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.

21201–21225 of 21633

  • ModerateFDA (Devices)·Z-0044-2013·2012-10-17

    IDS-iSYS Intact PINP Assay Recalled for Incorrect IVD Labeling

    Immunodiagnostics Systems Ltd is recalling IDS-iSYS Intact PINP assays because they were labeled for In Vitro Diagnostic use but are not registered for that purpose in the US.

    Product
    IDS-iSYS Intact PINP, Catalog Number IS-4000. Packaged in cardboard Box containing plastic bottles. The IDS-iSYS Intact amino-terminal propeptide of type I procollagen (Intact PINP) assay is intended for the quantitative determination of intact PINP in human serum or plasma on…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0055-2013·2012-10-17

    ICU Medical Recalls 3 Port Off Manifold Due to Component Commingling

    ICU Medical is recalling 60 units of a 3 Port Off Manifold waste system because a 60 drop micro drip chamber may have been included on a 20 drop macro drip set.

    Product
    3 PORT "OFF" MANIFOLD w/WASTE BAG, SYRINGE and DyePod¿, Part Number (Item #) AG8049-NS, Lot # 2528655. K914299. Waste system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0033-2013·2012-10-17

    Beckman Coulter Recalls CYTO-STAT Reagents Due to Labeling Updates

    Beckman Coulter is recalling CYTO-STAT tetraCHROME reagents because stability claims in the product labeling need to be updated to align with current standards.

    Product
    CYTO-STAT tetraCHROME CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5, Part Number 6607013. Allows simultaneous identification and enumeration of total CD3+, total CD4+, total CD8+, dual CD3+/CD4+, dual CD3+/CD8+ and/or total CD3+, CD19+ and CD3+/CD56+ lymphocyte percentages and absolute…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0051-2013·2012-10-17

    Pacific Northwest Tofu Recalls Hot & Spicy Tofu Due to Labeling Error

    Pacific Northwest Tofu, LLC is recalling 10 packages of Hot & Spicy Tofu because the ingredient list is cut off, partially declaring wheat or sesame seed oil.

    Product
    Hot & Spicy Tofu is packaged in a retail vacuum plastic package and each has net wt. 7.5 oz.. The product is sold under the Dae Han Tofu Soya Select brand. Hot & Spicy Tofu has the UPC 0 34199 719191.
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-007-2013·2012-10-17

    Paddock Recalls Moexipril HCl Tablets Due to Dissolution Failure

    Paddock Laboratories is recalling one lot of Moexipril HCl Tablets 7.5mg due to a dissolution failure found during routine stability testing.

    Product
    Moexipril HCl Tablets 7.5mg, 100 tabs, Rx Only, Paddock Laboratories, Inc., Minneapolis, MN 55427, NDC 0574-0110-01 ,
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0042-2013·2012-10-17

    IDS-iSYS Osteocalcin Assay Recalled for Incorrect IVD Labeling

    Immunodiagnostics Systems Ltd is recalling IDS-iSYS N-Mid Osteocalcin assays because they were labeled as In Vitro Diagnostics (IVD) despite not being registered for that use in the US.

    Product
    IDS-iSYS N-Mid¿ Osteocalcin, Catalog Number IS-2900. Packaged in cardboard Box containing plastic bottles. The IDS-iSYS N-Mid¿ Osteocalcin Assay is intended for the quantitative determination of Osteocalcin in human serum or plasma on the IDS-iSYS Multi-Discipline Automated…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-003-2013·2012-10-10

    Caraco Recalls Nimodipine Capsules Due to Crystallization

    Caraco Pharmaceutical Laboratories is recalling Nimodipine Capsules 30 mg because crystals of the drug were found within the capsule solution.

    Product
    Nimodipine Capsules 30 mg, Rx Only, For Institutional Use Only, a) 30-count unit dose Capsules (5x6 blister cards per carton), NDC 57664-135-64, b) 100-count unit dose Capsules (25x4 blister cards per carton), NDC 57664-135-65, Distributed by: Caraco Pharmaceutical…
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0004-2013·2012-10-10

    Cure Medical Recalls M16 Straight-Tip Intermittent Urinary Catheters Due to Labeling Error

    Cure Medical LLC is recalling M16 straight-tip intermittent urinary catheters because some intermediate boxes are mislabeled as M16C coudé-tip catheters.

    Product
    Male, 16Fr, Straight-tip Intermittent Urinary Catheters M16. The product is distributed individually or in intermediate boxes containing 30 individual, sterile packaged catheters (PA/PE film and dialyzing paper pouches). There are 30 catheters packaged in sterile pouches that…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-001-2013·2012-10-10

    McKesson Recalls bupropion Hydrochloride Extended-Release Tablets Due to Dissolution Failure

    McKesson Packaging Services is recalling 187 cartons of bupropion Hydrochloride Extended-Release Tablets, 150 mg, because they failed USP dissolution test requirements.

    Product
    buPROPion Hydrochloride Extended-Release Tablets (XL), 150 mg, UD 100 Tablets (10 x 10) per carton, Rx only, Mfg By: CMIC-VPS Corporation, Cranbury, New Jersey 08512; blister barcode N (01)003 63739 449 10 7, Dist By: McKesson Packaging, Concord, NC 28027; NDC 63739-449-10…
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0003-2013·2012-10-10

    Beckman Coulter Recalls IMMAGE Rheumatoid Factor Reagent Due to False Results

    Beckman Coulter is recalling specific lots of IMMAGE Rheumatoid Factor reagent because they may produce false abnormal results in patient samples.

    Product
    IMMAGE Immunochemistry Systems Rheumatoid Factor (RF) Reagent, PN 447070 The IMMAGE Immunochemistry Systems Rheumatoid Factor (RF) reagent, in conjunction with Beckman Cal 5 Plus, is intended for use in the quantitative determination of human rheumatoid factor concentrations…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0001-2013·2012-10-10

    Synthes MIRS Spinal Fixation Devices Recalled for Labeling Correction

    Synthes is correcting labeling for MIRS spinal fixation devices to emphasize avoiding rod mis-alignment following reported complaints.

    Product
    MIRS for MATRIX Spine System. Minimally Invasive Reduction Screw (MIRS) for percutaneous instrumentation of the thoracolumbar spine. The Synthes USS are non-cervial spinal fixation devices intended for posterior pedicle screw fixation (T1-S2/ilium), posterior hook fixation…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2072-2012·2012-10-10

    Eos Imaging Recalls EOS X-ray Systems Due to Generator Failures

    Eos Imaging Inc is recalling 12 EOS X-ray systems in the US because the anode controller board can fail, causing generator issues.

    Product
    EOS X-ray Medical Diagnostic , X-ray Equipment System Digital Radiography used in general radiographic examination.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2487-2012·2012-10-10

    Stryker Orthopaedics Recalls Cone Body Trials Due to Metal Shavings

    Stryker Howmedica Osteonics Corp. is recalling 10,983 Restoration Modular Cone Body Trials because metal shavings were found in the internal threaded portion.

    Product
    Stryker Orthopaedics Restoration Modular Cone Body Trials Stryker Ireland Carrigtwohill Industrial Estate Carrigtwohill County Cork, Ireland. The Cone Body Trials simulate the respective Cone Body implants and mate with the stem trials to assist the surgeon in assessing…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0005-2013·2012-10-10

    Animas Insulin Pumps Recalled for Keypad Wear and Peeling

    Animas Corporation is recalling insulin pumps due to keypad wear that may cause tearing or peeling. The recall covers 236,470 units distributed worldwide.

    Product
    IR1200, IR1250(IR1200 Plus), 2020 and One Touch(R) Ping(R) Insulin Pump glucose management system. The device is intended to deliver insulin therapy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0007-2013·2012-10-10

    Invuity Recalls Obsolete BriteField Illuminated Suction Devices

    Invuity is recalling 197 obsolete BriteField Illuminated Suction Devices nationwide. The devices were not distributed after March 2011.

    Product
    BriteField illuminated Suction Device; Model numbers 8Fr, 10Fr and 12Fr, Kit (included 8Fr, 10Fr and 12Fr and a sterilization tray. The Invuity Brite Field Illuminated Suction Device is intended to aspirate from the surgical site and to provide illumination from a high…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0002-2013·2012-10-10

    Beckman Coulter PrepPlus Recalled for Reagent Level Sense Failures

    Beckman Coulter is recalling the PrepPlus pipetting system because it may fail to warn users when reagent levels are low or out.

    Product
    COULTER PrepPlus, Part Number: 286600 Product Usage: The COULTER PrepPlus, is a microprocessor-controlled pipetting and diluting system, designed for automating sample preparation or assay methods. It is capable of aspirating and dispensing liquid samples.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0010-2013·2012-10-10

    C.R. Bard Recalls Pediatric Foley Catheters with Incorrect Valve Cap Labeling

    C.R. Bard is recalling 4,032 units of 8 Fr. Bardex Pediatric All-Silicone Foley Catheters because the valve cap displays an incorrect inflation volume of 10 ml instead of 5 ml.

    Product
    8 Fr. Bardex Pediatric All-Silicone Foley Catheter with a 3cc balloon. The product is packaged individually with 12 units per corrugated case. The product is sold sterile for single use and is used to provide continuous urinary drainage from the bladder.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2447-2012·2012-10-03

    Applied Medical Recalls Biliary Catheters Due to Packaging Particulate Matter

    Applied Medical is recalling specific lots of biliary catheters because packaging particulate matter may reside on the product.

    Product
    Biliary Catheters (Models A47XX and CB0XXXXX): Model Numbers & Description: A4752, SYNTEL BILIARY 5F-23CM CATHETER; A4754, SYNTEL BILIARY 5F-40CM CATHETER; A4762, SYNTEL BILIARY 6F-23CM CATHETER; CB052308, SYNTEL BILIARY 5F-23CM CATH; CB054008, SYNTEL BILIARY 5F-40CM…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2455-2012·2012-10-03

    ConMed Linvatec Recalls Xenon Light Sources for Endoscopic Procedures

    ConMed Linvatec is recalling LS7700 and LS7600 Xenon Light Sources used to illuminate endoscopes during medical procedures.

    Product
    ***REF LS7600***Qty 1*** EC REP*** ConMed Linvatec Xenon Light Source
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2434-2012·2012-10-03

    Pulmuone Wildwood Organic Mild Salsa Recalled for Premature Spoilage

    Pulmuone Wildwood Inc. is recalling 21,841 units of Wildwood Emerald Valley Kitchen Organic Mild Salsa due to a non-safety quality concern causing premature spoilage.

    Product
    Wildwood Emerald Valley Kitchen Organic Mild Salsa, 14 oz. Pack size 6/14 oz per case. Packaged in plastic cup, sealed with film and capped with plastic cap. Product labeling reads in part:" WILDWOOD Emerald Valley KITCHEN ORGANIC MILD SALSA***NET WT. 14 OZ (850g)***MANUFACTURED…
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2452-2012·2012-10-03

    Hologic Fluoroscan Mini C-Arm Recalled for Flipped DICOM Images

    Hologic is recalling Fluoroscan Mini C-Arm devices with InSight2 software versions 4.0 and 4.0.1 because DICOM images stored in PACS may be flipped 180 degrees.

    Product
    Hologic Fluoroscan Mini C-Arm Model with InSight2, Software version 4.0 and 4.0.1 The device is a Mini C-arm Fluoroscopic Imaging System designed to provide -physicians with general fluoroscopic visualization of a patient, including but not limited to surgical orthopedic and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2458-2012·2012-10-03

    Integra Limited Recalls Mayfield Horseshoe Gel Pads Due to Packaging Error

    Integra Limited is recalling Mayfield Horseshoe Gel Pads because left and right pads were incorrectly packaged. No patient injuries or surgical delays were reported.

    Product
    The MAYFIELD¿ Horseshoe Gel Pads are used in conjunction with the MAYFIELD¿ Base Units and MAYFIELD¿ Swivel Adaptors for neurosurgeries in the prone or supine positions. Those devices provide cranial stability and immobility for various craniotomies and spinal procedures. The…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2442-2012·2012-10-03

    Cordis Recalls Sleek OTW PTA Catheters Due to Incorrect Labeling

    Cordis Corporation is recalling specific lots of Sleek OTW PTA Dilatation Catheters because the products are incorrectly labeled.

    Product
    Sleek ***OTW ***Ref ***426-1501X***Inflated Balloon Dia/mm 1.5 Inflated Balloon Length/mm 15 Usable Catheter Length/cm 150***Lot 50026688***2013-09***Cordis***PTA Dilatation Catheter***Cordis***Johnson Johnson Company***Sterile***EO***Method of Sterilization…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Food)·F-2436-2012·2012-10-03

    Pulmuone Wildwood Organic Medium Salsa Recalled for Premature Spoilage

    Pulmuone Wildwood Inc. is recalling 575 units of Wildwood Emerald Valley Kitchen Organic Medium Salsa due to a potential non-safety quality concern causing premature spoilage.

    Product
    Wildwood Emerald Valley Kitchen Organic Medium Salsa - Canada (containing French in labeling), 397 mL. Pack size 6/14 oz per case. Packaged in plastic cup, sealed with film and capped with plastic cap. Product labeling reads in part:" WILDWOOD Emerald Valley KITCHEN ORGANIC…
    Category
    Food
    Distribution
    Distributed nationwide