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.

16776–16800 of 21645

  • ModerateFDA (Devices)·Z-1263-2015·2015-03-18

    Ortho-Clinical VITROS Hand-held Barcode Scanner Recall for Sample Skipping

    Ortho-Clinical Diagnostics is recalling VITROS Hand-held Barcode Scanners because they may skip sample cup positions when using the Batch Programming option.

    Product
    VITROS Hand-held Barcode Scanner, Catalog Number 6844210, for use with the following VITROS Systems: VITROS 5,1 FS Chemistry System, VITROS 3600 Immunodiagnostics System, VITROS 4600 Chemistry System, VITROS 5600 Integrated System. This product is an accessory for use with…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1216-2015·2015-03-11

    Arjo RotoRest Delta Therapy System Recalled for Unapproved Medical Claims

    Arjo Hospital Equipment AB is recalling 271 RotoRest Delta Advanced Therapy Systems because their labeling contains unapproved medical claims.

    Product
    RotoRest Delta Advanced Therapy System. The RotoRest Delta Advanced Kinetic Therapy System offers kinetic therapy for the most aggressive treatment of pulmonary complications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1218-2015·2015-03-11

    Arjo TriaDyne Proventa Critical Care Therapy System Recalled for Unapproved Claims

    Arjo Hospital Equipment AB is recalling 567 TriaDyne Proventa Critical Care Therapy Systems because their labeling and instructions for use contain unapproved medical claims.

    Product
    TriaDyne Proventa Critical Care Therapy System. The TriaDyne Proventa Critical Care Therapy System provides a comprehensive system of pulmonary and skin care therapies for the critically ill, immobilized patient.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0405-2015·2015-03-11

    Akorn Recalls Fluticasone Nasal Spray Due to Preservative Failure

    Akorn, Inc. is recalling Fluticasone Propionate Nasal Spray because the preservative benazalkonium chloride failed to meet stability specifications.

    Product
    Fluticasone Propionate Nasal Spray, USP, 50 mcg per spray, in amber glass bottle with net fill weight of 16 g that provides 120 actuations, Rx only, Manufactured by HI-TECH PHARMACAL CO., INC. Amityville, NY 11701 for Akorn Inc. 1925 W. Field Court, Suite 300 Lake Forest…
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1246-2015·2015-03-11

    DePuy Orthopaedics Recalls Partially Agglomerated SMARTSET GHV Bone Cement

    DePuy Orthopaedics is recalling one lot of SMARTSET GHV Gentamicin Bone Cement because it is partially agglomerated, which may cause surgical delays.

    Product
    SMARTSET GHV Gentamicin Bone Cement. A self-curing, radiopaque, polymethyl methacrylate based cement containing antibiotic. It is used for securing a metal or polymeric prosthesis to living bone in arthroplasty procedures. The bone cement has no intrinsic adhesive properties…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0397-2015·2015-03-11

    Qualitest Recalls Amlodipine Besylate Tablets Due to Oversized Size

    Qualitest Pharmaceuticals is recalling 2,808 bottles of Amlodipine Besylate tablets because one lot contains oversized tablets.

    Product
    AMLODIPINE BESYLATE TABLETS USP, 10 mg*, 1000 count bottles (NDC 0603-2110-32), Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1380-2015·2015-03-11

    Hi-Tech Pharmacal Recalls Ferrous Sulfate Elixir Due to pH Issues

    Hi-Tech Pharmacal is recalling 581 units of Ferrous Sulfate Elixir because stability testing showed out-of-specification pH results.

    Product
    FERROUS SULFATE ELIXIR 220 mg/5 mL, UPC 350838778059, NDC 50383-778-05 --- HI-TECH PHARMACAL CO, INC. AMITYVILLE, NY 11701
    Category
    Drug
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1227-2015·2015-03-11

    Baxter Recalls Syringe Tip Caps for Missing Latex Symbol

    Baxter is recalling Self-Righting Syringe Tip Caps because the latex symbol is missing from the labels.

    Product
    Baxter, Self-Righting Syringe Tip Caps, Self-Righting DISCPAC Syringe Tip Caps. Product codes H93866100, H93869100, H93866025, H93867025, H93867100, H938671025, H938671100, H938673025, H938673100, H938674025, H938674100, H938676025, H938676100, H938677025, H938677100…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0404-2015·2015-03-11

    Pfizer Recalls Oxecta Tablets Due to Failed Impurity Specifications

    Pfizer is recalling 139 bottles of Oxecta (oxycodone HCl) 7.5 mg tablets because they failed impurity and degradation specifications.

    Product
    Oxecta(TM) (oxycodone HCl) tablets, 7.5 mg, 100 count bottles, Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc. Bristol, TN, NDC 60793-526-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0395-2015·2015-03-11

    Actavis Recalls Dextroamphetamine Sulfate Capsules for Dissolution Failures

    Actavis Elizabeth LLC is recalling 42 bottles of Dextroamphetamine Sulfate Extended-Release Capsules, 15 mg, because they failed dissolution specifications.

    Product
    DEXTROAMPHETAMINE SULFATE — DEXTROAMPHETAMINE SULFATE (DEXTROAMPHETAMINE SULFATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1241-2015·2015-03-11

    Stryker Recalls V40 Femoral Heads Due to Assembly Issues

    Stryker Howmedica Osteonics is recalling nine V40 femoral heads because they could not be assembled with their corresponding stem trunnions.

    Product
    LFT v40 Femoral Head; Catalog Number 6260-9-032; V40 CoCr LFit Head 32mm/-4. Designed to be assembled onto a femoral hip stem trunnion during surgery for a total hip arthroplasty.
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1217-2015·2015-03-11

    Arjo Rotoprone Therapy System Recalled for Unapproved Medical Claims

    Arjo Hospital Equipment AB is recalling 226 Rotoprone Therapy Systems because their labeling and instructions for use contain unapproved medical claims.

    Product
    Rotoprone Therapy System. The Rotoprone Therapy System is an advanced patient care system for the treatment and prevention of pulmonary complications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1231-2015·2015-03-11

    Siemens ADVIA Centaur Progesterone Kit Recalled for High Result Bias

    Siemens is recalling ADVIA Centaur Progesterone Kits due to high bias in results above 30 ng/mL. The recall affects 1,719 kits distributed worldwide.

    Product
    ADVIA Centaur Systems Progesterone Kit, (5-pack Ref); In Vitro Diagnostic Catalog number: 02177364; SMN: 10333111.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1229-2015·2015-03-11

    Siemens ADVIA Centaur Progesterone Kit Recall for High Bias in Results

    Siemens Healthcare Diagnostics is recalling ADVIA Centaur Systems Progesterone Kits because results above 30 ng/mL may show high bias.

    Product
    ADVIA Centaur Systems Progesterone Kit, (1 -pack) In Vitro Diagnostic; Catalog number: 02382928; SMN: 10310305.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1245-2015·2015-03-11

    Baxter AMIA v1.0 APD System Recall for Labeling Warning

    Baxter Healthcare is recalling 55 AMIA v1.0 APD Systems to add a warning about the risk of unintended increased intraperitoneal volume for vulnerable patients.

    Product
    AMIA v1.0 APD System. For Automated Peritoneal Dialysis (APD) therapy for pediatric and adult renal patients.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1226-2015·2015-03-11

    Intuitive Surgical Recalls Vacuum Source Tubing Sets for Sterility Concerns

    Intuitive Surgical is recalling 706 Vacuum Source Tubing Sets for the EndoWrist Stabilizer because shipping damage may have compromised the sterile packaging.

    Product
    Vacuum Source Tubing Set for the EndoWrist Stabilizer for da Vinci S (IS2000) and Si (IS3000); Part number 420187-05. The Intuitive Surgical EndoWrist Stabilizer Instrument is intended to be used with the fourth arm of the da Vinci S Surgical System. The Intuitive Surgical…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1232-2015·2015-03-11

    Remel Recalls Oxoid Legionella BCYE Growth Supplement Due to False Negatives

    Remel Inc is recalling Oxoid Legionella BCYE Growth Supplement SR0110A because it may fail to recover Legionella pneumophila, leading to false negative test results.

    Product
    Oxoid Legionella BCYE Growth Supplement SR0110A packaged in packs of 10- 100 ml vials. The responsible firm name on the label is Oxoid Ltd., Basingstoke, Hampshire, England and Oxoid Ltd., Basingstoke, Hants, England.
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1219-2015·2015-03-11

    Zimmer Segmental System Hip Stem Recalled for Coating Defect

    Zimmer, Inc. is recalling specific Zimmer Segmental System hip stems because the PMMA coating may be missing or not meet specifications.

    Product
    Zimmer Segmental System (ZSS) Cemented Stem / ZSS Cemented Stem, Smooth Stem Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented or Non-Porous, Uncemented.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1239-2015·2015-03-11

    CooperSurgical Pessary Kit Recalled for Incorrect Size Labeling

    CooperSurgical is recalling 95 units of Pessary Kit-CUBE#2 because the packaging label displays the incorrect size.

    Product
    CooperSurgical PESSARY KIT-CUBE#2, 1-3/8 in , 35 mm Part Number: MXKPEC02
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0403-2015·2015-03-11

    Pfizer Recalls Oxecta Tablets Due to Failed Impurity Specifications

    Pfizer is recalling 137 bottles of Oxecta (oxycodone HCl) 5 mg tablets because they failed impurity and degradation specifications.

    Product
    Oxecta(TM) (oxycodone HCl) tablets, 5 mg, 100 count bottles, Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc. Bristol, TN, NDC 60793-525-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1233-2015·2015-03-11

    Arrow FiberOptix Intra-Aortic Balloon Catheter Kit Recalled for Labeling Error

    Arrow International Inc. is recalling 165 units of FiberOptix Intra-Aortic Balloon Catheter Kits because the outer package label incorrectly identifies the product size.

    Product
    ARROW FiberOptix Intra-Aortic Balloon Catheter Kit, 40 cc 7.5 Fr Product Code: IAB-05840-LWS The Arrow IAB is utilized for intra-aortic balloon counter-pulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation, during systole increases blood…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1208-2015·2015-03-04

    Biomet Shoulder Implant Recall Due to Missing Taper Adaptor

    Biomet is recalling specific shoulder implant baseplates because a taper adaptor is missing from the packaging, which may delay surgery.

    Product
    Comprehensive Reverse Shoulder Glenosphere Mini Baseplate 25mm with Taper Adaptor, Part Number: 010000589 Lot: 527400
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-1141-2015·2015-03-04

    Intuitive Surgical Recalls EndoWrist Vessel Sealers Due to Grip Interference

    Intuitive Surgical is recalling 3,282 EndoWrist One Vessel Sealers because manufacturing variability may cause interference in the instrument grips.

    Product
    EndoWrist One Vessel Sealer, IS3000, 6 pack used in conjunction with the da Vinci Surgical System Si IS3000 The EndoWrist One Vessel Sealer is a bipolar electrosurgical instrument for use with the da Vinci Surgical System and the ERBE VIO 300 D electrosurgical generator. It is…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0394-2015·2015-03-04

    Sun Pharma Recalls Ketorolac Ophthalmic Solution Due to Particulate Matter

    Sun Pharma Global Fze is recalling specific bottles of Ketorolac Tromethamine Ophthalmic Solution because the product contains particulate matter exceeding specification limits.

    Product
    Ketorolac Tromethamine Ophthalmic Solution, 0.5%, 3 mL bottle, Rx only, Distributed by: Caraco Pharmaceutical Laboratories Ltd., 1150 Elijah Mccoy Drive, Detroit, MI 48202; Manufactured at: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India; NDC…
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1214-2015·2015-03-04

    GE Healthcare Recalls Centricity PACS Workstation Due to Exam Merge Failure

    GE Healthcare is recalling 128 Centricity PACS Workstation systems because a software defect may cause exam records to go missing in single Study Mode.

    Product
    The Centricity PACS Workstation is intended for use as a primary diagnostic and analysis tool for diagnostic images by trained healthcare professionals, including radiologists, physicians, technologists, clinicians and nurses. It is also intended for use as a clinical review…
    Category
    Medical Device
    Distribution
    Distributed nationwide