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.

19701–19725 of 21751

  • ModerateFDA (Drugs)·D-019-2014·2013-12-04

    Cetylite Recalls Cetacaine Topical Anesthetic Due to Low Tetracaine Levels

    Cetylite Industries is recalling Cetacaine Topical Anesthetic Liquid because the tetracaine ingredient is below specification limits at the 21-month stability test point.

    Product
    CETACAINE ANESTHETIC — CETACAINE ANESTHETIC (BENZOCAINE, BUTAMBEN, AND TETRACAINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0399-2014·2013-12-04

    Medtronic Recalls Strata II Shunt Kits Due to Label Discrepancies

    Medtronic Neurosurgery is recalling Strata II Shunt Assembly Kits and other CSF shunts because of label discrepancies. The recall affects 5 units distributed worldwide.

    Product
    Medtronic Strata II Shunt Assembly Kit, Small, Catalog No. 27848. Strata II Shunt Assemblies are designed to provide continued cerebrospinal fluid (CSF) flow from the ventricles of the brain into the right atrium of the heart of the peritoneal cavity.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0405-2014·2013-12-04

    Kraft and Polly-O String Cheese Recalled for Potential Spoilage

    Kraft Foods Group is recalling specific varieties of Kraft and Polly-O String Cheese that may spoil before their expiration dates, causing discoloration.

    Product
    Low-Moisture Part-Skim Mozzarella String Cheese With Cracked Pepper, sold under Kraft brand or Polly-O brand and packaged with 12 pieces of mozzarella cheese with cracked pepper individually wrapped in plastic and sold in a plastic bag with a net weight of 10 oz. (283g).
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0403-2014·2013-12-04

    Kraft and Polly-O String Cheese Recalled for Potential Spoilage

    Kraft Foods Group is recalling specific varieties of Kraft and Polly-O String Cheese that may spoil before their expiration dates, causing discoloration.

    Product
    Low-Moisture Part-Skim Mozzarella String Cheese With Tomato and Italian Style Seasonings, sold under Kraft brand or Polly-O brand and packaged with 12 pieces of mozzarella cheese with tomato and Italian style seasoning individually wrapped in plastic and sold in a plastic bag…
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0401-2014·2013-12-04

    Synthes 4.5mm Condylar Plate Recalled for Restricted Sales Release

    Synthes USA is recalling a specific lot of 4.5mm condylar plates that were inadvertently released to a sales consultant restricted for sale.

    Product
    Synthes 4.5MM TI VA-LCP CRVD Condylar Plate/6H/159MM/RT-STER Synthes 4.5MM TI VA-LCP CRVD Condylar Plate/6H/159MM/RT-STER is used for buttressing multi fragmentary diatal femur fractures including: supra-condylar, intra-articular and extra articular condylar fractures…
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Food)·F-0368-2014·2013-12-04

    Plum Organics Apple & Carrot Baby Food Recalled for Contamination

    Plum Inc is recalling Apple & Carrot Organic Baby Food due to a manufacturing defect that led to post-process contamination.

    Product
    Plum Organics Apple & Carrot Organic Baby Food, 4.0 oz. pouch.. Flexible pouch with Resealable spout. Packaged for individual sale in 6 count cartons and in 4 count packages. Best By dates ranging from 08/05/14 to 12/08/14 and the letters AT. DISTRIBUTED BY: NEST…
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0409-2014·2013-12-04

    Synthes 4.5 mm LCP Curved Condylar Plate Recalled for Mislabeling

    Synthes USA HQ, Inc. is recalling 13 units of the 4.5 mm LCP Curved Condylar Plate because straight plates are etched with the curved plate's part number.

    Product
    Synthes 4.5 mm LCP Curved Condylar Plate Intended for buttressing multifragmentary distal femur fractures.
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-0378-2014·2013-12-04

    Mizuho Sugita Titanium Aneurysm Clips Recalled for Discoloration

    Mizuho America is recalling 35 units of Sugita Titanium Standard Aneurysm Clip II, Temporary Mini Type No 58 due to discoloration in specific lots.

    Product
    Mizuho Sugita Titanium Standard Aneurysm Clip II , Temporary Mini Type No 58 Temporary and permanent occlusion of cervical segment of cerebral aneurysms and peripheral blood vessels. They are designed for Single Use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0381-2014·2013-12-04

    Houston Nutraceuticals Recalls TriEnza Bulk Powder for Chloramphenicol

    Houston Nutraceuticals is recalling TriEnza bulk powder because it may contain chloramphenicol above permitted limits. The product was distributed internationally to Brazil.

    Product
    TriEnza bulk powder distributed in a 5 kilogram polyethylene bag.
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-0230-2014·2013-12-04

    Cenk Disczyme A Dietary Supplement Recalled for Chloramphenicol Contamination

    FoodScience Corporation is recalling Cenk Disczyme A dietary supplements because they may contain trace amounts of the antibiotic chloramphenicol.

    Product
    Cenk Disczyme A Dietary Supplement for Complete Digestive Support, 180 count capsule Distributed by Cenk Integrated Health & Spine Services, 107 Gamma Drive Ste 100, Pittsburgh, PA 15328
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·F-0406-2014·2013-12-04

    Kraft and Polly-O String Cheese Recalled for Potential Spoilage

    Kraft Foods Group is recalling specific varieties of Kraft and Polly-O String Cheese and String Cheese Twist products because they may spoil before their 'Best When Used By' dates, causing discoloration.

    Product
    Low-Moisture Part-Skim Mozzarella String Cheese With Barbecue Seasoning, sold under Kraft brand or Polly-O brand and packaged with 12 pieces of mozzarella cheese with barbecue seasoning individually wrapped in plastic and sold in a plastic bag with a net weight of 9 oz. (255g).
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0377-2014·2013-12-04

    Mizuho Sugita Titanium Aneurysm Clips Recalled for Discoloration

    Mizuho America is recalling 32 units of Sugita Titanium Standard Aneurysm Clip II due to discoloration. The devices are intended for single use in cerebral aneurysms.

    Product
    Mizuho Sugita Titanium Standard Aneurysm Clip II , Temporary and permanent occlusion of cervical segment of cerebral aneurysms and peripheral blood vessels. They are designed for Single Use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0403-2014·2013-12-04

    Advanced Sterilization Products Recalls STERRAD NX Sterilization Systems

    Advanced Sterilization Products is recalling STERRAD NX and STERRAD 100NX sterilization systems because bronchoscopes may contain unlisted polyurethane material in the suction channel.

    Product
    STERRAD NX, Product Code: 10033 The STERRAD Steri lization System is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0349-2014·2013-12-04

    4Life Recalls Digestive Enzymes Due to Chloramphenicol Contamination

    4Life Research is voluntarily recalling specific lots of Digestive Enzymes dietary supplements because they contain trace amounts of the antibiotic chloramphenicol.

    Product
    Digestive Enzymes, Digestion, 4Life, Dietary Supplement, 90 Capsules, A Product of 4Life Manufactured by BioMedical Research Laboratories, LLC, Sandy, UT, Item #23017.
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0404-2014·2013-12-04

    Synthes 14.5 mm Outer Protection Sleeve Recalled for Incorrect Size

    Synthes (USA) Products LLC is recalling 55 units of 14.5 mm Outer Protection Sleeves that were incorrectly packaged as 12.0 mm units.

    Product
    Synthes 14.5 mm Outer Protection Sleeve for Suprapatellar Synthes 14.5 mm Outer Protection Sleeve for Suprapatellar is used as part of the Synthes Tibial Nail System EX to stabilize fractures of the proximal and distal tibia and the tibia shaft, open and closed tibia shaft…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0380-2014·2013-12-04

    Synthes 2.4 and 2.7 mm Locking Screws Recalled for Mislabeling

    Synthes USA is recalling 98 units of 2.4 and 2.7 mm Locking Screws because 2.7 mm screws were incorrectly labeled as 2.4 mm.

    Product
    2.4 and 2.7 MM Locking Screw SLF-TPNG with T8 Stardrive Recess 12 MM Fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragments, particularly in osteopenic bone.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0407-2014·2013-12-04

    Kraft and Polly-O String Cheese Recalled for Potential Spoilage

    Kraft Foods Group is recalling specific varieties of Kraft and Polly-O String Cheese and String Cheese Twist products that may spoil before their expiration dates, causing discoloration.

    Product
    Low-Moisture Part-Skim Mozzarella String Cheese With Jalapeno Peppers, sold under Kraft brand and packaged with 24 pieces of mozzarella cheese with jalapeno peppers individually wrapped in plastic and sold in a cardstock display box bag with a net weight of 24 oz. (1 lb. 8 oz.)…
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0228-2014·2013-12-04

    LWL Enzyme Life Dietary Supplement Recalled for Chloramphenicol

    FoodScience Corporation is recalling LWL Enzyme Life dietary supplements because they may contain trace amounts of the antibiotic chloramphenicol.

    Product
    Life Worth Living Nutriceuticals LWL Enzyme Life A Dietary Supplement for Complete Digestive Support, Distributed by Life Worth Living Nutriceuticals, 6488 Currin Drive, Orlando, Florida 32835 90 count
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·F-0348-2014·2013-12-04

    Ortho Molecular Products Recalls DigestzymeV. Due to Chloramphenicol Contamination

    Ortho Molecular Products is recalling DigestzymeV. dietary supplements because the vegetable enzyme raw material may be contaminated with chloramphenicol.

    Product
    Ortho Molecular Products DigestzymeV. Dietary Supplement. Gastrointestinal health. 90 (product code 128090 and 128090U) and 180 capsules (product code 128180 and 128180U).
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0394-2014·2013-12-04

    Synthes Spiked Washers Recalled Due to Mislabeled Size

    Synthes USA HQ, Inc. is recalling Spiked Washers 13.5/6.5 because they were mislabeled as 13.5/5.5 during a retrospective assessment.

    Product
    Synthes Spiked Washers 13.5/6.5 Spiked Washers 13.5/6.5 are intended to be used in ligament reattachment or fixation, specifically readaptation of torn or avulsed ligaments.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0400-2014·2013-12-04

    Lanx Recalls Timberline MPF Straight Split Tip Driver Due to Sizing Defect

    Lanx, Inc. is recalling 25 units of the Timberline MPF Straight Split Tip Driver - Short because the tip is oversized.

    Product
    LANX Timberline MPF Lateral Modular Plate Fixation System Straight Split Tip Driver - Short ("Driver"). Model Number 8630-0107. The Timberline MPF device is an intervertebral body fusion device consisting of a PEEK intervertebral spacer, titanium plate, and screws. The PEEK…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0398-2014·2013-12-04

    Medtronic Recalls Delta Shunt Assembly Kits Due to Label Discrepancies

    Medtronic Neurosurgery is recalling Delta Shunt Assembly Kits because label discrepancies were found. The recall covers 34 units distributed worldwide.

    Product
    Medtronic Delta Shunt Assembly Kit with Bioglide Small, Performance Level 1.0, Catalog No. 276201. Delta Shunt Assemblies are designed for use in shunting CSF from the lateral ventricle of the brain into the peritoneal cavity.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0400-2014·2013-12-04

    Kraft and Polly-O String Cheese Recalled for Potential Spoilage

    Kraft Foods Group is recalling specific varieties of Kraft and Polly-O String Cheese and String Cheese Twist products that may spoil before their expiration dates, causing discoloration.

    Product
    Mozzarella String Cheese made with 2% milk for 1/4 less fat, sold under Kraft brand or Polly-O brand and packaged with either 12 or 24 pieces of mozzarella cheese individually wrapped in plastic and sold in a plastic bag with a net weight respectively of 10 oz. (283g) or 20 oz.…
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0384-2014·2013-12-04

    Synthes Matrix Threaded Persuader Recalled Due to Reduction Insert Breakage

    Synthes USA HQ, Inc. is recalling 634 units of the Matrix Threaded Persuader because the Reduction Insert can break during use, preventing the instrument from functioning.

    Product
    Synthes Matrix Threaded Persuader Deformity is a comprehensive thoracolumbar pedical screw system designed to provide flexibility biomechanical performance and a solution to complex posterior pathological challenges.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0387-2014·2013-12-04

    Synthes Large Buttress Compression Nut Recalled for Threading Defect

    Synthes USA is recalling 135 Large Buttress Compression Nuts for Blade Guide Sleeve TFN because the nuts did not thread completely and became stuck.

    Product
    Large Buttress Compression Nut For Blade Guide Sleeve TFN The Synthes Large Buttress Compression Nut For Blade Guide Sleeve TFN is intended to treat stable and unstable pertrochanteric fractures, intertrochanteric fractures, basal neck fractures, and combinations there of.
    Category
    Medical Device
    Distribution
    14 states