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.

1001–1025 of 2769

LowFDA (Devices)·Z-1918-2018·2018-05-30
LivaNova Inspire 6 Integrated Phisio OXY Recall for Incorrect UDI Expiration Date
LivaNova USA is recalling 42 units of Inspire 6 Integrated Phisio OXY devices because the expiration date in the UDI barcode is printed in the wrong format.
Product
Inspire 6 Integrated Phisio OXY w/ HVR Reservoir, Sterile EO, Catalog # 050713 The intended uses for the two elements that constitute the oxygenator/reservoir integrated devices are: INSPIRE 6M Hollow Fiber Oxygenator: The INSPIRE 6M is intended for use in adult and small adul
Category
Medical Device
Distribution
5 states
LowUSDA FSIS·040-2018·2018-05-23
Uno Foods Recalls Ham and Cheese Calzones Due to Misbranding
Uno Foods Inc. is recalling 1,881 pounds of ham and cheese calzones because the packages contain buffalo chicken calzones instead.
Product
Great Kitchens Food Company — Uno Foods Inc. Recalls Ham and Cheese Calzones Due to Misbranding
Category
Food
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1875-2018·2018-05-23
Epic Extremity Plate System Caddy Recalled for Artwork Error
Epic Extremity, LLC is recalling 9 units of the 10x10 Plate Caddy due to an artwork error that misidentifies a specific plate and screw.
Product
Epic Extremity Plate System,10x10 Plate Caddy, Part 2111-1010 with 2.7 and 3.5mm Non-Locking Screw (2001-27XX-N & 2001-35XX-N)
Category
Medical Device
Distribution
3 states
LowFDA (Drugs)·D-0803-2018·2018-05-23
Boiron Recalls Calendula Cream Due to Outer Carton Labeling Error
Boiron Inc. is recalling 52,810 tubes of Calendula Cream because the outer carton incorrectly lists the active ingredient concentration as 7% instead of 10%.
Product
Calendula Cream, calendula officinalis 1X HUS-10%, 2.5 oz. tubes, Distributed by Boiron Inc., Newtown Square, PA
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0818-2018·2018-05-23
Sun Pharma Recalls Riomet Metformin Solution Due to Labeling Errors
Sun Pharmaceutical Industries is recalling Riomet (metformin hydrochloride) oral solution due to identified labeling discrepancies in the patient literature.
Product
RIOMET — RIOMET (METFORMIN HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1883-2018·2018-05-23
Coltene Whaledent Recalls Carbide Burs Due to Incorrect Product Number Labeling
Coltene Whaledent Inc is recalling 11 packs of Alpen Carbide 702 Cross Cut Tapered Fissure FG 10 pack carbide burs because they are labeled with an incorrect product number.
Product
Alpen Carbide 702 Cross Cut Tapered Fissure FG 10 pack (Carbide Burs), Model R100702 a rotary cutting device made from carbon steel or tungsten carbide intended to cut hard structures in the mouth, such as teeth or bone.
Category
Medical Device
Distribution
1 state
LowFDA (Drugs)·D-0810-2018·2018-05-23
Aidarex Recalls Ferrous Sulfate Tablets Due to Foreign Material Presence
Aidarex Pharmaceuticals LLC is recalling 450 bottles of Ferrous Sulfate 325 MG tablets distributed in Florida because foreign tablets or capsules were found in the product.
Product
Ferrous Sulfate 325 MG tablet; NDC 33261-0715-00
Category
Drug
Distribution
1 state
LowFDA (Devices)·Z-1874-2018·2018-05-23
Epic Extremity Plate System Recalled for Packaging Labeling Error
Epic Extremity, LLC is recalling 6 units of the Epic Extremity Plate System due to a packaging error that misidentifies a specific plate and screw.
Product
Epic Extremity Plate System, Midfoot/Flatfoot Insert, Part 2111-0005 with Extended Butterfly Plate (2000-5002)
Category
Medical Device
Distribution
3 states
LowFDA (Drugs)·D-0828-2018·2018-05-16
Septodont Recalls OraVerse Injection Due to Impurity Test Failure
Septodont Inc. is recalling OraVerse (Phentolamine Mesylate) Injection due to an out-of-specification result for a degradation product impurity.
Product
ORAVERSE — ORAVERSE (PHENTOLAMINE MESYLATE)
Category
Drug
Distribution
0 states
LowFDA (Devices)·Z-1799-2018·2018-05-16
Siemens Syva EMIT II Plus 6-Acetylmorphine Recalled for Calibration Error
Siemens Healthcare Diagnostics is recalling Syva EMIT II Plus 6-Acetylmorphine reagents because the calibrator level listed in the qualitative calibration steps is incorrect.
Product
Syva¿ EMIT¿ II Plus 6-Acetylmorphine Catalog # for 1000 mL: 9R129UL /SMN# 10481483
Category
Medical Device
Distribution
9 states
LowFDA (Devices)·Z-1562-2018·2018-05-16
Vyaire Medical Recalls AirLife Resuscitation Devices Due to Mask Sticking
Vyaire Medical is recalling 8,100 AirLife Resuscitation devices because the mask may stick to the elbow, making it difficult to disconnect.
Product
AirLife Resuscitation, Adult, with mask, 28inch large bore tubing Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their o
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1554-2018·2018-05-16
Vyaire Medical Recalls Pediatric AirLife Resuscitation Devices Due to Mask Sticking
Vyaire Medical is recalling 8,058 pediatric AirLife resuscitation devices because the mask may stick to the elbow, making it difficult or impossible to disconnect.
Product
AirLife Resuscitation, Pediatric, with mask, 40inch oxygen reservoir tubing, pressure-relief valve Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or can
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1780-2018·2018-05-16
MHC Medical Recalls EasyTouch Insulin Syringes Due to Labeling Error
MHC Medical Products LLC is recalling 46,600 EasyTouch insulin syringes because retail shelf cartons may display an incorrect lot number.
Product
EasyTouch (ET) Insulin Syringe 29G 0.5ml ¿" (Item 829555) Product Usage: INTENDED FOR INJECTION OF U100 INSULIN ONLY
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1800-2018·2018-05-16
Siemens Healthcare Recalls EMIT II Plus 6-Acetyl Morphine Reagents
Siemens Healthcare Diagnostics is recalling EMIT II Plus 6-Acetyl Morphine reagents due to incorrect calibrator levels listed in the calibration steps.
Product
Syva¿ EMIT¿ II Plus 6-Acetyl morphine Catalog # for 28 mL: 9R039UL /SMN# 10470440
Category
Medical Device
Distribution
9 states
LowFDA (Devices)·Z-1544-2018·2018-05-09
BD MAX DNA MMK Recalled for Incorrect Package Insert Volume Instructions
Becton Dickinson is recalling BD MAX DNA MMK (SPC) because the package insert lists the wrong volume of diluent, which could affect assay results.
Product
BD MAX DNA MMK (SPC) For Laboratory Use, catalog no. 442829
Category
Medical Device
Distribution
8 states
LowFDA (Devices)·Z-1490-2018·2018-05-09
Beijing Syntech Laser Trixel 11 CO2 Laser Recalled for Missing Label
Beijing Syntech Laser Co., Ltd is recalling three Trixel 11 CO2 surgical lasers because the required certification label was not affixed to the products.
Product
Beijing Syntech Laser Trixel 11 C02 Laser surgical lasers
Category
Medical Device
Distribution
0 states
LowFDA (Devices)·Z-1488-2018·2018-05-09
Beijing Syntech Laser Diode Surgical Lasers Recalled for Missing Certification Label
Beijing Syntech Laser Co., Ltd is recalling 13 Diode Laser surgical lasers because the required certification label was not affixed to the products.
Product
Beijing Syntech Laser Diode Laser surgical lasers
Category
Medical Device
Distribution
0 states
LowFDA (Devices)·Z-1542-2018·2018-05-09
Ameditech Recalls Alere iScreen Dx Urine Drug Screen Cards for Labeling Error
Ameditech is recalling Alere iScreen Dx Urine Drug Screen Cards because the box label incorrectly lists Phencyclidine (PCP) instead of Tricyclic Antidepressants (TCA).
Product
Alere iScreen Dx Urine Drug Screen Card
Category
Medical Device
Distribution
9 states
LowFDA (Devices)·Z-1518-2018·2018-05-02
CooperVision Clariti 1 Day Contact Lenses Recalled for Incorrect Expiration Date
CooperVision is recalling specific lots of Clariti 1 Day contact lenses because the secondary packaging displays an incorrect expiration date.
Product
56% 1 Day Silicone Hydrogel (-2.50), 10 pack, UV Blocking, daily disposable contact lenses The Clariti 1 Day (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with UV blocker is indicated for daily wear single use only for the correction of refractiveametropia
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1515-2018·2018-05-02
CooperVision Recalls Clariti 1 Day Contact Lenses for Incorrect Expiration Date
CooperVision is recalling Clariti 1 Day contact lenses because the secondary packaging displays an incorrect expiration date.
Product
clariti 1 day/Fresh Day 90 pack (-1.00), UV Blocking, 90 silicon hydrogel, daily disposable contact lenses The Clariti 1 Day (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with UV blocker is indicated for daily wear single use only for the correction of refra
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1479-2018·2018-05-02
Medtronic DxTerity Diagnostic Catheter Recalled for Incorrect Box Labeling
Medtronic is recalling 855 units of DxTerity Diagnostic Catheters because the outer box displays an incorrect 6 French size indicator, though the catheters inside are correct.
Product
Medtronic DxTerity Diagnostic Catheter, JL 4.0, REF DXT5JL40, marked with 6F color code on box.
Category
Medical Device
Distribution
0 states
LowFDA (Devices)·Z-1464-2018·2018-05-02
Ace Surgical Supply Recalls Mispackaged Double Blade Shoe Unigraft Knives
Ace Surgical Supply Co., Inc. is recalling six units of Double Blade Shoe F/Unigraft Knives because a single blade shoe was mistakenly packaged instead of the intended double blade.
Product
Double Blade Shoe F/Unigraft Knife 1.5 Thick X 9MM SKU 6500009 Used to achieve epithelial graft in the oral cavity.
Category
Medical Device
Distribution
3 states
LowFDA (Devices)·Z-1517-2018·2018-05-02
CooperVision Recalls Clariti 1 Day Contact Lenses for Incorrect Expiration Date
CooperVision is recalling Clariti 1 Day contact lenses because the secondary packaging displays an incorrect expiration date.
Product
56% 1 Day Silicone Hydrogel (-4.50), 10 pack, UV Blocking, daily disposable contact lenses The Clariti 1 Day (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with UV blocker is indicated for daily wear single use only for the correction of refractiveametropia
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Food)·F-1135-2018·2018-05-02
Italian Rose Garlic Spread Recalled for Documentation and Monitoring Failures
Italian Rose Garlic Products, LLC is recalling 842 pails of Italian Rose Garlic Spread because the firm failed to document mixing times and monitor pH levels during production.
Product
ITALIAN ROSE GARLIC SPREAD, Gluten Free, NET WT. 35 LB (16 kg), www.italian-rose.com, Riviera Beach, FL 33404
Category
Food
Distribution
1 state
LowFDA (Devices)·Z-1520-2018·2018-05-02
Quidel MicroVue Intact PTH EIA Recalled for Potential Calibration Issues
Diagnostic Hybrids, Inc. is recalling 26 units of the Quidel MicroVue Intact PTH EIA due to a potential loss of separation between calibrators that may impact assay calibration.
Product
Quidel MicroVue Intact PTH EIA, Model 8044. An enzyme immunoassay for the quantification of Intact Parathyroid Hormone (PTH) in serum.
Category
Medical Device
Distribution
0 states