DrugNov 6, 2019
Gatifloxacin Ophthalmic Solution 0.5%, For Use in the Eyes Only recall — FDA D-0163-2020
Labeling: Incorrect or missing package insert.
Class IIIFDA: TerminatedSandoz Inc.
Monthly breakdown
2019 recalls by month
Select a month to review the recall records reported during that period.
December 2019321 records · 4 categoriesNovember 2019597 records · 4 categoriesOctober 2019525 records · 4 categoriesSeptember 2019268 records · 4 categoriesAugust 2019505 records · 4 categoriesJuly 2019680 records · 4 categoriesJune 2019445 records · 4 categoriesMay 2019396 records · 4 categoriesApril 2019242 records · 4 categoriesMarch 2019250 records · 4 categoriesFebruary 2019381 records · 4 categoriesJanuary 2019142 records · 4 categories
2019 recalls — page 39
Records are ordered by the best available source date.
DrugNov 6, 2019
Estradiol Vaginal Inserts USP, 10 mcg recall — FDA D-0156-2020
Defective Delivery System: complaints for difficulty in pushing the plunger of the applicator.
Class IIFDA: TerminatedGlenmark Pharmaceuticals Inc., USA
DrugNov 6, 2019
Ibuprofen Oral Suspension USP, 100 mg/5 mL, One Pint, (473 mL) recall — FDA D-0299-2020
Presence of Foreign Substance: Ibuprofen Oral Suspension USP may have small particles of an inert plastic material introduced during manufacturing.
Class IIFDA: TerminatedTaro Pharmaceuticals U.S.A., Inc.
DrugNov 6, 2019
Nephron Pharmaceuticals Corporation dba Nephron PF-Succinylcholine Chloride Injection, USP recall — FDA D-0154-2020
Incorrect labeling: Incorrect or missing lot and/or exp date
Class IIIFDA: TerminatedNephron Pharmaceuticals Corporation dba Nephron…
DrugNov 6, 2019
Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Suspension recall — FDA D-0162-2020
Labeling: Incorrect or missing package insert.
Class IIIFDA: TerminatedSandoz Inc.
DrugNov 6, 2019
Testosterone Cypionate Injection, USP, 2000 mg/10 mL, 1 mL Vial, Single-Dose recall — FDA D-0167-2020
Labeling:Label Mix-up: Shipper Carton labelled Testosterone Cypionate Injection, USP, 200mg/mL, 1 ml single-dose vials, found to contain shelf cartons labelled as Testosterone Cypionate…
Class IIIFDA: TerminatedArbor Pharmaceuticals Inc.
VehicleOct 31, 2019
Honda body recall — NHTSA campaign 19V784000
Honda (American Honda Motor Co.) is recalling certain 2019-2020 Pilot and 2019 Passport vehicles. The front frame left and right side upper members may not have been welded completely to…
bodyHonda (American Honda Motor Co.)
Medical DeviceOct 30, 2019
Candela Canister HFC-134a /980g, ALUM, 15 pack Product Number: 1600-00-0224 Revision .0C recall — FDA Z-0209-2020
The canister neck bushing may become loose and separate from the body of the canister during use. The issue occurs only when the canisters are used in Candela legacy devices that utilize…
Class IIFDA: TerminatedCandela Corporation
Medical DeviceOct 30, 2019
Andover Healthcare Sterile Co-Flex LF2 4" - Product Usage: Single Use secondary wound recall — FDA Z-0182-2020
Incomplete packaging seal of sterile product
Class IIFDA: TerminatedAndover Healthcare Inc.
Medical DeviceOct 30, 2019
Andover Healthcare Sterile Co-Flex Med 4" - Product Usage: Single Use secondary wound recall — FDA Z-0184-2020
Incomplete packaging seal of sterile product
Class IIFDA: TerminatedAndover Healthcare Inc.
Medical DeviceOct 30, 2019
GE Healthcare ApexPro Telemetry Server System recall — FDA Z-0175-2020
May not provide visual and/or audible alarms at the CARESCAPE Central Station or Clinical Information Center monitor for ECG arrhythmias, ECG LEADS FAIL or Pulse Oximetry (SpO2) under…
Class IIFDA: OngoingGE Healthcare, LLC
Medical DeviceOct 30, 2019
Beckman Coulter Uric Acid, REF OSR6098, OSR6198, and OSR6698 recall — FDA Z-0211-2020
NAPQI, a metabolite of Acetominophen, causes negative interference with the recalled product assays at levels present in the serum/plasma of overdose patients.
Class IIFDA: TerminatedBeckman Coulter Inc.
Medical DeviceOct 30, 2019
Life Technologies Holdings Pte Torrent Suite Dx Software Version 5.6.4 recall — FDA Z-0187-2020
Torrent SuiteTM Dx analysis software, a component of the Ion PGM Dx Instrument System, incorrectly displays a positive result when a different analytical or de novo variant is detected at…
Class IIFDA: TerminatedLife Technologies Holdings Pte Ltd
Medical DeviceOct 30, 2019
Beckman Coulter Lipase, REF OSR6130 and OSR6230 recall — FDA Z-0210-2020
NAPQI, a metabolite of Acetaminophen, causes negative interference with the recalled product assays at levels present in the serum/plasma of overdose patients.
Class IIFDA: TerminatedBeckman Coulter Inc.
Medical DeviceOct 30, 2019
ICU Medical Plum 360 Infusion System With MedNet/ Smart Card Plug And Play Module, Model # recall — FDA Z-0171-2020
A software malfunction of the infuser when used with a MedNet Custom Drug Library (CDL). When a new CDL is downloaded and installed on the infuser the infuser can become inoperable and show…
Class IIFDA: TerminatedICU Medical Inc.
Medical DeviceOct 30, 2019
Community Products Rifton E-Pacer, SKU K660, powered lift device recall — FDA Z-0166-2020
A design change to the load-bearing quick release buckle renders the springs in the latch mechanism susceptible to fatigue failure after repeated use.
Class IIFDA: TerminatedCommunity Products, LLC
Medical DeviceOct 30, 2019
Exactech Ergo 3.2mm K-wire - Product Usage: The devices is used assist the surgeon in the recall — FDA Z-0168-2020
Potential for the wire to fracture at the threads and remain in the glenoid.
Class IIFDA: TerminatedExactech, Inc.
Medical DeviceOct 30, 2019
Luminex Molecular Diagnostics xTAG Respiratory Viral Panel (RVP): Box Label: xTAG RVP recall — FDA Z-0161-2020
The Assay may give a false negative result when detecting and subtyping Influenza A (H3) and detecting RSV A in patient specimens. However, the assay will continue to detect Influenza A,…
Class IIFDA: OngoingLuminex Molecular Diagnostics
Medical DeviceOct 30, 2019
Candela Canister HFC-134a / 980g, ALUM Product Number: 1600-00-0223 Revision .0C Coolant recall — FDA Z-0208-2020
The canister neck bushing may become loose and separate from the body of the canister during use. The issue occurs only when the canisters are used in Candela legacy devices that utilize…
Class IIFDA: TerminatedCandela Corporation
Medical DeviceOct 30, 2019
Life Technologies Holdings Pte Torrent Suite Dx Software Version (IUO) 5.4 recall — FDA Z-0186-2020
Torrent SuiteTM Dx analysis software, a component of the Ion PGM Dx Instrument System, incorrectly displays a positive result when a different analytical or de novo variant is detected at…
Class IIFDA: TerminatedLife Technologies Holdings Pte Ltd
Medical DeviceOct 30, 2019
Andover Healthcare Sterile Co-Flex NL 4" - Product Usage: Single Use secondary wound recall — FDA Z-0180-2020
Incomplete packaging seal of sterile product
Class IIFDA: TerminatedAndover Healthcare Inc.
Medical DeviceOct 30, 2019
IrriMAX Irrisept Wound Debridement and Cleansing System. 12 units per case recall — FDA Z-0191-2020
Potential defect in the sterile pouch seal, which may result in a lack of sterility assurance.
Class IIFDA: TerminatedIrriMAX Corporation
Medical DeviceOct 30, 2019
Arrow AGB+ Multi-Lumen CVC Kit-catheter permits venous access to central circulation by way recall — FDA Z-0192-2020
Arrow AGB+ Multi-Lumen CVC Kit - lidstock incorrectly states within CDC-45703-1A a catheter 20cm in length. The banner card correctly states the product is CDC-42703-1A with a catheter 16cm…
Class IIFDA: TerminatedArrow International Inc.
Medical DeviceOct 30, 2019
Abbott Laboratories Emerald Diluent Tubing, List number 09H50-01, accompanying CELL-DYN recall — FDA Z-0173-2020
The diluent tubing used on the instrument appears cloudy or to have a powder/film on the inner and outer surfaces which may result in falsely elevated platelet results.
Class IIFDA: TerminatedAbbott Laboratories
About the 2019 recall archive
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.