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.

9551–9575 of 21595

ModerateFDA (Devices)·Z-0613-2019·2018-12-26
Tosoh AIA-360 Analyzer Recalled for Table Home Sensor Malfunction
Tosoh Bioscience Inc is recalling 438 AIA-360 Analyzers because a table home sensor malfunction can cause the device to stop functioning, potentially delaying patient test results.
Product
AIA-360 Analyzer is capable of performing two methods of immunoassay: an immunoenzymetric (IEMA) or sandwich immunoassay, a competitive binding (EIA) immunoassay. An antigen-antibody reaction begins by combining a patient sample, control, or calibrator with a diluent in an immuno
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0638-2019·2018-12-26
Cardinal Health Recalls Protexis Neoprene Surgical Gloves Due to Labeling Errors
Cardinal Health is recalling Protexis Neoprene Surgical Gloves because the primary packaging contains incorrect breakthrough times for specific chemotherapy drugs.
Product
Protexis Neoprene Surgical Glove, Size 9.0 This powder-free sterile light brown colored surgeons gloves are a disposable device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0620-2019·2018-12-26
Clark Laboratories Recalls ultra2 Genesys Variants Analyzer for Lack of 510(k)
Clark Laboratories is recalling 14 ultra2 Genesys Variants Analyzer devices because they lack FDA 510(k) clearance. The recall is voluntary and affects in vitro diagnostic use.
Product
ultra2 Genesys Variants Analyzer, REF 03-01-0045 intended to be used with automated high performance liquid chromatography (HPLC) systems employing ion exchange chromatography. For in vitro diagnostic use only.
Category
Medical Device
Distribution
6 states
ModerateFDA (Devices)·Z-0644-2019·2018-12-26
Zimmer GmbH Recalls Mislabeled Avenir Muller Stem Hip Implants
Zimmer GmbH is recalling 13 units of Avenir Muller Stem hip implants because size 1 stems were packaged as size 2. The recall covers distribution in Germany and Switzerland.
Product
Avenir¿ Muller Stem Standard, uncemented HA, 1, Taper 12/14 Item Number: 01.06010.001 - Product Usage: Avenir@ Muller Stems are intended to reduce pain and increase hip mobility through long term cementless fixation of total or hemi hip arthroplasty in the femur of patients with
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0641-2019·2018-12-26
GE Healthcare Recalls Centricity Universal Viewer Software Due to Orientation Marker Errors
GE Healthcare is recalling specific versions of the Centricity Universal Viewer Zero Footprint Client because orientation markers may display incorrectly after image manipulation.
Product
Centricity Universal Viewer Zero Footprint Client, Model Number 2090258-001, Software Versions 6.0 SP7, SP7.0.1, SP7.0.2, SP7.0.3, SP8, SP8.0.1, SP8.0.a and SP8.0.2, SP9 and SP9.0.1 display o orientation markers can become is incorrect.
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0653-2019·2018-12-26
Ortho-Clinical Diagnostics Recalls VITROS 4600 Chemistry System Software
Ortho-Clinical Diagnostics is recalling 728 VITROS 4600 Chemistry Systems because a software anomaly may incorrectly extend reagent stability time.
Product
VITROS 4600 Chemistry System, Version 3.3.1 & below For use in the in vitro quantitative measurement of a variety of analytes of clinical interest in certain biological fluids (depending on the analyte) such as serum, plasma, urine and cerebrospinal fluid.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0623-2019·2018-12-26
Clark Laboratories Recalls Genesys 2 Reagent Due to Lack of 510(k) Clearance
Clark Laboratories is recalling 216 units of Genesys 2 Reagent because the product lacks the required FDA 510(k) clearance for marketing.
Product
Genesys 2 Reagent, REF 01-03-0022 intended to be used with automated high performance liquid chromatography (HPLC) systems employing ion exchange chromatography. For in vitro diagnostic use only.
Category
Medical Device
Distribution
6 states
ModerateFDA (Drugs)·D-1207-2019·2018-12-26
Sun Pharmaceutical Recalls Subpotent Absorica LD Isotretinoin Capsules
Sun Pharmaceutical Industries is recalling Absorica LD (Isotretinoin) capsules because the active ingredient content was lower than the required specification limit.
Product
ABSORICA LD — ABSORICA LD (ISOTRETINOIN)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0635-2019·2018-12-26
Cardinal Health Recalls Protexis Neoprene Surgical Gloves Due to Labeling Error
Cardinal Health 200, LLC is recalling Protexis Neoprene Surgical Gloves because the packaging contains incorrect breakthrough times for specific chemotherapy drugs.
Product
Protexis Neoprene Surgical Glove, Size 7.5 This powder-free sterile light brown colored surgeons gloves are a disposable device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0651-2019·2018-12-26
Ortho-Clinical Diagnostics Recalls VITROS 5,1 FS Chemistry System Software
Ortho-Clinical Diagnostics is recalling VITROS 5,1 FS Chemistry Systems due to a software anomaly that may incorrectly extend reagent stability time.
Product
VITROS 5,1 FS Chemistry System, Version 3.0 & below For use in the in vitro quantitative measurement of a variety of analytes of clinical interest in certain biological fluids (depending on the analyte) such as serum, plasma, urine and cerebrospinal fluid.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0632-2019·2018-12-26
Cardinal Health Recalls Protexis Neoprene Surgical Gloves Due to Labeling Error
Cardinal Health 200, LLC is recalling Protexis Neoprene Surgical Gloves because the primary packaging contains incorrect breakthrough times for specific chemotherapy drugs.
Product
Protexis Neoprene Surgical Glove, Size 6.0 This powder-free sterile light brown colored surgeons gloves are a disposable device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0637-2019·2018-12-26
Cardinal Health Recalls Protexis Neoprene Surgical Gloves Due to Labeling Error
Cardinal Health is recalling Protexis Neoprene Surgical Gloves because the packaging contains incorrect breakthrough times for specific chemotherapy drugs.
Product
Protexis Neoprene Surgical Glove, Size 8.5 This powder-free sterile light brown colored surgeons gloves are a disposable device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0610-2019·2018-12-26
Diagnostica Stago Recalls Staclot LA Test Kits Due to Result Variability
Diagnostica Stago is recalling Staclot LA test kits because some results showed shortened times, potentially affecting lupus anticoagulant detection accuracy.
Product
Staclot¿ LA (REF 00600) The Staclot¿ LA and Staclot¿ LA 20 test kits are reagent systems designed for the qualitative detection of lupus anticoagulants (LA) in plasma by the use of hexagonal HII phase phospholipid molecules (1, 2).
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0611-2019·2018-12-26
Diagnostica Stago Recalls Staclot LA 20 Test Kits Due to Result Variability
Diagnostica Stago is recalling Staclot LA 20 test kits because some results showed shortened times outside the expected range.
Product
Staclot LA 20 (REF 00594) The Staclot¿ LA and Staclot¿ LA 20 test kits are reagent systems designed for the qualitative detection of lupus anticoagulants (LA) in plasma by the use of hexagonal HII phase phospholipid molecules (1, 2).
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0634-2019·2018-12-26
Cardinal Health Recalls Protexis Neoprene Surgical Gloves Due to Labeling Errors
Cardinal Health 200, LLC is recalling Protexis Neoprene Surgical Gloves because the primary packaging contains incorrect breakthrough times for specific chemotherapy drugs.
Product
Protexis Neoprene Surgical Glove, Size 7.0 This powder-free sterile light brown colored surgeons gloves are a disposable device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0622-2019·2018-12-26
Clark Laboratories Recalls Genesys 1 Reagent for Lack of 510(k) Clearance
Clark Laboratories is recalling 252 units of Genesys 1 Reagent because the product lacks FDA 510(k) clearance. The recall is voluntary and has been terminated.
Product
Genesys 1 Reagent, REF 01-03-0020 intended to be used with automated high performance liquid chromatography (HPLC) systems employing ion exchange chromatography. For in vitro diagnostic use only.
Category
Medical Device
Distribution
6 states
ModerateFDA (Devices)·Z-0630-2019·2018-12-26
Zimmer Biomet Recalls NexGen Knee Augment Blocks Due to Missing Screws
Zimmer Biomet is recalling 19 NexGen Complete Knee Solution Femoral Augment Blocks because a screw is missing from the package.
Product
NexGen¿ Complete Knee Solution Femoral Augment Block Distal only, 15mm, Size E with Screw Item Number: 00599003523 NexGen Distal Femoral Augment Block is used when femoral components can neither be downsized nor can be distally augmented by increasing the thickness of the cem
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0319-2019·2018-12-26
GE Healthcare Recalls Omnipaque Injection Due to Vial Defect
GE Healthcare is recalling 1,092 cartons of Omnipaque (iohexol) Injection in Tennessee due to a vial defect that could compromise sterility or introduce glass particles.
Product
OMNIPAQUE — OMNIPAQUE (IOHEXOL)
Category
Drug
Distribution
1 state
ModerateFDA (Food)·F-0767-2019·2018-12-26
Luckyberry Recalls Unpasteurized Cold-Pressed Juice for Regulatory Violation
Luckyberry is recalling unpasteurized cold-pressed juice products because they were manufactured and distributed in violation of FDA regulations.
Product
Luckyberry Cold-Pressed Juice, Reset, Carrot, Apple, Ginger, Lemon, 16 FL OZ, Manufactured at Luckyberry Juice Caf¿, Lawrence, KS
Category
Food
Distribution
0 states
ModerateFDA (Devices)·Z-0624-2019·2018-12-26
Clark Laboratories Recalls Genesys Diluent Reagent for Lack of 510(k) Clearance
Clark Laboratories is recalling 463 units of Genesys Diluent Reagent because the product lacks FDA 510(k) clearance. The recall is voluntary and affects in vitro diagnostic use.
Product
Genesys Diluent Reagent, REF 01-03-0019 intended to be used with automated high performance liquid chromatography (HPLC) systems employing ion exchange chromatography. For in vitro diagnostic use only.
Category
Medical Device
Distribution
6 states
ModerateFDA (Devices)·Z-0631-2019·2018-12-26
Cardinal Health Recalls Protexis Neoprene Surgical Gloves Due to Labeling Error
Cardinal Health 200, LLC is recalling Protexis Neoprene Surgical Gloves because the primary packaging contains incorrect breakthrough times for specific chemotherapy drugs.
Product
Protexis Neoprene Surgical Glove, Size 5.5 This powder-free sterile light brown colored surgeons gloves are a disposable device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0636-2019·2018-12-26
Cardinal Health Recalls Protexis Neoprene Surgical Gloves Due to Labeling Errors
Cardinal Health is recalling Protexis Neoprene Surgical Gloves because the packaging contains incorrect breakthrough times for specific chemotherapy drugs.
Product
Protexis Neoprene Surgical Glove, Size 8.0 This powder-free sterile light brown colored surgeons gloves are a disposable device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0340-2019·2018-12-26
KVK-Tech Recalls Oxybutynin Chloride Tablets Due to Wrong Bar Code
KVK-Tech, Inc. is recalling 156 bottles of Oxybutynin Chloride Tablets, 5 mg, because they bear the wrong bar code.
Product
OXYBUTYNIN CHLORIDE — OXYBUTYNIN CHLORIDE (OXYBUTYNIN CHLORIDE)
Category
Drug
Distribution
0 states
ModerateFDA (Drugs)·D-0382-2019·2018-12-26
Cipla Recalls Nevirapine Extended Release Tablets for Dissolution Failure
Cipla Limited is recalling 4,800 bottles of Nevirapine Extended Release Tablets, 400 mg, because they failed to meet dissolution specifications.
Product
Nevirapine Extended Release Tablets, 400 mg, 30-count bottle, Rx Only, Manufactured by: Cipla Ltd. Verna Goa, India, Manufactured for: Cipla USA Inc. 9100 S Dadeland Blvd., Suite 1500 Miami, FL 33156, NDC 69097-403-02
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0621-2019·2018-12-26
Clark Laboratories Recalls Genesys Analytical Columns Due to Missing 510(k) Clearance
Clark Laboratories, Inc. is voluntarily recalling 372 Genesys Analytical Columns because they were distributed without FDA 510(k) clearance.
Product
Genesys Analytical Column, REF 01-05-0017 intended to be used with automated high performance liquid chromatography (HPLC) systems employing ion exchange chromatography. For in vitro diagnostic use only.
Category
Medical Device
Distribution
6 states