Severity 2 of 5

Moderate recalls

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

What “moderate” means here

Severity 2 (Moderate) recalls cover minor labeling errors, low-risk contamination, and voluntary precautionary recalls. The agency's own classification is typically FDA Class III, or the issue is something like incomplete instructions or a small UPC mismatch where the product itself is safe but doesn't meet documentation requirements. Use the same brand-name product safely; follow the manufacturer's instructions for return or exchange if you want a refund.

The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.

11901–11925 of 21617

ModerateFDA (Devices)·Z-3124-2017·2017-09-20
Leica Biosystems Recalls Napsin A Antibody Due to Temperature Excursion
Leica Biosystems Richmond Inc. is recalling 33 units of Napsin A (MRQ-60 Mab.) antibody because a delay in transit may have caused the product to be stored outside of defined temperature requirements.
Product
Cell Marque, Napsin A (MRQ-60 Mab.), 7 mL, REF PA0805, IVD, The antibody is intended for in vitro diagnostic (IVD) use. Napsin A (MRQ-60) Mouse Monoclonal Primary Antibody is intended for laboratory use in the detection of the Napsin A protein in formalin-fixed…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-3122-2017·2017-09-20
Leica Biosystems Recalls MiTF Antibody Due to Temperature Deviation
Leica Biosystems Richmond Inc. is recalling 10 units of Microphthalmia Transcription Factor (MiTF) antibody because a transit delay caused the product to be stored outside required temperature ranges.
Product
Cell Marque, Microphthalmia Transcription Factor (MiTF) (C5/D5 Mab.), 7 mL, REF PA0803, IVD, The antibody is intended for in vitro diagnostic (IVD) use. The Microphthalmia Transcription Factor (MiTF) (C5/D5) antibody is intended for qualified laboratories to qualitatively…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-3116-2017·2017-09-20
Becton Dickinson Recalls SafetyGlide Needles Due to Foreign Matter
Becton Dickinson is recalling 1,249,200 units of BD SafetyGlide needles because they contain loose polypropylene foreign matter above release specifications.
Product
BD Needle 22GA 1-1/2in SafetyGlide(TM) Non Sterile, Bulk, REF 301701 The BD SafetyGlide(TM) needle is intended to be used for general purpose injection, aspiration of fluids from parts of the body below the surface of the skin, injection into intravenous ports and tubings…
Category
Medical Device
Distribution
10 states
ModerateFDA (Devices)·Z-3119-2017·2017-09-20
bioMerieux Recalls eMAG System Due to Manufacturing Anomalies
bioMerieux, Inc. is recalling 15 eMAG System units in the US and 11 countries due to anomalies identified during manufacturing controls.
Product
eMAG System, Ref 418591 It is an In Vitro Diagnostic Medical device intended for the automated isolation (purification and concentration) of total nucleic acids (RNA/DNA) from biological specimens, with liquid and homogeneous properties (as part of their natural…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1136-2017·2017-09-20
Mid Valley Pharmaceutical Recalls Doctor Manzanilla Cough & Cold Syrup
Mid Valley Pharmaceutical is recalling Doctor Manzanilla Cough & Cold Syrup due to a potential risk of contamination with B. cepacia bacteria.
Product
Doctor Manzanilla Cough & Cold (diphenhydramine hydrochloride and phenylephrine hydrochloride) Syrup, 12.5 mg and 5 mg in each 5 mL, 4 fl oz. (118 mL) bottle, Distributed by: Midvalley Pharmaceuticals, Raymondville, TX 78580, UPC 7 62558 00316 1.
Category
Drug
Distribution
1 state
ModerateFDA (Drugs)·D-1134-2017·2017-09-20
Ascend Amlodipine Besylate Tablets Recalled for Foreign Tablet Presence
Ascend Laboratories is recalling 10 mg Amlodipine Besylate tablets because 2.5 mg tablets were found mixed in the bottles.
Product
AMLODIPINE BESYLATE — AMLODIPINE BESYLATE (AMLODIPINE BESYLATE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-3125-2017·2017-09-20
Leica Biosystems Recalls PAX8 Antibody Due to Temperature Deviation
Leica Biosystems Richmond Inc. is recalling five units of PAX8 antibody because a transit delay may have caused the product to be stored outside required temperature limits.
Product
Cell Marque, PAX8 (MRQ-50 Mab.), 7 mL, REF PA0808, IVD, This antibody is intended for in vitro diagnostic (IVD) use. PAX-8 (MRQ-50) Mouse Monoclonal Primary Antibody is intended for laboratory use in the detection of the PAX-8 protein in formalin-fixed, paraffin-embedded tissue…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1138-2017·2017-09-20
Medline Recalls Mislabelled Vitamin A&D Ointment Packets
Medline Industries is recalling Vitamin A&D Ointment packets that are incorrectly labeled as petroleum jelly. The outer boxes are correctly labeled.
Product
Vitamin A&D Ointment (petroleum 93.5%), Skin Protectant, NET Wt. 0.18 OZ (5g), Manufactured for Medline Industries, Inc., Northfield, IL 60093 USA. NDC: 53329-090-16
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-3129-2017·2017-09-20
Fujifilm Endoscope Corrective Action Following FDA Inspection
Fujifilm Medical Systems U.S.A., Inc. is conducting a corrective action for specific endoscope models following an FDA inspection.
Product
Fujifilm Endoscope Models ED-250XL5 ED-250XT5 ED-450XT5 ED-450XL5 Product Usage: This product is a medical endoscope for the duodenum and upper GI tract. It is intended for observation, diagnosis, and endoscopic treatment of the esophagus, stomach and duodenum. This…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-3123-2017·2017-09-20
Leica Biosystems Recalls MSH6 Antibody Due to Temperature Deviation
Leica Biosystems Richmond Inc. is recalling 13 units of MSH6 antibody (REF PA0804) because a delay in transit may have caused the product to be stored outside of required temperature ranges.
Product
Cell Marque, MSH6 (44 Mab.), 7 mL, REF PA0804, IVD, The antibody is intended for in vitro diagnostic (IVD) use. MSH6 is a mismatch repair gene which is deficient in a high proportion of patients with microsatellite instability (MSI-H). This finding is associated with the…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Food)·F-3485-2017·2017-09-13
Rushing Waters Recalls Smoked Atlantic Salmon Portions for Underprocessing
Rushing Waters Fisheries is recalling Smoked Peppered Atlantic Salmon Portions because they may have been underprocessed. The product was distributed in Illinois.
Product
Whole Foods Smoked Peppered Atlantic Salmon Portion, packed in bulk boxes. Labeling states: Smoked on: 08/09/17, Sell Through: 09/04/17. Smoked fish portions are placed inside of a box lined with a plastic bag, which is hand-tied when the box is filled. Weights of each box…
Category
Food
Distribution
1 state
ModerateFDA (Drugs)·D-1129-2017·2017-09-13
Povidone Iodine Solution Recalled for Labeling Error
Degasa Sa De Cv is recalling 720 bottles of Povidone Iodine 10% solution due to a label mix-up where 7.5% product was labeled as 10%.
Product
Povidone Iodine, USP Prep Solution, 10%, packaged in 1 gallon bottle, OTC, Manufactured for PSS World Medical, Inc. Southpoint Blvd. Jacksonville, FL Made in Mexico, NDC 68345-350-09
Category
Drug
Distribution
2 states
ModerateFDA (Drugs)·D-1131-2017·2017-09-13
ImprimisRx Recalls Latanoprost Ophthalmic Drops Due to Undeclared Excipient
ImprimisRx is recalling 19 bottles of compounded Latanoprost ophthalmic drops because they contain non-pharmaceutical grade PEG 40 Castor Oil due to supplier mislabeling.
Product
Latanoprost PF Solution, 0.005%, Ophthalmic Drops in Sterile 5ml Bottles, Compounded for a licensed professional or patient use, imprimisRx, Irvine, CA
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-3108-2017·2017-09-13
CryoLife On-X Heart Valve Recall Due to Device Mix-Up
CryoLife is recalling five On-X Prosthetic Heart Valves because a return authorization error caused them to be redistributed and implanted in two patients.
Product
On-X Prosthetic Heart Valve with Gelweave Valsalva Graft, single use. Indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic heart valves in the aortic position in cases that involve an ascending aortic aneurysm or other associated aortic…
Category
Medical Device
Distribution
1 state
ModerateFDA (Food)·F-3487-2017·2017-09-13
Rushing Waters Fisheries Recalls Smoked Whitefish Fillet for Underprocessing
Rushing Waters Fisheries is recalling smoked whitefish fillets because they may have been underprocessed. The product was distributed in Illinois.
Product
Whole Foods Smoked Whitefish Fillet, packed in bulk boxes. Labeling states: Smoked on: 08/09/17, Sell Through: 09/04/17. Smoked fish portions are placed inside of a box lined with a plastic bag, which is hand-tied when the box is filled. Weights of each box vary.
Category
Food
Distribution
1 state
ModerateFDA (Drugs)·D-1132-2017·2017-09-13
ImprimisRx Recalls Timolol-Latanoprost Ophthalmic Drops Due to Mislabeling
ImprimisRx is recalling 16 bottles of compounded Timolol-Latanoprost ophthalmic drops because non-pharmaceutical grade PEG 40 Castor Oil was used due to supplier mislabeling.
Product
Timolol-Latanoprost PF Solution (0.5-0.005)%, Ophthalmic Drops, Sterile 5ml Bottle, Compounded for a licensed professional or patient use, imprimisRx, Irvine, CA
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Food)·F-3486-2017·2017-09-13
Rushing Waters Fisheries Recalls Smoked Atlantic Salmon Portions
Rushing Waters Fisheries is recalling smoked Atlantic salmon portions because they may have been underprocessed.
Product
Whole Foods Smoked Traditional Atlantic Salmon Portion, packed in bulk boxes. Labeling states: Smoked on: 08/09/17, Sell Through: 09/04/17. Smoked fish portions are placed inside of a box lined with a plastic bag, which is hand-tied when the box is filled. Weights of each box…
Category
Food
Distribution
1 state
ModerateFDA (Devices)·Z-3075-2017·2017-09-06
BioMérieux Recalls VITEK 2 Compact 15 Software and Reagent Cards
BioMérieux is recalling VITEK 2 Compact 15 software and reagent cards because they may fail to finalize test results after a software update.
Product
VITEK¿ 2 Compact 15, REF numbers: 27415 and 27415R software and reagent cards designed for the identification (ID) and antimicrobial susceptibility testing (AST) of bacteria and yeast.
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-3094-2017·2017-09-06
Siemens AXIOM Artis zee and Q/Q.zen x-ray systems recalled for cooling leak
Siemens is recalling 986 AXIOM Artis zee and Q/Q.zen x-ray systems in the US because a cooling system leak could cause equipment failure.
Product
Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis zee and Q/Q.zen is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to , pediatric and obese…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0010-2018·2017-09-06
Optovue iVue 500 Recalled for Missing 510(k) for Vault Mapping Software
Optovue is recalling 326 iVue 500 devices because FDA determined a 510(k) is needed for the Vault Mapping software.
Product
iVue 500 with iScan, D216606. Product non-contact, high resolution tomographic imaging device. It is intended for in vivo imaging, axial cross-sectional and three-dimensional imaging and measurement of anterior and posterior ocular structures, including retina, retinal nerve…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-3083-2017·2017-09-06
Med Tec Recalls CIVCO Rigid Arm Supports for Height Discrepancy
Med Tec Inc is recalling CIVCO Rigid Arm Supports used in Posiboard-2 and Posirest assemblies due to a potential 17mm height difference.
Product
CIVCO Arm Support, REF 106047, distributed as: (a) Rigid Arm Support, Large, Set, Red (PN: 106047) (b) PB2-BDLRL (PN: 109040) (c) Rigid Adj. Arm Support, Large, Set (PN: 106048) (d) PSR2-CF-DLRL-2P Posirest-2 (PN: 106522) The Rigid Arm Supports are utilized on the…
Category
Medical Device
Distribution
3 states
ModerateFDA (Drugs)·D-1124-2017·2017-09-06
Amphastar Recalls Ketorolac Injection Due to Crystallization
Amphastar Pharmaceuticals is recalling Ketorolac Tromethamine Injection because crystallization was observed in retained samples.
Product
Ketorolac Tromethamine Injection, USP 30 mg/mL, packaged in 1 mL single-dose vials, Rx only, Amphastar Pharmaceuticals, Inc., Rancho Cucamonga, CA 91730, NDC 0548-9021-00
Category
Drug
Distribution
0 states
ModerateFDA (Devices)·Z-3102-2017·2017-09-06
Encore Medical Recalls Turon Glenoid Reamers Due to Dimensional Error
Encore Medical is recalling five Turon Glenoid Reamers because the spherical radius cutting surface was manufactured with the wrong dimension, resulting in a larger surface than intended.
Product
MODIFIED/SPECIAL INSTRUMENT, TURON GLENOID REAMER, REAM AND RUN, Catalog Numbers: REF S-200956 - 5mm PIN, SIZE 46 REF S-200957 - 5mm PIN, SIZE 50 REF S-200958 - 5mm PIN, SIZE 58
Category
Medical Device
Distribution
2 states
ModerateFDA (Drugs)·D-1126-2017·2017-09-06
Tris Pharma Recalls Morphine Sulfate Oral Solution Due to Leaking
Tris Pharma is recalling 34,824 bottles of Morphine Sulfate Oral Solution because the liquid is leaking from the containers.
Product
MORPHINE SULFATE — MORPHINE SULFATE (MORPHINE SULFATE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-3044-2017·2017-09-06
Neusoft Medical NeuViz 64 CT Scanner Software Defect Recall
Neusoft Medical Systems is recalling 234 NeuViz 64 CT scanners due to a software defect. The FDA mandated this recall for units distributed nationwide.
Product
Neusoft Medical NeuViz 64 Multi-slice CT Scanner System, including: NeuViz 64e, NeuViz 64i with software version 1.0.6.3258 +P11 or previous version, NeuViz 64En, NeuViz 641n with software version 1.0.7.4021+P11 or previous version Product Usage: The Multi-Slice CT…
Category
Medical Device
Distribution
Distributed nationwide