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.

16751–16775 of 21645

  • ModerateFDA (Devices)·Z-1315-2015·2015-04-01

    Leica CD15 Antibody Recalled for Decreasing Staining Intensity

    Leica Microsystems is recalling 309 units of CD15 antibody because staining intensity decreases over shelf life.

    Product
    Liquid Mouse Monoclonal Antibody CD15 used is laboratories to perform immunohistochemical (IHC) staining. Product Usage: NCL-L-CD15 is intended for the qualitative identification by light microscopy of CD15 molecules in paraffin sections. The clinical interpretation of any…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1574-2015·2015-04-01

    Cocola Macaroons Recalled for Undeclared Colors

    Cocola INC is recalling Cocola Macaroons due to a complaint regarding undeclared colors in the product.

    Product
    Cocola Macaroons; Each box contains 5 flavors (3 ct each): Mango Passion, Raspberry, Pistachio, Coffee, and Chocolate. Net wt. 7 oz. ; UPC 091037037985. Ingredient: Fresh Egg White, Mango Puree, Passion Fruit Puree, Granulated sugar, powdered sugar, Almond Flour,Butter N&A…
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1320-2015·2015-04-01

    Roche Recalls cobas EGFR Mutation Test Kits Due to False Positives

    Roche Molecular Systems is recalling 190 kits of the cobas EGFR Mutation Test because they may produce false positive results for Exon 20 insertion mutations.

    Product
    cobas¿ EGFR Mutation Test epidermal growth factor receptor (EGFR) gene DNA assay
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1297-2015·2015-03-25

    Siemens E.CAM Systems Recalled for Incorrectly Assembled Radial Motor Drives

    Siemens Medical Solutions is recalling E.CAM emission computed tomography systems because radial motor drives replaced during service were assembled backwards.

    Product
    E.CAM emission computed tomography system used to detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588 keV.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1301-2015·2015-03-25

    CooperSurgical Recalls NovaPlus Infant Heel Warmers Due to Burn Risk

    CooperSurgical is recalling NovaPlus infant heel warmers because products without expiration dates may cause minor burns.

    Product
    NovaPlus Brand Warm Gel Infant Heel Gel Warmer, Item # V6391 NovaPlus Brand Liquid Heal Warmer. Item #V6393 Single Use and Disposable To provide gentle heat to increase blood flow and enhance infant blood sample collection
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0413-2015·2015-03-25

    Mylan Recalls Subpotent Nicardipine Hydrochloride Injection Vials

    Mylan Institutional LLC is recalling specific lots of Nicardipine Hydrochloride Injection because the product failed potency and impurity specifications.

    Product
    Nicardipine Hydrochloride Injection, 25 mg/10 ml (2.5 mg/mL),10 mL single dose vial, Rx only, Manufactured in India for: Mylan Institutional LLC, Rockford, IL 61103, NDC 67457-224-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1293-2015·2015-03-25

    Radiometer Crea A and B Membranes Recalled for Negative QC Drift

    Radiometer America Inc. is recalling Crea A and B membranes used with ABL800 FLEX analyzers due to negative drift on quality control during their in-use lifetime.

    Product
    Crea A and B membranes, packaged 4 per box Used in conjunction with the ABL800 FLEX analyzers which are intended for: In Vitro Testing of samples of whole blood for the parameters pCO2, cK+,cNa+, cCa2+,cCl-,cGlu, cLac, cCrea, ctBil, and co-oximetry parameters,(ctHb, sO2, and…
    Category
    Medical Device
    Distribution
    27 states
  • ModerateFDA (Drugs)·D-0419-2015·2015-03-25

    Tarmac Recalls Antacid Liquid Due to Microbial Contamination

    Tarmac Products is recalling specific lots of Antacid Liquid Regular Strength because they failed microbiological testing at the 12-month time point.

    Product
    Antacid Liquid Regular Strength Antacid & Anti-Gas (Aluminum hydroxide 200 mg, Magnesium hydroxide 200 mg, Simethicone 20 mg (in each 5 mL, 1 teaspoon), Mint flavor, 12 fl oz (355 mL) bottle, Distributed By: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015, NDC 0363-0073-02…
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1275-2015·2015-03-25

    Bard Access Systems Recalls BD PosiFlush Saline Flush Syringes Due to Open Seals

    Bard Access Systems is recalling BD PosiFlush Saline Flush Syringes included in certain device kits because open seals may compromise product sterility.

    Product
    BD Posiflush Saline Flush Syringe 10 ml inlcuded in the following device kits: Groshong Midline Bard MYPICC Kit 4F (Single-Lumen) The syringe is used to pre-flush the catheter prior to placement and may also be used to verify patency post-placement.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1287-2015·2015-03-25

    Materialise Recalls Signature TKA Surgical Guides Due to Incorrect Patient Images

    Materialise N.V. is recalling Signature TKA GDE/MDL Set 04-05 surgical guides because images from a different patient were used for production.

    Product
    Signature TKA GDE/MDL Set 04-05 (Femur & Tibia) The Signature Patient-Specific Surgical Guides are intended to be used as part of the Signature Personalized Patient Care System. Lt is intended to be used as a guide during the surgical procedure for total and partial knee…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1296-2015·2015-03-25

    Siemens Symbia E SPECT Systems Recalled for Incorrect Radial Motor Assembly

    Siemens Medical Solutions is recalling 419 Symbia E SPECT systems worldwide because radial motor drives were incorrectly assembled backwards during a customer service action.

    Product
    Symbia E is a multi-purpose SPECT system used to detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588 keV.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1268-2015·2015-03-25

    Med-logics Recalls ML 7090 Calibrated LASIK Blades Due to Fit Issues

    Med-logics Inc is recalling 360 units of ML 7090 Calibrated LASIK Blades because they do not fit into the AMO Amadeus Metal Blade Holder.

    Product
    ML 7090 Calibrated LASIK Blade (CLB); CLB CALIBRATED LASIK BLADE 10. ML 7090 Calibrated LASIK Blade (CLB) is to be used as replacement blades for the AMO Amadeus Microkeratome, to perform lamellar keratectomy procedures.
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-1277-2015·2015-03-25

    US Infusion Recalls Medstream IV Sets Due to Leaking

    US Infusion is recalling 62,700 Medstream IV infusion sets because they may leak at the Y site. The sets were distributed in six states.

    Product
    Medstream 81" (206 cm) 20 drop Universal Administration Sets. Disposable IV infusion set with 3 year expiration date.
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Food)·F-1452-2015·2015-03-25

    Mi Pepito Ground Shrimp Recalled for Unallowed Dyes and Sulfites

    N.A.C. Foods is recalling Mi Pepito Ground Shrimp in New Jersey and New York due to unallowed dyes and undeclared sulfites.

    Product
    Mi Pepito Camaron Molido Ground Shrimp, Net wt. .75 oz (16 gr), Packaged in a plastic bag, Packed & Distributed by: N.A.C. Corp., Palisades Park, NJ, UPC 707425900051
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1284-2015·2015-03-25

    St Jude Medical Recalls TactiSys Quartz Pack for Configuration Update

    St Jude Medical is recalling 89 TactiSys Quartz Packs because a configuration update is needed to ensure the device appropriately recognizes all TactiCath catheters.

    Product
    TactiSys Quartz Pack, PN-004 400. For percutaneous catheter radiofrequency (RF) ablation of atrial cardiac arrhythmias that allows visualization of the contact force between TactiCath quartz catheter tip and the heart wall. Product Usage: This device is indicated for…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1291-2015·2015-03-25

    Sybron Recalls Pinnacle Cure Sleeves Due to Mislabeling and Cross-Contamination Risk

    Sybron Dental Specialties is recalling 172 units of Pinnacle Cure Sleeves because inner packaging is mislabeled, creating a risk of cross-contamination if the sleeves tear.

    Product
    Outer cardboard box labeling: Pinnacle Cure Sleeve, Curing Light Tip Sleeves. Kerr Total Care. Part Number: 4513C or 4513-1 Single Patient Use Fits 13mm Tips. Pack of 400. Metrex Research, Manufacturer. Inner individual packaging of each sleeve: Cure Sleeve by…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1409-2015·2015-03-18

    Similac Advance Infant Formula Recalled for Chinese Labeling

    Abbott Laboratories is recalling Similac Advance infant formula because export-bound product with Chinese labeling was distributed in the US.

    Product
    Similac¿ Advance Complete Nutrition Infant Formula with Iron, 1.45lb plastic container.
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1252-2015·2015-03-18

    Siemens RAPIDPoint 405 Blood Gas Analyzer Recalled for Neonatal Bilirubin Variability

    Siemens is recalling 3,420 RAPIDPoint 405 Blood Gas Analyzers worldwide because the neonatal bilirubin parameter may show increased variability under specific high-concentration conditions.

    Product
    RAPIDPoint 405 Blood Gas Analyzer; Siemens Material Number: 10310464, 10322347, 10314817, 10317193, 10318999, 10320055, 10322347, 10328278, 10328302, 10336784. These systems are intended for near-patient and laboratory testing of blood gases, electrolytes, metabolites, total…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0408-2015·2015-03-18

    Micro Labs Recalls Simvastatin Tablets Due to Impurity Failure

    Micro Labs USA Inc. is recalling Simvastatin Tablets, 40mg, because the product failed a known impurity specification. The recall affects 13,488 bottles distributed nationwide.

    Product
    Simvastatin Tablets, USP, 40mg, Rx Only, 90 count bottles, Manufactured by: Micro Labs Limited Goa-403 722, India, Manufactured for: Micro Labs USA Inc., Princeton, NJ 08540 NDC 42571-0040-90.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1265-2015·2015-03-18

    Southern Implants Recalls Dental Implants Due to Labeling Mismatch

    Southern Implants, Inc. is recalling 130 units of MAX-TL and Z-MAX dental implants because the labeled packages contained the wrong implant type.

    Product
    MAX-TL 9.0 x 7.0 mm Implant, Catalog No. 15711K; Z-MAX Implant 9.0 x 7 mm Length, Catalog No. Z-MAX9-7. Dental implant. Product Usage: The MAX Implant is intended to be implanted in the upper and lower jaw arches to provide support for fixed or removable dental prostheses…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0409-2015·2015-03-18

    Micro Labs Recalls Simvastatin Tablets Due to Impurity Failure

    Micro Labs USA Inc. is recalling 13,464 bottles of Simvastatin 80mg tablets because the product failed a known impurity specification.

    Product
    Simvastatin Tablets, USP, 80mg, Rx Only, 90 count bottles, Manufactured by: Micro Labs Limited Goa-403 722, India, Manufactured for: Micro Labs USA Inc., Princeton, NJ 08540 NDC 42571-080-90.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1255-2015·2015-03-18

    Siemens RAPIDLab 1265 System Recalled for Neonatal Bilirubin Variability

    Siemens Healthcare Diagnostics Inc is recalling 2,863 RAPIDLab 1265 Systems because the neonatal bilirubin parameter may show increased variability under specific high-concentration conditions.

    Product
    RAPIDLab 1265 System; Siemens Material Number: 10491395, 10321852, 10335524. The Rapidlab 1200 systems are intended for in vitro diagnostic use by healthcare professionals in the quantitative testing of human whole blood. The systems can determine the following parameters…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1253-2015·2015-03-18

    Siemens RAPIDPoint 500 Blood Gas Analyzer Recalled for Neonatal Bilirubin Variability

    Siemens is recalling 4,376 RAPIDPoint 500 Blood Gas Analyzers worldwide because the neonatal bilirubin parameter may show increased variability under specific high-concentration conditions.

    Product
    RAPIDPoint 500 Blood Gas Analyzer; Siemens Material Number: 10492730, 10696855, 10696857, 10697306. The RAPIDPoint 500 system is designed for professional use in a point-of-care or laboratory environment. This system tests blood gases, electrolytes, metabolites, total…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0411-2015·2015-03-18

    Qualitest Recalls Promethazine DM Syrup Due to Plastic Particulates

    Qualitest Pharmaceuticals is recalling 972 bottles of Promethazine DM Syrup because plastic cap closure particulates may be present in the product.

    Product
    PROMETHAZINE DM SYRUP (Promethazine Hydrochloride, USP and Dextromethorphan Hydrobromide, USP), EACH 5 ml (ONE TEASPOONFUL) CONTAINS: Promethazine Hydrochloride 6.25 mg, Dextromethorphan Hydrobromide 15 mg, alcohol 7%, ONE PINT (574 mL), Rx only, Manufactured for: QUALITEST…
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1254-2015·2015-03-18

    Siemens RapidLab 1245 System Recalled for Neonatal Bilirubin Variability

    Siemens is recalling 241 RapidLab 1245 systems because the neonatal bilirubin parameter may show increased variability under specific high-concentration conditions.

    Product
    RAPIDLab 1245 System; Siemens Material Number: 10321844, 10491393, 10337179. The Rapidlab 1200 systems are intended for in vitro diagnostic use by healthcare professionals in the quantitative testing of human whole blood. The systems can determine the following parameters…
    Category
    Medical Device
    Distribution
    Distributed nationwide