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.

17951–17975 of 21645

ModerateFDA (Devices)·Z-2187-2014·2014-08-20
Codman Certas Valve Recalled to Clarify Pressure Specifications in Instructions
Codman & Shurtleff is recalling 9,498 Codman Certas valves to clarify the pressure specification for the virtual off setting in the product's Instructions for Use.
Product
Codman Certas - In line Valve with Unitized BACTISEAL¿ Catheter and Accessories; Product Code: 82-8803 The Codman Certas Programmable valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrospinal fluid) for the management…
Category
Medical Device
Distribution
43 states
ModerateFDA (Devices)·Z-2190-2014·2014-08-20
Codman Certas Valve Recalled for Pressure Specification Clarification
Codman & Shurtleff is recalling 9,498 Codman Certas In Line Valves to clarify the pressure specification for the virtual off setting in the product's Instructions for Use.
Product
Codman Certas - In Line Valve with SIPHONGUARD¿, Unitized Catheter and Accessories; Product Code: 82-8806 The Codman Certas Programmable valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrospinal fluid) for the…
Category
Medical Device
Distribution
43 states
ModerateFDA (Food)·F-2311-2014·2014-08-20
Frederick Farms Chocolate Ice Cream Cups Recalled for Wrong Lid
Garber Ice Cream Company is recalling Frederick Farms 4oz chocolate ice cream cups because the wrong lids were used during production.
Product
Frederick Farms 4oz chocolate ice cream cups, net wt. 67grams, 24 per box, 231 boxes per pallet, expiration 6-10-15
Category
Food
Distribution
4 states
ModerateFDA (Food)·F-2307-2014·2014-08-20
Ocean Garden Wild Co-treated Steak IVP Recalled for High Histamine Levels
Blue Venture Inc. is recalling Ocean Garden Wild Co-treated Steak IVP due to histamine levels above allowable limits.
Product
Ocean Garden Wild Co-treated Steak IVP 10LB 10 oz. UPC 076550080922
Category
Food
Distribution
1 state
ModerateFDA (Devices)·Z-2235-2014·2014-08-20
Vital Sync Virtual Patient Monitoring Platform Recalled for Alarm Priority Mismatch
Nellcor Puritan Bennett Inc. is correcting Vital Sync Virtual Patient Monitoring Platform units due to a mismatch between device alarm priorities and the system.
Product
Vital Sync RMS 1.0 when loaded with v2.4 software, packaged on a CD or other electronically controlled device. CDs are packaged in clam shell jeweled cases within a carton box. The Vital Sync Virtual Patient Monitoring Platform is intended to be used by healthcare…
Category
Medical Device
Distribution
8 states
ModerateFDA (Devices)·Z-2171-2014·2014-08-20
Intuitive Surgical Recalls EndoWrist Stapler Manuals for pH Specification Change
Intuitive Surgical is recalling EndoWrist Stapler 45 User Manual Addenda and Wall Charts to correct the pH range specification for enzymatic cleaners.
Product
EndoWrist Stapler System User Manual Addendum and Wall Chart; The EndoWrist Stapler 45 System and EndoWrist Stapler 45 Reloads are intended to be used with the da Vinci Si Surgical System (Model IS3000) for resection, transection and/or creation of anastomoses in General…
Category
Medical Device
Distribution
2 states
ModerateFDA (Devices)·Z-2180-2014·2014-08-20
Siemens Syngo RT Software Recalled for Sporadic System Crashes
Siemens is recalling Syngo RT Therapist and Oncologist software versions 4.3.SP1 due to sporadic system crashes that prevent unloading patient data.
Product
Siemens Syngo RT Therapist and Syngo RT Oncologist intended use of the SIEMENS branded Syngo RT Therapist and Syngo RT Oncologist software applications used with SIEMENS family of linear accelerator systems is to deliver X-Ray photon and electron radiation for the therapeutic…
Category
Medical Device
Distribution
3 states
ModerateFDA (Food)·F-2328-2014·2014-08-20
Cool Tropics Rips Slush Cherry Limeade Recalled for Spoilage Bacteria
Manufacturing Solutions International is recalling specific batches of Cool Tropics Rips Slush Cherry Limeade because laboratory tests revealed spoilage bacteria and yeasts.
Product
Cool Tropics Rips Slush, Cherry LimeadeFlavored 100% Juice No artificial colors or flavors, Juice from Concentrate 4 fl oz, (118 mL),Manufactured in USA for Tropical Paradise, Inc., www.cool-tropics.com DO NOT MICROWAVE
Category
Food
Distribution
7 states
ModerateFDA (Food)·F-2321-2014·2014-08-20
Miceli Dairy Products Recalls Ricotta Cheese Due to Beta Lactam Residues
Miceli Dairy Products is recalling specific ricotta cheese products because they were made from whey protein concentrate containing beta lactam residues.
Product
Part Skim Ricotta cheese: SYSCO Imperial Ricotta Cheese packaged in 5 pound tubs and Sargento Part-Skim Ricotta Natural Cheese and Miceli's Part-Skim Ricotta Cheese packaged in 15 ounce tubs.
Category
Food
Distribution
4 states
ModerateFDA (Drugs)·D-1536-2014·2014-08-20
Bracco Recalls E-Z-HD Barium Sulfate Due to Low Potency
Bracco Diagnostic Inc is recalling E-Z-HD (barium sulfate) bottles because routine stability testing revealed low pH and assay results.
Product
E-Z-HD — E-Z-HD (BARIUM SULFATE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Food)·F-2323-2014·2014-08-20
Sargento Light Ricotta Cheese Recalled for Beta Lactam Residues
Miceli Dairy Products Co is recalling Sargento Light Ricotta Natural Cheese because the whey protein concentrate used in manufacturing tested positive for beta lactam residues.
Product
Sargento Light Ricotta Natural Cheese packaged in 15 ounce plastic tubs.
Category
Food
Distribution
4 states
ModerateFDA (Devices)·Z-2185-2014·2014-08-20
Codman Certas Valve Recalled to Clarify Pressure Specifications in Instructions
Codman & Shurtleff is recalling 9,498 Codman Certas In Line Valves to clarify the pressure specification for the virtual off setting in the product's Instructions for Use.
Product
Codman Certas - In Line Valve with Catheter and Accessories; Product Code: 82-8801 The Codman Certas Programmable valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrospinal fluid) for the management of hydrocephalus.
Category
Medical Device
Distribution
43 states
ModerateFDA (Devices)·Z-2188-2014·2014-08-20
Codman Certas Valve Recalled for Pressure Specification Clarification
Codman & Shurtleff is recalling 9,498 Codman Certas In Line Valves to clarify the pressure specification for the virtual off setting in the Instructions for Use.
Product
Codman Certas - In Line Valve only with SIPHONGUARD¿ Device; Product Code: 82-8804 The Codman Certas Programmable valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrospinal fluid) for the management of hydrocephalus.
Category
Medical Device
Distribution
43 states
ModerateFDA (Food)·F-2317-2014·2014-08-20
Nutrition Express Recalls Vitamins Due to Excess Folic Acid Content
Nutrition Express is recalling specific vitamin products because the folic acid content was found to be higher than the amount stated on the label.
Product
Fitness Labs Fitness Multi 2, 90 capsules (UPC 654186946203) and 180 capsules (UPC 654186946227).
Category
Food
Distribution
1 state
ModerateFDA (Devices)·Z-2138-2014·2014-08-13
Advandx Quick FISH Fixation Kit Recalled for Quality Control Failure
Advandx Inc is recalling 10 kits of the Quick FISH Fixation Kit for Blood Cultures because they failed internal quality control tests.
Product
AdvanDx Quick FISH Fixation Kit for BC ( Blood Cultures), 50 tests. In vitro diagnostic. The QuickFISH Fixation Kits are components that are sold separately for the Staphylococcus QuickFISH BC test Catalog number: QFFixBC1-50 (a component for QFSTABC1-50)
Category
Medical Device
Distribution
8 states
ModerateFDA (Drugs)·D-1511-2014·2014-08-13
Caraco Recalls Cephalexin Capsules Due to Manufacturing Practice Deviations
Caraco Pharmaceutical Laboratories is recalling Cephalexin Capsules, 500 mg, because they were manufactured with active pharmaceutical ingredients that did not follow good manufacturing practices.
Product
Cephalexin Capsules, USP, 500 mg, packaged in a) 100-count bottles (NDC 62756-294-88) and b) 500-count bottles (NDC 62756-294-13), Rx only, Manufactured by: Sun Pharmaceutical Ind. Ltd., Acme Plaza, Andheri-Kurla Road, Andheri (East), Mumbai-400 059, India.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1518-2014·2014-08-13
Alcohol-Free Hand Sanitizer Recalled for Microbial Contamination
HLI dba Humphreyline Inc is recalling 975 bottles of alcohol-free hand sanitizer due to microbial contamination. The product was distributed in Kentucky, Maryland, and Virginia.
Product
Alcohol-Free Hand Sanitizer, 1. fl. oz. (30 ml) bottles capped with white sprayer, OTC, contains Benzalkonium chloride. Mfg. for HLI, Portland, OR 97222 NDC: 19392-120-03. Labeled A) Anne Arundel County Mental Health Agency, Inc., B) Family Advocacy Program, and C) Henderson…
Category
Drug
Distribution
3 states
ModerateFDA (Devices)·Z-2139-2014·2014-08-13
Ortho VITROS 3600 Immunodiagnostic System Software Recall
Ortho-Clinical Diagnostics is recalling VITROS 3600 systems due to a software defect that may associate incorrect patient demographics with sample IDs.
Product
VITROS 3600 Immunodiagnostic System --- For use in the in vitro quantitative, semi-quantitative and qualitative measurement of a variety of analytes of clinical interest, using VITROS Immunodiagnostic Products Reagents. The VITROS Software is a part of the VITROS 3600, 4600, &…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1533-2014·2014-08-13
FDA Recalls Unapproved Glutathione Injection Vials Nationwide and Abroad
Medical Supply Liquidators LLC is recalling Glutathione Injection USP vials because the manufacturer is not FDA-registered and the product lacks an approved NDA or ANDA.
Product
Glutathione Injection USP, 200 mg/ml, packaged in 30 ml vials, Sterile, For IM of Deep SQ Use, Multiple Dose Vial, Manufactured by: CB Inc. for Sunshine Labs, www.sunshinelabs.us.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2141-2014·2014-08-13
Ortho-Clinical Diagnostics Recalls VITROS 5600 Systems Due to Software Error
Ortho-Clinical Diagnostics is recalling VITROS 5600 Integrated Systems because a software anomaly may associate incorrect patient demographics with sample IDs.
Product
VITROS 5600 Integrated System --- For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products Slides, VITROS Chemistry Products MicroTip Reagents and VITROS Immunodiagnostic…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2149-2014·2014-08-13
Siemens ADVIA Centaur CP BNP Kit Recalled for Failed Calibration
Siemens is recalling 1,191 BNP immunoassay kits worldwide due to complaints of failed calibration. The kits are used for in vitro diagnostic testing.
Product
SIEMENS ADVIA Centaur CP Immunoassay System BNP kit; SMN 10309044 - 100 test For in vitro diagnostic use in the quantitative determination of B-type Natriuretic Peptide (BNP) in human plasma using the ADVIA Centaur CP System.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1519-2014·2014-08-13
FDA Recalls Unapproved Vitamin B12 Injections Due to Unregistered Manufacturer
Medical Supply Liquidators LLC is recalling Vitamin B12 Methylcobalamin injections because the manufacturer is not registered with the FDA and the product lacks an approved NDA/ANDA.
Product
Vitamin B12 Methylcobalamin with MIC Injection USP 1000 mcg/ml, Sterile, 10 ml vial and 30 ml vial. For IM or Deep SQ Use, Multiple Dose Vial. Manufactured by: CB Inc. for Sunshine Labs, www.sunshinelabs.us
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2152-2014·2014-08-13
BioMerieux VIDAS TPSA Diagnostic Recalled for Unauthorized Distribution
BioMerieux SA is recalling 1,902 units of VIDAS TPSA in vitro diagnostic tests because the product is not approved or authorized for distribution in the US.
Product
VIDAS TPSA, in vitro diagnostic, for use as an automated quantitative measurement of prostate specific antigen levels in human serum or plasma.
Category
Medical Device
Distribution
9 states
ModerateFDA (Drugs)·D-1520-1014·2014-08-13
FDA Recalls Unapproved Vitamin B12 Injections Due to Unregistered Manufacturer
Medical Supply Liquidators LLC is recalling Vitamin B12 Methylcobalamin Injections because the manufacturer is not registered with the FDA and the product lacks an approved NDA or ANDA.
Product
Vitamin B12 Methylcobalamin Injection USP 1000 mcg/ml, Sterile, 10 ml vial and 30 ml vial. For IM or Deep SQ Use, Multiple Dose Vial, Manufactured by: CB Inc. for Sunshine Labs, www.sunshinelabs.us
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2136-2014·2014-08-13
X Spine Systems Recalls Serrated Soft Tissue Shields for Spinal Surgery
X Spine Systems Inc is recalling Serrated Soft Tissue Shields from the Silex Sacroiliac Fusion System because Revision B is 7 mm longer than the previous design.
Product
Serrated Soft Tissue Shields. Orthopedic surgical instruments, part of the Silex Sacroiliac Fusion System. The soft tissue shields are surgical instrument guides in the Silex Sacroiliac Joint Fusion System for spinal surgery.
Category
Medical Device
Distribution
2 states