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.

6976–7000 of 21595

  • ModerateFDA (Devices)·Z-1782-2020·2020-04-29

    Degania Temperature Sensing Foley Catheters Recalled for Sensor Inspection Failures

    Degania Medical Devices is recalling specific lots of temperature sensing Foley catheters because inadequate inspection practices were used on the thermistor sensors during production.

    Product
    Temperature Sensing 100% Silicone Foley Catheter, Part Number 102201101463MD - Product Usage: is a 3 lumen silicone catheter with a sensor to measure temperature while draining the urinary bladder.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1753-2020·2020-04-29

    Rayner RaySert PLUS Intraocular Lens Injector Recall for Labeling Error

    Rayner Intraocular Lenses Limited is recalling RaySert PLUS RSP01 injectors due to a mismatch between the outer and inner tray expiration dates and lot numbers.

    Product
    RaySert PLUS RSP01. LOT K030. Expiry of 2024-01 - Product Usage: The single use injectors (Model STWOl and Model RSPOl) are intended to be used to compress and insert into the capsular bag only those intraocular lenses that allow the use of these injectors in their approved label
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1250-2020·2020-04-29

    Lupin Recalls 20 mg Lisinopril Tablets Due to Product Mix-Up

    Lupin Pharmaceuticals is recalling 20 mg Lisinopril tablets because 10 mg tablets were found inside sealed 20 mg bottles.

    Product
    Lisinopril Tablets USP, 20 mg, 1000-count bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore MD 21202, Manufactured by: Lupin Limited Pithampur (M.P.) 454 775, India. NDC 68180-0981-03
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1251-2020·2020-04-29

    Yusef Recalls SPF Lip Moisturizers with Excess Oxybenzone

    Yusef Manufacturing is recalling 12,983 tubes of SPF 15 lip moisturizers because they contain up to 150% of the labeled amount of oxybenzone.

    Product
    PEPPERMINT LIP MOISTURIZER (oxybenzone (4%) and Octinoxate (7%) SPF 15, 4.2 g tube, labeled as a) Bimark Inc., bimark.com; b) NOCO TRAIL REPORT, www.NoCoTrailReport.org; c) Herbruck's, d) St. Mark's Outpatient Surgery Center, 1250 East 3900 South Suite 100, Salt Lake City, UT 841
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1742-2020·2020-04-29

    Biomerieux Recalls VITEK 2 Gram-positive Susceptibility Cards Due to False Positives

    Biomerieux Inc is recalling VITEK 2 Gram-positive Susceptibility Cards because they may produce false positive results for certain Staphylococcus aureus strains.

    Product
    The VITEK 2 Gram-positive Susceptibility Card is intended for use with the VITEK 2 Systems in clinical laboratories as an in-vitro test to determine susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae to antimicrobial agents when used as instructed.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1734-2020·2020-04-29

    Boston Scientific Recalls Percuflex Plus Ureteral Stent Sets

    Boston Scientific is recalling 32 Percuflex Plus Ureteral Stent Sets due to increased complaints about difficulty tracking over the guidewire, which may cause procedural delays.

    Product
    Percuflex Plus Ureteral Stent Set 6FX26CM with .038 Sensor UPN: M006175263110
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1762-2020·2020-04-29

    Olympus Pleuravideoscope Recalled Due to Missing Compatibility Data

    Olympus Corporation of the Americas is recalling 265 Pleuravideoscope Model LTF-160 units because data validating compatibility with certain endo-therapy devices was missing.

    Product
    Olympus Pleuravideoscope, Model LTF-160
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1783-2020·2020-04-29

    Degania Temperature Sensing Foley Catheters Recalled for Inspection Failures

    Degania Medical Devices is recalling specific lots of temperature sensing Foley catheters due to inadequate incoming inspection practices for the thermistor sensors.

    Product
    Temperature Sensing 100% Silicone Foley Catheter, Part Number 102201101663MD - Product Usage: is a 3 lumen silicone catheter with a sensor to measure temperature while draining the urinary bladder.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1790-2020·2020-04-29

    CSL Behring Recalls Siemens N Latex CDT Kit for Negative Bias

    CSL Behring GmbH is recalling Siemens N Latex CDT Kits due to negative bias in carbohydrate-deficient transferrin measurements observed after 15 months.

    Product
    Siemens N Latex CDT Kit- IVD quantitative determination of carbohydrate-deficient transferrin (CDT) in human serum. Siemens Material Number (SMN): 10445997
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1743-2020·2020-04-29

    Fentanyl Reagent Kit Recalled for Mislabeling as Clinical Diagnostic

    Carolina Liquid Chemistries Corp is recalling Fentanyl Reagent Kits sold to clinical labs without FDA clearance. The products were mislabeled for diagnostic use but are intended for forensic use only.

    Product
    Fentanyl Reagent Kit, Product N. CC444, Contains: FENT R1 Reagent and FENT R2 Reagent
    Category
    Medical Device
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-1777-2020·2020-04-29

    Medivators Recalls Endo SmartCap Tubing Due to Manufacturing Anomaly

    Medivators is recalling Endo SmartCap Tubing kits due to a manufacturing anomaly that may cause inadequate insufflation, air bubbles, or water leaks during endoscopic procedures.

    Product
    Medivators EndoGator REF 100651. Kit for Olympus 140/160/180/190 Series GI Endoscopes for CO2 Connection with Endogator EGP-100, Olympus OFP, Olympus AFU-100 & Erbe EIP 2 Irrigation Pump Units. Contents 10. Sterile EO. of 100145CO2EXT Endo SmartCap Irrigation Tubing for Ol
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1787-2020·2020-04-29

    Degania Recalls Temperature Sensing Foley Catheters Due to Inspection Failures

    Degania Medical Devices is recalling 9,137 temperature sensing Foley catheters because inadequate incoming inspection practices were used on the thermistor sensors.

    Product
    Temperature Sensing 100% Silicone Foley Catheter, Part Number 102203101463DO - Product Usage: is a 3 lumen silicone catheter with a sensor to measure temperature while draining the urinary bladder.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1749-2020·2020-04-29

    Fresenius 2008T BlueStar Hemodialysis Machines Recalled for USB False Alarm

    Fresenius Medical Care is recalling 15,342 hemodialysis machines because a false alarm may appear when a USB device is connected.

    Product
    Fresenius 2008T BlueStar Hemodialysis Machine Part Number Description: 191124 2008T HD SYS. CDX BLUEST AR; 191126 2008T HD SYS. CDX W/BIBAG BLUEST AR; 191128 2008T HD SYS. W/O CDX BLUEST AR; 191130 2008T HD SYS. W/O CDX W/BIBAG BLUEST AR
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1252-2020·2020-04-29

    Lupin Recalls Cefixime Oral Suspension Due to Low Potency

    Lupin Pharmaceuticals is recalling 4,518 bottles of Cefixime for Oral Suspension because a stability study showed the drug was below the required strength.

    Product
    CEFIXIME — CEFIXIME (CEFIXIME)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1739-2020·2020-04-29

    Boston Scientific Recalls Stretch VL Ureteral Stent Sets Due to Tracking Issues

    Boston Scientific is recalling 40 units of Stretch VL Ureteral Stent Sets because they may be difficult to track over a guidewire, potentially delaying procedures.

    Product
    Stretch VL Ureteral Stent Set 7FX22-30CM with .035 Sensor UPN: M006185157080
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1728-2020·2020-04-29

    Abbott Recalls Architect HAVAB G Reagent Kits Due to Antigen Concentration Error

    Abbott is recalling 7,347 Architect HAVAB G Reagent Kits because an erroneous concentration value was used during manufacture, resulting in a decreased amount of antigen.

    Product
    ARCHITECT HAVAB G Reagent Kit. List Number 6L27 25.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1763-2020·2020-04-29

    Olympus Pleuravideoscope Recalled Due to Compatibility Data Gaps

    Olympus is recalling 265 Pleuravideoscope units because data validating compatibility with certain endo-therapy devices was missing. Updated manuals are being provided.

    Product
    Olympus Pleuravideoscope, Model LTF-240
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1748-2020·2020-04-29

    Fresenius 2008T Hemodialysis Machines Recalled for False USB Alarm

    Fresenius Medical Care is recalling 2008T hemodialysis machines because they may display a false 'Remove USB Device 2' alarm when no USB device is connected.

    Product
    Fresenius 2008T Hemodialysis Machine: Part Number Description 190573 2008T HEMODIAL YSIS SYS. OLC/DIASAFE PLUS; 190713 2008T HEMODIAL YSIS SYS., with CDX; 190766 2008T HEMODIAL YSIS SYSTEM W/BIBAG; 190858 2008T HEMODIAL YSIS SYSTEM WITHOUT CDX; 190895 2008T GEN 2 BIBAG WITH
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1729-2020·2020-04-29

    Boston Scientific Recalls Sensor Nitinol Wire Due to Tracking Issues

    Boston Scientific is recalling Sensor Nitinol Wires with Hydrophilic Tips because an increased rate of complaints indicates difficulty tracking over the guidewire, which may cause procedural delays.

    Product
    Sensor Nitinol Wire with Hydrophilic Tip .035 3CM FLEX STR/150CM UPN: M0066703051 box 5 UPN: M0066703050 single unit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1241-2020·2020-04-22

    Dermatone Sunscreen Recalled for Microbial Contamination

    Filltech USA is recalling Dermatone Sunscreen Lotion due to positive tests for yeast and bacteria.

    Product
    Dermatone (avobenzone, homosalate, octisalate, and octocrylene) Sunscreen Lotion Fragrance Free, SPF 30, package in 1.5 fl. oz. (44 mL) tottles, Distributed By: Beaumont Products, Inc. Kennesaw, GA 30144, UPC 020908422698
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1706-2020·2020-04-22

    Life Technologies Recalls Oncomine Dx Target Test Due to Expiration Date Error

    Life Technologies is recalling 35 units of the Oncomine Dx Target Test because the expiration date was extended prior to clearance.

    Product
    Oncomine Dx Target Test RNA/DNA Panel- IVD for detection of DNA and RNA isolated from non-small cell lung cancer (NSCLC) tumor specimens, Catalog Number: A32441
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1208-2020·2020-04-22

    Naltrexone Suspension Recalled for Lack of Processing Control

    The Medicine Shoppe Pharmacy is recalling Naltrexone 4.5 mg/mL Suspension due to lack of processing control. The product was distributed in Florida.

    Product
    Naltrexone 4.5 mg/mL Suspension 30 mL bottle, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL
    Category
    Drug
    Distribution
    1 state