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.

6851–6875 of 21595

  • ModerateFDA (Devices)·Z-2192-2020·2020-06-10

    Abbott Afinion 2 Power Supply Recall for Electrostatic Discharge Risk

    Abbott is recalling Afinion 2 and Alere Afinion AS100 power supplies due to a risk of electrostatic discharge and sparking that can render the unit non-functional.

    Product
    Power supply provided with Afinion 2, Catalog numbers 1116553, 1116554, 1116556, 1116557, 1116597, 1116598, 1116663, 1116679, 1116680, 1116681, 1116682, 1116684, 1116770, 1116771, 1116772, 1116777, 1116778, 1116970, 1116971, 1116985, 1116986, IVD. The firm name on the label is A
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2188-2020·2020-06-10

    Osteomed Recalls Osteovation 5cc Impactformula Bone Void Filler Kits

    Osteomed is recalling Osteovation 5cc Impactformula bone void filler kits because the product may not maintain its setting characteristics for the labeled shelf-life duration.

    Product
    OSTEOVATION 5CC IMPACTFORMULA. REF/UDI: 390-2105/00813845020085 - Product Usage: The product provides a bone void filler that is replaced by bone during the healing process.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2175-2020·2020-06-10

    FDA Recalls Sterile Custom Surgical Packs Due to Unregistered Facility

    American Contract Systems is recalling 2,868 sterile custom surgical packs because they were manufactured in a facility not registered by the FDA.

    Product
    Sterile Custom Packs to be used in surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2178-2020·2020-06-10

    FDA Recalls Sterile Custom Surgical Packs Due to Unregistered Facility

    American Contract Systems is recalling 2,868 sterile custom surgical packs because they were manufactured in a facility not registered with the FDA.

    Product
    Sterile Custom Packs to be used in surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2108-2020·2020-06-03

    Siemens ARTIS Pheno X-Ray Systems Recalled for Drivetrain Faults

    Siemens is recalling 105 ARTIS Pheno X-ray systems because a drivetrain fault may prevent the C-arm from moving, requiring field service to restore operation.

    Product
    ARTIS Pheno - Interventional Fluoroscopic X-Ray System Model: 10849000 - Product Usage: is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1278-2020·2020-06-03

    LidoPro Patches Recalled Due to Missing Manufacturing Records

    Wuhan Bingbing Pharmaceutical is recalling LidoPro patches because manufacturing records and samples were lost, preventing verification of product stability.

    Product
    LidoPro (lidocaine 4%, menthol 5%, methyl salicylate 4%) patch, 15 Patches per box, Manufactured For: Terrain Pharmaceuticals, Reno, NV 89501; NDC 53225-1023-1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0962-2020·2020-06-03

    Jindilli Beverages Recalls Milkadamia Unsalted Buttery Spread for Potential Mold

    Jindilli Beverages LLC is recalling Milkadamia Unsalted Buttery Spread due to the potential to contain mold. The product was distributed nationwide.

    Product
    Milkadamia Unsalted Buttery Spread 8 ounces packaged in plastic tub, 6 packaged per case UPC 858045004725
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2111-2020·2020-06-03

    GE Healthcare Recalls Giraffe Shuttle Upgrade Kits Due to Battery Odor

    GE Healthcare is recalling Giraffe Shuttle upgrade kits because the batteries emit a strong sulfur odor during charging.

    Product
    Giraffe Shuttle. Upgrade Kits with part number 2109672-001 and 2109673-001 GTIN: 00840682110808.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0963-2020·2020-06-03

    Jindilli Beverages Recalls Milkadamia Salted Buttery Spread for Potential Mold

    Jindilli Beverages LLC is recalling 2,981 cases of Milkadamia Salted Buttery Spread due to the potential presence of mold.

    Product
    Milkadamia Salted Buttery Spread 8 ounces packaged in plastic tub, 6 packaged per case UPC 858045004718
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1277-2020·2020-06-03

    LidoPatch Pain Relief Patches Recalled Due to Missing Manufacturing Records

    Wuhan Bingbing Pharmaceutical is recalling LidoPatch pain relief patches because missing manufacturing records prevent verification that the product remains within specification through its expiration date.

    Product
    LidoPatch (lidocaine HCl 3.6%, menthol 1.25%) Pain Relief Patch, packaged in 1 patch/box (NDC 10882-527-01); 30 patches/box (NDC 10882-527-02 and 10882-527-04), Manufactured for: JAR Laboratories, Elmhurst, IL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1280-2020·2020-06-03

    CVS Lidocaine Cold and Hot Patch Recalled for Manufacturing Record Loss

    CVS Pharmacy is recalling Maximum Strength Lidocaine Cold & Hot Patches because manufacturing records and samples were lost, meaning the product may not remain within specification through its expiration date.

    Product
    Maximum Strength Lidocaine Cold & Hot Patch (lidocaine 4%, menthol 1%), 5 patches per box, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895; NDC 66902-218-05.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1276-2020·2020-06-03

    PD-Rx Recalls Doxycycline Hyclate Tablets for Failed Dissolution Specifications

    PD-Rx Pharmaceuticals is recalling Doxycycline Hyclate 100 mg tablets because they failed to meet dissolution specifications. The recall covers 14,030 bottles distributed nationwide.

    Product
    DOXYCYCLINE — DOXYCYCLINE (DOXYCYCLINE HYCLATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1274-2020·2020-06-03

    West-Ward Recalls Doxycycline Hyclate Tablets Due to Dissolution Failure

    West-Ward Columbus Inc. is recalling Doxycycline Hyclate 100 mg tablets because they failed a dissolution test at the end of their shelf life.

    Product
    DOXYCYCLINE HYCLATE — DOXYCYCLINE HYCLATE (DOXYCYCLINE HYCLATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2129-2020·2020-06-03

    Teleflex Recalls Sprotte Lumbar Puncture Needles Due to Sterility Concerns

    Teleflex Medical is recalling 4,227 Sprotte lumbar puncture needles because a packaging issue prevents the manufacturer from guaranteeing their sterility.

    Product
    Sprotte Needle, REF 32115130C w/ Intro 22 G x 3.5", distributed by Teleflex Medical The SPROTTE lumbar puncture needles are intended to gain entry into or puncture the spinal cavity permitting injection (including anesthesia) / withdrawal of fluids for purposes of diagnostic l
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2142-2020·2020-06-03

    Inpeco Aptio Automation System Recalled for Sample Association Error

    Inpeco S.A. is recalling 70 Aptio Automation Systems with specific interface modules due to a firmware communication error that can cause erroneous sample-tube associations.

    Product
    Aptio Automation System with Advia2120LAS Interface Module (P/N FLX-219-00, FLX-219-10), ImmunoCAP 1000 Interface Module (P/N FLX-226-01, FLX-226-10), or StaRRsed Interface Module (P/N FLX-268-00) - Product Usage: is a modular system designed to automate Pre-Analytical and Post-A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2124-2020·2020-06-03

    Boston Scientific Recalls Spinal Cord Stimulation Lead Extensions Due to Labeling Error

    Boston Scientific is voluntarily removing 41 units of spinal cord stimulation lead extensions because the 'use by date' on the label is later than the correct date. No adverse health consequences are expected.

    Product
    Fifty-five (55) cm 8 Contact Extension Kit, part number M365SC3138550 - Product Usage: Lead Extensions are designed to connect the percutaneous leads to the Implantable Pulse Generator (IPG) for spinal cord stimulation. The extension may be added to a lead to externalize the le
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-1279-2020·2020-06-03

    Mencaine Lidocaine Patches Recalled Due to Missing Manufacturing Records

    Wuhan Bingbing Pharmaceutical is recalling Mencaine patches because manufacturing records and samples were lost, preventing verification that the product remains within specification through expiration.

    Product
    Mencaine (lidocaine 4.5%, menthol 5%) Patch, 1 patch per pouch, Manufactured For: Terrain Pharmaceuticals, Reno, NV 89501; NDC 53225-1090-1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2130-2020·2020-06-03

    Teleflex Recalls Sprotte Lumbar Puncture Needles Due to Sterility Concerns

    Teleflex Medical is recalling 800 Sprotte lumbar puncture needles because a packaging issue prevents the manufacturer from guaranteeing sterility.

    Product
    Sprotte Needle, REF 33115131B w/ Intro 20 G x 3.5", distributed by Teleflex Medical The SPROTTE lumbar puncture needles are intended to gain entry into or puncture the spinal cavity permitting injection (including anesthesia) / withdrawal of fluids for purposes of diagnostic l
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2141-2020·2020-06-03

    Inpeco Accelerator a3600 Automation System Recalled for Sample Association Errors

    Inpeco S.A. is recalling three Accelerator a3600 Automation Systems due to a firmware communication error that can cause incorrect sample-tube associations.

    Product
    Accelerator a3600 Automation System with Advia2120LAS Interface Module (P/N FLX-219-00, FLX-219-10), ImmunoCAP 1000 Interface Module (P/N FLX-226-01, FLX-226-10), or StaRRsed Interface Module (P/N FLX-268-00) is a modular system designed to automate Pre-Analytical and Post-Analyt
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2140-2020·2020-06-03

    Inpeco FlexLab Automation System Recalled for Sample Association Errors

    Inpeco S.A. is recalling 37 FlexLab Automation Systems due to a firmware communication error that can cause sample tubes to be incorrectly associated with carriers.

    Product
    FlexLab Automation System with Advia2120LAS Interface Module (P/N FLX-219-00, FLX-219-10), ImmunoCAP 1000 Interface Module (P/N FLX-226-01, FLX-226-10), or StaRRsed Interface Module (P/N FLX-268-00)is a modular system designed to automate Pre-Analytical and Post-Analytical proces
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2106-2020·2020-06-03

    Medtronic Guardian Connect App iOS Recall for Battery Life Issues

    Medtronic is recalling the Guardian Connect App for iOS due to shortened transmitter battery life on specific iPhone, iPad, and iPod Touch devices.

    Product
    Guardian Connect App CSS7200 iOS and Guardian Connect Transmitter GST4C used on the iPhone, iPad and iPod Touch devices.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0959-2020·2020-06-03

    Siete Grain Free Cashew Flour Tortillas Recalled for Foreign Material

    Garza Food Ventures is recalling Siete Grain Free Cashew Flour Tortillas due to a potential to contain foreign material.

    Product
    Siete Grain Free Cashew Flour Tortillas NET WT 7 OZ (200g) 8 Count UPC 865336000045 packaged in flexible plastic
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2099-2020·2020-05-27

    Stryker Restoration Anatomic Shell Recalled Due to Packaging Defect

    Howmedica Osteonics Corp. is recalling Stryker Restoration Anatomic Shell devices because they may fall off their post in packaging, resulting in loose devices with coating debris.

    Product
    Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 68 right, Sterile, Catalog # 504-02-68F-R, UDI (01)07613327012514(17)
    Category
    Medical Device
    Distribution
    30 states