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.

15026–15050 of 21645

  • ModerateFDA (Devices)·Z-1232-2016·2016-03-30

    Siemens syngo X Workplace Medical Workstation Recalled for Segmentation Error

    Siemens Medical Solutions USA is recalling six syngo X Workplace medical workstations because imported segmentation results appear mirrored, rendering them unusable for ablation procedures.

    Product
    syngo X Workplace is a medical workstation for real-time viewing, image manipulation, 3D-visualization, communication, and storage of medical images and data on exchange media. It is used for diagnostic image viewing and post processing during interventional procedures. .
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1240-2016·2016-03-30

    Siemens Estradiol Test Recalled Due to Potential False Results

    Siemens is recalling ADVIA Centaur Enhance Estradiol tests because the drug fulvestrant may cause falsely elevated results.

    Product
    Siemens ADVIA Centaur Enhance Estradiol Test Code eE2 Catalog Number: 10490889, 10491445, 10697757 Product Usage: For in vitro diagnostic use in the quantitative determination of estradiol in human serum and plasma (heparinized and EDTA) using the ADVIA Centaur¿, ADVIA…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1190-2016·2016-03-30

    Zimmer Biomet Issues Correction Notice for Instinct Java System Cleaning Instructions

    Zimmer Biomet is issuing a correction notice to provide updated cleaning and disinfecting instructions for the Instinct Java System and Universal Clamp System.

    Product
    Instinct¿ Java¿ System (IFU reference: 046WAN0000T) . Stabilizes one or more vertebral segments from the thoracic spine to the sacrum during the development of bone tissue.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1237-2016·2016-03-30

    Cook Medical Recalls Nephrostomy Balloon Sets Due to Labeling Mix-up

    Cook Medical is voluntarily recalling specific lots of Ultraxx Nephrostomy Balloon Sets and Ascend AQ Ureteral Dilation Balloon Catheter Sets because of a labeling mix-up.

    Product
    UltraxxTM Nephrostomy Balloon Set The Ultraxx" Nephrostomy Balloon Set consists of a radiopaque balloon catheter, radiopaque sheath, and inflation device. The Ultraxx" Nephrostomy Balloon Set is used to dilate the musculofascia, renal capsule, and parenchyma to establish and…
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-1247-2016·2016-03-30

    Neurotherm Curved Radiofrequency Cannula Recalled for Mislabeling

    Neurotherm, Inc. is recalling 135 curved radiofrequency cannulas because straight needles were incorrectly labeled as curved.

    Product
    Neurotherm Curved Radiofrequency (RF) cannnula 10 cm 18 gauge, 10 mm active tip Model Number: C-1010-R-18 Product Usage: The device is a radiofrequency needle, used for the application of radiofrequency energy with as intended result, thermo coagulation of nervous tissue…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1238-2016·2016-03-30

    Cook Medical Recalls Ureteral Balloon Catheters Due to Labeling Mix-Up

    Cook Medical is voluntarily recalling specific lots of Ascend AQ Ureteral Dilation Balloon Catheter Sets and Ultraxx Nephrostomy Balloon Sets due to a labeling error where packages may contain the wrong product.

    Product
    Ascend¿ AQ¿ Ureteral Dilation Balloon Catheter Set The Ascend¿ AQ¿ Ureteral Dilation Balloon Catheter Set consists of a radiopaque balloon catheter and inflation device. The Ascend¿ AQ¿ Ureteral Dilation Balloon Catheter Set is used for transluminal dilation of ureteral…
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-1244-2016·2016-03-30

    MHI-TM2000 Linear Accelerator Software Recall for Treatment Status Error

    Mitsubishi Heavy Industries is recalling MHI-TM2000 Linear Accelerator Systems due to a software anomaly that may incorrectly change a patient's treatment status to 'Untreated'.

    Product
    MHI-TM2000 Linear Accelerator System (Software Version 3.0.0 and after) Intended for radiation therapy of lesions, tumors. conditions anywhere in the body where radiation therapy is indicated.
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Food)·F-0773-2016·2016-03-30

    ShopRite Unsalted Dry Roasted Cashews Recalled for Mislabeling

    Wakefern Foods Corp. is recalling ShopRite Unsalted Dry Roasted Cashews because the product may be mislabeled.

    Product
    ShopRite Dry Roasted Unsalted Cashews 7 oz. (198 g) Distributed by Wakefern Food Corp., Elizabeth, NJ 07207 UPC 4119001620
    Category
    Food
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-1115-2016·2016-03-23

    Zimmer Manufacturing Recalls Sterile Bone Screws Due to Calibration Issues

    Zimmer Manufacturing B.V. is recalling sterile bone screws used in hip arthroplasty due to insufficient sealer calibration data for products packaged between August 2010 and April 2013.

    Product
    Product 17 consists of all product under product code: LPH and same usage: Item no: 625004515 BONE SCREW 4.5X15 SELF-TA 625004520 BONE SCREW 4.5X20 SELF-TA 625004525 BONE SCREW 4.5X25 SELF-TA 625004530 BONE SCREW 4.5X30 SELF-TA 625004535 BONE SCREW 4.5X35 SELF-TA…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1120-2016·2016-03-23

    Zimmer Manufacturing Recalls Hip Arthroplasty Components Due to Sealer Calibration Issues

    Zimmer Manufacturing B.V. is recalling specific hip arthroplasty components due to insufficient sealer calibration data for products packaged between August 2010 and April 2013.

    Product
    Product 22 consists of all product under product code: JDI and same usage: Item no: 811400218 CPT 12/14 COCR REVISION S 811400318 CPT 12/14 COCR REVISION S 811400420 CPT 12/14 COCR REVISION S 811400423 CPT 12/14 COCR REVISION S 811400426 CPT 12/14 COCR REVISION S…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1180-2016·2016-03-23

    Steris Quick Connects Recalled Due to Hysteroscope Port Mismatch

    Steris Corporation is recalling 809 Quick Connect flow units because processing instructions incorrectly list a hysteroscope model with two inlet ports when the device has only one.

    Product
    Quick Connects. Steris Corporation. Model numbers: QKC1736E, QKC1736INT, QKC1737E, and QKC1737INT. Each Quick Connect contains a flow unit consisting of tubing, tethers, and adapters. For sterilant and rinse water used in endoscope washers.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1135-2016·2016-03-23

    Zimmer Manufacturing Recalls Interlocking Intramedullary Screws Due to Calibration Issues

    Zimmer Manufacturing B.V. is recalling 1,777 sterile interlocking intramedullary screws due to insufficient sealer calibration data for products packaged between August 2010 and April 2013.

    Product
    Product 37 consists of all product under product code: HSB and same usage: Item no: 225302055 INTERLOCKING IM SCREW LG 225303055 INTERLOCKING IM SCREW LG 225304055 INTERLOCKING IM SCREW LG 225304555 INTERLOCKING IM SCREW LG 225305055 INTERLOCKING IM SCREW LG 225305555…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1186-2016·2016-03-23

    Sorin Recalls Stockert Heater-Cooler 3T Units for Instruction Manual Updates

    Sorin Group USA is recalling 1,125 Stockert Heater-Cooler 3T units to update instruction manuals with water quality enhancements.

    Product
    Stockert Heater-Cooler 3T; Item Number 16-02-8, H3T/240V/60Hz ; 16-02-82, H3T208V/60Hz ; 16-02-85, H3T/120V/60Hz. Device Listing E572259
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1153-2016·2016-03-23

    Zimmer Manufacturing Recalls One-Piece Lag Screws Due to Sealer Calibration Issues

    Zimmer Manufacturing B.V. is recalling 58,320 sterile one-piece lag screws due to insufficient sealer calibration data for products packaged between August 2010 and April 2013.

    Product
    Product 55 consists of all product under product code: HSB and same usage: Item no: 225900132 ONE-PIECE LAG SCREW 11MM 225900135 ONE-PIECE LAG SCREW 11MM 225900137 ONE-PIECE LAG SCREW 11MM 225900140 ONE-PIECE LAG SCREW 11MM 225900142 ONE-PIECE LAG SCREW 11MM 225900145…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1188-2016·2016-03-23

    Richard Wolf Vesa 75/100 Adaptation Recalled for Missing Rivets

    Richard Wolf Medical Instruments Corp. is recalling 108 Vesa 75/100 adaptations with rotation because monitor mounts may be missing riveting.

    Product
    The Vesa 75/100 adaptation with rotation is an accessory to a surgical camera intended to be used to record operative procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1134-2016·2016-03-23

    Zimmer Manufacturing Recalls Interlocking IM Screws Due to Sealer Calibration Issues

    Zimmer Manufacturing B.V. is recalling 268 units of Interlocking IM Screws 4.5 due to insufficient sealer calibration data for products packaged between August 2010 and April 2013.

    Product
    Product 36 consists of all product under product code: HSB and same usage: Item no: 225302745 INTERLOCKING IM SCREW 4.5 225303045 INTERLOCKING IM SCREW 4.5 225303245 INTERLOCKING IM SCREW 4.5 225303545 INTERLOCKING IM SCREW 4.5 225303745 INTERLOCKING IM SCREW 4.5…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1165-2016·2016-03-23

    Zimmer Versys Advocate Cemented Hip Implants Recalled for Calibration Data Issues

    Zimmer Manufacturing B.V. is recalling 5,013 units of Versys Advocate Cemented hip implants due to insufficient sealer calibration data. The affected sterile products were distributed nationwide.

    Product
    Product 67 consists of all product under product code: JDI and same usage: Item no: 785001100 VERSYS ADVOCATE CEMENTED 785001200 VERSYS ADVOCATE CEMENTED 785001220 VERSYS ADVOCATE CEMENTED 785001300 VERSYS ADVOCATE CEMENTED 785001320 VERSYS ADVOCATE CEMENTED 785001400…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1140-2016·2016-03-23

    Zimmer Manufacturing Recalls Sterile Femoral and Humeral Intramedullary Nails

    Zimmer Manufacturing B.V. is recalling 1,622 sterile femoral and humeral intramedullary nails due to insufficient sealer calibration data.

    Product
    Product 42 consists of all product under product code: HSB and same usage: Item no: 225224010 M/DN FEM IM NAIL 10MM DIA 225228010 M/DN FEM IM NAIL 10MM DIA 225230010 M/DN FEM IM NAIL 10MM DIA 225232010 M/DN FEM IM NAIL 10MM DIA 225234010 M/DN FEM IM NAIL 10MM DIA…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1159-2016·2016-03-23

    Zimmer Precoat Tibia Plates Recalled for Sealer Calibration Issues

    Zimmer Manufacturing B.V. is recalling 39 sterile precoat tibia plates used in total knee arthroplasty due to insufficient sealer calibration data.

    Product
    Product 61 consists of all product under product code: JWH and same usage: Item no: 598003712 STD PRECOAT TIBIA PLATE S for use in total knee arthroplasty
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1122-2016·2016-03-23

    Zimmer Manufacturing Recalls Distal Femoral Bone Fixation Appliances

    Zimmer Manufacturing B.V. is recalling 37 sterile distal femoral bone fixation appliances due to insufficient sealer calibration data.

    Product
    Product 24 consists of all product under product code: HRS and same usage: Item no: 234703104 DISTAL MEDIAL FEMORAL CON 234703206 DISTAL MEDIAL FEMORAL CON 234703208 DISTAL MEDIAL FEMORAL CON 234800504 DISTAL POSTERIOR/LATERAL 234800506 DISTAL POSTERIOR/LATERAL…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1099-2016·2016-03-23

    Zimmer Manufacturing Recalls Sterile Bone Fixation Screws Due to Sealer Calibration

    Zimmer Manufacturing B.V. is recalling sterile 1.5 x 6 Cortical Screws due to insufficient sealer calibration data for products packaged between August 2010 and April 2013.

    Product
    Product 1 consists of all product under , product code: JWH and same usage: Item no: 47481500601 1.5 X 6 CORT SCREW HEX/SE Product Usage: A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1171-2016·2016-03-23

    Sekisui Diagnostics Recalls Acetaminophen Assay Kits Due to Crystal Formation

    Sekisui Diagnostics is recalling 14,407 Acetaminophen L3K Assay kits because crystal formation in the reagent can cause samples to under-recover.

    Product
    Sekure Chemistry Sekisui Diagnostics Acetaminophen L3K Assay, In-vitro Diagnostic Catalog Number: 506-10: R1: 1 x 10ml, R2: 2 x 10ml Catalog Number: 506-30: R1: 3 x 10ml, R2: 6 x 10ml In-Vitro quantitative measurement of Acetaminophen in serum and plasma used m the…
    Category
    Medical Device
    Distribution
    10 states
  • ModerateFDA (Devices)·Z-1125-2016·2016-03-23

    Zimmer Manufacturing Recalls Distal Femoral Components Due to Calibration Data Issues

    Zimmer Manufacturing B.V. is recalling 945 units of distal femoral components due to insufficient sealer calibration data for products packaged between August 2010 and April 2013.

    Product
    Product 27 consists of all product under product code: HSB and same usage: Item no: 234703104 DISTAL MEDIAL FEMORAL CON 234703206 DISTAL MEDIAL FEMORAL CON 234703208 DISTAL MEDIAL FEMORAL CON 234800504 DISTAL POSTERIOR/LATERAL 234800506 DISTAL POSTERIOR/LATERAL…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1095-2016·2016-03-23

    Pro-Dex Recalls Battery Packs for Surgical Screwdriver Due to Particulates

    Pro-Dex Inc is recalling 1,995 sterile battery packs for the KLS Martin Max Driver because they may contain particulates within the sterile package.

    Product
    Battery Pack KLS-SD-1000 Single Models: KLS-BP-001 Used to power the KLS Martin Max Driver (battery powdered surgical screwdriver).
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0777-2016·2016-03-23

    Pharmedium Recalls Subpotent Epinephrine Injection Bags

    Pharmedium Services, LLC is recalling 6,816 bags of subpotent epinephrine injection due to discoloration and FDA-confirmed potency issues.

    Product
    NORepinephrine Bitartrate, 4 mg (16 mcg/mL) added to 250 mL 0.9% Sodium Chloride Injection USP, in 250 mL Viaflex Bag, Rx only, PharMEDium Services, LLC, Sugar Land, TX NDC 61553-134-61
    Category
    Drug
    Distribution
    Distributed nationwide