The Recall Desk

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.

16501–16525 of 21645

  • ModerateFDA (Drugs)·D-929-2015·2015-04-29

    Attix Pharmaceuticals Recalls Ticarcillin Sodium/Potassium Clavulanate API Due to Stability Data Issues

    Attix Pharmaceuticals is recalling Ticarcillin Sodium/Potassium Clavulanate API because stability data does not support the printed expiry dates for lots distributed between 2012 and 2015.

    Product
    Ticarcillin Sodium/Potassium Clavulanate (30:1) active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-968-2015·2015-04-29

    Tarmac Recalls Well at Walgreens Antacid Liquid for Failed Antimicrobial Test

    Tarmac Products, Inc. is recalling Well at Walgreens Regular Strength Antacid Liquid because the product failed the Antimicrobial Effectiveness Test.

    Product
    Well at Walgreens Regular Strength Antacid Liquid, Mint Flavor 12 FL OZ (355 mL) bottle
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1479-2015·2015-04-29

    SpineFrontier Recalls MISquito Pedicle Screw System Surgical Technique Document

    SpineFrontier is recalling the MISquito Pedicle Screw System Surgical Technique document because it does not adequately convey the intended use of the Rod Caliper.

    Product
    SpineFrontier MISquito Percutaneous Pedicle Screw System Surgical Technique; Part Number: DOC80023. The Rod Caliper is a manual surgical instrument that may be used as part of the PedFuse Pedicle Screw System and its MISquito components during percutaneous, minimally…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2021-2015·2015-04-29

    Summit Import Recalls Preserved Duck Eggs for pH and Salt Standard Failures

    Summit Import Corporation is recalling Yang Sheng Preserved Duck Eggs because the product failed to meet required pH and salt standards.

    Product
    Yang Sheng Preserved Egg (Long-Lansing Duck Egg), each box contains 6 preserved eggs, each box weighs about 12 ounce (340g), Manufacturer: Ya Nong Co., Ltd, No. 181-1, Singdong Rd., Jhongli City, Taoyuan County, 320, Taiwan R.O.C., Product of Taiwan
    Category
    Food
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-966-2015·2015-04-29

    Tarmac Recalls Well at Walgreens Comfort Gel for Antimicrobial Failure

    Tarmac Products, Inc. is recalling 41,743 bottles of Well at Walgreens Maximum Strength Comfort Gel because the product failed the Antimicrobial Effectiveness Test.

    Product
    Well at Walgreens Maximum Strength Comfort Gel 12 FL OZ (355 mL) bottle,
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1444-2015·2015-04-22

    Hardy Diagnostics Recalls HardyCHROM SS Agar Due to Color Development Issue

    Hardy Diagnostics is recalling HardyCHROM SS Agar (Lot 15037) due to a report of possible lack of color development in Shigella organisms.

    Product
    Hardy Diagnostics cat no. G327 HardyCHROM SS Agar (HardyCHROM Salmonella Shigella) Cat no: G327 Container type: 15x100mm monoplate Packaged: 10 plates/sleeve Storage: 2 to 8 degrees C. on receipt in dark A selective chromogenic medium for the primary screening…
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-1435-2015·2015-04-22

    Nobel Biocare Recalls Dental Implants Due to Packaging Material Issue

    Nobel Biocare is recalling 216 units of NobelReplace CC PMC NP dental implants because packaging material may leave a sticky substance on the implant surfaces.

    Product
    NobelReplace CC PMC NP 3.5x11.5mm, Article No. 37287.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1416-2015·2015-04-22

    Nobel Biocare Recalls Dental Implants Due to Packaging Material Contamination

    Nobel Biocare is recalling 24 units of Replace Select Tapered TiU NP 3.5x16mm dental implants because packaging material may leave a sticky substance on the implant surfaces.

    Product
    Replace Select Tapered TiU NP 3.5x16mm, Article No. 29403. Nobel Biocare's Dental Implants are root-form endosseous implants intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1432-2015·2015-04-22

    Nobel Biocare Recalls Dental Implants Due to Packaging Material Issue

    Nobel Biocare is recalling 56 dental implants because packaging material may leave a sticky substance on the implant surfaces.

    Product
    NobelReplace CC RP 5.0x8mm, Article No. 36710.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1452-2015·2015-04-22

    Integra Flowable Wound Matrix Recalled for Stability Criteria Failures

    Integra LifeSciences is recalling 287 packages of Flowable Wound Matrix because the product failed stability acceptance criteria for visual appearance and force vs. displacement.

    Product
    Integra¿ Flowable Wound Matrix Size 3cc 1 unit/box single use, sterile device Rx Only Model Number FWD301 (US) & FDR301 (Non-US) Flowable Wound Matrix is comprised of the following components which are provided in a sealed and sterilized Tyvek / plastic tray: - An empty…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1439-2015·2015-04-22

    Nobel Biocare Recalls Dental Implants Due to Packaging Material Contamination

    Nobel Biocare is recalling 53 units of NobelReplace CC PMC RP 5.0x10mm dental implants because packaging material may leave a sticky substance on the implant surfaces.

    Product
    NobelReplace CC PMC RP 5.0x10mm, Article No. 37296.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1446-2015·2015-04-22

    Biomet Recalls Low Profile Non-Locking Screws Due to Anodizing Error

    Biomet is recalling 45 Low Profile Non-Locking Screws because they were anodized green instead of the required gold color.

    Product
    LOW PROFILE NON-LOCK SCREW; 2.7mm x 22 mm; REF 131227222; LOT RM105E. Provides the orthopaedic surgeon a means of bone fixation and helps generally in the management of fractures and reconstructive surgeries.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1420-2015·2015-04-22

    Nobel Biocare Recalls Dental Implants Due to Packaging Contamination

    Nobel Biocare is recalling 74 dental implants because packaging material may leave a sticky substance on the implant surfaces.

    Product
    NOBELREPLACE Tapered Groovy RP 4.3x10mm, Article No. 32216. Nobel Biocare's Dental Implants are root-form endosseous implants intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1421-2015·2015-04-22

    Nobel Biocare Recalls Dental Implants Due to Packaging Material Contamination

    Nobel Biocare is recalling 7 dental implants because packaging material may leave a sticky substance on the implant surfaces.

    Product
    NOBELREPLACE Tapered Groovy 6.0 6x8mm, Article No. 32223. Nobel Biocare's Dental Implants are root-form endosseous implants intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0488-2015·2015-04-22

    Actavis Recalls Cartia XT Capsules Due to Aluminum Residue on Exterior

    Actavis is recalling 2,628 bottles of Cartia XT capsules because fine aluminum residue was found on the exterior of the capsule shells.

    Product
    Cartia XT (diltiazem HCl extended-release capsules, USP), Once-A-Day Dosage, 300 mg, 90-count bottles, Rx only, Manufactured by: Watson Laboratories, Inc., Corona, CA --- NDC 62037-0600-90
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1414-2015·2015-04-22

    Nobel Biocare Recalls Dental Implants Due to Packaging Material Contamination

    Nobel Biocare is recalling 131 units of Replace Select Tapered TiU NP dental implants because packaging material may leave a sticky substance on the implant surfaces.

    Product
    Replace Select Tapered TiU NP 3.5x10mm, Article No. 29401. Nobel Biocare's Dental Implants are root-form endosseous implants intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1440-2015·2015-04-22

    Nobel Biocare Recalls Dental Implants Due to Packaging Material Contamination

    Nobel Biocare is recalling 38 units of NobelReplace CC PMC RP 5.0x13mm dental implants because packaging material may leave a sticky substance on the implant surfaces.

    Product
    NobelReplace CC PMC RP 5.0x13mm, Article No. 37298.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1445-2015·2015-04-22

    Siemens Artis Q and Q zen Angiography Systems Recalled for Electrical Connection

    Siemens is recalling 139 Artis Q and Q zen angiography systems nationwide because an electrical connection in the equipment cabinet may not be installed correctly.

    Product
    Artis Q/ Q zen systems; Artis Q/ Q zen systems are dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed include cardiac…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1412-2015·2015-04-22

    Natus neoBLUE blanket LED Phototherapy System Recalled for Fiberoptic Pad Failures

    Natus Medical Incorporated is recalling neoBLUE blanket LED Phototherapy systems due to early failure of fiberoptic pads, which may discolor and melt.

    Product
    Natus neoBLUE blanket LED Phototherapy system which includes the following items: 006224 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad 006254 neoBLUE blanket LED Light Box 006895 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad 007299…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1410-2015·2015-04-22

    Biomet 3i Recalls Discolored OSSEOTITE Tapered Dental Implants

    Biomet 3i is recalling 620 OSSEOTITE Tapered dental implants because contact with residual machine fluid caused discoloration.

    Product
    OSSEOTITE Tapered Certain Implant Rx Only; 3.25 x 18.5 - 15.0 mm. Dental Implants.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1424-2015·2015-04-22

    Nobel Biocare Dental Implants Recalled for Packaging Material Contamination

    Nobel Biocare is recalling 32 units of Replace Select Tapered TiU RP dental implants because packaging material may leave a sticky substance on the implant surfaces.

    Product
    Replace Select Tapered TiU RP 4.3x11.5mm, Article No. 36107.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1448-2015·2015-04-22

    Vitrolife Recalls SpermMAR IgA Test Kits Due to Sperm Motility Reduction

    Vitrolife Inc is recalling 45 kits of SpermMAR IgA test because a new formulation reduces sperm cell motility in certain samples.

    Product
    SpermMar Test 0.7ml Beads Particles Label on bottle: SpermMar Test IgA 0.7ml Beads/Particles-50 Tests IND REF SPMA_S LOT Expiration DO NOT FREEZE/NE PAS CONGELER FertiPro N.V. Label on box: SpermMar Test IGA 50 Determination Test Kit CONTENTS 1 vial…
    Category
    Medical Device
    Distribution
    1 state