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.

18401–18425 of 21645

  • ModerateFDA (Devices)·Z-1622-2014·2014-05-28

    Siemens syngo Imaging XS Software Recall Due to Data Deletion Risk

    Siemens Medical Solutions is recalling 64 syngo Imaging XS systems because a software change may have caused the deletion of archived medical images.

    Product
    syngo Imaging XS Syngo Imaging XS is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images. It supports the physician in diagnosis and treatment planning. Syngo Imaging…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1927-2014·2014-05-28

    Verdex Fresh Snow Peas Recalled for Unapproved Fungicide Residue

    Harvest Sensations LLC is recalling Verdex Fresh Snow Peas due to unapproved fungicide residue detected in a random sample.

    Product
    Verdex Fresh Snow Peas packed in 10 pounds cartons, keep refrigerated, Lot # 2161100811 product from Guatemala
    Category
    Food
    Distribution
    16 states
  • ModerateFDA (Food)·F-1952-2014·2014-05-28

    Meijer Baby Pediatric Electrolyte Drinks Recalled for Seal Defect

    H:20 Innovations is recalling Meijer Baby Pediatric Electrolyte Fruit and Strawberry Flavor drinks due to a seal defect identified during a complaint investigation.

    Product
    Meijer Baby Pediatric Electrolyte Fruit Flavor 8oz x 4 with Best by: 10/01/15; 24 bottles per case, 6-4packs
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1629-2014·2014-05-28

    Anspach Irrigation Clip 40 Recalled Due to Incorrect Assembly

    The Anspach Effort, Inc. is recalling 150 Anspach Irrigation Clip 40 units because they were assembled with incorrect, smaller clips.

    Product
    Anspach Irrigation Clip 40 Product Usage: Irrigation clips provide a method of supplying controlled, cooling irrigation during cutting, shaping, and removal of bone, including bones of the skull and spine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1631-2014·2014-05-28

    SCM True Air Technologies Recalls ECATS E 850 Bariatric Beds

    SCM True Air Technologies is recalling 48 ECATS E 850 Bariatric Beds due to manufacturing documentation and vendor approval failures.

    Product
    ECATS E 850 Bariatric Bed, True Air Technologies, Inc.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1571-2014·2014-05-21

    Codman MedStream Infusion Pump Recall for Low Battery Alarm Issue

    Codman & Shurtleff is recalling 90 MedStream Programmable Infusion Pumps because a small number may trigger a low battery alarm at the beginning of the implanted life.

    Product
    MedStream Programmable Infusion Pump, 20 mL, Product Code: 91-4200 The MedStream programmable pump is intended for the intrathecal delivery of Baclofen in the US market and for the intrathecal delivery of Morphine or Baclofen in the EMEA market.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D1292-2014·2014-05-21

    Teva Recalls Methyldopa Tablets Due to Manufacturing Deviations

    Teva Pharmaceuticals USA is recalling Methyldopa Tablets USP, 500 mg, due to CGMP deviations and laboratory testing not following GMP requirements.

    Product
    METHYLDOPA Tablets USP, 500 mg, 100 count bottle, Rx only, Manufactured In INDIA By: EMCURE PHARMACEUTICALS LTD harmaceuticals Ltd., Hinjwadi, Pune, India, Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960, NDC 0093-2932-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1610-2014·2014-05-21

    Ortho Development Recalls PS-C Femoral Knee Implant Components

    Ortho Development Corporation is recalling five PS-C Femoral Nonporous Rt Sz 6 knee implant components because pegged versions were found in boxes labeled for the pegless version.

    Product
    PS-C Femoral Nonporous Rt Sz 6, Model Number 161-1604 Component of the Balanced Knee System and Balanced Knee Revision System, for total knee arthroplasty procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1944-2014·2014-05-21

    Kaija Ivasi Herring Fillets Recalled for Salt Standard Violation

    Zip International Group LLC is recalling Kaija Ivasi Lightly Salted Herring Fillets in Oil because the product does not meet the required water phase salt standard for processed fish.

    Product
    Kaija Ivasi Lightly Salted Herring Fillets in Oil UPC 3585600709
    Category
    Food
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1572-2014·2014-05-21

    Codman MedStream Infusion Pump Recall for Low Battery Alarm Issue

    Codman & Shurtleff is recalling 34 MedStream Programmable Infusion Pumps because they may trigger a low battery alarm at the beginning of the implanted life.

    Product
    MedStream Programmable Infusion Pump, 40 mL, Product Code: 91-4201 The MedStream programmable pump is intended for the intrathecal delivery of Baclofen in the US market and for the intrathecal delivery of Morphine or Baclofen in the EMEA market.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1576-2014·2014-05-21

    FDA Recalls Unapproved Enaly 1000 BT-12 Ozone Generator for Medical Use

    William C. Domb, D.M.D., A Professional Corporation is recalling 16 units of the Enaly 1000 BT-12 Ozone Generator because the device is not approved or cleared by the FDA for medical use.

    Product
    Enaly 1000 BT-12 Ozone Generator, Model # 1000BT-12 The 1000BT-12 ozone generator is capable of delivering up to 1gram of ozone per hour from pure oxygen. The 1000BT-12 ozone generator is designed to continuously generate ozone by corona discharge. The conversion of oxygen to…
    Category
    Medical Device
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-1611-2014·2014-05-21

    Mindray DPM 6 Patient Monitor Recalled for Uncleared ST/Arrhythmia Feature

    Mindray DS USA is recalling four DPM 6 patient monitors in Ohio because the included Multi Parameter Module contains a cardiac ST/Arrhythmia analysis feature that is not cleared for marketing.

    Product
    DPM 6 Monitor in use with a Multi Parameter Module (MPM). Patient monitor used for monitoring, displaying, reviewing, storing, and alarming of multiple physiological parameters including ECG, arrhythmia detection, ST segment analysis, heart rate (HR), respiration rate (RESP)…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1614-2014·2014-05-21

    Greatbatch Recalls Coaxial Micro-Introducer Kits Due to Shelf Life Documentation Issues

    Greatbatch Medical is recalling Coaxial Micro-Introducer Kits because documentation does not support the claimed five-year shelf life.

    Product
    Coaxial Micro-Introducer Kit. Greatbatch Part Number/Bard Access Systems Order Number/Part Description 10636-001 8004011 Kit Coax 10 Pack 4FR Bard 10636-002 8005011 Kit Coax 10 Pack 5FR Bard 10636-007 8004012 Kit Coax 10 Pack 4FR Bard 10636-008 8005012 Kit…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1574-2014·2014-05-21

    Anspach Cutting Bur Recall Due to Incorrect Product Code Labeling

    The Anspach Effort, Inc. is recalling 30 Anspach Cutting Burs (REF L-3SD) because the product code S-3SD was included, which is shorter than the labeled product.

    Product
    ANSPACH Cutting bur, 3 mm Diamond Ball, Standard Length. REF L-3SD Use with LONG Attachments. Used for cutting and shaping bone, including the spine and cranium.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1323-2014·2014-05-21

    First Aid Only Recalls Ibuprofen Dispenser Boxes Containing Aspirin

    First Aid Only is recalling Smart Tab First Aid ezRefill System Ibuprofen boxes that were accidentally filled with aspirin packs.

    Product
    Smart Tab First Aid ezRefill System Ibuprofen dispenser boxes (Item Number FAE 7014), 20 count boxes, First Aid Only Inc., Vancouver, WA
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1316-2014·2014-05-21

    Flawless Beauty LLC Recalls Laroscorbine Platinium Injectable Solution

    Flawless Beauty LLC is recalling Laroscorbine Platinium injectable solution because it was marketed without an approved NDA/ANDA and includes drug claims to act as an antidote.

    Product
    Laroscorbine Platinium (vitamin C/collagen) injectable I.V. solution, 1 gm/0.35 gm, 5 mL ampoules, packaged in 10-count ampoules per box, Laboratories Roche Nicholas S.A., F-74240 Gaillard, - Tel.: 04 50 87 70 70, Fabricant : Produits Roche, 52, Bld du Parc, 92521 Neulilly…
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1617-2014·2014-05-21

    McKesson Radiology-PACS software recall for missing high-priority alert icon

    McKesson Medical Imaging is recalling 45 units of McKesson Radiology-PACS software because the high-priority alert icon was not displayed when no Stat studies were present.

    Product
    McKesson Radiology-PACS. McKesson Radiology is a medical image and information application that is intended to receive, transmit, store, retrieve, display, print and process digital medical images, digital medical video, and associated medical information from various medical…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1294-2014·2014-05-21

    Teva Recalls Indomethacin Capsules Due to Manufacturing Quality Deviations

    Teva Pharmaceuticals USA is recalling 7,694 bottles of Indomethacin Capsules USP, 25 mg, due to CGMP deviations and laboratory testing failures.

    Product
    INDOMETHACIN Capsules USP, 25 mg 100 count bottle, Rx only , Manufactured In INDIA By: EMCURE PHARMACEUTICALS LTD harmaceuticals Ltd., Hinjwadi, Pune, India, Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960, NDC 0093-4029-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1295-2014·2014-05-21

    Teva Recalls Indomethacin Capsules Due to Manufacturing Quality Deviations

    Teva Pharmaceuticals USA is recalling Indomethacin Capsules USP, 50 mg, because laboratory testing was not conducted in accordance with Good Manufacturing Practice (GMP) requirements.

    Product
    INDOMETHACIN Capsules USP, 50 mg, a) 100 count bottle, (NDC 0093-4030-01), b) 500 count bottle, (NDC 0093-4030-05), Manufactured In INDIA By: EMCURE PHARMACEUTICALS LTD harmaceuticals Ltd., Hinjwadi, Pune, India, Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1293-2014·2014-05-21

    Teva Recalls Glyburide and Metformin Tablets Due to GMP Deviations

    Teva Pharmaceuticals USA is recalling specific bottles of Glyburide and Metformin Hydrochloride tablets due to laboratory testing deviations from GMP requirements.

    Product
    GLYBURIDE and METFORMIN HYDROCHLORIDE Tablets USP, 5mg/500mg, 500 count bottle, Manufactured In INDIA By: EMCURE PHARMACEUTICALS LTD harmaceuticals Ltd., Hinjwadi, Pune, India, Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960, NDC: 0093-5712-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateUSDA FSIS·029-2014·2014-05-16

    Transatlantic Foods Recalls Pork Products Due to Misbranding

    Transatlantic Foods is recalling 449,000 pounds of pork products because labels falsely claimed the items contained no antibiotics.

    Product
    Recall Notification Report 029-2014 (Pork Products)
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1307-2014·2014-05-14

    Mangiacotti Pomegranate Hand Sanitizer Recalled for Bacterial Contamination

    Mangiacotti is recalling Pomegranate Hand Sanitizer Spray due to elevated counts of Serratia liquefaciens bacteria.

    Product
    Mangiacotti - Pomegranate Hand Sanitizer Spray, alcohol free, 0.5 fl Oz. 15 mL spray bottle, UPC 870678005344, Active Ingredient Benzalkonium Chloride 0.1%, Dist By: Mangiacotti, Attleboro, MA 02703.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1563-2014·2014-05-14

    Mar Cor Purification Recalls Central Water Platform Reverse Osmosis Systems

    Mar Cor Purification is recalling 197 Central Water Platform (CWP) reverse osmosis systems because a specific lot of water inlet solenoid valves may fail, stopping water production.

    Product
    Mar Cor Purification, Central Water Platform (CWP), 102, 104 and 106. Product Usage: The CWP is a Central reverse osmosis system with the intended use of producing water for dialysis of multiple patients.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1554-2014·2014-05-14

    Bausch & Lomb Recalls Biotrue Multi-Purpose Contact Lens Solution

    Bausch & Lomb is recalling Biotrue Multi-Purpose Contact Lens Solution due to out-of-specification results for a disinfectant.

    Product
    Bausch & Lomb, Biotrue, Multi-purpose contact lens solution, 10 fl.oz., Sterile.
    Category
    Medical Device
    Distribution
    Distributed nationwide