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.

11626–11650 of 21617

  • ModerateFDA (Drugs)·D-0129-2018·2017-12-27

    Premier Pharmacy Labs Recalls Neostigmine Methylsulfate Syringes Due to Labeling Error

    Premier Pharmacy Labs is recalling Neostigmine Methylsulfate syringes because the printed beyond-use dates exceed current stability data.

    Product
    Neostigmine Methylsulfate (single dose syringe) 1 mg per mL 5 mg per 5 mL Injectable Hospital/Office Use Only Compounded by: Premier Pharmacy Labs., Inc. 8265 Commercial Way Weeki Wachee, FL 34613, NDC# 69623-234-15
    Category
    Drug
    Distribution
    6 states
  • ModerateFDA (Drugs)·D-0118-2018·2017-12-27

    Advanced Pharma Recalls NitroGlycerin Syringes Due to Stability Data Issues

    Advanced Pharma Inc. is recalling 680 syringes of NitroGlycerin injection because stability data does not support the product's expiry dates.

    Product
    NitroGlycerin (1 mg/5 mL) 1 mg in 5% Dextrose Inj, USP QS 5 mL (200 mcg per mL), 5 mL Sterile single dose syringe, packaged in 8 x 5 (FORTY) syringes per box, Rx only, Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054, NDC 15082-863-67.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0283-2018·2017-12-27

    Implant Direct Recalls Spectra Guided Surgery Handle Kits for Dimensional Defects

    Implant Direct is recalling 560 Spectra System/Legacy Guided Surgery Handle Kits because some guide inserts do not meet specifications, preventing proper drill passage.

    Product
    Spectra System/Legacy Guided Surgery Handle Kit (Part Number: G-HK) Spectra System/Legacy Guided Surgery Handle Kit (Part Number: G-HK) allows clinicians to drill through a surgical guide to create an osteotomy for implant placement with the precision and accuracy as designed
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0267-2018·2017-12-27

    C.R. Bard Recalls I-125 QuickLink Cartridges Due to Incorrect Quantity

    C.R. Bard is recalling I-125 QuickLink Cartridges because the quantity of seeds sent in shipments was incorrect.

    Product
    I-125 CE Marked QuickLink Cartridges; Sterile; Bard Brachysource Radioactive Seeds in QuickLink Cartridges Indicated for permanent interstitial treatment of selected localized tumors such as: head and neck, lung, pancreas, and early stage prostate. Implants are indicated to tr
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0269-2018·2017-12-27

    Zimmer Biomet Recalls ExploR Radial Head Replacement System Due to Missing Screw

    Zimmer Biomet is recalling the ExploR Radial Head Replacement System because a complaint alleged the modular lock screw was missing from the package.

    Product
    ExploR Radial Head Replacement System. PN: 11-210061 LN: 243610. The stem is placed inside a polyurethane bag. The bagged component will then be placed in an inner PETG tray. The screw will be placed inside a separate polybag, and placed in the PETG tray with foam pieces added
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0272-2018·2017-12-27

    Stryker Recalls Mislabeled VenaFlow Calf Compression Garments

    Stryker is recalling 280 VenaFlow Calf Garments mislabeled as Pos-Lock Connectors in Texas due to labeling errors.

    Product
    3040-VenaFlow Calf Garment (Aircast) Quick Connect was mislabeled as 3010-PL Aircast Pos-Lock Connector. Intended for use in preventing deep vein thrombosis (DVT), diminishing post-operative pain and swelling, enhancing blood circulation and reducing wound healing time on the
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0117-2018·2017-12-27

    Advanced Pharma Recalls NitroGlycerin Syringes Due to Stability Data Issues

    Advanced Pharma Inc. is recalling NitroGlycerin 100 mcg/mL syringes because stability data does not support the product's expiry date.

    Product
    NitroGlycerin 100 mcg/mL QS 5% Dextrose Inj, USP (2 mg per 20 mL) 20 mL Sterile single dose syringe, packaged in 10 x 5 (FIFTY) syringes per box, Rx only, Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054, NDC 15082-818-62.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0271-2018·2017-12-27

    C.R. Bard Recalls Medivance ArcticGel Small Pad Kits Due to Peeling

    C.R. Bard is recalling 24 Medivance ArcticGel Small Pad Kits because the hydrogel is peeling from the pads. The affected units were distributed to 10 US states.

    Product
    Medivance ArcticGel Small Pad Kit - a box containing a single foil pouch, which contains a set of four (4) pads. A set of pads comprise a left and a right torso pad, and a left and a right thigh pad. Is a Thermal regulating system, indicated for monitoring and controlling pati
    Category
    Medical Device
    Distribution
    10 states
  • ModerateFDA (Devices)·Z-0276-2018·2017-12-27

    Stryker Neurovascular Recalls Stroke Intervention Kits Due to Label Mismatch

    Stryker Neurovascular is recalling specific Stroke Fast Packs and Trevo Procedure Packs because the carton sleeve labels did not match the physical contents inside the packs.

    Product
    Stroke Fast Pack(TM), Trevo(TM) XP, TREVO(TM) XP PROVUE RETRIEVER, 4 mm, 20 mm, ; Trevo(TM) Pro 18, TREVO PRO 18 MICROCATHETER, 0.021 in ID, 150 cm; AXS Catalyst(TM) 6, Distal Access Catheter, 0.060 in, 132 cm; UPN M0033PK42022002 Stroke intervention kit
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0277-2018·2017-12-27

    Stryker Recalls Stroke Intervention Kits Due to Label Mismatch

    Stryker Neurovascular is recalling specific stroke intervention kits because the carton sleeve labels did not match the physical contents inside the packs.

    Product
    Trevo(TM) XP ProVue Procedure Pack, TREVO(TM) XP PROVUE RETRIEVER, 6 mm, 25 mm, .Excelsior(TM) XT-27(TM) 1 TIP STRAIGHT, 150 cm, 6 cm, Microcatheter; UPN 93068 Stroke intervention kit
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0236-2018·2017-12-20

    Beckman Coulter UniCel DxH800 Automated Hematology Analyzer Recall

    Beckman Coulter is recalling 15 UniCel DxH800 automated hematology analyzers because the Single-Tube Station shield may interfere with sample aspiration.

    Product
    UniCel DxH800, Part Numbers: 629029 and B24802, automated hematology analyzer
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-0253-2018·2017-12-20

    ConMed Recalls Nonabsorbable Suture Anchor System Due to Manufacturing Error

    ConMed Corporation is recalling 56 units of a nonabsorbable suture anchor system because they were manufactured with the incorrect anchor outer body.

    Product
    Nonabsorbable suture anchor system intended to reattach soft tissue to bone in orthopedic surgical procedures may be used in either arthroscopic or open surgical procedures.
    Category
    Medical Device
    Distribution
    10 states
  • ModerateFDA (Devices)·Z-0225-2018·2017-12-20

    Terumo Recalls Glidesheath Introducer Sheaths Due to Incomplete Packaging Seal

    Terumo Medical Corp is recalling specific lots of Glidesheath Introducer Sheaths because an incomplete seal may compromise sterility.

    Product
    Glidesheath Slender Hydrophilic Coated Introducer Sheath, 5FR - 10CM (0.025), REF/Product Code RM*RS5J10PA, STERILE, Rx ONLY
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0233-2018·2017-12-20

    Dukal Blue Burn Sheets Recalled Due to Shredded Product in Cartons

    Dukal Corp. is recalling sterile Blue Burn Sheets because intact cartons were found to contain shredded sheets, compromising the sterile barrier.

    Product
    BLUE BURN SHEET, STERILE, 60" x 96"; Item 7305, GAM item 30-01 Product Usage - May provide a sterile, barrier environment to protect patient from infection.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0187-2018·2017-12-20

    Physio-Control Recalls LIFEPAK Electrode Starter Kits Due to Labeling Errors

    Physio-Control is recalling 14,219 LIFEPAK Electrode Starter Kits because the infant artwork shows incorrect pad placement and is missing required warning symbols.

    Product
    LIFEPAK(R) Electrode Starter Kits, Catalog # 11101-000017, MIN #3202784-009 The defibrillation electrodes are used only with LIFEPAK EXPRESS(R) AED, LIFEPAK CR(R) Plus AED, LIFEPAK 1000 defibrillator, or LIFEPAK 500 Biphasic AED s with a pink connector.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0051-2018·2017-12-20

    United Nuclear Scientific Recalls Three High Power Handheld Lasers

    United Nuclear Scientific Supplies, LLC is recalling three high power handheld laser products for failing to comply with laser class limitations.

    Product
    United Nuclear Scientific High Power Handheld Lasers. Laser products
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0220-2018·2017-12-20

    Terumo Recalls Glidesheath Introducer Sheaths Due to Packaging Seal Defect

    Terumo Medical Corp is recalling specific lots of Glidesheath Introducer Sheaths because an incomplete seal may compromise sterility.

    Product
    Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 6FR - 10CM (0.021), REF/Product Code RM*ES6F10HAU, STERILE, Rx ONLY
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0222-2018·2017-12-20

    Terumo Recalls Glidesheath Introducer Sheaths Due to Packaging Seal Defect

    Terumo Medical Corp is recalling specific lots of Glidesheath Introducer Sheaths because an incomplete seal may compromise sterility.

    Product
    Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 6FR - 10CM (0.025), REF/Product Code RM*ES6J10HAT, STERILE, Rx ONLY
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0229-2018·2017-12-20

    Terumo Recalls Glidesheath Introducer Sheaths Due to Packaging Seal Defect

    Terumo Medical Corp is recalling specific lots of Glidesheath Introducer Sheaths because an incomplete seal may compromise sterility.

    Product
    Glidesheath Slender Hydrophilic Coated Introducer Sheath, 7FR - 10CM (0.021), REF/Product Code RM*RS7F10PA, STERILE, Rx ONLY
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0186-2018·2017-12-20

    Physio-Control Recalls Defibrillation Electrodes Due to Incorrect Pad Placement Artwork

    Physio-Control is recalling 14,219 LIFEPAK defibrillation electrodes because the artwork instructs incorrect pad placement and is missing required warning symbols.

    Product
    LIFEPAK(R) defibrillation electrodes, Catalog # 11101-000016, MIN #3202380-006 The defibrillation electrodes are used only with LIFEPAK EXPRESS(R) AED, LIFEPAK CR(R) Plus AED, LIFEPAK 1000 defibrillator, or LIFEPAK 500 Biphasic AED s with a pink connector.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0216-2018·2017-12-20

    Terumo Recalls Glidesheath Introducer Sheaths Due to Incomplete Packaging Seal

    Terumo Medical Corp is recalling specific lots of Glidesheath Introducer Sheaths because an incomplete seal may compromise sterility.

    Product
    Glidesheath Slender Hydrophilic Coated Introducer Sheath, 7FR - 10CM (0.021), REF/Product Code RM*CS7F10NA, STERILE, Rx ONLY
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0486-2018·2017-12-20

    Gourmet International Recalls Premio Strawberry Pralinati for Undeclared Colors

    Gourmet International Inc. is voluntarily recalling Premio Strawberry Pralinati cookies due to undeclared colors. The recall covers 24,179 cases distributed in several US states.

    Product
    Premio Strawberry Pralinati, Strawberry with Cocoa, 3.53oz, 10 units per case, packed in Paper Cartons
    Category
    Food
    Distribution
    13 states
  • ModerateFDA (Devices)·Z-0237-2018·2017-12-20

    Beckman Coulter UniCel DxH600 Hematology Analyzer Recall for Sample Aspiration Issue

    Beckman Coulter is recalling the UniCel DxH600 automated hematology analyzer because a shield may interfere with sample aspiration.

    Product
    UniCel DxH600, Part Number B23858, automated hematology analyzer (Note: the DxH 600 is the same instrument as the DxH 800 except that it is a bench top unit with no instrument cart, computer stand, and no connectivity capabilities)
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-0221-2018·2017-12-20

    Terumo Recalls Glidesheath Introducer Sheaths Due to Packaging Seal Defect

    Terumo Medical Corp is recalling specific lots of Glidesheath Introducer Sheaths because an incomplete packaging seal may compromise sterility.

    Product
    Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 6FR - 16CM (0.021), REF/Product Code RM*ES6F16HAU, STERILE, Rx ONLY
    Category
    Medical Device
    Distribution
    Distributed nationwide