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.

14426–14450 of 21645

  • ModerateFDA (Devices)·Z-2095-2016·2016-07-06

    Smith & Nephew Legion HK Femoral Assembly Recalled for Surface Defect

    Smith & Nephew is recalling 97 units of the Legion HK Femoral Assembly because the internal surface is below specification, potentially affecting cement adhesion.

    Product
    LEGION(TM) HK FEMORAL ASSEMBLY, SIZE 5 RIGHT, A/P 62 MM, M/L 70 MM, REF 71421365 The LEGION Hinge Knee System is indicated for: 1. Rheumatoid arthritis. 2. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight and activity…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2057-2016·2016-07-06

    Dynarex Recalls Specimen Containers Due to Incorrect Sterile Labeling

    Dynarex Corporation is recalling non-sterile specimen containers that were mistakenly packed in cartons labeled as sterile. The recall covers specific lots distributed in the US and Canada.

    Product
    dynarex Specimen Containers, Screw-On, Leak-Resistant Lid, Tamper-Evident Seal, Sterile, Single Use Only Product Usage:containers for sample collection
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2091-2016·2016-07-06

    Smith & Nephew Recalls Legion Hinge Knee Femoral Assemblies

    Smith & Nephew is recalling Legion Hinge Knee femoral assemblies because the cement application surface is below specification.

    Product
    LEGION(TM) HK FEMORAL ASSEMBLY, SIZE 3 RIGHT, A/P 54.5 MM, M/L 62 MM, REF 71421363 The LEGION Hinge Knee System is indicated for: 1. Rheumatoid arthritis. 2. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight and activity…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2110-2016·2016-07-06

    Philips Big Bore Radiology Scanner Recalled for Incorrect Screw Material

    Philips is recalling 89 Big Bore Radiology scanners because adjustment plate screws were made of stainless steel instead of the specified alloy steel.

    Product
    Big Bore Radiology tomography X-ray system scanner, model number 728244. The Big Bore Radiology scanner is a whole body computed tomography X-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2117-2016·2016-07-06

    Philips Ingenuity Core CT Systems Recalled for Image Artifacts

    Philips is recalling 18 Ingenuity Core CT systems because software version 3.5.4 may cause swirl-like artifacts on images, potentially requiring patient rescans.

    Product
    Ingenuity Core-Computed Tomography X-ray system Product Usage: The Ingenuity Core scanner is a whole body Computed Tomography X-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2112-2016·2016-07-06

    Philips Brilliance iCT Scanner Recall Due to Cracking Cover

    Philips is recalling Brilliance iCT scanners because a design change resulted in a thinner plastic cover that may crack.

    Product
    Brilliance iCT model #728306; Intended to produce cross- sectional images of the body.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2107-2016·2016-07-06

    Siemens Recalls SYNGO Breast Care Software Due to Display Issues

    Siemens is voluntarily recalling 29 units of SYNGO Breast Care software because patient information can obscure view markers and facility details are not shown by default.

    Product
    SYNGO Breast Care, visualization and image enhancement tools to aid radiologist in the review of digital Mammography images and tomosynthesis datasets.
    Category
    Medical Device
    Distribution
    12 states
  • ModerateFDA (Devices)·Z-2084-2016·2016-07-06

    Integra LifeSciences Recalls METASURG Capture Screw System K-wires

    Integra LifeSciences is recalling 182 K-wires used in the METASURG Capture Screw System because they do not meet material, surface, and dimensional specifications.

    Product
    K-wire, Smooth Double-pointed 0.8 x 90mm, a component of the METASURG Capture Screw System The K-wire is used in conjunction with the 2.0 mm cannulated screws for the METASURG Capture Screw System. The K-wire is used by the physician to insert into the bone and to act as a…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2086-2016·2016-07-06

    Integra LifeSciences Recalls Cadence Tibial Tray Implant Due to Labeling Error

    Integra LifeSciences is recalling 12 units of the Cadence Size 5 Left Tibial Tray Implant because the outer package label incorrectly identifies the material as Cobalt Chromium instead of Titanium.

    Product
    Cadence Size 5 Left Tibial Tray Implant, designed to treat ankle arthritis through replacement of the ankle joint with a prosthesis, thereby reducing pain, restoring alignment, and allowing for movement at the replaced joint. Catalog Number: 10207205; Lot Number #QJ0248
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-2116-2016·2016-07-06

    Philips Brilliance 64 CT Scanner Recall for Image Artifacts

    Philips is recalling 94 Brilliance 64 CT scanners due to intermittent swirl-like ring artifacts on images, which may require patient rescans.

    Product
    Brilliance 64, Computed Tomography X-ray system Product Usage: The Brilliance CT 64 scanner is a whole body Computed Tomography X-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1056-2016·2016-07-06

    Vital Care Compounder Recalls Trypan Blue Vials Due to Sterility Concerns

    Vital Care Compounder is recalling 54 vials of Trypan Blue 0.3% because aluminum crimps may not fully seal the rubber stopper, compromising sterility.

    Product
    Trypan Blue 0.3%, 0.5 mL Vial, Vital Care Compounder, Hattiesburg, MS
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1052-2016·2016-07-06

    Lupin Recalls Lisinopril and Hydrochlorothiazide Tablets Due to CGMP Deviations

    Lupin Pharmaceuticals is recalling specific lots of Lisinopril and Hydrochlorothiazide tablets because they were manufactured using active ingredients that failed specifications.

    Product
    LISINOPRIL AND HYDROCHLOROTHIAZIDE — LISINOPRIL AND HYDROCHLOROTHIAZIDE (LISINOPRIL AND HYDROCHLOROTHIAZIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1053-2016·2016-07-06

    Aloe Source Recalls Topical Analgesic Products Due to Manufacturing Deviations

    The Aloe Source is voluntarily recalling specific lots of aloe SPORT liniment and eucalyptus cream due to CGMP deviations.

    Product
    aloe SPORT liniment TOPICAL ANALGESIC 8 fl oz. tube, ALOE VERA Liniment Topical Analgesic 8 fl oz. bottle, Manufactured by Coats International, Inc., the ALOE SOURCE SPORT Sport Thermogenic Eucalyptus Cream 1 fl oz. plastic bottle, Dallas, TX 75243, NDC 58826-704-08, UPC…
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2109-2016·2016-07-06

    Philips Big Bore Oncology Scanner Recalled for Incorrect Screw Material

    Philips is recalling 47 Big Bore Oncology scanners because the socket head cap screws in the Z-Axis Adjustment Plate were made of stainless steel instead of the specified alloy steel.

    Product
    Big Bore Oncology tomography X-ray system scanner, model number 728243. The Big Bore Oncology scanner is a whole body computed tomography X-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2031-2016·2016-06-29

    Siemens Biograph mCT-S PET/CT Scanners Recalled for Calibration Error

    Siemens Medical Solutions is recalling 100 Biograph mCT-S PET/CT scanners because using non-Siemens phantoms for calibration may result in unexpected SUV values.

    Product
    Biograph mCT-S(40) 4R, MATERIAL NUMBER 10248671 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2042-2016·2016-06-29

    Surgical Specialties Recalls Sharpoint Polypropylene Suture Due to Contamination

    Surgical Specialties Corporation is recalling Sharpoint Polypropylene Blue Monofilament 9-0 USP suture because it may contain Black Nylon 9-0 suture.

    Product
    Sharpoint Polypropylene Blue Monofilament 6"/15cm 9-0 USP, Product No. J2558N
    Category
    Medical Device
    Distribution
    9 states
  • ModerateFDA (Devices)·Z-2009-2016·2016-06-29

    Siemens Biograph PET/CT Scanners Recalled for Calibration Error Risk

    Siemens is recalling 46 Biograph 40 TruePoint PET/CT scanners due to a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.

    Product
    BIOGRAPH 40 TruePoint w/TrueV, Material Number 10097304 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2046-2016·2016-06-29

    Implant Direct Recalls InterActive Implant Open-Tray Transfers Due to Sizing Error

    Implant Direct is recalling 48 units of InterActive Implant Open-Tray Transfers because the wrong size was packaged, which may lead to oversized crown fabrication.

    Product
    6534-08N InterActive¿ Implant Open-Tray Transfer Narrow Part Number: 6534-08N Product Usage: Intended Use of Implant Direct Open Tray Transfers are to capture implant position in an elastomeric impression of the mandible or maxilla. Open Tray transfers stay within the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2034-2016·2016-06-29

    Siemens Biograph mCT-X 3R PET/CT Scanner Recall for Calibration Error

    Siemens is recalling 22 Biograph mCT-X 3R PET/CT scanners because using non-Siemens phantoms for calibration may result in unexpected SUV values.

    Product
    Biograph mCT-X 3R, MATERIAL NUMBER 10248673 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2006-2016·2016-06-29

    Siemens Biograph 16 TruePoint TV Recall for Calibration Error

    Siemens is recalling 36 Biograph 16 TruePoint TV scanners because using non-Siemens phantoms for calibration may result in unexpected SUV values.

    Product
    Biograph 16 TruePoint TV, Material Number 10249556 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2038-2016·2016-06-29

    Cell Marque Recalls SIOOA I Rabbit Monoclonal Antibody Lots

    Cell Marque is recalling specific lots of SIOOA I Rabbit Monoclonal Antibody due to unacceptable IHC test results. The affected units were distributed in the US and several international countries.

    Product
    SIOOA I (EP I84) Rabbit Monoclonal Antibody; Catalogue numbers 408R-14, 408R-15, and 408R-16; Part number: 470361. Intended for identifying by light microscopy the presence of associated antigens in sections of formalin-fixed, paraffin embedded tissue sections using IHC test…
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-2013-2016·2016-06-29

    Siemens Biograph 64 PET/CT Scanner Recall for Calibration Error

    Siemens is recalling 15 Biograph 64 PET/CT scanners because using non-Siemens phantoms for calibration may result in unexpected SUV values.

    Product
    BIOGRAPH 64 - 3 Ring, Material Number 08727450 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1040-2016·2016-06-29

    Profarma Recalls tabcin NOCHE Capsules Due to Manufacturing Deviations

    Profarma Distributors LLC is recalling 31 boxes of tabcin NOCHE capsules nationwide due to Current Good Manufacturing Practice (CGMP) deviations.

    Product
    tabcin NOCHE; Capsules,12-count box, UPC 501008485033
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1041-2016·2016-06-29

    Profarma Recalls Vermox Tablets Due to Manufacturing Deviations

    Profarma Distributors LLC is recalling 163 boxes of Vermox Tablets 100 mg due to CGMP deviations. The recall is voluntary and nationwide.

    Product
    VERMOX Tablets 100 mg; 6-count box, UPC 7501109900619
    Category
    Drug
    Distribution
    Distributed nationwide