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.

17201–17225 of 21645

ModerateFDA (Devices)·Z-0425-2015·2014-12-03
Discus Dental Recalls Relief ACP Oral Care Gel Due to Filling Error
Discus Dental LLC is recalling Relief ACP Oral Care Gel because some units were filled with hydrogen peroxide instead of phosphate gel, potentially causing increased sensitivity.
Product
Relief ACP Oral Care Gel intended to relieve discomfort from dentin sensitivity. Sold separately in single, single syringe, 4 packs, 6 packs and in teeth whitening kits
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Food)·F-0574-2015·2014-12-03
Sushi House Inc. Recalls Frozen Raw Yellowfin Tuna Ground Meat
Sushi House Inc. is voluntarily recalling frozen raw yellowfin tuna ground meat because it may contain histamines exceeding 50 ppm.
Product
Frozen Raw Yellowfin Tuna Ground Meat (Thunnus albacares), Grade: AAA, Net Weight: 10 lbs (100%), Wild Caught, Product of Indonesia, Imported and distributed by Heartlight Seafood LLC, 429 SW 195th Ave., Pembroke Pines, FL 33029, Production Date: 06/10/2014, Best used by…
Category
Food
Distribution
3 states
ModerateFDA (Devices)·Z-0476-2015·2014-12-03
Dharma Cavity Varnish Recalled for Missing FDA Clearance
Dharma Research, Inc. is recalling Dharma Cavity Varnish 15mL because the product was marketed without a cleared 510(k) submission.
Product
Dharma Cavity Varnish 15mL
Category
Medical Device
Distribution
5 states
ModerateFDA (Devices)·Z-0477-2015·2014-12-03
ZOLL Recalls NeuroFlo Catheter Due to Missing Regulatory Filing
ZOLL Circulation is recalling one lot of NeuroFlo Catheters because a required regulatory supplement was not filed after the company acquired the product's assets.
Product
7F NeuroFlo Catheter, Model 1027 The NeuroFlo Catheter is a multi-lumen device with two balloons mounted near the distal tip for the treatment of cerebral ischemia resulting from symptomatic vasospasm following aneurysmal subarachnoid hemorrhage. The NeuroFlo Catheter is…
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-0418-2015·2014-12-03
Materialise Recalls Zimmer Patient Specific Instrument PERSONA CR Pin Guides
Materialise USA LLC is recalling specific Zimmer Patient Specific Instrument PERSONA CR Pin Guides because the packaging contained incorrect components and one guide exceeded size specifications.
Product
Zimmer Patient Specific Instrument PERSONA CR Pin Guides (Femur and Tibia) is intended to be used as a surgical instrument to assist in the positioning of Total Knee Replacement components intraoperatively and in guiding the marking of bone before cutting provided that anatomic…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0484-2015·2014-12-03
CooperSurgical LEEP Loop Electrode Recalled for Outer Box Mislabeling
CooperSurgical is recalling LEEP Radius Loop Electrodes because the outer box is mislabeled with the wrong part number.
Product
CooperSurgical LEEP RADIUS LOOP ELECTRODE (W 2.0 cm x D 1.0 cm D, 12 cm shaft ). Box of 5 Model Number(s): R2010 Intended Use: Diagnosis and treatment of non-invasive HPV-related or unrelated lesions of the lower genital tract.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0465-2015·2014-12-03
Remel Recalls Legionella Pneumo Groups 2-14 Latex Test Kits
Remel Inc is recalling specific lots of the Oxoid Legionella Pneumo Groups 2-14 Latex Test because a reagent may produce false negative results.
Product
Oxoid Legionella Pneumo Groups 2-14 Latex Test, DR0802M, containing 50 tests per box. The box contains a variety of components, one of which is Oxoid L. pneumophila Group 2-14 Latex Reagent, Lot 1301912. The product is a latex agglutination test for the identification of…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0424-2015·2014-12-03
Zimmer Recalls Trabecular Metal Tibial Impactor Replacement Pads
Zimmer, Inc. is recalling 4,961 Trabecular Metal Tibial Impactor Replacement Pads due to complaints of pad fracture. The recall provides clarifying instructions for assembly and disassembly.
Product
Trabecular Metal Tibial Impactor Replacement Pads. Product Usage: TM Tibial Impactor pads are used in conjunction with the TM Tibial Impactor to impact the tibial tray onto the tibia.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0475-2015·2014-12-03
Dharma Cavity Varnish Recalled for Lack of FDA Clearance
Dharma Research, Inc. is recalling Dharma Cavity Varnish with Fluoride because the product was marketed without a cleared 510(k).
Product
Dharma Cavity Varnish with Fluoride
Category
Medical Device
Distribution
5 states
ModerateFDA (Devices)·Z-0431-2015·2014-12-03
Intuitive Surgical Recalls 8mm Micro Bipolar Forceps Due to Reprocessing Deviations
Intuitive Surgical is recalling 509 units of 8mm Micro Bipolar Forceps because deviations in reprocessing steps can cause surface degradation and mechanical wear.
Product
8MM,MICRO BIPOLAR FORCEPS; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Category
Medical Device
Distribution
8 states
ModerateFDA (Devices)·Z-0433-2015·2014-12-03
Intuitive Surgical Recalls 8mm Maryland Bipolar Forceps Due to Reprocessing Deviations
Intuitive Surgical is recalling 8mm Maryland Bipolar Forceps because deviations in reprocessing steps can cause surface degradation and accelerated mechanical wear.
Product
8MM,MARYLAND BIPOLAR FORCEPS; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Category
Medical Device
Distribution
8 states
ModerateFDA (Devices)·Z-0437-2015·2014-12-03
Intuitive Surgical Recalls 8mm Permanent Cautery Spatulas for Housing Degradation
Intuitive Surgical is recalling 509 units of 8mm Permanent Cautery Spatulas because deviations in reprocessing steps can cause surface degradation of the housing and accelerate mechanical wear.
Product
8MM PERMANENT CAUTERY SPATULA,; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Category
Medical Device
Distribution
8 states
ModerateFDA (Devices)·Z-0423-2015·2014-12-03
Zimmer Recalls Trabecular Metal Tibial Impactor Pads Due to Fracture Complaints
Zimmer, Inc. is recalling Trabecular Metal Tibial Impactor Pads to provide clarifying instructions on assembly and disassembly following complaints of pad fracture.
Product
Trabecular Metal Tibial Impactor. Product Usage: TM Tibial Impactor pads are used in conjunction with the TM Tibial Impactor to impact the tibial tray onto the tibia.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0256-2015·2014-12-03
Baxter Recalls Potassium Chloride Injection Bags Due to Labeling Error
Baxter Healthcare is recalling 63,360 bags of Potassium Chloride Injection due to incorrect outer packaging labels indicating a higher strength.
Product
POTASSIUM CHLORIDE — POTASSIUM CHLORIDE (POTASSIUM CHLORIDE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0430-2015·2014-12-03
Intuitive Surgical Recalls 8mm Long Tip Forceps Due to Reprocessing Deviations
Intuitive Surgical is recalling 509 units of 8mm Long Tip Forceps because deviations in reprocessing steps can cause surface degradation and accelerated mechanical wear.
Product
8MM,LONG TIP FORCEPS; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Category
Medical Device
Distribution
8 states
ModerateFDA (Devices)·Z-0436-2015·2014-12-03
Intuitive Surgical Recalls 8mm Permanent Cautery Hooks Due to Reprocessing Deviations
Intuitive Surgical is recalling 509 8mm Permanent Cautery Hooks because deviations in reprocessing steps can cause surface degradation and accelerated mechanical wear.
Product
8MM PERMANENT CAUTERY HOOK,; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Category
Medical Device
Distribution
8 states
ModerateFDA (Devices)·Z-2145-2014·2014-12-03
Market-Tiers recalls laparoscopic morcellator instructions with missing safety pages
Market-Tiers Inc. is recalling 100 units of the blue endo MOREsolution Electromechanical Laparoscopic Morcellator System because the Instructions for Use omitted critical safety pages.
Product
Instructions for Use for the blue endo MOREsolution Electromechanical Laparoscopic Morcellator System, Model 55-000011, consisting of the control unit, hand-grip, flexible shaft, trocars/obturators, sleeves, valves, and blades.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0450-2015·2014-12-03
Philips BrightView Ultrasound Systems Recalled for Software Issues
Philips Medical Systems is recalling 85 BrightView ultrasound systems worldwide due to software issues. The voluntary recall was initiated in November 2014.
Product
BrightView product code: 882478 BrightView X product code: 882480 BrightView XCT product code: 882482 and 882454
Category
Medical Device
Distribution
17 states
ModerateFDA (Devices)·Z-0438-2015·2014-12-03
Intuitive Surgical Recalls 8mm Fenestrated Bipolar Forceps Due to Reprocessing Deviations
Intuitive Surgical is recalling 509 units of 8mm Fenestrated Bipolar Forceps because deviations in reprocessing steps can cause surface degradation and accelerated mechanical wear.
Product
8MM FENESTRATED BIPOLAR FORCEPS,; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Category
Medical Device
Distribution
8 states
ModerateFDA (Devices)·Z-0448-2015·2014-12-03
Intuitive Surgical Recalls 8mm Tip-Up Fenestrated Graspers for Reprocessing Deviations
Intuitive Surgical is recalling 509 units of 8mm Tip-Up Fenestrated Graspers because deviations in reprocessing steps can cause surface degradation and mechanical wear.
Product
8MM, TIP-UP FENESTRATED GRASPER; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Category
Medical Device
Distribution
8 states
ModerateFDA (Drugs)·D-0258-2015·2014-12-03
Actavis Recalls Diclofenac Sodium and Misoprostol Tablets Due to Split Tablets
Actavis Laboratories is recalling 5,451 bottles of Diclofenac Sodium and Misoprostol tablets because some contain split or broken tablets.
Product
DICLOFENAC SODIUM AND MISOPROSTOL — DICLOFENAC SODIUM AND MISOPROSTOL (DICLOFENAC SODIUM AND MISOPROSTOL)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0466-2015·2014-12-03
Remel Recalls Oxoid Legionella Latex Test Due to False Negative Results
Remel Inc is recalling Oxoid Legionella Latex Test kits because a reagent may produce false negative results. The recall covers 59 boxes distributed nationwide.
Product
Oxoid Legionella Latex Test, DR0800M, containing 50 tests per box. The box contains a variety of components, one of which is Oxoid L. pneumophila Latex Reagent, DR0802, Lot 1301912. The responsible firm on the label is Oxoid Ltd.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0445-2015·2014-12-03
Intuitive Surgical Recalls 8mm Small Grasping Retractor for Reprocessing Deviations
Intuitive Surgical is recalling 509 units of the 8mm Small Grasping Retractor because deviations in reprocessing steps can cause surface degradation and mechanical wear.
Product
8MM, SMALL GRASPING RETRACTOR ; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Category
Medical Device
Distribution
8 states
ModerateFDA (Devices)·Z-0420-2015·2014-12-03
Siemens Hemoglobin A1c Reagent Cartridges Recalled for Positive Bias
Siemens is recalling certain lots of Dimension HB1C Flex reagent cartridges because they show a positive bias in hemoglobin A1c measurements.
Product
Siemens Dimension HB1C Flex reagent cartridge; Dimension Hemoglobin A1c (HB1C) Flex reagent cartridge on the Dimension clinical chemistry system is an in vitro diagnostic assay for the quantitative determination of hemoglobin A1c (HbA1c) in human anticoagulated whole blood.…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0483-2015·2014-12-03
Beevers Cannulaide Respirator Recalled for Improper Pouch Seal
Beevers Manufacturing recalled Cannulaide respirators due to improper pouch seals that could affect device shelf life.
Product
Cannulaide, Model 101, 102, 103. Respirator. The Cannulaide product is composed of die-cut hydrocolloid-coated polyurethane film with an integral hook strip (i.e., Velcro) to allow for the use of a loop material to help secure a nasal interface. The Cannulaide is…
Category
Medical Device
Distribution
7 states