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.

5251–5275 of 21589

ModerateFDA (Drugs)·D-0021-2022·2021-10-27
AirDuo Digihaler 113/14 Inhalation Powder Subpotent Drug Recall
Teva Pharmaceuticals is recalling AirDuo Digihaler 113/14 inhalation powder because some units contain less salmeterol than the labeled dose. The affected sample batch was distributed nationwide.
Product
AirDuo Digihaler 113/14 (fluticasone propionate 113 mcg and salmeterol 14 mcg) Inhalation Powder, Sample Not For Sale, Rx Only, Mktd by: Teva Respiratory, LLC , Frazer, PA 19355, Manufactured in Ireland, NDC 59310-520-08
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0018-2022·2021-10-27
Cleaning Solutions Foaming Hand Sanitizer Recalled for Skin Irritation Risk
Sanitor Corporation is recalling Cleaning Solutions Foaming Hand Sanitizer (Benzalkonium chloride 0.1%) due to contamination from Current Good Manufacturing Practice (CGMP) deviations. Use may cause skin or soft tissue infection and irritation.
Product
Cleaning Solutions Foaming Hand Sanitizer, Active Ingredient Benzalkonium chloride 0.1%, New Wave Cleaning Solutions LLC, 7001 W Arby Ave Suite 100, Las Vegas, NV 89113, UPC#: 8 60001 93396 3
Category
Drug
Distribution
1 state
ModerateNHTSA·21V836000·2021-10-25
Yamaha Recalls 2021 Tracer 9 GT for Incorrect VIN Label
Yamaha is recalling 2021 Tracer 9 GT motorcycles because the VIN on the certification label may not match the vehicle's stamped VIN, potentially preventing owners from receiving safety recall remedies.
Product
YAMAHA — YAMAHA TRACER 9 GT
Category
Vehicle
Distribution
Distributed nationwide
ModerateNHTSA·21V831000·2021-10-22
2022 BMW X4 Rear License Plate Lamp Illumination Defect
BMW is recalling certain 2022 X4 vehicles because the rear license plate may not be properly illuminated, violating federal safety standards and potentially creating visibility issues for other drivers.
Product
BMW — BMW X4
Category
Vehicle
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0006-2022·2021-10-20
Potassium Chloride Extended-Release Tablets Recalled for Failed Dissolution
Strides Pharma Inc. is recalling Potassium Chloride Extended-Release Tablets, USP 10 mEq because the tablets fail to meet dissolution specifications, which may affect drug effectiveness.
Product
POTASSIUM CHLORIDE — POTASSIUM CHLORIDE (POTASSIUM CHLORIDE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0114-2022·2021-10-20
Flower Lag Screw Kit drill bits missing AO connect feature recalled
Flower Orthopedics is recalling Flower Lag Screw Kit 2.7 mm because drill bits lack the AO connect feature, which may delay surgical procedures.
Product
Flower Lag Screw Kit 2.7 mm-intended to be used with 2.7mm lag screws and can be used with any plate that as part of the Flower Small and Medium Implant Set, Flower Ankle Plating Set , Flower Rear Foot/Calcaneus Plating Set , or Flower Upper Extremity Plating Set and uses the med
Category
Medical Device
Distribution
10 states
ModerateFDA (Devices)·Z-0111-2022·2021-10-20
Flower Drill Bit Kit missing AO connect feature may delay procedures
Flower Orthopedics is recalling Flower Drill Bit Kit 2.0 mm kits because drill bits are missing the AO connect feature, which may result in procedural delays. Affected units were distributed across multiple states.
Product
Flower Drill Bit Kit 2.0 mm - intended to be used with solid 2.0mm screws and can be used with any plate that has been cleared as part of the Flower Small and Medium Implant Set and uses the small locking mechanism. mechanism. Catalog Number: DBK 020 2013002721
Category
Medical Device
Distribution
10 states
ModerateFDA (Food)·F-0024-2022·2021-10-20
Driscoll's Fresh Blueberries Recalled for Metal Fragment Contamination
Driscoll's Inc. is recalling Fresh Blueberries in 6 oz. and 1 pt. clamshell containers due to the presence of small metal spheres (approximately 2.45 mm in diameter) found in berries from this grower. The recall affects products distributed to California, Hawaii, Minnesota, Nevada, and Washington.
Product
Driscolls's Fresh Blueberries 6 oz. and 1 pt. clamshell containers Keep refrigerated and rinse before use.
Category
Food
Distribution
5 states
ModerateFDA (Devices)·Z-0081-2022·2021-10-20
Philips HeartStart HS1 OnSite Defibrillator Recall: Notification of Previous Recalls
Philips North America LLC is recalling 15 units of the HeartStart HS1 OnSite Defibrillator (Models M5066A and M5067A) due to failure to notify customers of previous recalls associated with these devices.
Product
Philips, HeartStart HS1 OnSite Defibrillator, Model #'s: M5066A and M5067A
Category
Medical Device
Distribution
12 states
ModerateFDA (Devices)·Z-0113-2022·2021-10-20
Flower Drill Bit Kit Missing AO Connect Feature, May Delay Procedures
Flower Orthopedics Corporation is recalling Flower Drill Bit Kit 2.7mm (DBK 027) due to missing AO connect feature that may delay surgical procedures. Affected kits were distributed across multiple U.S. states.
Product
Flower Drill Bit Kit 2.7mm- The Drill Bit Kit, 2.7mm (DBK 027) is intended to be used with solid 2.7mm screws and can be used with any the Flower Small and Medium Implant Set Flower Ankle Plating Set , Flower Rear Foot/Calcaneus Plating Set or Flower Upper Extremity Plating Set
Category
Medical Device
Distribution
10 states
ModerateFDA (Food)·F-0012-2022·2021-10-20
Fairlife Milk 8oz 6-Pack Chocolate Recalled for Spoilage Risk
Fairlife Llc is recalling Fairlife Milk 8oz 6-pack chocolate bottles with date code MAY2722 FA due to potential spoilage and lack of commercial sterility. The affected product was distributed to retailers in Arizona, California, Oregon, Utah, Washington, and military distributors.
Product
FAIRLIFE MILK 8OZ / 6PK CHOCOLATE (multi-pack format of small single serve bottle); Date Code "MAY2722 FA"; Case UPC 008-11620-02207-1; Unit UPC 008-11620-02206-4
Category
Food
Distribution
5 states
ModerateFDA (Devices)·Z-0080-2022·2021-10-20
Philips HeartStart HS1 Home Defibrillator: Customers Not Notified of Previous Recalls
Philips is recalling nine units of the HeartStart HS1 Home Defibrillator (Model M5068A) because customers were not notified of previous recalls associated with various defibrillator models.
Product
Philips, HeartStart HS1 Home Defibrillator, Model # Model number: M5068A
Category
Medical Device
Distribution
12 states
ModerateFDA (Devices)·Z-0019-2022·2021-10-13
OPTETRAK Comprehensive Knee System components recalled for inadequate packaging barrier
Exactech is recalling approximately 242,397 OPTETRAK Comprehensive Knee System tibial components due to inadequate oxygen barrier in vacuum bag packaging. No injuries have been reported.
Product
OPTETRAK Comprehensive Knee System, labeled as the following: a. OPTETRAK All-polyethylene CR Tibial Components, with Product Line Numbers: 200-11-XX, 200-12-XX, 200-13-XX, 200-14-XX, 200-15-XX, 200-16-XX; b. OPTETRAK All-polyethylene PS Tibial Components, with Product L
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0013-2022·2021-10-13
Paltop Scan Abutment SP Recalled for Dimensional Tolerance Deviations
Paltop Advanced Dental Solutions is recalling Scan Abutment SP devices due to manufacturing tolerance deviations that may delay dental restoration. Affected devices showed orientation misalignment and size engraving errors.
Product
Scan Abutment SP, Cat. No. 30-70101 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0046-2022·2021-10-13
ZOLL ICY Intravascular Catheter Kit: Labeling Update for Potential Leaks
ZOLL Circulation recalls 333 units of its ICY Intravascular Heat Exchange Catheter Kit due to potential leaks in the catheter or start-up kit tubing. A labeling update addresses the leak risk affecting medical facilities worldwide.
Product
ZOLL, REF 8700-0787-40 (IC-3893AE), ICY Intravascular Heat Exchange Catheter Kit with central venous infusion capabilities (3 lumens), STERILE EO, Rx Only, UDI: (01)00849111075220
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0014-2022·2021-10-13
Scan Abutment NP Dental Implant Components Recalled for Dimensional Deviations
Paltop Advanced Dental Solutions is recalling Scan Abutment NP dental implant components due to manufacturing tolerance deviations that may affect implant restoration fit and timing.
Product
Scan Abutment NP, Cat. No. 30-70102 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0016-2022·2021-10-13
Dental implant abutments recalled for orientation and sizing tolerance issues
Paltop Advanced Dental Solutions is recalling Scan Abutment SU devices (Catalog No. 30-70104) manufactured before July 21, 2021, due to manufacturing tolerance deviations that may delay dental restoration.
Product
Scan Abutment SU, Cat. No. 30-70104 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgica
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0020-2022·2021-10-13
Orthopedic Knee Implants Lack Protective Oxygen Barrier in Packaging
Exactech OPTETRAK Comprehensive Knee System inserts were packaged in vacuum bags lacking an additional oxygen barrier layer, which could allow material degradation. The recall affects 2,774 devices distributed worldwide.
Product
OPTETRAK Comprehensive Knee System including OPTETRAK All-polyethylene UNI Tibial Components, Product Lines, 252-12-XX, 252-13-XX, 252-22-XX, 252-23-XX. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Food)·F-0010-2022·2021-10-13
Brain MD dietary supplement bottles filled with wrong product
BrainMD is recalling Brain & Memory Power Boost dietary supplement (120-capsule bottles) because some units were filled with NeuroVite Plus, a different multivitamin-mineral product, instead of the labeled contents.
Product
Brain MD - Brain & Memory Power Boost Supports Healthy Brain and Memory Performance 120 capsules - Dietary Supplement UPC: 8 57568 00341 3 Serving Size - 4 capsules' Servings per container - 30 Ingredients - amount per serving: Phosphatidylserine (PS) - 100 mg Acetylcarnitine
Category
Consumer Product
Distribution
0 states
ModerateFDA (Devices)·Z-0032-2022·2021-10-13
Beckman Coulter Troponin I Reagent Packs Recalled Due to Sample Contamination
Beckman Coulter is recalling 293,640 Access hsTnI High Sensitivity Troponin I reagent packs due to sample carryover contamination occurring with very high concentration samples, potentially affecting test accuracy.
Product
Access hsTnI High Sensitivity Troponin I, REF B52699 Access Immunoassay System REAGENT PACK
Category
Medical Device
Distribution
46 states
ModerateFDA (Devices)·Z-0017-2022·2021-10-13
Scan Abutment PCA dental implant component recalled for tolerance deviations
Paltop Advanced Dental Solutions is recalling Scan Abutment PCA devices due to manufacturing tolerance deviations that may delay implant restoration. Some devices show up to 2-degree orientation variance and sizing discrepancies.
Product
Scan Abutment PCA, Cat. No. 30-70105 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgic
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0073-2022·2021-10-13
AngioDynamics NanoKnife Disposable Probes Recalled for Programming Issue
AngioDynamics is recalling 37 NanoKnife Disposable Single Electrode Probes (Lot 5577754) due to a RFID programming issue that prevents the devices from being recognized by the NanoKnife generator.
Product
AngioDynamics NanoKnife Disposable Single Electrode Probes, Irreversible Electroporation (IRE) Device, 15 cm IRE Single Electrode RFID Activation, PG. Catalog No. 20400103
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0033-2022·2021-10-13
Medical Device Calibrator Kit Recall for Incorrect Labeling
FDA recalls Alinity c CRP Vario Cardiac High Sensitivity Calibrator Kit due to incorrectly labeled calibrator vials in Lot 00681Y600. The labeling error prevents the instrument from completing calibration successfully.
Product
Alinity c CRP Vario Cardiac High Sensitivity Calibrator Kit (ref 07P5605) - Product Usage: use in the calibration of the Alinity c CRP Vario assay, Cardiac CRP high sensitivity method [Cardiac CRP], on the Alinity c analyzer.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0005-2022·2021-10-13
Meclizine HCl Tablets 25 mg Recalled for Incorrect Instructions
Rising Pharmaceuticals is recalling Meclizine HCl Tablets 25 mg (Lot # CB21024, expiring 2/2023) due to incorrect labeling instructions on the packaging.
Product
Meclizine HCl Tablets, 25 mg, packaged in 100-count HDPE bottle, Distributed by: Rising Pharma Holdings, Inc. East Brunswick, NJ 08816, Manufactured by: Aurex laboratories LLC, East Windsor, NJ 08520, NDC 16571-752-01
Category
Drug
Distribution
0 states
ModerateFDA (Devices)·Z-0063-2022·2021-10-13
Zoll Cool Line Catheter Kits Recalled Due to Potential Tubing Leaks
ZOLL Circulation recalls Cool Line (Heparin) IVTM catheter kits due to potential leaks in catheter or start-up kit tubing. The recall affects 144 bundles distributed worldwide.
Product
Zoll, REF 8700-000869-40, Cool Line (Heparin) IVTM Disposable Pack and Start UP Kit (6 ft.), EU, New Luer
Category
Medical Device
Distribution
Distributed nationwide