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.

20826–20850 of 21633

ModerateFDA (Drugs)·D-139-2013·2013-02-06
Schering-Plough Recalls Temodar Capsules Due to Degradation Testing Failures
Schering-Plough is recalling 17,169 packages of Temodar (temozolomide) 20 mg capsules due to out-of-specification degradation product testing results.
Product
Temodar (temozolomide) Capsule, 20 mg per capsule, 5 capsules per package, For Oral Administration, Rx Only, Cytotoxic, NDC: 0085-1519-02, Schering Corporation, Kenilworth, New Jersey, 07033
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0702-2013·2013-02-06
Philips Juno DRF X-ray System Recalled for Display Compliance Issues
Philips Healthcare is recalling 16 Juno DRF X-ray systems because fluoroscopy dose values may not display correctly at the operator's position.
Product
Juno DRF , X-ray system, diagnostic, Fluoroscopic, general-purpose Model: 70920 Product Usage: Universal R/F, general use
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0755-2013·2013-02-06
Ortho VITROS Vapor Adsorption Cartridges Recalled for Incorrect Packaging
Ortho-Clinical Diagnostics is recalling VITROS Vapor Adsorption Cartridges because some cartons incorrectly contain Particulate Cartridges, which may bias test results.
Product
Ortho Clinical Diagnostics VITROS¿ Chemistry Products Vapor Adsorption Cartridge REF/CAT No. 680 0100. VITROS¿ Vapor Adsorption Cartridges are used to remove vapor contaminants that may potentially interfere with Signal Reagent used with MicroWell Assays on the VITROS¿ 3600…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-133-2013·2013-01-30
West-ward Recalls Prednisone Tablets Due to Foreign Substance Presence
West-ward Pharmaceutical Corp. is recalling PredniSONE Tablets, USP, 20 mg, due to the presence of foreign substances including stainless steel inclusions.
Product
PredniSONE Tablets, USP, 20 mg, packaged in a) 100-count tablets per bottle (NDC 0143-1477-01), b) 500-count tablets per bottle (NDC 0143-1477-05), and c) 1000-count tablets per bottle (NDC 0143-1477-10), Rx only, Manufactured by: West-ward Pharmaceutical Corp., Eatowntown, NJ…
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0718-2013·2013-01-30
ConMed Recalls Disposable Hyfrecator Electrodes Due to Compromised Sterile Seals
ConMed is recalling 313,190 disposable Hyfrecator electrodes because some sterile pouch seals were compromised. No illnesses or injuries have been reported.
Product
ELECTROLASE(R) HYFRECATOR(R) ELECTRODES - SHARP, Disposable Hyfrecator(R) Tips, REF/Catalog No. 7-100-8CS, Sterile, Rx ONLY -- CONMED CORPORATION Electrosurgical, Cutting and Coagulation and Accessories.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0717-2013·2013-01-30
Ansell Recalls Lifestyles Condoms Due to Mislabeling of Ultra Thin Style
Ansell Healthcare Products LLC is recalling one lot of Lifestyles Pleasure Collection condoms because Ultra Thin condoms were included instead of the labeled Skyn style.
Product
Lifestyles Pleasure Collection 30 Premium Lubricated Condoms Assortment of Ultra Sensitive, Flavors and Colors, Skyn, Thryll, Thyn, and Ultra Thin. UPC 0-70907-02625-0.
Category
Medical Device
Distribution
Distributed nationwide
ModerateNHTSA·13V034000·2013-01-30
Wilson Livestock Trailer Recall for Lift Deck Guide Failure
Wilson Trailer Company is recalling 2007-2013 livestock trailers because plastic deck guides may fail, allowing the lift deck to shift and fall.
Product
WILSON — WILSON LIVESTOCK TRAILER
Category
Vehicle
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0726-2013·2013-01-30
ConMed Recalls Electrosurgical Safety Holsters Due to Compromised Sterile Seals
ConMed is recalling 313,190 electrosurgical safety holsters because some sterile pouch seals were compromised. No illnesses or injuries have been reported.
Product
CONMED(R) ELECTROSURGICAL SAFETY HOLSTER, Disposable Safety Holster, REF/Catalog No. 137668, Sterile, Rx ONLY -- CONMED CORPORATION Electrosurgical, Cutting and Coagulation and Accessories.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0727-2013·2013-01-30
ConMed Recalls Electrosurgical ENT Needle Electrodes Due to Compromised Sterile Seals
ConMed is recalling 313,190 electrosurgical ENT needle electrodes because some sterile pouch seals were compromised. No illnesses or injuries have been reported.
Product
ELECTROSURGICAL ENT NEEDLE ELECTRODE, 6 inch with Extended Insulation, REF/Catalog No. 138025, Single Use, Sterile, Rx ONLY -- CONMED CORPORATION Electrosurgical, Cutting and Coagulation and Accessories.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0716-2013·2013-01-30
Abbott i-Stat cTnI Cartridges Recalled for Incorrect Barcode
Abbott Point of Care Canada Limited is recalling 10 boxes of i-Stat cTnI cartridges from lot P12179 due to incorrect barcodes on the cartridge portion pack.
Product
Abbott Point of Care i-Stat cTnI cartridge. The i-Stat cardiac troponin I (cTnI) test is an in vitro diagnostic test for the quantitive measurement of cardiac troponin I (cTnI) in whole blood or plasma. Measurements of cardiac troponin I are used in the diagnosis and…
Category
Medical Device
Distribution
0 states
ModerateFDA (Food)·F-0924-2013·2013-01-30
Pepsi Wild Cherry Recall Due to Swapped Labels
Pepsi Cola North America is recalling Regular and Diet Wild Cherry Pepsi two-liter bottles because labels were swapped during production, posing a risk to individuals with phenylketonuria or diabetes.
Product
Regular Wild Cherry Pepsi two liter plastic bottles UPC 1231100
Category
Food
Distribution
5 states
ModerateFDA (Devices)·Z-0723-2013·2013-01-30
ConMed Recalls Goldvac UltraClean Accessory Electrode Due to Seal Compromise
ConMed is recalling Goldvac UltraClean Accessory Electrodes because some sterile pouch seals were compromised. No illnesses or injuries have been reported.
Product
Goldvac(TM) UltraClean(R) Accessory Electrode 6 inch Coated Blade, REF/Catalog No. 60-7526-001, Sterile, Rx ONLY -- CONMED CORPORATION Electrosurgical, Cutting and Coagulation and Accessories.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0701-2013·2013-01-30
BD MAX Clinical Diagnostic Instruments Recalled for Minor Defects
Becton Dickinson is recalling 86 BD MAX clinical diagnostic instruments because minor defects may cause erroneous test results.
Product
Becton, Dickinson and Company, BD MAX (tm) (6 channel) Instruments, Catalog number 441916, clinical diagnostic instrument.
Category
Medical Device
Distribution
12 states
ModerateFDA (Devices)·Z-0731-2013·2013-01-30
ConMed Recalls UltraClean Accessory Electrode Due to Compromised Sterile Seals
ConMed is recalling UltraClean Accessory Electrodes because some sterile pouch seals were compromised. No illnesses or injuries have been reported.
Product
UltraClean(R) Accessory Electrode 1 inch Coated Blade with Extended Insulation, REF/Catalog No. 139104EXT, Single Use, Sterile, Rx ONLY -- CONMED CORPORATION 525 Electrosurgical, Cutting and Coagulation and Accessories.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0715-2013·2013-01-30
Medisystems 17 Gauge AV Fistula Needles Recalled for Mislabeling
Medisystems is recalling 17 Gauge AV Fistula Needles because single needle packs are mislabeled as 15 Gauge. The recall covers 4,000 needles distributed in New York, Pennsylvania, and Tennessee.
Product
Medisystems 17 Gauge x 1" inch AV Fistula Needle Product Code: D9-2007MGLB Product Usage: Medisystems AVF with MasterGuard anti-stick needle protector is indicated for use as a vascular access device in hemodialysis or other extracorporeal procedures. It is intended for use…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0735-2013·2013-01-30
ConMed Recalls UltraClean Accessory Electrodes Due to Compromised Sterile Seals
ConMed is recalling 313,190 UltraClean Accessory Electrodes because some sterile pouch seals were compromised. No illnesses or injuries have been reported.
Product
UltraClean(R) Accessory Electrode 6 inch Coated Blade with Extended Insulation, REF/Catalog No. 139110EXT, Single Use, Sterile, Rx ONLY -- CONMED CORPORATION Electrosurgical, Cutting and Coagulation and Accessories.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0696-2013·2013-01-30
Roche COBAS INTEGRA 400 Analyzer Recalled for Software Security Issue
Roche is recalling COBAS INTEGRA 400 analyzers due to a security vulnerability in the Oracle TNS-Listener component that could allow unauthorized database access.
Product
Roche COBAS INTEGRA 400 and 400 plus Analyzer, an in vitro diagnostic analyzer.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0700-2013·2013-01-30
AMS GreenLight HPS and XPS Surgical Lasers Recalled for Electrical Non-Conformance
AMS Innovative Center is recalling 389 GreenLight HPS and XPS surgical laser systems because the Voltage Scaling Board failed to meet IEC 60601-1-2 electrical safety standards.
Product
GreenLight HPS (High Performance System) GreenLight XPS (Xcelerated Performance System) Manufactured by AMS, Solutions for Life Innovation Center. GreenLight HPS and XPS Surgical Lasers Systems and accessories are intended for use in endoscopic 532 nm laser resection of…
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0719-2013·2013-01-30
ConMed Recalls Disposable Hyfrecator Electrodes Due to Compromised Sterile Seals
ConMed is recalling 313,190 disposable Hyfrecator electrodes because some sterile pouch seals were compromised. No illnesses or injuries have been reported.
Product
ELECTROLASE(R) HYFRECATOR(R) ELECTRODES - BLUNT, Disposable Hyfrecator(R) Tips, REF/Catalog No. 7-101-8CS, Sterile, Rx ONLY -- CONMED CORPORATION Electrosurgical, Cutting and Coagulation and Accessories.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Food)·F-0916-2013·2013-01-30
Cardinal Health Recalls Dairy Aid Lactase Caplets Due to Labeling Error
Cardinal Health is recalling specific lots of Dairy Aid Lactase Enzyme Supplement caplets because the packaging incorrectly lists the strength as 9,000 FCC Units instead of 3,000 FCC Units.
Product
Dairy Aid Lactase Enzyme Supplement, Caplet, 3,000 FCC Units, 60 caplets, OTC, Repackaged by: Cardinal Health, Zanesville, OH 43701, NDC 55154-1335-4
Category
Drug
Distribution
2 states
ModerateFDA (Devices)·Z-0699-2013·2013-01-30
Becton Dickinson Recalls BBL Crystal Enteric/Nonfermenter ID Kits
Becton Dickinson is recalling BBL Crystal Enteric/Nonfermenter ID Kits because reversed reagent positions may cause bacteria misidentification.
Product
Becton, Dickinson and Company, BBL Crystal Enteric/Nonfermenter ID Kit, Catalog # 24500, cartons of 20 kits, In-vitro diagnostic reagents for microbiological testing. The BBL Crystal Enteric/Nonfermentor (E/NF) identification (ID) System is for the identification of aerobic…
Category
Medical Device
Distribution
14 states
ModerateFDA (Devices)·Z-0714-2013·2013-01-30
Medisystems Buttonhole Needle Set Recalled for Mislabeled Length
Medisystems is recalling 5 mislabeled buttonhole needle pouches that were labeled as 15 Ga x 1 inch instead of 15 Ga x 3/5 inch.
Product
Medisystems 15 Gauge x 3/5 inch Buttonhole Needle Set Product Code: BH-2035PE Product Usage: Medisystems Buttonhole Needle Sets are indicated for use as an access device for dialysis and pheresis procedures using a constant site orbuttonhole method of needle insertion.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Food)·F-0884-2013·2013-01-23
S & M International Recalls Preserved Duck Eggs for pH Standard Violation
S & M International Inc is recalling 855 cases of Yangsheng Preserved Duck Eggs because they do not meet the required pH standard for preserved eggs.
Product
Yangsheng Eggs Preserved Duck Eggs Content 6 pcs Net Wt: approx 12.69 oz (360g) S&amp;amp;amp;amp;amp;amp; M (USA) Enterprise Corp Rm3 8/F., Yuexiu Bldg., 160-174 Lockhart Road, Wan Chai, HK Distributed by : S &amp;amp;amp;amp;amp;amp; M Int'l Inc 100 Pulaski ST.…
Category
Food
Distribution
5 states
ModerateFDA (Devices)·Z-0688-2013·2013-01-23
Perkinelmer Recalls Neonatal Total Galactose Kits Due to Defective Microplate Wells
Perkinelmer is recalling Neonatal Total Galactose Kits because the microplate wells used in the assays are defective, which may affect the accuracy of newborn screening results.
Product
NEONATAL TOTAL GALACTOSE KIT Product Numbers: 3029-0010, 3029-001B. This kit is intended for the quantitative determination of total galactose (galactose and galactose-1-phosphate) concentrations in blood specimens dried on filter paper…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0691-2013·2013-01-23
Quanta System Q-Plus T Laser Recall for Promotional Material Labeling
Quanta System is recalling 75 Q-Plus T laser units because promotional materials on their website did not specify that certain claims did not apply to U.S. distributed devices.
Product
Q-Plus T Powered Laser Surgical Instrument Nd:YAG 1064 nm and 532 nm: Treatment of vascular lesions and pigmented lesions; Hair and tattoo removal; The incision, excision, ablation, vaporization of soft tissue for general dermatology. Ruby 694nm: Cutting, vaporization and…
Category
Medical Device
Distribution
4 states