Severity 1 of 5

Low recalls

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

What “low” means here

Severity 1 (Low) recalls are typically cosmetic defects, documentation issues, packaging-only problems, and Class III administrative corrections. The product itself is unlikely to cause adverse health consequences. The manufacturer is correcting the issue to comply with FDA or USDA rules, not because anyone is at risk. You can almost always continue using a Severity-1 product without concern.

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.

2626–2650 of 2769

LowFDA (Devices)·Z-0504-2013·2012-12-19
ConMed Recalls WANG Transbronchial Aspiration Needles Due to Fit Issues
ConMed is recalling WANG Transbronchial Aspiration Needles because they may not fit through a 2.0 mm bronchoscope, causing minor inconvenience.
Product
WANG Transbronchial Aspiration Needles Cat. No. SW-121, WANG Cytology Needles, Central, Carinal and Mediastinal Regions, 21 g x 15 mm long needle. --- Common Name: Bronchoscope (flexible or rigid) and accessories. The ConMed WANG Transbronchial Aspiration Needles are designed f
Category
Medical Device
Distribution
14 states
LowFDA (Drugs)·D-092-2013·2012-12-19
Physicians Total Care Recalls Subpotent Enjuvia Tablets
Physicians Total Care is recalling Enjuvia tablets due to low assay results. The recall is limited to a specific lot and expiration date.
Product
Enjuvia (synthetic conjugated estrogens, B) tablets, 0.9mg, 30-count tablets per bottle, Rx only, Mfg. By: Duramed Pharmaceuticals, Pomona NY 10970; Repacked & distributed by: Physicians Total Care, Inc., Tulsa, OK 74146; NDC 54868-6165-1.
Category
Drug
Distribution
1 state
LowFDA (Drugs)·D-064-2013·2012-12-05
GlaxoSmithKline Recalls Advair HFA Inhalers Due to Particle Size Issues
GlaxoSmithKline is recalling specific lots of Advair HFA inhalers because they failed to meet particle size distribution specifications.
Product
ADVAIR HFA — ADVAIR HFA (FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE)
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-065-2013·2012-12-05
GlaxoSmithKline Recalls Advair HFA Inhalers Due to Particle Size Issues
GlaxoSmithKline is recalling 18,676 units of Advair HFA inhalers because they failed to meet particle size distribution specifications.
Product
ADVAIR HFA — ADVAIR HFA (FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE)
Category
Drug
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0429-2013·2012-11-28
Horiba Medical Recalls Minotrol 16 Hematology Control Material
Horiba Medical is recalling Minotrol 16 lot MX090 (Level High) due to reports of high hemoglobin recovery values.
Product
Minotrol 16, Model Numbers: 2043748, 2043752, 2043756, Lot Number: MX090(Levels: Low, Normal, and High). Minotrol 16 is a tri-level control intended for in vitro diagnostic use in monitoring the accuracy and precision on HORIBA Medical hematology blood cell counters using HORI
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Food)·F-0705-2013·2012-11-28
Swanson Organic Fennel Seed Recalled Due to Insect Contamination
Swanson Health Products is recalling two lots of Organic Fennel Seed because some jars contain small, red beetle-type insects.
Product
Swanson Organic, 100% Certified Organic Fennel Seed, Net Wt 6 oz (45 grams), SWF092, UPC 0 87614 24092 3.
Category
Food
Distribution
4 states
LowFDA (Devices)·Z-0292-2013·2012-11-28
Ethicon Surgiflo Hemostatic Matrix Kit Packaging Defect Recall
Ethicon is recalling Surgiflo Hemostatic Matrix Kits due to a packaging defect that could breach the Tyvek pouch.
Product
ETHICON SURGIFLO HEMOSTATIC MATRIX KIT Plus FlexTip with Thrombin distributed by ETHICON ETHICON Inc. Somerville, NJ 08876 USA Ref 2993 SURGIFLO Hemostatic Matrix, mixed with sterile saline or thrombin solution, is indicated for surgical procedures (except ophthalmic)
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0386-2013·2012-11-28
Zimmer Recalls Trilogy Longevity Constrained Liners Due to Packaging Error
Zimmer, Inc. is recalling Trilogy Longevity Constrained Liners because they were packaged in incorrect cartons, although the product labels are correct.
Product
Trilogy II Constrained Liner The Trilogy Longevity Constrained Liner serves as the articular surface for a femoral head in total hip arthroplasty.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Food)·F-0710-2013·2012-11-28
Postres de Aqui Oatmeal Recalled for Missing Phenylketonuria Warning
Postres de Aqui, Inc. is recalling 8-ounce boxes of Avena de Aqui Si Azucar Añadida because the packaging lacks a required warning for individuals with phenylketonuria.
Product
"***Avena de Aqu¿ Si Azucar A¿adida****8oz****Fabricado por Postres de Aqui, Inc. Calle B Parrio Plamas Cata¿o PR 00962***"
Category
Food
Distribution
1 state
LowFDA (Drugs)·D-056-2013·2012-11-21
ITW Dymon Recalls Lemon Hand Sanitizing Wipes for CGMP Deviations
ITW Dymon is recalling specific lots of Lemon Hand Sanitizing Wipes because they were manufactured with raw material containing unknown particles believed to be water and dirt.
Product
Lemon Hand Sanitizing Wipes [n-alkyl dimethyl benzyl ammonium chloride (0.1%) and n-alkyl dimethyl ethyl benzyl ammonium chloride (0.1%)], labeled as a) Genuine Joe Cleaning Supplies, Lemon Scent, Anti-microbial Hand Sanitizing Wipes, 120-count premoistened wipes per bucket, 6 bu
Category
Consumer Product
Distribution
Distributed nationwide
LowFDA (Drugs)·D-051-2013·2012-11-21
Stat Rx USA Recalls Venlafaxine ER Due to Labeling Error
Stat Rx USA is recalling 5 bottles of Venlafaxine ER 150mg because the label incorrectly identifies the dosage form as 'Tabs' instead of 'Capsules.'
Product
Venlafaxine ER 150mg, 30 Tabs bottle, Generic for: Effexor, Packaged and Distributed by: Stat Rx USA, LLC, Gainesville, GA 30501 NDC 42549-684-30
Category
Drug
Distribution
2 states
LowFDA (Drugs)·D-050-2013·2012-11-21
Stat Rx USA Recalls Tobramycin Ophthalmic Ointment Due to Labeling Error
Stat Rx USA is recalling 22 units of Tobramycin Ophthalmic Ointment because the labels incorrectly identify the product as an ointment instead of a solution.
Product
Tobramycin Ophthalmic Oint., 0.3%, 5ml bottle, (Generic for: Tobrex), Rx only, Sterile, Mfg By Akorn, Inc., Lake Forest, IL 60045, NDC 16590-224-05,
Category
Drug
Distribution
3 states
LowFDA (Devices)·Z-0295-2013·2012-11-21
Gulf South Medical Supply Recalls Vinyl Exam Gloves Shipped Before Customs Clearance
Gulf South Medical Supply is recalling Select Medical Products Vinyl Powder-Free Exam Gloves because they were shipped before U.S. Customs cleared them for sale.
Product
Select Medical Products Vinyl Powder-Free Exam Gloves, Medium Model # 6370 and Large Model # 6371, 100 per box; 10 boxes per case. Usage: Patient Examination.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0289-2013·2012-11-21
Horiba Medical Recalls ABX PENTRA Creatinine 120 CP Reagent
Horiba Medical is recalling ABX PENTRA Creatinine 120 CP reagent because a calibration alarm prevents the assay from being used.
Product
ABX PENTRA Creatinine 120 CP, Model Number Creatinine Part # A11A01868, Lot Numbers: 203273706, 203273707, 203273808, 203273709. The ABX PENTRA Creatinine 120 CP is an in vitro diagnostic assay for the quantitative determination of creatinine in human serum, plasma and urine ba
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0221-2013·2012-11-14
Zimmer Recalls Wagner Cone Prostheses Due to Label Discrepancies
Zimmer Inc. is correcting patient labels for Wagner cone prostheses manufactured before March 2010 due to discrepancies in reference and lot numbers.
Product
Wagner cone Prosthesis, uncemented, sterile, Rx
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0192-2013·2012-11-14
Abbott Recalls Cliniqa Liquid QC Cardiac Marker Control for i-STAT
Abbott Point of Care is recalling specific lots of Cliniqa Liquid QC Cardiac Marker Control for i-STAT because results may be generated below the lower value assignment range.
Product
Cliniqa Liquid QCTM Cardiac Marker Control for i-STAT Level 1 (List Number 06F12-09; Lot Number 071039) Cliniqa Liquid QCTM Cardiac Marker Control for i-STAT Level 2 (List Number 06F12-10; Lot Number 081039) Cliniqa Liquid QCTM Cardiac Marker Control for i-STAT Level 3 (Lis
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0225-2013·2012-11-14
Zimmer Anatomical Shoulder Humeral Head Label Correction
Zimmer, Inc. is correcting patient labels for Anatomical Shoulder Humeral Heads manufactured before March 2010 due to discrepancies in reference and lot numbers.
Product
Anatomical Shoulder" Humeral Head
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0214-2013·2012-11-14
Alloclassic SL-Offset Stem Patient Labels Corrected for Number Discrepancies
Zimmer is correcting patient labels on 126 Alloclassic SL-Offset Stems made before March 2010 after four complaints that their reference and lot numbers differed from the correct product labels.
Product
Alloclassic¿ SL-Offset Stem sterile, Rx
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Drugs)·D-046-2013·2012-11-14
Valeant Recalls AcneFree Toner Pads Due to Low Salicylic Acid Content
Valeant Pharmaceuticals is recalling AcneFree Acne Astringent Toner Pads because the salicylic acid ingredient was found to be subpotent.
Product
AcneFree Acne Astringent Toner Pads (salicylic acid 2% w/v); 60-count pads per jar, Dist. by: University Medical Pharmaceuticals Corp., Irvine, CA 92618, UPC 7 88521 13551 6.
Category
Drug
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0190-2013·2012-11-14
Clinical Diagnostic Solutions Recalls Boule Con-Diff Hematology Control Vials
Clinical Diagnostic Solutions is recalling Boule Con-Diff hematology control vials due to a received complaint. The product is used to monitor multi-parameter hematology instruments.
Product
Boule Con-Diff Hematology Control For in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments.
Category
Medical Device
Distribution
31 states
LowFDA (Devices)·Z-0244-2013·2012-11-14
Zimmer NCB Screw Label Correction for Reference and Lot Number Discrepancies
Zimmer Inc. is correcting patient labels for NCB screws manufactured before March 2010 due to discrepancies in reference and lot numbers.
Product
NCB¿ screw ¿ 4.0 self-tapping
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0248-2013·2012-11-14
Zimmer Kopf Adapter S Sterile Recalled for Label Discrepancies
Zimmer Inc. is correcting patient labels for Kopf Adapter S Sterile products manufactured before March 2010 due to reference and lot number discrepancies.
Product
Kopf Adapter S Sterile, Rx
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0243-2013·2012-11-14
Zimmer NCB Cancellous Screw Label Correction Recall
Zimmer Inc. is correcting patient labels for NCB cancellous screws due to discrepancies in reference and lot numbers.
Product
NCB¿ cancellous screw
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0194-2013·2012-11-14
Clinical Diagnostic Solutions Recalls Boule Con-Diff Hematology Control Vials
Clinical Diagnostic Solutions is recalling Boule Con-Diff hematology control vials because customers reported inaccurate MCV and RDW% values.
Product
Boule Con-Diff Hematology Control 9 vials. For in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Drugs)·D-042-2013·2012-11-14
Valeant Recalls Subpotent AcneFree 24 Hour Clearing System
Valeant Pharmaceuticals is recalling AcneFree 24 Hour Clearing System cartons because the benzoyl peroxide active ingredient is subpotent and the labels contain errors regarding inactive ingredients.
Product
AcneFree 24 Hour Clearing System containing 1-count 4 fl oz (118 mL) Oil-Free Purifying Cleanser (benzoyl peroxide 2.5% w/v) AFCS-0101-00, 1-count 4 fl oz (118 mL) Renewing Toner AFCS-0201-01, and 1-count 2 fl oz (59 mL) Repair Lotion (benzoyl peroxide 3.7% w/v) AFCS-0301-00 per
Category
Drug
Distribution
Distributed nationwide