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.

751–775 of 2766

LowFDA (Devices)·Z-1389-2019·2019-05-29
Collagen Matrix Recalls Neomem Membrane Due to Incorrect Packaging
Collagen Matrix, Inc. is recalling Neomem Resorbable Collagen Membranes because they were packaged in the wrong box, potentially inside a Neomem FLEXPLUS box.
Product
Neomem Resorbable Collagen Membrane, 15 mm x 20 mm Reference Number (model): N1520 - Product Usage: Neomem is a bioresorbable, implantable collagen material that is intended for use in dental surgery procedures as a material for placement in the area of dental implant, bone defe
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1362-2019·2019-05-22
Abbott Multichem S Plus Quality Control Serum Recalled for Missing Dry Ice
Abbott Laboratories is recalling Technopath Multichem S Plus Level 1 quality control serum because units were delivered without required dry ice.
Product
Technopath Multichem S Plus Level 1 - Product Usage: Multichem S Plus (Assayed) is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.
Category
Medical Device
Distribution
0 states
LowFDA (Devices)·Z-1357-2019·2019-05-22
Abbott Recalls ARCHITECT Intact PTH Controls Due to Missing Dry Ice
Abbott Laboratories is recalling ARCHITECT Intact PTH Controls because they were delivered without required dry ice. The recall affects units distributed to Latvia.
Product
ARCHITECT Intact PTH Controls - Product Usage: The ARCHITECT Intact PTH Calibrators are for the calibration of the ARCHITECT iSystem when used for the quantitative determination of Intact PTH in human serum and plasma.
Category
Medical Device
Distribution
0 states
LowFDA (Devices)·Z-1356-2019·2019-05-22
Abbott Recalls ARCHITECT HbA1C Calibrators Shipped Without Dry Ice
Abbott Laboratories is recalling ARCHITECT HbA1C Calibrators in Latvia because they were delivered without the required dry ice.
Product
ARCHITECT HbA1C Calibrators - Product Usage: The ARCHITECT HbA1c Calibrators are for the calibration of the ARCHITECT i System when used for the quantitative determination of percent hemoglobin A1c (HbA1c) in human whole blood.
Category
Medical Device
Distribution
0 states
LowFDA (Devices)·Z-1359-2019·2019-05-22
Abbott Troponin-I Controls Recalled for Missing Dry Ice
Abbott Laboratories is recalling ARCHITECT STAT High Sensitive Troponin-I Controls delivered without required dry ice to Latvia.
Product
ARCHITECT STAT High Sensitive Troponin-I Controls - Product Usage: The ARCHITECT STAT High Sensitive Troponin-I Controls are for the estimation of test precision and the detection of systematic analytical deviations of the ARCHITECT i System with STAT protocol capability when use
Category
Medical Device
Distribution
0 states
LowFDA (Devices)·Z-1355-2019·2019-05-22
Abbott Recalls ARCHITECT Sirolimus Calibrators Shipped Without Dry Ice
Abbott Laboratories is recalling ARCHITECT Sirolimus Calibrators in Latvia because they were delivered without the required dry ice.
Product
ARCHITECT Sirolimus Calibrators - Product Usage: The ARCHITECT Sirolimus Calibrators are for the calibration of the ARCHITECT iSystem when used for the quantitative determination of sirolimus in human whole blood.
Category
Medical Device
Distribution
0 states
LowFDA (Devices)·Z-1358-2019·2019-05-22
Abbott Recalls ARCHITECT Intact PTH Calibrators Due to Missing Dry Ice
Abbott Laboratories is recalling two units of ARCHITECT Intact PTH Calibrators because they were delivered without the required dry ice.
Product
ARCHITECT Intact PTH Calibrators - Product Usage: The ARCHITECT Intact PTH Calibrators are for the calibration of the ARCHITECT iSystem when used for the quantitative determination of Intact PTH in human serum and plasma.
Category
Medical Device
Distribution
0 states
LowFDA (Devices)·Z-1360-2019·2019-05-22
Abbott Troponin-I Calibrators Recalled for Missing Dry Ice Packaging
Abbott Laboratories is recalling ARCHITECT STAT High Sensitive Troponin-I Calibrators because they were delivered without the required dry ice.
Product
ARCHITECT STAT High Sensitive Troponin-I Calibrators - Product Usage: The ARCHITECT STAT High Sensitive Troponin-I Controls are for the estimation of test precision and the detection of systematic analytical deviations of the ARCHITECT i System with STAT protocol capability when
Category
Medical Device
Distribution
0 states
LowFDA (Devices)·Z-1363-2019·2019-05-22
Abbott Technopath Multichem S Plus Level 2 Recalled for Missing Dry Ice
Abbott Laboratories is recalling Technopath Multichem S Plus Level 2 quality control serum delivered to Latvia without required dry ice.
Product
Technopath Multichem S Plus Level 2 - Product Usage: Multichem S Plus (Assayed) is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.
Category
Medical Device
Distribution
0 states
LowFDA (Devices)·Z-1361-2019·2019-05-22
Abbott Recalls Alinity i Anti-TPO Calibrators Due to Missing Dry Ice
Abbott Laboratories is recalling Alinity i Anti-TPO Calibrators in Latvia because they were delivered without required dry ice.
Product
ALINITY i Anti-TPO Calibrators - Product Usage: The Alinity i Anti-TPO Calibrators are for the calibration of the Alinity i analyzer when used for the quantitative determination of the IgG class of thyroid peroxidase autoantibodies (anti-TPO) in human serum and plasma.
Category
Medical Device
Distribution
0 states
LowFDA (Devices)·Z-1256-2019·2019-05-08
Lin-Zhi International Recalls Ethyl Alcohol Enzymatic Assay Kits
Lin-Zhi International Inc is recalling 49 Ethyl Alcohol Enzymatic Assay kits due to potential detergent contamination that may reduce shelf life.
Product
Ethyl Alcohol Enzymatic Assay, (a) REF 0220 (small test kit), (b) REF 0221 (large test kit) Product Usage: Detergent causes faster degradation in EtOH assay. Possible container or pitchers with some detergent residue was used while producing R2 of the defective lot.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Drugs)·D-1280-2019·2019-05-08
Dermoplast Anesthetic Spray Recalled for Incorrect Net Weight Labeling
Advantice Health is recalling Dermoplast Anesthetic Spray canisters because some full cases contain cans labeled with an incorrect net weight of 2.75 oz instead of 2.0 oz.
Product
Dermoplast Anesthetic PAIN & ITCH (benzocaine and menthol) SPRAY canisters, 20%, 0.5%; full case of 12-2 oz. cans only; Distributed by Moberg Pharma North America LLC, Cedar Knolls, NJ 07927; Product Code 80-6802; Case UPC 1 03 16864 68002 7.
Category
Drug
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1253-2019·2019-05-08
Carolina Liquid Chemistries Recalls Ethyl Alcohol Assay Kits
Carolina Liquid Chemistries is recalling 20 Ethyl Alcohol Assay Kits because supplier testing showed the absorbance rate did not meet internal quality control specifications.
Product
CAROLINA(R) LIQUID CHEMISTRIES CORP. ETHA RGT. KIT, IVD, REF ST321
Category
Medical Device
Distribution
10 states
LowFDA (Devices)·Z-1252-2019·2019-05-08
Carolina Liquid Chemistries Recalls 14 Etha RGT. Kits for Quality Issues
Carolina Liquid Chemistries is recalling 14 Etha RGT. Kits (Lot 11686) due to quality concerns. The recall is voluntary and has been terminated.
Product
CAROLINA(R) LIQUID CHEMISTRIES CORP. ETHA RGT. KIT, IVD, REF ST321
Category
Medical Device
Distribution
10 states
LowFDA (Drugs)·D-1279-2019·2019-05-08
Dermoplast Anesthetic Spray Recalled for Incorrect Net Weight Labeling
Advantice Health is recalling Dermoplast Anesthetic Spray canisters because the label incorrectly states the net weight as 2.75 oz instead of 2.0 oz.
Product
Dermoplast Anesthetic PAIN & ITCH (benzocaine and menthol) SPRAY canisters, 20%, 0.5%, Net WT 2.75 oz (78g); Distributed by Moberg Pharma North America LLC, Cedar Knolls, NJ 07927; UPC 8 51409 00722 6
Category
Drug
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1202-2019·2019-05-01
Cytocell Recalls Aquarius CSF1R/RPS14 Probe Due to Labeling Error
Cytocell Ltd. is recalling 19 units of the Aquarius CSF1R/RPS14 Probe Red due to an error in the chromomap labeling.
Product
Aquarius CSF1R/RPS14 (5q32-q33) Probe Red, Model LPH540-A Analyte specific reagent.
Category
Medical Device
Distribution
2 states
LowFDA (Devices)·Z-1221-2019·2019-05-01
Maquet Edi Catheter Recalled for Incorrect Expiry Date Labeling
Getinge is recalling Maquet Edi Catheters because the single-pack boxes are labeled with the wrong expiry date. The recall covers 17 boxes distributed in the US and several countries.
Product
Maquet Servo-I Ventilator System -EDI CATHETER PHT Free 6Fr/49cm 5/pkg Product Code/REF Number: 6685775 Product Usage: The Edi Catheter is a single-use naso-gastric feeding tube with an electrode array of ten electrodes. The Edi Catheter is intended for: - Detecting diaphragm
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Drugs)·D-1243-2019·2019-05-01
Lupin Recalls Morphine Sulfate Extended-Release Tablets Due to Impurity Failures
Lupin Pharmaceuticals is recalling 17,328 bottles of Morphine Sulfate Extended-Release Tablets because they failed impurity and degradation specifications.
Product
MORPHINE SULFATE — MORPHINE SULFATE (MORPHINE SULFATE)
Category
Drug
Distribution
0 states
LowFDA (Drugs)·D-1241-2019·2019-05-01
Akorn Recalls Fentanyl Citrate Injection Due to Impurity Specification Failure
Akorn Inc. is recalling Fentanyl Citrate Injection, USP, 100 mcg/2 mL, because it failed impurity specifications during stability testing.
Product
Fentanyl Citrate Injection, USP, 100 mcg/2 mL (50 mcg/mL), 25 Ampules per carton, (2 mL each), Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-030-25
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-1242-2019·2019-05-01
Zydus Recalls Carvedilol Tablets Due to Foreign Tablet Fragments
Zydus Pharmaceuticals is recalling Carvedilol tablets 3.125 mg because a customer complaint identified a fragmented tablet of another drug product mixed in the bottle.
Product
CARVEDILOL — CARVEDILOL (CARVEDILOL)
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-1252-2019·2019-04-24
Johnson Matthey Recalls Remifentanil HCl API Due to Impurity Issues
Johnson Matthey Inc. is recalling Remifentanil HCl active pharmaceutical ingredient (API) because an unknown impurity exceeded specification limits.
Product
Remifentanil HCl active pharmaceutical ingredient (API) for manufacturing, processing or repackaging, 416.95 g glass container, Rx ONLY, Johnson Matthey Pharmaceutical Materials, 2003 Nolte Drive, West Deptford, NJ 08066-1742.
Category
Drug
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1097-2019·2019-04-24
ICU Medical Recalls ChemoLock Vial Spikes Due to Plastic Particulate
ICU Medical is recalling specific lots of ChemoLock Vial Spikes because they may contain plastic burr particulate from the protective cap.
Product
icumedical ChemoLock Closed Vial Spike w/Skirt, (a) REF CL-80S-4 (4 units) (b) REF CL-80S-5 (5 units). Used in IV administration sets. The ChemoLock Closed System Drug Transfer Device prevents the transfer of environmental contaminants, including bacterial and airborne
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1096-2019·2019-04-24
ICU Medical Recalls ChemoLock Devices Due to Plastic Particulate
ICU Medical is recalling specific lots of ChemoLock devices because they may contain plastic burr particulate from the protective cap.
Product
icumedical ChemoLock, 20mm, (a) REF CL-80S (b) REF CL-80S-10 (10 units). Used in IV administration sets. The ChemoLock Closed System Drug Transfer Device prevents the transfer of environmental contaminants, including bacterial and airborne contaminants into the system, a
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1190-2019·2019-04-24
Aniara Biophen LMWH Control C4 Recall for Incorrect Instructions
Aniara Diagnostica LLC is recalling three units of BIOPHEN LMWH Control C4 because incorrect versions of the Instructions for Use were packaged.
Product
BIOPHEN LMWH Control C4, REF 224201
Category
Medical Device
Distribution
2 states
LowFDA (Devices)·Z-1198-2019·2019-04-24
Cordis Guiding Catheters Recalled for Frayed Mounting Card Fragments
Cordis Corporation is recalling Vista Brite Tip and Androit guiding catheters because frayed pieces of the mounting card were found inside the primary packaging.
Product
Cordis Vista Brite Tip & Androit Guiding Catheters Product Usage: The guiding catheter is intended for use for intravascular introduction of interventional/diagnostic devices into the coronary or peripheral vascular systems.
Category
Medical Device
Distribution
Distributed nationwide