RapidFire Clip, Item Number 95-0154 - Product Usage: Fixation of Craniofacial bone recall — FDA Z-0626-2021
Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.
Class IIFDA: TerminatedBiomet, Inc.
Medical DeviceDec 23, 2020
Synthes (USA) Products DePuy Synthes 17.0MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual recall — FDA Z-0585-2021
RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue reaction, soft tissue damage, and/or bone damage, when the recommended surgical techniques are…
Class IIFDA: TerminatedSynthes (USA) Products LLC
Medical DeviceDec 23, 2020
Synthes (USA) Products DePuy Synthes 17.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual recall — FDA Z-0586-2021
RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue reaction, soft tissue damage, and/or bone damage, when the recommended surgical techniques are…
Class IIFDA: TerminatedSynthes (USA) Products LLC
Medical DeviceDec 23, 2020
Biomet RingLoc+ Quick Connect Drill Bit, Item numbers 31-323215, 31-323220, 31-323230 recall — FDA Z-0631-2021
Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.
Class IIFDA: TerminatedBiomet, Inc.
Medical DeviceDec 23, 2020
Carl Zeiss Meditec Ag VISULENS 550 REF 2268-038 - Product Usage: is a device for measuring recall — FDA Z-0613-2021
Due to the incorrect DC/DC converter being assembled onto the communication board. As a result the effectiveness of the communication board cannot be guaranteed in that the safety function…
Class IIFDA: TerminatedCarl Zeiss Meditec AG
Medical DeviceDec 23, 2020
Helena Laboratories K-ACT Actalyke Clotting Test Tubes that are used in the: ACTALYKE XL recall — FDA Z-0635-2021
Due to complaints received associated with cracked/split test tube caps.
Class IIFDA: OngoingHelena Laboratories, Corp.
Medical DeviceDec 23, 2020
Biomet Titanium IFS, Item number 909680 - Product Usage: Bone to bone fixation recall — FDA Z-0630-2021
Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.
Class IIFDA: TerminatedBiomet, Inc.
Medical DeviceDec 23, 2020
Synthes (USA) Products DePuy Synthes 15.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual recall — FDA Z-0582-2021
RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue reaction, soft tissue damage, and/or bone damage, when the recommended surgical techniques are…
Class IIFDA: TerminatedSynthes (USA) Products LLC
Medical DeviceDec 23, 2020
Synthes (USA) Products DePuy Synthes 13.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual recall — FDA Z-0578-2021
RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue reaction, soft tissue damage, and/or bone damage, when the recommended surgical techniques are…
Class IIFDA: TerminatedSynthes (USA) Products LLC
Medical DeviceDec 23, 2020
Becton Dickinson & Company BD PrecisionGlide Needle 30G x 1/2 (0.3 mm X 13mm) REF 305106 recall — FDA Z-0588-2021
BD has confirmed the presence of blood on the cannulas of the BD PrecisionGlide needles 30G X 1/2" Lot No. 9128897. The possibility of infection may be present if the blood is not noticed…
Class IIFDA: TerminatedBecton Dickinson & Company
Medical DeviceDec 23, 2020
Synthes (USA) Products DePuy Synthes 10.0MM REAMER HEAD FOR RIA 2, STERILE-Orthopedic manual recall — FDA Z-0571-2021
RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue reaction, soft tissue damage, and/or bone damage, when the recommended surgical techniques are…
Class IIFDA: TerminatedSynthes (USA) Products LLC
Medical DeviceDec 23, 2020
RAYSEARCH LABORATORIES AB RayStation 4, 4.5, 4.7, 4.9, 5, 6, 7, 8A, 8B, 9A, 9B, RayPlan 1 recall — FDA Z-0589-2021
Two issues were found with the treatment plan report: 1) There may be incorrect information for the percent of a region of interest with a clinical goal that is outside the dose grid; and…
Class IIFDA: TerminatedRAYSEARCH LABORATORIES AB
Medical DeviceDec 23, 2020
Roche Diagnostics Operations Tina-quant C-Reactive Protein Gen.3, Catalog number 05172373190 recall — FDA Z-0634-2021
Roche confirmed customer complaints of low quality (QC) recovery and invalid calibrations for the Tina-quant C-Reactive Protein Gen. 3 on the cobas c701 and 702 modules. A discoloration…
Class IIFDA: TerminatedRoche Diagnostics Operations, Inc.
Medical DeviceDec 23, 2020
Synthes (USA) Products DePuy Synthes 10.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual recall — FDA Z-0572-2021
RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue reaction, soft tissue damage, and/or bone damage, when the recommended surgical techniques are…
Class IIFDA: TerminatedSynthes (USA) Products LLC
Medical DeviceDec 23, 2020
Biomet 6.5/8.0mm Cannulated Screw System, BCS Cannulated Screw System recall — FDA Z-0618-2021
Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.
Class IIFDA: TerminatedBiomet, Inc.
How to use this monthly recall archive
Use this page to compare the recalls reported during the month, then open an individual record for the exact reason, classification, company, remedy or distribution information available from the official source. Monthly counts are descriptive, not a safety rating.