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.

21151–21175 of 21633

  • ModerateFDA (Devices)·Z-0098-2013·2012-10-31

    Westmed Recalls Arterial Blood Gas Kits Due to Alcohol Pad Contaminants

    Westmed is recalling Pulset Arterial Blood Gas sampling kits because they contain TRIAD brand alcohol pads that are being recalled for potential contaminants.

    Product
    Pulset Arterial Blood Gas (ABG) sampling kit. Full Kit, Pulset, 1 cc, 25 g x 5/8" A Needle, 25U Balanced Heparin, part number: 3173-14. An arterial blood sampling kit is a device, in kit form, used to obtain arterial blood samples from a patient for blood gas…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0105-2013·2012-10-31

    Westmed Recalls Arterial Blood Gas Kits Due to Contaminated Alcohol Pads

    Westmed is recalling Pulset ABG sampling kits because they contain TRIAD alcohol pads that may have potential contaminants.

    Product
    Pulset Arterial Blood Gas (ABG) sampling kit. Full Kit, Pulset, 3 cc, w/Crickett 22g x 1" A Needle, 25U Balanced Heparin, part number: 3372-95. An arterial blood sampling kit is a device, in kit form, used to obtain arterial blood samples from a patient for blood gas…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0096-2013·2012-10-31

    Westmed Recalls Arterial Blood Gas Kits Due to Contaminated Alcohol Pads

    Westmed is recalling Pulset ABG sampling kits because they contain TRIAD alcohol pads that are being recalled for potential contaminants.

    Product
    Pulset Arterial Blood Gas (ABG) sampling kit. Modified Kit, Pulset, 1 cc, w/Crickett 25g x 5/8" A Needle, 25U Balanced Heparin, part number: 3165-95. An arterial blood sampling kit is a device, in kit form, used to obtain arterial blood samples from a patient for blood gas…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0134-2013·2012-10-31

    Nipro AquaLiner Hydrophilic Guidewire Recalled for Insufficient Lubricity

    Nipro Medical Corporation is recalling AquaLiner Hydrophilic Guidewires because insufficient lubricity causes them to get stuck in the housing and become nonfunctional.

    Product
    AquaLiner Hydrophilic Guidewire 0.035" X 260cm, Angle/ Regular. AquaLiner Hydrophilic Guidewire is designed for use in angiographic procedures to introduce/ position catheters and interventional devices within the vasculature.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0122-2013·2012-10-31

    Orthosensor Recalls Knee Trial Software Due to Signal Interference

    Orthosensor is recalling 9 units of Knee Trial software version 1.82 because metal objects in the operating room obstruct the line of sight between the knee balancer and the Link station.

    Product
    "****ORTHO SENSOR**12-123-A Knee Trial for Trithion***1560 Saw grass Corporate Pkwy***4Th floor***Sunrise, FL 33323***www.orthosensor.com***" Rx Only*** Sterile/EO***Made exclusively for Stryker Orthopaedics***. Is the graphic user interface software associated with the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0099-2013·2012-10-31

    Westmed Recalls Arterial Blood Gas Kits Due to Alcohol Pad Contaminants

    Westmed is recalling ABG sampling kits containing TRIAD alcohol pads due to potential contaminants in the pads.

    Product
    Pulset Arterial Blood Gas (ABG) sampling kit. Full Kit, Pulset, 1 cc, with Eclipse, 25 g x 5/8" A Needle, 25U Balanced Heparin, part number: 3173-98. An arterial blood sampling kit is a device, in kit form, used to obtain arterial blood samples from a patient for blood gas…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-019-2013·2012-10-31

    Bristol-Myers Squibb Recalls Mislabelled Kombiglyze XR Physician Sample Cartons

    Bristol-Myers Squibb is recalling specific lots of Kombiglyze XR physician sample cartons because the external packaging was incorrectly labeled as 2.5mg/1000mg, while the contents were 5mg/500mg.

    Product
    Kombiglyze XR (saxagliptin and metformin HCl extended-release) tablets, Physician Sample-Not For Sale, 7 Tablets per Carton, 5 mg/500 mg, Rx only, Manufactured By: Bristol-Myers Squibb Company, Princeton NJ 08543, USA, Marketed By: Bristol-Myers Squibb Company, Princeton NJ…
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-018-2013·2012-10-31

    Bristol-Myers Squibb Recalls Mispackaged Kombiglyze XR Physician Sample Cartons

    Bristol-Myers Squibb is recalling 117,049 physician sample cartons of Kombiglyze XR because some external cartons were mislabeled with the wrong dosage, though the individual blister units inside are correctly labeled.

    Product
    Kombiglyze XR (saxagliptin and metformin HCl extended-release) tablets, Physician Sample-Not For Sale, 6 Tablets per Carton, 2.5 mg/1000 mg, Rx only, Manufactured By: Bristol-Myers Squibb Company, Princeton NJ 08543, USA, Marketed By: Bristol-Myers Squibb Company, Princeton NJ…
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0024-2013·2012-10-31

    Optovue Recalls Reference Materials Shipped with iVue and RTVue Systems

    Optovue is recalling 795 units of reference materials shipped with iVue and RTVue systems because they were not included in the FDA clearance.

    Product
    Reference materials "RETINAL OCT Analysis and Interpretation Method" shipped with iVue System (K091404) and the "Retina Poster" shipped with iVue System (K091404) and RTVue Systems (K101505); Models: iVue-100, RTVue-100; The physical Product is manufactured and distributed by…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0101-2013·2012-10-31

    Westmed Recalls Arterial Blood Gas Kits Due to Alcohol Pad Contaminants

    Westmed is recalling ABG sampling kits containing TRIAD alcohol pads due to potential contaminants in the pads.

    Product
    Pulset Arterial Blood Gas (ABG) sampling kit. Modified Kit, Pulset, 3 cc, w/Crickett 23g x 1" A Needle, 25U Balanced Heparin, No B Needle or Q-Cork, part number: 3363-95. An arterial blood sampling kit is a device, in kit form, used to obtain arterial blood samples from a…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0100-2013·2012-10-31

    Westmed Recalls Arterial Blood Gas Kits Due to Contaminated Alcohol Pads

    Westmed is recalling Pulset ABG sampling kits because they contain TRIAD brand alcohol pads that are being recalled for potential contaminants.

    Product
    Pulset Arterial Blood Gas (ABG) sampling kit. Modified Kit, Pulset, 3 cc, w/Crickett 22g x 1" A Needle, 25U Balanced Heparin, part number: 3342-95. An arterial blood sampling kit is a device, in kit form, used to obtain arterial blood samples from a patient for blood gas…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0106-2013·2012-10-31

    Westmed Recalls ABG Sampling Kits Due to Contaminated Alcohol Pads

    Westmed is recalling Pulset ABG sampling kits because they contain TRIAD alcohol pads that may have potential contaminants.

    Product
    Pulset Arterial Blood Gas (ABG) sampling kit. Full Kit, Pulset, 3 cc, 23g x 1" A/B Needle, 25U Balanced Heparin, part numbers: 3373, 3393. An arterial blood sampling kit is a device, in kit form, used to obtain arterial blood samples from a patient for blood gas…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0103-2013·2012-10-31

    Westmed Recalls Arterial Blood Gas Kits Due to Contaminated Alcohol Pads

    Westmed is recalling Pulset Arterial Blood Gas sampling kits because they contain TRIAD brand alcohol pads that are being recalled for potential contaminants.

    Product
    Pulset Arterial Blood Gas (ABG) sampling kit. Modified Kit, Pulset, 3 cc, w/Crickett 23g x 1" A Needle, Luer Slip Barrel, 25U Balanced Heparin, No B Needle or Q-Cork, part number: 3363-95S. An arterial blood sampling kit is a device, in kit form, used to obtain arterial…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0081-2013·2012-10-24

    Boston Scientific Recalls Leveen Coaccess Introducer Sets for Incorrect Portuguese Instructions

    Boston Scientific is recalling 19,716 Leveen Coaccess Introducer Sets because the Portuguese instructions for use contain errors. The devices were distributed in Brazil, Portugal, and Hong Kong.

    Product
    Leveen Coaccess Introducer Set. Disposable, monopolar, electrosurgical devices, intended for use in conjunction with BSC radiofrequency generator for the thermal coagulation necrosis of soft tissues, including partial or complete ablation of nonresectable liver lesions.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Food)·F-0295-2013·2012-10-24

    Sun Boricua Pa'l Mundo Recalls Marlin-Filled Turnovers for Undeclared Color Additives

    Sun Boricua Pa'l Mundo Inc. is recalling 36,000 units of Marlin-filled turnovers in Puerto Rico due to undeclared color additives.

    Product
    "Tacos de Marlin" (Marlin-filled turnovers)***Keep Refrigerated***Manufacturado por Sun Boricua Pa'l Mundo Inc, Carr. 486 km 0.1 Bo. Quebrada, Camuy PR 00627
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·F-0123-2013·2012-10-24

    Southwind Foods Recalls Frozen Snapper Fill IQF for Mislabeling

    Southwind Foods is recalling 145 cases of frozen snapper fill IQF because the product was mislabeled and misleading.

    Product
    Frozen Red Cod Fillet (Red Snapper) Individually Quick Frozen was labeled and identified as Snapper FILL IQF (ROCKFISH). 1/10 lb, code #14343.
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Food)·F-0296-2013·2012-10-24

    Sun Boricua Pa'l Mundo Shrimp Turnovers Recalled for Undeclared Color Additives

    Sun Boricua Pa'l Mundo Inc. is recalling shrimp-filled turnovers in Puerto Rico because they contain undeclared color additives.

    Product
    "Tacos de Camarones" (Shrimp-filled turnovers)***Keep Refrigerated***Manufacturado por Sun Boricua Pa'l Mundo Inc, Carr. 486 km 0.1 Bo. Quebrada, Camuy PR 00627
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0060-2013·2012-10-24

    Zimmer Recalls CPT Modular Hip Stems Due to Packaging Errors

    Zimmer Inc. is removing CPT Modular Hip Stems from the market because they were packaged in incorrect cartons and distributed internationally and domestically.

    Product
    CPT Modular Stem, Item No. 00-8011-001-00; Lot 61947708. CPT stems are primary cemented femoral hip stems used by surgeons in total hip arthroplasty.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0293-2013·2012-10-24

    Sun Boricua Lobster-Filled Turnovers Recalled for Undeclared Color Additives

    Sun Boricua Pa'l Mundo Inc. is recalling lobster-filled turnovers in Puerto Rico due to undeclared color additives.

    Product
    "Tacos de Langosta" (Lobster-filled turnovers)***Keep Refrigerated***Manufacturado por Sun Boricua Pa'l Mundo Inc, Carr. 486 km 0.1 Bo. Quebrada, Camuy PR 00627
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0062-2013·2012-10-24

    Zimmer Recalls CPT Hip Stems Due to Incorrect Packaging Cartons

    Zimmer Inc. is removing CPT hip stems from the market because they were packaged in incorrect cartons and distributed domestically and internationally.

    Product
    CPT Femoral Stem 12/14 Neck Taper Extended Offset,(item 00-8114-001-10. CPT stems are primary cemented femoral hip stems used by surgeons in total hip arthroplasty.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0080-2013·2012-10-24

    Boston Scientific Recalls Leveen Needle Electrodes Due to Incorrect Portuguese Instructions

    Boston Scientific is recalling Leveen Coaccess Needle Electrodes because the Portuguese instructions for use contain errors. The recall affects units distributed in Brazil, Portugal, and Hong Kong.

    Product
    Leveen Coaccess Needle Electrode (3.5/15) and (4.0/15). Disposable, monopolar, electrosurgical devices, intended for use in conjunction with BSC radiofrequency generator for the thermal coagulation necrosis of soft tissues, including partial or complete ablation of…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0059-2013·2012-10-24

    Beckman Coulter Recalls Unicel Closed Tube Aliquotter Units Due to Hardware Error

    Beckman Coulter is recalling 18 Unicel Closed Tube Aliquotter units because a hardware motion error may occur. The recall covers units distributed in the US and several international locations.

    Product
    Unicel Closed Tube Aliquotter (UCTA) for UniCel DxC 660i, UniCel DxC 680i, UniCel DxC 860i, UniCel DxC 880i Synchron Access Clinical Systems. Part Number A45853. Product Usage: The UniCel DxC Synchron Clinical Systems are fully automated, computer-controlled clinical…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0297-2013·2012-10-24

    SunFresh Natural Pitted Prunes Recalled for Unapproved Color and Undeclared Ingredient

    SunFresh Natural LLC is recalling 1,200 bags of 6-ounce pitted prunes nationwide because the product contains unapproved Rhodamine B45170 and undeclared sorbic acid.

    Product
    SunFresh Natural Pitted Prunes Net wt. 6 oz. Distributed by: Sunfresh Natural LLC, Passaic, NJ 07055 Please visit us at: www.sunfreshnatural.com
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0071-2013·2012-10-24

    Terumo Backplate Replacement CXFVR 1500 Holder Recalled for Incorrect Configuration

    Terumo is recalling 33 Backplate Replacement CXFVR 1500 Holders because they were manufactured with an incorrect configuration of connector supports.

    Product
    Terumo Backplate Replacement CXFVR 1500 Holder The Flexible venous Reservoir is mounted on the Backplate/Holder and secures the flexible reservoir by strategically placed mounting arms. Additionally, there are three port supports the user incorporates to position the lines…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0061-2013·2012-10-24

    Zimmer Recalls CPT Hip Stems Due to Incorrect Packaging

    Zimmer, Inc. is removing CPT Hip System femoral stems from the market because they were packaged in incorrect cartons and distributed internationally and domestically.

    Product
    CPT Hip System Femoral Stem Petite, Item No. 00-8011-000-05. CPT stems are primary cemented femoral hip stems used by surgeons in total hip arthroplasty.
    Category
    Medical Device
    Distribution
    Distributed nationwide