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.

8976–9000 of 21595

  • ModerateFDA (Devices)·Z-1391-2019·2019-05-29

    Boston Scientific Recalls Auriga XL 4007 Laser System for Cooling Defect

    Boston Scientific is recalling specific Auriga XL 4007 laser systems due to a mechanical cooling issue that may cause premature power degradation and low power errors.

    Product
    AURIGA XL 4007 BRAZIL SYSTEM Model: M0068FS4007B0 Product Usage: The Auriga XL 4007 Laser System and the Auriga 30 Laser System including a fiber optic delivery system is intended to be used in surgical procedures such as open, laparoscopic and endoscopic, to perform inc
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1404-2019·2019-05-29

    Remel Thio Med Media Recalled for Potential Performance Failure

    Remel Inc is recalling Thio Med w/o Ind, w/Dex media because it may fail performance testing after 106 days. The expiration date is being shortened to 105 days.

    Product
    Thio Med w/o Ind, w/Dex (10ml) 20/PK Product Usage: Recommended for use in qualitative procedures as a general purpose media for the cultivation of aerobes and anaerobes
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1387-2019·2019-05-29

    KaVo Recalls DEXIS Titanium Intraoral Sensors Due to Calibration Error

    KaVo Dental Technologies is recalling 211 DEXIS Titanium Intraoral Sensors because incorrectly programmed calibration files may reduce image quality.

    Product
    DEXIS Titanium Intraoral Sensor Product Usage: The DEXIS Titanium Intraoral Sensor is a USB-driven sensor which is intended to acquire dental intraoral radiographic images. The DEXIS / KaVo sensor shall be operated by healthcare professionals, who are educated and competent t
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1372-2019·2019-05-29

    Polymer Technology Systems Recalls Lipid Panel Test Strips for Fit Issues

    Polymer Technology Systems is recalling certain Lipid Panel test strips because they may not fit tightly into the optical block, potentially causing incorrect test results.

    Product
    Lipid Panel test strips (as a component of smart bundles), REF 2729, also private labeled under Henry Schein as REF 570-0412
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1438-2019·2019-05-29

    Zimmer GmbH Recalls Cannulated Drills Due to Potential Material Deviation

    Zimmer GmbH is recalling specific cannulated drills because they may have been manufactured from a material different from the specifications.

    Product
    Drill, cannulated, 2.5x95mm, round shaft, Item Number 502015620
    Category
    Medical Device
    Distribution
    42 states
  • ModerateFDA (Devices)·Z-1403-2019·2019-05-29

    Remel Thio Med w/Dex, Hem, Vit K Media Recalled for Performance Failure

    Remel Inc is recalling Thio Med w/Dex, Hem, Vit K media because it may fail performance testing after 106 days. The expiration date is being shortened from 9 months to 105 days.

    Product
    Thio Med w/Dex, Hem, Vit K (9ml) 20/PK Product Usage: Recommended for use in qualitative procedures as a general purpose media for the cultivation of aerobes and anaerobes
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1401-2019·2019-05-29

    Remel Thio Med w/Dex, Hem, Vit K Media Recall for Performance Failure

    Remel Inc is recalling Thio Med w/Dex, Hem, Vit K media because products may fail performance testing after 106 days from manufacturing.

    Product
    Thio Med w/Dex, Hem, Vit K (9ml) 100/PK Product Usage: Recommended for use in qualitative procedures as a general purpose media for the cultivation of aerobes and anaerobes
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1460-2019·2019-05-29

    Zimmer GmbH Recalls CBS Micro Countersink Cannulated AO Screws

    Zimmer GmbH is recalling CBS micro, countersink, cannulated, AO screws (Item Number 503004541) because they may have been manufactured from a different material than specified.

    Product
    CBS micro, countersink, cannulated, AO, Item Number 503004541
    Category
    Medical Device
    Distribution
    42 states
  • ModerateFDA (Devices)·Z-1396-2019·2019-05-29

    Boston Scientific Recalls Auriga 30 Laser Systems Due to Power Degradation

    Boston Scientific is recalling specific Auriga 30 laser systems because a mechanical cooling issue may cause faster-than-normal power degradation and low power errors.

    Product
    AURIGA 30 BRAZIL ZERO COST SYSTEM UPN: M0068S30BZ0 Product Usage: The Auriga XL 4007 Laser System and the Auriga 30 Laser System including a fiber optic delivery system is intended to be used in surgical procedures such as open, laparoscopic and endoscopic, to perform inc
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1279-2019·2019-05-29

    Neusoft NeuViz 64 CT Scanner Recalled for Image Loss Defect

    Neusoft Medical Systems is recalling 37 NeuViz 64 CT scanners due to a software defect that can cause image loss during specific scans.

    Product
    NeuViz 64 Multi-slice CT Scanner System Product Usage: The Multi-Slice CT Scanner System can be used as a whole body computed tomography x-ray system featuring a continuously rotating x-ray tube and detector array. The acquired x-ray transmission data is reconstructed by comp
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1428-2019·2019-05-29

    Zimmer GmbH Recalls 2.7mm AO Surgical Drills Due to Material Concerns

    Zimmer GmbH is recalling specific 2.7mm AO surgical drills because they may have been manufactured from a material different from the specifications.

    Product
    Drill for 2.7mm screw, 2x100mm, AO, Item Number 502015208
    Category
    Medical Device
    Distribution
    42 states
  • ModerateFDA (Devices)·Z-1379-2019·2019-05-29

    Remel Thio Med w/Dex, Hem, Vit K Media Recalled for Performance Failure

    Remel Inc is recalling Thio Med w/Dex, Hem, Vit K media because it may fail performance testing after 57 days. The expiration date is shortened to 56 days.

    Product
    Thio Med w/Dex, Hem, Vit K (7ml) 20/PK Product Usage; Recommended for use in qualitative procedures as a general purpose media for the cultivation of aerobes and anaerobes
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1390-2019·2019-05-29

    Thommen Medical Recalls Dental Adapters for Handpiece Due to Deformation Risk

    Thommen Medical AG is recalling 15 units of dental adapters for handpieces because the coupling may deform, making removal difficult.

    Product
    Adapter for handpiece, guided, reusable, for guide sleeve 0 4.8 mm Article number: 3.04.090 - Product Usage: The adapter for handpiece, guided reusable, for guide sleeve ¿ 4.8 mm is used to transfer the implant from the packaging to the patient via a plug-in connection and scre
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1408-2019·2019-05-29

    Remel Thio Med Culture Media Recalled for Potential Performance Failure

    Remel Inc is recalling Thio Med culture media due to potential performance failures after 106 days. The expiration date is shortened to 105 days.

    Product
    Thio Med w/o Ind, w/Dex (18ml) 100/PK Product Usage: Recommended for use in qualitative procedures as a general purpose media for the cultivation of aerobes and anaerobes
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1441-2019·2019-05-29

    Zimmer GmbH Recalls Cannulated Drills Due to Material Specification Concerns

    Zimmer GmbH is recalling specific cannulated drills because an investigation found they may have been manufactured from a different material than specified.

    Product
    Drill, cannulated, 2.8x120mm, AO, Item Number 502015628
    Category
    Medical Device
    Distribution
    42 states
  • ModerateFDA (Devices)·Z-1378-2019·2019-05-29

    Remel Inc Recalls Thio Med w/Dex, Hemin, Vit K Media

    Remel Inc is recalling Thio Med w/Dex, Hemin, Vit K media because the products may fail performance testing after 57 days.

    Product
    Thio Med w/Dex, Hemin, Vit K (5ml) 20/PK Product Usage: Recommended for use in qualitative procedures as a general purpose media for the cultivation of aerobes and anaerobes
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1442-2019·2019-05-29

    Zimmer GmbH Recalls Cannulated Drills Due to Material Specification Concerns

    Zimmer GmbH is recalling specific cannulated drills because they may have been manufactured from a material different from the defined specifications.

    Product
    Drill, cannulated, 2.8x150mm, AO, Item Number 502015629
    Category
    Medical Device
    Distribution
    42 states
  • ModerateFDA (Devices)·Z-1281-2019·2019-05-29

    NeuViz 16 Essence CT Scanner Recalled for Software Defect

    Neusoft Medical Systems is recalling two NeuViz 16 Essence CT scanners due to a software defect that may cause image loss during specific scans.

    Product
    NeuViz 16 Essence Multi-slice CT Scanner System Product Usage: The Multi-Slice CT Scanner System can be used as a whole body computed tomography x-ray system featuring a continuously rotating x-ray tube and detector array. The acquired x-ray transmission data is reconstructed
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1443-2019·2019-05-29

    Zimmer GmbH Recalls Cannulated Drills Due to Potential Material Deviation

    Zimmer GmbH is recalling specific cannulated drills because they may have been manufactured from a material different from the specifications. The products were distributed to 41 US states.

    Product
    Drill, cannulated, 3x90mm, round shaft, Item Number 502015630
    Category
    Medical Device
    Distribution
    42 states
  • ModerateFDA (Devices)·Z-1445-2019·2019-05-29

    Zimmer V-TEK IVP Step Drill Recalled for Material Specification Deviation

    Zimmer GmbH is recalling V-TEK IVP step drills because they may have been manufactured from a different material than specified.

    Product
    V-TEK", IVP step drill 2-3.4x124mm, 16mm stop, contra-angle, Item Number 502015634
    Category
    Medical Device
    Distribution
    42 states
  • ModerateFDA (Devices)·Z-1370-2019·2019-05-29

    Cook Stent Sets Recalled for Missing Warning About Stent Knotting

    Cook Inc. is recalling Kwart RetroInject and Salle Intraoperative Pyeloplasty Stent Sets because the instructions for use did not include a warning for stent knotting.

    Product
    Cook Salle Intraoperative Pyeloplasty Stent Set PRODUCT/CATALOG NUMBER/GPN: 4.0 Fr - SIPSF-040018-56-6 G18168 4.0 Fr - SIPSF-040018-59 G32773 4.7 Fr SIPSF-050018-59 G32774
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1400-2019·2019-05-29

    Remel Thio Med Culture Media Recalled for Potential Performance Failure

    Remel Inc is recalling Thio Med culture media because the product may fail performance testing after 106 days. The expiration date is being shortened from 9 months to 105 days.

    Product
    Thio Med w/o Ind, w/Dex (9ml) 100/PK Product Usage: Recommended for use in qualitative procedures as a general purpose media for the cultivation of aerobes and anaerobes
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1405-2019·2019-05-29

    Remel Thio Med Media Recalled for Potential Performance Failure

    Remel Inc is recalling Thio Med w/o Ind, w/Dex media because it may fail performance testing after 106 days. The expiration date is shortened from 9 months to 105 days.

    Product
    Thio Med w/o Ind, w/Dex (10ml) 100/PK Product Usage: Recommended for use in qualitative procedures as a general purpose media for the cultivation of aerobes and anaerobes
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1421-2019·2019-05-29

    Stryker 2.5x94mm Drill Recalled for Potential Material Deviation

    Zimmer GmbH is recalling Stryker 2.5x94mm Drills because an investigation found they may have been manufactured from a different material than specified.

    Product
    Drill, 2.5x94mm, Stryker, Item Number 502015136
    Category
    Medical Device
    Distribution
    42 states
  • ModerateFDA (Devices)·Z-1394-2019·2019-05-29

    Boston Scientific Recalls Auriga XL 4007 Laser Systems for Cooling Defect

    Boston Scientific is recalling six Auriga XL 4007 laser systems worldwide due to a mechanical cooling issue that may cause power degradation and stop laser emission.

    Product
    AURIGA XL 4007 GENERAL - ZERO COST SYSTE UPN: FS4007GZ0 Product Usage: The Auriga XL 4007 Laser System and the Auriga 30 Laser System including a fiber optic delivery system is intended to be used in surgical procedures such as open, laparoscopic and endoscopic, to perfo
    Category
    Medical Device
    Distribution
    0 states