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.

2676–2700 of 2769

LowFDA (Devices)·Z-2454-2012·2012-10-03
Neomend Recalls Progel Pleural Air Leak Sealant Due to Incorrect Expiration Date
Neomend Inc is recalling 95 units of Progel Pleural Air Leak Sealant because the product was labeled with an incorrect expiration date.
Product
Progel Pleural Air Leak Sealant, Model #: PGPS002 Lot #: 111202-002 Product Usage: The Progel Pleural Air Leak Sealant is indicated for application to visceral pleura during an open thoracotomy after standard visceral pleural closure with, for example, sutures or staples, of
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Drugs)·D-1692-2012·2012-10-03
Mallinckrodt Recalls Thallous Chloride Tl 201 Injection Due to Labeling Mismatch
Mallinckrodt Inc. is recalling specific lots of Thallous Chloride Tl 201 Injection because outer container labels do not match the vial labels.
Product
Thallous Chloride Tl 201 Injection, Diagnostic Sterile, Non-Pyrogenic Solution, a) 2.8 mL (NDC 0019N12028) b) 6.3ml (NDC 0019N12063) For Intravenous Administration, each milliliter contains 37 MBq (1 mCi) Thallous Chloride Tl 201 (no carrier added) at date and time of calibration
Category
Drug
Distribution
11 states
LowFDA (Drugs)·D-1678-2012·2012-09-26
Sandoz Recalls Pramipexole Dihydrochloride Tablets Due to Impurity
Sandoz Incorporated is recalling specific lots of Pramipexole Dihydrochloride Tablets because stability testing revealed an out-of-specification impurity.
Product
Pramipexole Dihydrochloride Tablets, 0.125 mg, 90-count tablets per bottle, Rx only, Manufactured in India by Sandoz Private Ltd., for Sandoz Inc., Princeton, NJ 08540, NDC 0781-5248-92
Category
Drug
Distribution
Distributed nationwide
LowFDA (Devices)·Z-2430-2012·2012-09-26
Impact Instrumentation Recalls Two On-Board Suction Systems Due to Shipment Mix-Up
Impact Instrumentation, Inc. is recalling two Model 324JL On-Board Suction Systems due to a shipment mix-up. The devices were distributed nationwide, including in Florida and Ohio.
Product
Model 324JL On-Board Suction System Intended use: On-board suction system for Ambulance manufacturers.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Drugs)·D-1677-2012·2012-09-26
Sandoz Recalls Pramipexole Dihydrochloride Tablets Due to Impurity
Sandoz Incorporated is recalling Pramipexole Dihydrochloride Tablets, 0.25 mg, because an out-of-specification result for a known impurity occurred during stability testing.
Product
Pramipexole Dihydrochloride Tablets, 0.25 mg, 90-count tablets per bottle, Rx only, Manufactured in India by Sandoz Private Ltd., for Sandoz Inc., Princeton, NJ 08540, NDC 0781- 5249-92,
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-1683-2012·2012-09-26
Apace Recalls Enalapril Maleate Tablets Due to Illegible Labeling
Apace KY LLC is recalling 81,516 bottles of Enalapril Maleate 5mg tablets because some labels have incomplete NDC numbers and missing strength information.
Product
Enalapril Maleate Tablet, USP 5mg 30 Tablet bottle, Rx, Apace Packaging LLC, Ft. Run, KY 42133, NDC 15338-211-30
Category
Drug
Distribution
Distributed nationwide
LowFDA (Devices)·Z-2393-2012·2012-09-26
Amsino Medical Recalls Mislabeled 0.9% Sodium Chloride Flush Syringes
Amsino Medical USA is recalling one lot of 0.9% Sodium Chloride Flush syringes that may be mislabeled as 10 mL instead of 3 mL.
Product
0.9% Sodium Chloride Injection, USP, Pre-Filled Flush Solution, 3 mL in 12 mL Single Use Syringe, Rx only, List no. 1078-33, made in Nashville, TN, manufactured for Hospira, Inc., Lake Forest, IL 60045 USA. Flush syringe.
Category
Medical Device
Distribution
1 state
LowFDA (Food)·F-2297-2012·2012-09-26
GMP Laboratories Recalls Herbal Supplement Due to Missing Capsules
GMP Laboratories of America Inc is recalling 1,027 boxes of 'Rescue Me' herbal supplements because some packets contain fewer capsules than labeled.
Product
Dietary supplement. Product is labeled as :" Rescue Me***911 Damage Control***brantley living herbal formulas***HERBAL SUPPLEMENT 15 INDIVIDUAL PACKETS 4 VEGAN CAPSULES PER PACKET (2-368mg/2-584mg Each)***DISTRIBUTED EXCLUSIVELY BY: Living Herbal Pharmacy, LLC PO Box 56-2410, Mia
Category
Food
Distribution
Distributed nationwide
LowFDA (Devices)·Z-2425-2012·2012-09-26
Kimberly-Clark Recalls Non-Commercial Sterile Surgical Gowns
Kimberly-Clark is recalling 32 cases of sterile surgical gowns that were not intended for commercial distribution to end users.
Product
ULTRA Fabric Reinforced Surgical Gown, X-Large, Sterile, Test File. The Kimberly-Clark ULTRA Fabric Reinforced Surgical Gown is a sterile, single use surgical gown intended to protect surgical patients and operating room personnel from the transfer of microorganisms, body flui
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-2397-2012·2012-09-26
BD FACS 7-color Setup Beads Recalled for Incorrect CD Version
BD Biosciences is recalling 96 kits of BD FACS 7-color Setup Beads because the included CD contained the incorrect version.
Product
BD FACS 7-color Setup beads BD Biosciences, San Jose, CA 95131. BD FACS 7 color Setup Beads are for in vitro diagnostic use on BD FACSCanto or BD FACSCanto II systems. The beads are run with BD FACSCanto clinical software. This system provides application specific setup, in
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-2404-2012·2012-09-26
Philips Brilliance CT 16 System Recalled for Software Logout Failure
Philips is recalling 93 Brilliance CT 16 systems because a software defect may cause the system to fail to log out, requiring a forced restart.
Product
The Brilliance CT 16 System Product Usage: The Brilliance 16 is a Whole Body Computed Tomography X-ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-2410-2012·2012-09-26
Siemens ADVIA Centaur FSH Calibrator B Recalled for Analytical Sensitivity Failure
Siemens Healthcare Diagnostics is recalling ADVIA Centaur FSH Calibrator B kits because they fail to meet the analytical sensitivity stated in the instructions for use.
Product
ADVIA Centaur FSH Assay: ADVIA Centaur Calibrator B US: Calibrator B 00652707 (6 pack) or 00649625 (2 pack ) OUS:OUS: 2 pack REF: 00650577 and Ref: 00654130 (6 pack) Product Usage: ADVIA Centaur CP FSH assay: For in vitro diagnostic use in the quantitative determination
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-2394-2012·2012-09-26
Amsino Medical Recalls Mislabeled 0.9% Sodium Chloride Flush Syringes
Amsino Medical USA is recalling one lot of 0.9% Sodium Chloride Flush syringes that may be mislabeled as 10 mL instead of 3 mL.
Product
0.9% Sodium Chloride Injection, USP, Pre-Filled Flush Solution, 10 mL in 12 mL Single Use Syringe, Rx only, List no. 1078-20, made in Nashville, TN, manufactured for Hospira, Inc., Lake Forest, IL 60045 USA. Flush syringe.
Category
Medical Device
Distribution
1 state
LowFDA (Food)·F-2296-2012·2012-09-19
Meijer Brand Mushrooms Recalled for Sodium Labeling Error
Meijer Distribution, Inc. is recalling Meijer Brand Mushrooms because the sodium content is above the declared value on the label.
Product
Meijer Brand Mushrooms, imported from The Netherlands Stems & Pieces, DR WT 4-oz and 8-oz sizes/Net Wt. 6.5-oz and 13.25-oz, UPC 7-1373337545-0 and UPC 7-1373337544-3
Category
Food
Distribution
5 states
LowFDA (Devices)·Z-2336-2012·2012-09-19
Helix Medical Recalls Blom-Singer Occluder for Invalid Expiration Date
Helix Medical LLC is recalling the Blom-Singer indwelling TEP Occluder due to an invalid expiration date. The recall covers devices distributed in the US and UK.
Product
BLOM-SINGER indwelling TEP Occluder, catalog IN2004-TO The Blom-Singer Indwelling (TEP(tracheoesophageal Puncture) Occluder is a non-valved silicone prosthesis designed for placement in and maintenance of the TE (tracheoesophageal) puncture following total laryngectomy. The Bl
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-2338-2012·2012-09-19
Advanced Sterilization Products Recalls STERRAD NX Cassettes Due to Printing Verification Failure
Advanced Sterilization Products is recalling STERRAD NX cassettes because the camera used to verify printing was disabled, resulting in unverified product labels.
Product
STERRAD NX Cassette, Batch # 12A078. The STERRAD 100S and STERRAD NX sterilizations systems are low-temperature general purpose sterilizers used to sterilize heat and moisture sensitive reusable medical devices. The sterilant used is hydrogen peroxide supplied in cassette form
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-2337-2012·2012-09-19
Advanced Sterilization Products Recalls STERRAD 100S and NX Cassettes
Advanced Sterilization Products is recalling STERRAD 100S and NX cassettes because a camera used to verify printing was disabled, resulting in unverified product labels.
Product
STERRAD 100S Cassette, Batch # 12A077. The STERRAD 100S and STERRAD NX sterilizations systems are low-temperature general purpose sterilizers used to sterilize heat and moisture sensitive reusable medical devices. The sterilant used is hydrogen peroxide supplied in cassette fo
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-2314-2012·2012-09-12
Quality Electrodynamics Recalls 17 Non-Functional MRI Knee Coils
Quality Electrodynamics LLC is recalling 17 TxRx Knee 15 Coil 3T units because the coil identification code is incorrect, rendering the devices non-functional.
Product
TxRx Knee 15 Coil 3T. For use in conjunction with magnetic resonance scanners to produce diagnostic images of the knee that can be interpreted by a trained physician.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-2325-2012·2012-09-12
Steris recalls 77 packs of medical tubing due to failed process indicators
Steris Corporation is recalling 77 packs of medical tubing that failed process indicators. The tubing is used to maintain the sterility of enclosed medical devices.
Product
100 ft roll of tubing inside a cardboard box. Medical devices are sealed into the tubes prior to ethylene oxide sterilization. Tube maintains sterility of the enclosed medical devices until opened.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-2268-2012·2012-09-05
Baxter Mini-Infuser 150XL Infusion Pump Recalled for Battery Contact Defect
Baxter Healthcare is recalling Mini-Infuser Model 150XL infusion pumps because a battery contact defect may prevent the device from operating.
Product
Mini-Infuser Model 150XL Single Speed Infusion Pump, an Rx battery operated syringe infusion pump; Product Usage: These product codes includes refurbished units. Intended for the controlled rate delivery of small volume parental fluids as prescribed by a physician. Usage:
Category
Medical Device
Distribution
0 states
LowFDA (Devices)·Z-2277-2012·2012-09-05
Bard Access Systems Recalls HemoStar XK Hemodialysis Catheters for Incorrect Expiration Date
Bard Access Systems is recalling 120 units of 16 Fr HemoStar XK Long-Term Hemodialysis Catheters because they were labeled with an incorrect expiration date.
Product
16 Fr HemoStar XK Long-Term Hemodialysis Catheter, implanted Standard kit containing an AirGuard introducer. The device is used for patients requiring hemodialysis. The HemoStar XK catheter is made of radio-opaque polyurethane and allows for flow rates as high as 500 ml/min d
Category
Medical Device
Distribution
16 states
LowFDA (Devices)·Z-2285-2012·2012-09-05
Phadia Varelisa Cardiolipin IgM Test Kits Recalled for Elevated Results
Phadia US Inc is recalling Varelisa Cardiolipin IgM test kits because a material change combined with a prior instruction to omit a pre-wash step caused elevated assay results.
Product
PHADIA Varelisa Cardiolipin IgM Cardiolipin autoantibody immunological test system (IgM class antibodies)
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Drugs)·D-1667-2012·2012-09-05
Apotex Recalls Azelastine Hydrochloride Nasal Solution Due to CGMP Deviations
Apotex Corp. is recalling Azelastine Hydrochloride Nasal Solution because tubing used for filling may interact with the nasal formulation.
Product
AZELASTINE HYDROCHLORIDE — AZELASTINE HYDROCHLORIDE (AZELASTINE HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
LowFDA (Devices)·Z-2276-2012·2012-09-05
Advanced Sterilization Products Recalls CIDEX OPA Solution Due to Missing Labels
Advanced Sterilization Products is recalling CIDEX OPA Solution bottles manufactured between May 2011 and April 2012 because some are missing labels.
Product
CIDEX OPA, High Level Disinfectant Solution, Glutaraldehyde-free (0.55% ortho-phthaladehyde) solution. The CIDEX OPA solution is intended for automated and manual cleaning and disinfection.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Drugs)·D-1669-2012·2012-09-05
VistaPharm Recalls Metoclopramide Oral Solution Due to Labeling Error
VistaPharm is recalling 73,800 cups of Metoclopramide Oral Solution because the shipper label incorrectly displayed '5 mL x 50' instead of '10 mL x 50'.
Product
METOCLOPRAMIDE ORAL SOLUTION, USP 5 mg/5 mL, This cup delivers 10 mL, Rx Only, Manufactured by VistaPharm, Inc., Largo FL33771
Category
Drug
Distribution
Distributed nationwide