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.

15576–15600 of 21645

  • ModerateFDA (Drugs)·D-0388-2016·2015-12-09

    Nephron Recalls Asthmanefrin Inhalation Solution Due to Discoloration

    Nephron Pharmaceuticals is voluntarily recalling Asthmanefrin inhalation solution starter kits due to discoloration. The recall covers 47,754 cartons distributed nationwide.

    Product
    Asthmanefrin Racepinephrine Inhalation Solution Bronchodilator, Starter Kit (Racepinephrine 11.25 mg) 10 individual foil wrapped vials with 1 EZ Breathe Atomizer per carton, Manufactured By: nephron pharmaceuticals corporation, Orlando, FL --- NDC 0487-2784-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0266-2016·2015-12-02

    Curley Parsley Recalled for Pesticide Contamination

    MR Cuta dba Riley's is recalling Curley Parsley because it tested positive for the pesticides propanocarb and trifloxystrobin.

    Product
    Curley Parsley 4/5 lb packaged in cardboard box, UPC code 740695801109
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0332-2016·2015-12-02

    Palindrome Precision Chronic Catheter Kit Recalled for Packaging Defect

    Covidien LLC is recalling 150 units of Palindrome Precision Chronic Catheter Kits due to incorrect packaging with a 90-degree bend at the distal tip.

    Product
    Palindrome Precision Chronic Catheter Kit Symmetrical Tip, Tal VenaTrac" Stylet 14.5 Fr/Ch (4.8mm) X 33 cm Item Number: 8888145046C The Palindrome chronic catheter is intended for acute and chronic hemodialysis, apheresis, and infusion. It may be inserted either…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0319-2016·2015-12-02

    Siemens Syngo Imaging Software Recall for Version VB36D_HF02

    Siemens Medical Solutions is recalling three units of Syngo Imaging software to provide supplementary information regarding the release of Version VB36D_HF02.

    Product
    Syngo Imaging VB36D_HF02. Radiological image processing system.
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-0321-2016·2015-12-02

    Medtronic Sofamor Danek Recalls Midas Rex Legend Wire Pass Tools

    Medtronic Sofamor Danek is recalling 9 Midas Rex Legend wire pass tools because the wire pass hole is missing. The tools were distributed in California, New York, Texas, and Belgium.

    Product
    Tool Legend 16cm 2.4 mm wire pass for Midas Rex Legend Dissecting Tool. Used by surgeons to drill holes.
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-0329-2016·2015-12-02

    Palindrome Chronic Catheter Kit Recalled for Packaging Defect

    Covidien LLC is recalling 280 units of Palindrome Chronic Catheter Kits because they were incorrectly packaged with a 90-degree bend at the distal tip.

    Product
    Palindrome" Chronic Catheter Kit Symmetrical Tip, Tal VenaTrac" Stylet 14.5 Fr/Ch (4.8mm) X 33 cm Item Number: 8888145042 The Palindrome chronic catheter is intended for acute and chronic hemodialysis, apheresis, and infusion. It may be inserted either percutaneously or by…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0326-2016·2015-12-02

    Cranberry Chipotle Spread Recalled for Potential Mold Contamination

    Something Special Deli-Foods Ltd. is voluntarily recalling Cranberry Chipotle Spread due to the potential for mold.

    Product
    Cranberry Chipotle Spread, 10.5 oz, packed in glass jar with metal lid, inside a cardboard box
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-0330-2016·2015-12-02

    Palindrome Precision Chronic Catheter Kit Recalled for Packaging Defect

    Covidien LLC is recalling 160 units of Palindrome Precision Chronic Catheter Kits because they were incorrectly packaged with a 90-degree bend at the distal tip.

    Product
    Palindrome Precision Chronic Catheter Kit Symmetrical Tip 14.5 Fr/Ch (4.8mm) X 33 cm Item Number: 8888145017P The Palindrome chronic catheter is intended for acute and chronic hemodialysis, apheresis, and infusion. It may be inserted either percutaneously or by cutdown.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0341-2016·2015-12-02

    Leica Microsystems Recalls Unstable CD10 Monoclonal Antibody Diagnostic Reagents

    Leica Microsystems is recalling specific lots of Novocastra CD10 antibody reagents because they are not stable up to the labeled expiry date.

    Product
    Novocastra Lyophilized Mouse Monoclonal Antibody CD10 (CD10). Immunohistochemistry. in vitro diagnostic. 0.1ml NCL-CD10-270 and 1mL NCL-CD10-270 are intended for the qualitative identification by light microscopy of CD10 molecules in paraffin sections.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0334-2016·2015-12-02

    BD CD64 APC-R700 Reagent Recalled Due to CD4 Antibody Contamination

    Becton, Dickinson and Company is recalling three lots of CD64 APC-R700 reagent because they are contaminated with CD4 antibody, which may cause unexpected staining patterns.

    Product
    BD CD64 APC-R700; Analyte Specific Reagent; Model 657701; Lot No. 4344945, 5037611 and 5063945. Hematology - used as analyte specific reagent - contamination leads to possibility of unexpected staining pattern.
    Category
    Medical Device
    Distribution
    9 states
  • ModerateFDA (Devices)·Z-0325-2016·2015-12-02

    Philips MRI Systems Recalled for Reversed Image Order in MobiView Software

    Philips is recalling specific MRI systems with MobiView software due to a defect that reverses the order of fused multi-station scan images.

    Product
    Ingenia, Intera, Achieva and Achieve dStream MR systems on Software versions R5.1.7 and R5.1.8 with the Mobi View software option. Diagnostic imaging system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0293-2016·2015-11-25

    TZ Medical Neptune Plus Hemostasis Pad Recall for Labeling Mismatch

    TZ Medical Inc. is recalling Neptune Plus hemostasis pads because the instructions for use do not match the original FDA submission.

    Product
    Neptune Plus, HEMOSTASIS PAD WITH ANTIMICROBIAL BARRIER, For hemostasis following needle/sheath removal, Part number 8870-03
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0275-2016·2015-11-25

    Medacta Recalls GMK Hinge Knee Prosthesis Due to Incorrect Screws

    Medacta USA is recalling 4 units of GMK Hinge knee prostheses because they contain 5 mm screws instead of the required 10 mm screws.

    Product
    GMK Hinge knee prosthesis; Model Number: 02.09.TA410; Orthopedics and Orthopedic Surgery
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0232-2016·2015-11-25

    Qualitest Recalls Hydrochlorothiazide Capsules Due to Particulate Matter

    Vintage Pharmaceuticals is recalling 912 bottles of 12.5 mg Hydrochlorothiazide capsules because of the presence of particulate matter.

    Product
    HYDROCHLOROTHIAZIDE CAPSULES, USP, 12.5 mg, 3000 count bottles, Rx only, Manufactured for: Qualitest Pharmaceuticals, Inc., Huntsville, AL 35811, NDC: 0603-3855-93.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0312-2016·2015-11-25

    Ameditech Recalls Immutest Drug Screen Cups Due to Reduced Reactivity

    Ameditech is recalling specific Immutest drug screen cups because they have shown reduced reactivity. The affected units were distributed nationwide in the US and in Australia.

    Product
    Immutest 10 Pnl Drug Screen Cup w/ Adult, Item No. IMCA-10M5; Immutest 11 Pnl Drug Screen Cup w/ Adult, Item No. IMCA-11OP; Immutest 12 Panel Cup w/Adulteration, Item No. IMCA-12BUP; Immutest 5 panel, Item No. IMCA-5AB-W; Immutest 5 Pnl Drug Cup w/ Adult -waived, Item No.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0298-2016·2015-11-25

    Ameditech Recalls 1 Step 12 Panel Cup Drug Tests

    Ameditech is recalling 787 kits of 1 Step 12 Panel Cup drug tests due to reduced reactivity. The products were distributed in the US and Australia.

    Product
    1 Step 12 Panel Cup, Item No. NBCA-12M-W These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse Tests consist of a combination of drug strips, including…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0279-2016·2015-11-25

    Astora Recalls MiniArc Pro Sling System Due to Labeling Mismatch

    Astora is recalling 52 units of the MiniArc Pro Single incision Sling System because the lot number on the outer carton did not match the labels inside the box.

    Product
    MiniArc Pro Single incision Sling System, Model number / Product Reference 9000261, Lot 936405xxx. Designed to treat female stress urinary incontinence.
    Category
    Medical Device
    Distribution
    11 states
  • ModerateFDA (Devices)·Z-0311-2016·2015-11-25

    Ameditech Recalls iCup Drug Screen Cups Due to Reduced Reactivity

    Ameditech is recalling iCup drug screen cups because they have shown reduced reactivity. The affected units were distributed nationwide in the US and internationally to Australia.

    Product
    iCup Drug Screen Cup, Item No. I-DXA-187-016, I-DXA-167-013; iCup DX 10 Panel w/Adulterant, Item No. I-DXA-1107-142; iCup DX 11 Panel w/Adulterant, Item No. I-DXA-1117-131; iCup DX 12 Panel w/Adulterant, Item No. I-DXA-1127-023; iCup DX 6 Panel w/Adulterant, Item No.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0278-2016·2015-11-25

    Ethicon Harmonic ACE+ 7 Laparoscopic Shears Recalled for Packaging Defect

    Ethicon Endo-Surgery is recalling Harmonic ACE+ 7 Laparoscopic Shears because holes in the Tyvek packaging can compromise the sterile barrier.

    Product
    HARMONIC ACE+ 7 Laparoscopic Shears with Advanced Hemostasis (23cm, 36cm, 45cm length), Ethicon Endo-Surgery. Indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0234-2016·2015-11-25

    Par Pharmaceutical Recalls Meclizine Hydrochloride Tablets Due to Impurity Failures

    Par Pharmaceutical is recalling Meclizine Hydrochloride Tablets because they failed impurity specifications. The recall covers 100 and 1000-count bottles distributed nationwide.

    Product
    Meclizine Hydrochloride Tablets USP, 25 mg Tablets, Packaged in a) 100 Ct Bottles (NDC: 49884-035-01) and b) 1000 Ct Bottles (NDC: 49884-035-10), Rx only. Par Pharmaceutical Companies, Inc., Spring Valley, NY 10977.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0300-2016·2015-11-25

    Ameditech Recalls 11 Panel Drug Abuse Tests Due to Reduced Reactivity

    Ameditech is recalling 11 Panel Drug Abuse Tests because they have shown reduced reactivity. The affected products are distributed in the US and Australia.

    Product
    11 Panel Cup (OPI2000) w/Adult, Item No. 71125AA2K ; and 11 Panel Cup (OPI300) w/Adult, Item No. 71125AA These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0318-2016·2015-11-25

    TZ Medical Recalls SilverStat Hemostasis Pads Due to Labeling Discrepancy

    TZ Medical Inc. is recalling 10,180 units of SilverStat hemostasis pads because the instructions for use did not match the original FDA submission.

    Product
    SilverStat, sterile 2" x 2 " calcium alginate hemostasis pad with sliver nitrate, Part number 8870-07. Product Usage: SilverStat is an effective barrier to microbial penetration for moderate to heavy exudating partial and full-thickness wounds, including pressure…
    Category
    Medical Device
    Distribution
    18 states
  • ModerateFDA (Devices)·Z-0303-2016·2015-11-25

    Ameditech Recalls ArcPoint Labs 10 Panel Dip Screen Due to Reduced Reactivity

    Ameditech is recalling ArcPoint Labs 10 Panel Dip Screen (OXY) drug tests because they have shown reduced reactivity.

    Product
    ArcPoint Labs 10 Panel Dip Screen (OXY), Item No. APD-10MO These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse Tests consist of a combination of drug…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0315-2016·2015-11-25

    Ameditech Recalls ProScreen Drug Panel Tests Due to Reduced Reactivity

    Ameditech is recalling ProScreen drug panel tests because they have shown reduced reactivity. The recall covers 31,530 units distributed in the US and Australia.

    Product
    ProScreen 10 Drug Panel Cassette Test, Item No. CPSP-10PPX; ProScreen 10 Panel Cup, Item No. PSCup-10MMO-300, PSCup-10M, PSCupA-10MO, PSCUp-10AB; ProScreen 10 Panel Cup with Adulterants, Item No. PSCupA-10AM; ProScreen 10 Panel Dip Card, Item No. PSD-10MMO-300, PSD-10MOX…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0304-2016·2015-11-25

    Ameditech Recalls CLIA RDTC 12-Panel Drug Abuse Tests for Reduced Reactivity

    Ameditech is recalling 7,482 units of CLIA RDTC 12-Panel Cup drug abuse tests because they have shown reduced reactivity. The products were distributed in the US and Australia.

    Product
    CLIA RDTC 12-Panel Cup and CLIA RDTC 12-Panel Cup (w/Adulteration), Item No. CLIA-RDTC-12 These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse Tests…
    Category
    Medical Device
    Distribution
    Distributed nationwide