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.

21126–21150 of 21633

  • ModerateFDA (Devices)·Z-0234-2013·2012-11-14

    Zimmer Recalls 18 CLS Stem Implants Due to Labeling Discrepancies

    Zimmer Inc. is correcting patient labels for 18 CLS Stem implants manufactured before March 2010 due to discrepancies in reference and lot numbers.

    Product
    CLS Stem
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0256-2013·2012-11-14

    Sysmex XE-2100C Hematology System Recalled for Reticulocyte Count Bias

    Sysmex America is recalling 69 XE-2100C automated hematology systems because reticulocyte counts may be 21% lower than expected.

    Product
    Sysmex XE-2100C Automated Hematology System; an automated differential cell counter; Sysmex Corporation, Kobe, Japan; Sysmex America, One Nelson C. White Parkway, Mundelein, IL 60060; catalog #053-2311-4 The Sysmex XE-2100C is an automated hematology analyzer for in vitro…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0168-2013·2012-11-07

    Alphatec Spine Recalls Illico MIS Posterior Fixation System Screws

    Alphatec Spine is recalling 209 Illico MIS Posterior Fixation System screws because a guide-wire fit issue renders them nonfunctional.

    Product
    ILLlCO¿ MIS Posterior Fixation System, Bone-screw Internal Spinal Fixation System, Orthosis, Spinal Pedical Fixation Orthosis, Spondylolisthesis Spinal Fixation The ILLICO MIS Posterior Fixation System is intended to facilitate the surgical correction of noncervical…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0184-2013·2012-11-07

    Wright Medical Recalls Knee Components Due to Shelf Life Labeling Errors

    Wright Medical Technology Inc is recalling 729 knee components due to potential inaccuracies in labeled shelf life at the Toulon, France facility.

    Product
    Knee Components: ROTULE "913" D=32 , Part Number PGA00030, Lot Number X02383380 INSERT TIBIAL "913 PCR" T.1 - EP.10-, PGA00050, Lot Numbers: V11272719, W02300988, W09372781, W09372781, and W10372876 INSERT TIBIAL "913 PCR" T.1 - EP.14-, PGA00054, Lot Number: V0266952…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0183-2013·2012-11-07

    Wright Medical Recalls Hip Components Due to Potential Shelf Life Labeling Errors

    Wright Medical Technology Inc. is recalling 31,566 hip implant components distributed worldwide due to potential inaccuracies in labeled shelf life.

    Product
    Hip Components: INSERT MOBILE "COLLEGIA" TAILLE 58*28, OT22C58, Lot Numbers: W07335080 and X06391225 INSERT MOBILE "COLLEGIA" TAILLE 60*28, OT22C60, Lot Number: X06391226 TETE INOX "COLLEGIA" T 28/0 CONE 6 DEG. -N30NW-, OT32H28, Lot Numbers: 068573172 and X03396534…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0185-2013·2012-11-07

    Wright Medical Recalls Extremity Components Due to Shelf Life Labeling Errors

    Wright Medical Technology Inc. is recalling 840 units of orthopaedic extremity components because the labeled shelf life may be inaccurate for products packaged in Toulon, France.

    Product
    Extremity Components: PROTHESE A EXPANSION COMPLETE D=6 LG 12 MM, Part Number PPO90000, Lot Numbers: U11113596, W12372884, W12376849, X01383482, X06391313, X07401148, X07401445, and X09418985 PROTHESE A EXPANSION COMPLETE D=8 LG 15 MM, Part Number PPO90100, Lot Number…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0164-2013·2012-11-07

    ConMed Linvatec Recalls Mis-assembled CrossFT Punches for Suture Anchor Insertion

    ConMed Linvatec is recalling 2 units of CrossFT Punches (Lot 330889) because they were mis-assembled with the incorrect handle.

    Product
    "***All in one CrossFT***Punch***PFT-00M***4.5mm to 6.5mm***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA***" To create pathway for insertion of CrossFT Suture Anchor into bone.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-035-2013·2012-11-07

    Target UP & UP Kids Foaming Hand Sanitizer Recalled for Microbial Contamination

    DermaCare is recalling 43,272 bottles of UP & UP brand kids' foaming hand sanitizer due to high microbial counts.

    Product
    UP & UP brand, kid's foaming hand sanitizer, alcohol free, 99.9% effective against germs, Sweet s'melon, 6.7FL oz (200mL), Distributed by Target Corp., Minneapollis, MN 55403
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-034-2013·2012-11-07

    Target UP & UP Kids Foaming Hand Sanitizer Recalled for Microbial Contamination

    DermaCare is recalling UP & UP brand kids' foaming hand sanitizer sold at Target due to laboratory findings of high total plate count above specification.

    Product
    UP & UP brand, kid's foaming hand sanitizer, alcohol free, 99.9% effective against germs, Apple-cleani, 6.7FL oz (200mL), Distributed by Target Corp., Minneapollis, MN 55403
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-036-2013·2012-11-07

    Ben Venue Recalls Leucovorin Calcium Injection Due to Particulate Matter

    Ben Venue Laboratories is recalling 226,010 vials of Leucovorin Calcium Injection due to the presence of visible crystalline particulates.

    Product
    Leucovorin Calcium Injection USP, single use vials, 10mg/mL; 50mL, Rx only, Manufactured by: Ben Venue Labs, Inc., Bedford, OH 44146, NDC# 55390-009-01(Bedford); NDC# 55390-826-01(Novaplus)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0162-2013·2012-11-07

    Siemens ADVIA Centaur BR Assay Recalled for Quality Control Issues

    Siemens Healthcare Diagnostics is recalling ADVIA Centaur BR Assay kits because quality control results fell outside expected ranges.

    Product
    Siemens ADVIA Centaur BR Assay: Catalog Number: US: REF 02419937 (10214722) (50 Tests); REF 03896216(10334837)(250 Tests) Not CE Marked; OUS: REF03204829(10310271)(50 Tests); REF 01157807(1 0314722) (250 Tests) CE Marked; REF 09010686 (10340081)(250 Tests). The ADVIA…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0182-2013·2012-11-07

    Focus Diagnostics Recalls West Nile Virus IgG Test Kits

    Focus Diagnostics is recalling specific lots of West Nile Virus IgG test kits due to a higher false positive rate.

    Product
    West Nile Virus IgG DxSelect" kit Catalog No. EL0300G Kit Lots 122150, 122155, 122641, 122650 and 122859 that includes West Nile Virus IgG Antigen Wells, Catalog Number EL0351, Lot Number 121117. 510(k) No. K031953 The Focus Diagnostics West Nile Virus ELISA IgG is…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-013-2013·2012-10-31

    Watson Recalls Zovia Tablets Due to Potential Cross-Contamination

    Watson Laboratories is recalling Zovia tablets because certain lots may contain trace amounts of Hydrochlorothiazide (HCTZ) due to cross-contamination.

    Product
    Zovia (ethynodiol diacetate and ethinyl estradiol) Tablets USP, 1 mg/35 mcg, inert tablets, 28-count tablets per dispenser packaged in 6 Tablet Dispensers per carton, Rx only, Manufactured by: Watson Laboratories, Inc., Corona, CA 92880 USA; Distributed by: Watson Pharma, Inc.…
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0108-2013·2012-10-31

    Westmed Recalls Arterial Blood Gas Sampling Kits Due to Contaminated Alcohol Pads

    Westmed is recalling Pulset Arterial Blood Gas sampling kits because they contain TRIAD brand alcohol pads that are being recalled for potential contaminants.

    Product
    Pulset Arterial Blood Gas (ABG) sampling kit. Full Kit, Pulset, 3 cc, 23g x 1" A Needle w/Eclipse, 25U Balanced Heparin, No CE, part number: 3373-98. An arterial blood sampling kit is a device, in kit form, used to obtain arterial blood samples from a patient for blood gas…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0133-2013·2012-10-31

    DePuy Mitek VAPR Hook Electrode Recalled for Incorrect Labeling

    DePuy Mitek is recalling 376 VAPR Hook Electrodes because the packaging may display the wrong product identification label.

    Product
    DePuy Mitek VAPR Hook Electrode 3.5mm Hook Electrode with Integrated Handpiece Catalog Number: 227305 The DePuy Mitek VAPR Electrodes for use with the VAPR Radiofrequency System are intended for resection, ablation, excision, hemostasis of blood vessels, and coagulation…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-015-2013·2012-10-31

    Watson Recalls Zenchent Tablets Due to Potential Hydrochlorothiazide Contamination

    Watson Laboratories is recalling Zenchent tablets because certain lots may be contaminated with trace amounts of Hydrochlorothiazide (HCTZ).

    Product
    Zenchent (norethindrone and ethinyl estradiol) Tablets USP, 0.4 mg/0.035 mg, 28-count tablets per dispenser packaged in 6 Tablet Dispensers per carton, Rx only, Manufactured by: Watson Laboratories, Inc., Corona, CA 92880 USA; Distributed by: Watson Pharma, Inc., Corona, CA…
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0123-2013·2012-10-31

    Beckman Coulter Recalls DxC 600/800 Analyzers Due to Software Alignment Issue

    Beckman Coulter is recalling 7 UniCel DxC 600/800 analyzers because software v5.0.11 prevents operators from performing a necessary alignment procedure.

    Product
    UniCel¿ DxC 600/800 with Software v5.0.11, Part Number B12218. The UniCel¿ DxC Synchron¿ Clinical Systems are fully automated, computercontrolled clinical chemistry analyzers designed for the in vitro determination of a variety of general chemistries, therapeutic drugs, and…
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-0136-2013·2012-10-31

    Nipro AquaLiner Hydrophilic Guidewire Recalled for Insufficient Lubricity

    Nipro Medical Corporation is recalling AquaLiner Hydrophilic Guidewires because insufficient lubricity causes them to get stuck in the housing and become nonfunctional.

    Product
    AquaLiner Hydrophilic Guidewire 0.035" X 260cm, Straight/ Regular. AquaLiner Hydrophilic Guidewire is designed for use in angiographic procedures to introduce/ position catheters and interventional devices within the vasculature.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0137-2013·2012-10-31

    Nipro AquaLiner Hydrophilic Guidewires Recalled for Insufficient Lubricity

    Nipro Medical Corporation is recalling AquaLiner Hydrophilic Guidewires because insufficient lubricity causes the wires to get stuck in the housing and become nonfunctional.

    Product
    AquaLiner Hydrophilic Guidewire 0.035" X 260cm, Straight/ Stiff. AquaLiner Hydrophilic Guidewire is designed for use in angiographic procedures to introduce/ position catheters and interventional devices within the vasculature.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0102-2013·2012-10-31

    Westmed Recalls Arterial Blood Gas Kits Due to Alcohol Pad Contaminants

    Westmed is recalling Pulset ABG sampling kits because they contain TRIAD alcohol pads that are being recalled for potential contaminants.

    Product
    Pulset Arterial Blood Gas (ABG) sampling kit. Full Kit, Pulset, 3 cc, w/Crickett 22g x 1", 25U Balanced Heparin, part number: 3362-95. An arterial blood sampling kit is a device, in kit form, used to obtain arterial blood samples from a patient for blood gas…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0138-2013·2012-10-31

    Nipro AquaLiner Hydrophilic Guidewire Recalled for Insufficient Lubricity

    Nipro Medical Corporation is recalling AquaLiner Hydrophilic Guidewires because insufficient lubricity causes them to get stuck in the housing and become nonfunctional.

    Product
    AquaLiner Hydrophilic Guidewire 0.035" X 180cm, Angle / Regular. AquaLiner Hydrophilic Guidewire is designed for use in angiographic procedures to introduce/ position catheters and interventional devices within the vasculature.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0117-2013·2012-10-31

    Advanced Bionics Recalls HiRes 90K Cochlear Implants Due to Loose Tools

    Advanced Bionics is recalling 17 HiRes 90K cochlear implant devices with Helix Electrodes because of loose-fitting insertion tool assemblies.

    Product
    HiRes 90K devices with Helix Electrodes Model CI 1400-02H The HiResolution Bionic Ear System is a cochlear implant system designed to provide useful hearing to individuals with severe to profound hearing loss. It consists of internal and external components. The internal…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0112-2013·2012-10-31

    Advandx GNR Traffic Light PNA FISH Kit Recalled for False Positives

    Advandx Inc is recalling 187 GNR Traffic Light PNA FISH kits because they may produce false positive results for Pseudomonas putida and Pseudomonas fulva.

    Product
    AdvanDx GNR Traffic Light PNA FISH, In Vitro Diagnostic for Culture Identification Kit for Escherichia coli,and/or Klebsiella pneumoniae and/or Pseudomonas aeruginosa Catalog number: KT011. GNR Traffic Light PNA FISH is a multicolor, qualitative nucleic acid hybridization…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-010-2013·2012-10-31

    Qualitest Recalls Perphenazine Tablets Due to Cracked Coating

    Vintage Pharmaceuticals is recalling 2,755 bottles of Perphenazine 8 mg tablets due to a possibility of cracked or split tablet coatings.

    Product
    Perphenazine Tablets, USP, 8 mg, 100-count tablets per bottle, Manufactured for: Qualitest Pharmaceuticals, Huntsville, AL 35811, NDC 0603-5092-21.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-014-2013·2012-10-31

    Watson Recalls Lutera Tablets Due to Potential Hydrochlorothiazide Contamination

    Watson Laboratories is recalling specific lots of Lutera tablets because they may contain trace amounts of Hydrochlorothiazide (HCTZ).

    Product
    Lutera (levonorgestrel and ethinyl estradiol) Tablets USP, 0.1 mg/0.02 mg, inert tablets, 28-count tablets per dispenser packaged in 6 Tablet Dispensers per carton, Rx only, Manufactured by: Watson Laboratories, Inc., Corona, CA 92880 USA; Distributed by: Watson Pharma, Inc.…
    Category
    Drug
    Distribution
    Distributed nationwide