The Recall Desk

Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means the agency’s own highest classification or reported deaths or serious injuries, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

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28526–28550 of 40357

  • ModerateFDA (Devices)·Z-0365-2017·2016-11-16

    FDA Recalls Covidien Devon Light Glove Sub-Assembly for Added Instructions

    The FDA is recalling 118,800 units of the Covidien Devon Light Glove sub-assembly to add instructions for use regarding barrier integrity inspection.

    Product
    Covidien Devon Light Glove sub-assembly non-sterile For Kit Packers Product Usage: A disposable, sterile, single-use cover for compatible surgical light handles
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0379-2017·2016-11-16

    Abbott Recalls Architect Lactic Acid Assay Due to Drug Interference

    Abbott is recalling 26,837 kits of the ARCHITECT Lactic Acid assay because the drug N-Acetyl Cysteine causes negative interference with the reagent.

    Product
    ARCHITECT Lactic Acid Part # 09D891T21 The Lactic Acid assay is used for the quantitation of lactic acid in human plasma.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0364-2017·2016-11-16

    FDA Adds Instructions for Use to Covidien Devon Light Glove Recall

    The FDA is adding instructions to inspect the barrier integrity of the Covidien Devon Light Glove after application. This affects sterile surgical kits distributed in the US and abroad.

    Product
    Covidien Devon Light Glove packaged in sterile surgical kits Reference: 31140208 Product Usage: A disposable, sterile, single-use cover for compatible surgical light handles
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0372-2017·2016-11-16

    Schaerer Surgical Table Floor Locking Cylinders Recalled for Leak Risk

    Schaerer Medical USA Inc is recalling replacement floor locking cylinders for model 7300 surgical tables because they may leak due to an incorrect O-ring.

    Product
    Replacement floor locking cylinders for the Schaerer model 7300 surgical tables. Replacement cylinders are part number 85118. Product Usage: The cylinders are used to lock the surgical table in place.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0380-2017·2016-11-16

    Stryker Recalls Reprocessed Diagnostic Electrophysiology Catheters Due to Mislabeled French Size

    Stryker Sustainability Solutions is recalling four reprocessed Daig Steerable and Daig Supreme Fixed Curve Diagnostic Electrophysiology Catheters because they may be mislabeled for French size during reprocessing.

    Product
    Reprocessed Daig Steerable and Daig Supreme Fixed Curve Diagnostic Electrophysiology Catheters Model Numbers: 401940, 402004 UPC Code: 00885825007409 00885825007744 Diagnostic electrophysiology (EP) catheters are specially designed electrode catheters that transmit…
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-0369-2017·2016-11-16

    Medimaps TBS iNsight Software Recalled for Incorrect FRAX Calculations

    Medimaps Group is recalling TBS iNsight v.3.0.1 software because FRAX values are incorrect when specific spine scan conditions are met.

    Product
    TBS iNsight Version v.3.0.1 Product Usage: TBS iNsight is a medical device software that is installed on bone densitometers for analysis of bone microarchitecture and osteoporosis management.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0371-2017·2016-11-16

    Schaerer 7300 Surgical Tables Recalled for Defective Floor Locking Cylinders

    Schaerer Medical USA Inc is recalling four 7300 model surgical tables because defective floor locking cylinders may leak due to incorrect O-rings.

    Product
    The surgical table is a stand alone unit. Three (3) floor locking cylinders are attached to the base of the surgical table. The individual cylinders are replaceable. Product Usage: The cylinders are used to lock the surgical table in place.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0326-2017·2016-11-09

    Hill-Rom Recalls Ceiling Brackets Due to Potential Fall Hazard

    Hill-Rom is recalling 188 ceiling brackets with a larger center hole that could cause the system to fall if the safe working load is exceeded.

    Product
    Product Number 3102071 Ceiling Bracket, Arch 71 White with use on ceiling installed rail systems: Multirall 200, Likorall 200, 242, 243, 250, and LikoGuard L and XL.
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0325-2017·2016-11-09

    FDA Recalls Encore Medical Empowr PS Knee System Box Cut Guides

    Encore Medical is recalling 436 units of the Empowr PS Knee System Box Cut Guide because the design can cause femoral chipping during surgery.

    Product
    Empowr PS Knee System Box Cut Guide; Used to make the housing resection for the post of the posterior stabilized implant.
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0357-2017·2016-11-09

    Unomedical AC TenderLink Insulin Infusion Tubing Recalled for Detachment Risk

    Unomedical As is recalling AC TenderLink insulin infusion tubing sets due to a risk of tubing detachment. The voluntary recall affects 653,280 units distributed in the US and internationally.

    Product
    AC TenderLink 13/30 10 pcs; AC TenderLink I 13/60 10 pcs; AC TenderLink I 13/80 10 pcs; AC TenderLink I 17/110 10 pcs; AC TenderLink I 17/30 10 pcs; AC TenderLink I 17/60 10 pcs; AC TenderLink I 17/80 10 pcs; AC TenderLink I 13/110 10 pcs The products are used in combination…
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0349-2017·2016-11-09

    Battle Creek Thermophore Deep-Heat Therapy Devices Recalled for Fire Risk

    Battle Creek Equipment Co. is recalling Thermophore Classic and Plus deep-heat therapy devices because the power cord can spark, causing smoke, fire, and burns.

    Product
    Model 055: Thermophore Classic, Professional Quality, Deep-Heat Therapy, Model 055 Large 14' x 27", Model 056: Thermophore Classic, Professional Quality Deep-Heat Therapy, Model 056 Medium 14" x 14", Model 077: Thermophore Classic Professional Quality Deep-Heat Therapy…
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-0337-2017·2016-11-09

    Stryker Recalls Guider Softip XF Guide Catheters Due to Hub Leaks

    Stryker Neurovascular is recalling 1,478 Guider Softip XF guide catheters worldwide due to a manufacturing defect that may cause hub leaks.

    Product
    Guider Softip XF; GUIDER/ST XF/8FR/90CM, Model number: H965100520. Cardiology: Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the placement of interventional devices into the neurovascular system.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0336-2017·2016-11-09

    Stryker Neurovascular Recalls Guider Softip XF Guide Catheters

    Stryker Neurovascular is recalling 1,478 Guider Softip XF guide catheters due to a manufacturing defect that could cause hub leaks.

    Product
    Guider Softip XF; GUIDER/MP XF/6FR/90CM, Model number: H965100460. Cardiology: Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the placement of interventional devices into the neurovascular system.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0342-2017·2016-11-09

    Stryker Neurovascular Recalls Guider Softip XF Guide Catheters

    Stryker Neurovascular is recalling 1,478 Guider Softip XF guide catheters due to a manufacturing defect that could cause hub leaks.

    Product
    Guider Softip XF; GUIDER/40 DEG XF/7FR/100 cm, Model number: M003101430 . Cardiology: Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the placement of interventional devices into the neurovascular system.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0352-2017·2016-11-09

    Medline Recalls Rigid Suction Canisters Due to Implosion Risk

    Medline Industries is recalling 7,680 Rigid Suction Canisters (2000 CC and 3000 CC) because they may implode when subjected to excessive negative pressure.

    Product
    Rigid Suction Canister 3000 CC and 2000 CC.
    Category
    Medical Device
    Distribution
    18 states
  • HighFDA (Devices)·Z-0358-2017·2016-11-09

    Unomedical Comfort 5+5 Insulin Infusion Pump Sets Recalled for Tubing Detachment

    Unomedical As is recalling 22,114 Comfort 5+5 insulin infusion pump sets because the tubing may detach. The recall covers products distributed in the US and internationally.

    Product
    Comfort 5+5 Pack w/110cm Tube & 17mm Cann. UPC# 3-89110-14147-7; Comfort 5+5 Pack w/60cm Tube & 17mm Cann. UPC# 3-89110-14127-9; Comfort 5+5 Pack w/110cm Tube & 13mm Cann. UPC# 3-89110-14143-9; Conform 5+5 Pack w/60cm Tube & 13mm Cann. UPC# 3-89110-14123-1 The products are used…
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0333-2017·2016-11-09

    Stryker Recalls Guider Softip XF Guide Catheters Due to Hub Leaks

    Stryker Neurovascular is recalling Guider Softip XF guide catheters because a manufacturing defect may cause hub leaks.

    Product
    Guider Softip XF; GUIDER/40DEG XF/7FR/90CM, Model number: H965100430 . Cardiology: Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the placement of interventional devices into the neurovascular system.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0322-2017·2016-11-09

    Medtronic Recalls Visualase Visualization Stylets Due to MRI Magnetic Attraction

    Medtronic Navigation is voluntarily recalling Visualase Visualization Stylets because they bend or pull toward magnetic fields during MRI procedures.

    Product
    Visualase Visualization Stylets PN 020-2301. The individual components within the Visualase Body Accessory Kit are packaged in Tyvek pouches. The packaged devices are then placed into a cardboard box which is labeled with the Body Accessory Kit label. Labeled sterile. The…
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-0330-2017·2016-11-09

    Azer Scientific Recalls Fruit Punch Glucose Due to Microbiological Test Failures

    Azer Scientific is recalling Fruit Punch Glucose, 100 Gram Concentration, due to out-of-specification microbiological test results.

    Product
    Fruit Punch Glucose, 100 Gram Concentration, Liquid, 4/Pack of 6 Bottles, 24/cs Accessory to an In Vitro Diagnostic Oral Glucose Tolerance Test (OGTT) in the evaluation of diabetes mellitus and related disease conditions. Oral Glucose Tolerance Drinks provide a premeasured…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0354-2017·2016-11-09

    Hospira Symbiq Infusion Pumps Recalled for Backup Battery Failure

    Hospira is recalling Symbiq Two Channel Infusers due to a backup battery failure caused by incorrect component installation on some power supply boards.

    Product
    Symbiq Two Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids; Product List Number 16027
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0346-2017·2016-11-09

    Stryker Recalls Guider Softip XF Guide Catheters Due to Hub Leaks

    Stryker Neurovascular is recalling 1,478 Guider Softip XF guide catheters worldwide due to a manufacturing defect that could cause hub leaks.

    Product
    Guider Softip XF; GUIDER STRAIGHT XF 5F 100CM, Model number: M003101640. Cardiology: Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the placement of interventional devices into the neurovascular system.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0332-2017·2016-11-09

    Spacelabs Xhibit Central Station Recalled for Telemetry Display Issues

    Spacelabs Healthcare is recalling 348 Xhibit Central Station units because telemetry SpO2 numerics may drop off the display, though alarms function normally.

    Product
    Xhibit Central Station, Model 96102. Intended use is to provide clinicians with central monitoring of adult, pediatric and neonatal patient data of patients connected to networked Spacelabs Healthcare patient monitors and telemetry transmitters.
    Category
    Medical Device
    Distribution
    28 states
  • HighFDA (Devices)·Z-0355-2017·2016-11-09

    Unomedical Comfort Infusion Sets Recalled for Tubing Detachment Risk

    Unomedical As is recalling 1.3 million Comfort infusion sets used with insulin pumps due to a risk of tubing detachment.

    Product
    Infusion Set, Comfort, 23" Hosp 10; Comfort 13mm, 23", STD 5/5; Comfort 13mm, 23" Hosp 10; Infusion Set, Comfort, 43", Hosp 10; Infusion Set, Comfort, 31", Hosp 10; Comfort 13mm, 31". Hosp 10; Infusion Set, Comfort, 23", STD 5/6; Comfort 13mm, 43" Hosp 10; Infusion Set, Comfort…
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0340-2017·2016-11-09

    Stryker Recalls Guider Softip XF Guide Catheters Due to Hub Leaks

    Stryker Neurovascular is recalling 1,478 Guider Softip XF guide catheters worldwide due to a manufacturing defect that could cause hub leaks.

    Product
    Guider Softip XF; GUIDER/40 DEG XF/6FR/100 cm, Model number: M003101420. Cardiology: Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the placement of interventional devices into the neurovascular system.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0356-2017·2016-11-09

    Unomedical Recalls Insulin Infusion Sets Due to Tubing Detachment Risk

    Unomedical As is voluntarily recalling 664,000 Contact Detach infusion sets used with insulin pumps due to a risk of tubing detachment.

    Product
    Contact Detach, 8mm, 23", G29; Contact Detach 8 mm, 43", G29; Contact Detach, 6mm, 23" G29; Infusion Set, Contact Detach, 6mm x 23"; Infusion Set, Contact Detach, 6mm x 32"; Infusion Set, Contact Detach, 8mm x 23"; Infusion Set, Contact Detach, 8mm x 32" The products are used…
    Category
    Medical Device
    Distribution
    3 states