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 deaths or serious injuries are reported, 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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826–850 of 27327

  • HighFDA (Devices)·Z-1927-2026·2026-04-29

    Sequencing Agent SEQ0067 Component Recalled for Potential False-Positive Results

    Foundation Medicine is recalling Sequencing Agent SEQ0067, a component of the FoundationOne CDx test, due to a possible increase in phasing that could result in false-positive BARD1 splice site indel artifact variants.

    Product
    Sequencing Agent SEQ0067, component of FoundationOne CDx (F1CDx)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1906-2026·2026-04-29

    Olympus OER-ELITE Endoscope Reprocessor Connecting Tubes Recalled

    Olympus Corporation is recalling OER-ELITE Endoscope Reprocessor Connecting Tubes (Model MAJ-2118) due to potential premature failure of Version 2 reprocessor connecting tube lock levers. The recall affects 1,259 units distributed worldwide.

    Product
    OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2118.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1862-2026·2026-04-29

    Soft-Vu Angiographic Catheter, Kumpe, Non-Braided manufacturing defect

    Angiodynamics is recalling Soft-Vu Angiographic Catheter, Kumpe, Non-Braided devices due to a manufacturing defect that may prevent guidewires from passing through the catheter hub.

    Product
    Soft-Vu Angiographic Catheter, Kumpe, Non-Braided; SOFT-VU KMP 4F X 65CM 038 NB 0SH; Catalog No.: 10714014; Product/UPN No.: H787107140145 (Box), H787107140140 (Pouch); Box Quantity: 5 pouches;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1877-2026·2026-04-29

    Medline Convenience Kits With Syringes Recalled for Unapproved Design Changes

    Medline Industries is recalling Convenience Kits containing 10mL polycarbonate colored syringes due to unapproved design changes made outside of FDA 510(k) clearance. The recall affects 270,311 units distributed nationwide and internationally.

    Product
    Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes ADULT CATH PACK-LF DYNJ38395G ANGIO DRAPE PACK (ADLUG)642-LF DYNJ47665F DYNJ47665G ANGIO KIT PACK DYNJ83746 DYNJ83746A ANGIO PACK DYNJ30565G DYNJ51239C DYNJ66631A DYNJ6920
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1894-2026·2026-04-29

    LeadCare Plus Blood Lead Test Kit Recalled for Unexpectedly Elevated Results

    Magellan Diagnostics is recalling LeadCare Plus Blood Lead Test Kits (Catalog Number 82-0004) because they may produce falsely elevated lead results when used with certain third-party micro-collection devices, potentially causing delayed testing and unnecessary follow-up testing.

    Product
    LeadCare¿ Plus Blood Lead Test Kit; Catalog Number: 82-0004; The LeadCare¿ Plus kit is provided with the following materials: " Sensors (4 containers of 24 each; 96 tests) " Treatment Reagent Tubes (4 packages of 24 each; 96 tests) " Calibration Button (1 @) " Lead Contro
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1853-2026·2026-04-29

    Olympus Thunderbeat II shears 35 cm may shed a distal tip component

    Olympus is recalling Thunderbeat II Shears with Ultrasonic Mode, 5 mm and 35 cm, because a distal tip component may detach during use. 3,360 units are affected.

    Product
    Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 35cm. Model Number: TB2-0535FC.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1920-2026·2026-04-29

    IV Administration Sets from Windstone Medical for Infusion Pump Systems

    Windstone Medical Packaging is recalling Custom Convenience Kits Pre Op Kit units due to potential backflow of medication between IV containers and risk of priming failure in gravity and pump administration sets.

    Product
    Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14994
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1938-2026·2026-04-29

    Diversatek Healthcare Viper Balloon Dilator Inflation Tag Labeling Error

    Diversatek Healthcare is recalling Viper 3-Stage Fixed Wire Balloon Dilators because the catheter inflation tag may contain incorrect part numbers and balloon diameter and pressure specifications.

    Product
    Diversatek Healthcare Viper¿ 3-Stage Fixed Wire Balloon Dilator, 6mm-7mm-8mm, REF 1204-08
    Category
    Medical Device
    Distribution
    19 states
  • HighFDA (Devices)·Z-1872-2026·2026-04-29

    AccuVu Angiographic Catheter recall due to manufacturing defect

    Angiodynamics is recalling AccuVu Angiographic Catheters due to a manufacturing defect that may prevent a guidewire from passing through the catheter hub. The defect could interfere with proper device function during medical procedures.

    Product
    AccuVu Angiographic Catheter, Omni Flush, Non-Braided, With 2 R/O Markers; ACCU-VU OF 4F X 70CM 035 NB 6SH 2 R/O 2CM; Catalog No.: 13709005; Product/UPN No.: H787137090055 (Box), H787137090050 (Pouch); Box Quantity: 5 pouches;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1873-2026·2026-04-29

    AccuVu Angiographic Catheter Manufacturing Defect Recall Worldwide

    Angiodynamics is recalling AccuVu Angiographic Catheters worldwide due to a manufacturing defect that may prevent guidewires from passing through the catheter hub's inner diameter.

    Product
    AccuVu Angiographic Catheter, Straight Flush, Non-Braided, With 10 R/O Markers; ACCU-VU STR FL 4F X 100CM 035 NB 6SH 10 R/O 6@1CM 4@5CM; Catalog No.: 13709604; Product/UPN No.: H787137096045 (Box), H787137096040 (Pouch); Box Quantity: 5 pouches;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1904-2026·2026-04-29

    Olympus OER-ELITE Endoscope Reprocessor Connecting Tubes Recall

    Olympus Corporation of the Americas is recalling OER-ELITE Endoscope Reprocessor Connecting Tubes (Model MAJ-2116) because the Version 2 reprocessor connecting tube lock levers may fail prematurely.

    Product
    OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2116.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1870-2026·2026-04-29

    Soft-Vu Angiographic Catheter Omni Flush Non-Braided Defect Recall

    Angiodynamics is recalling Soft-Vu Angiographic Catheters (Omni Flush, Non-Braided) due to a manufacturing defect that may prevent guidewires from passing through the catheter hub.

    Product
    Soft-Vu Angiographic Catheter, Omni Flush, Non-Braided; SOFT-VU OF 4F X 65CM 035 NB 6SH; Catalog No.: 10732301; Product/UPN No.: H787107323015 (Box), H787107323010 (Pouch); Box Quantity: 10 units;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1923-2026·2026-04-29

    Oxoid Agglutinating Sera Salmonella 9-0 Serotyping Classification Error

    Remel Europe Ltd. is recalling specific lots of Oxoid Agglutinating Sera, Salmonella 9-0 due to cross-reactivity that may misidentify Salmonella 9-O serotypes as 2-O serotypes in laboratory testing.

    Product
    Oxoid Agglutinating Sera, Salmonella 9-0 R30957301
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1940-2026·2026-04-29

    Diversatek Viper balloon dilator tags may show incorrect inflation parameters

    Diversatek Viper 3-Stage Wire Guided Balloon Dilators are being recalled because the catheter inflation tag may show an incorrect part number with wrong balloon diameters and pressures.

    Product
    Diversatek Healthcare Viper¿ 3-Stage Wire Guided Balloon Dilator, 15mm-16.5mm-18mm, REF 1205-18
    Category
    Medical Device
    Distribution
    19 states
  • HighFDA (Devices)·Z-1861-2026·2026-04-29

    Angiodynamics Soft-Vu Angiographic Catheter Cobra Non-Braided Recall

    Angiodynamics is recalling specific lots of Soft-Vu Angiographic Catheter, Cobra (2), Non-Braided devices due to a manufacturing defect that may prevent guidewire passage through the catheter hub.

    Product
    Soft-Vu Angiographic Catheter, Cobra (2), Non-Braided; SOFT-VU CB2 4F X 65CM 038 NB 0SH; Catalog No.: 10714011; Product/UPN No.: H787107140115 (Box), H787107140110 (Pouch); Box Quantity: 5 pouches;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1874-2026·2026-04-29

    AccuVu Angiographic Catheter, Omni Flush, Non-Braided Defect Recall

    Angiodynamics recalls AccuVu Angiographic Catheters due to a manufacturing defect that may prevent guidewires from passing through the catheter hub. The affected devices were distributed worldwide.

    Product
    AccuVu Angiographic Catheter, Omni Flush, Non-Braided, With 21 R/O Markers; ACCU-VU OF 4F X 70CM 035 NB 6SH 21 R/O 1CM; Catalog No.: 13709704; Product/UPN No.: H787137097045 (Box), H787137097040 (Pouch); Box Quantity: 5 pouches;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1929-2026·2026-04-29

    LSL Healthcare Central Line Dressing Change Kit Recalled for Non-Sterility

    LSL Healthcare is recalling its Standard Central Line Dressing Change Kit (Model 2717J) because the included Webcol Large Alcohol Prep Pads were found to be non-sterile.

    Product
    LSL Healthcare, Standard Central Line Dressing Change Kit, Model/Catalog Number: 2717J
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1915-2026·2026-04-29

    Arrowg+ard Blue Plus four-lumen CVC kits recalled over adhesive manufacturing

    Pressure Injectable Arrowg+ard Blue Plus Four-Lumen CVC Kits are being recalled after a supplier notified the firm that the liquid adhesive was incorrectly manufactured.

    Product
    Pressure Injectable Arrowg+ard Blue Plus¿ Four-Lumen CVC Kit REF ASK-45854-PUPM1 UDI code: (01)10801902159578(17)270531(11)251205(10)33F25M0011 The Arrowg+ard technology is intended to provide protection against catheter-related bloodstream infections (CRBSIs). It is not int
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1860-2026·2026-04-29

    Soft-Vu Angiographic Catheter Angiodynamics Guidewire Passage Defect

    Angiodynamics is recalling Soft-Vu Angiographic Catheters (Berenstein, Non-Braided) due to a manufacturing defect that may prevent guidewires from passing through the catheter hub. The catheters were distributed worldwide including the US.

    Product
    Soft-Vu Angiographic Catheter, Berenstein, Non-Braided; SOFT-VU BER 4F X 65CM 038 NB 0SH; Catalog No.: 10714009; Product/UPN No.: H787107140095 (Box), H787107140090 (Pouch); Box Quantity: 5 pouches;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1799-2026·2026-04-22

    B. Braun Hemodialysis Bloodlines Recalled Due to Potential Air Bubble Accumulation

    B. Braun Medical Inc is recalling STREAMLINE BLOODLINE SET FOR DIALOG (Model Number: SL-2010M2096) because air bubbles may accumulate in the arterial line.

    Product
    B. Braun Hemodialysis Bloodlines, STREAMLINE BLOODLINE SET FOR DIALOG. Model Number: SL-2010M2096
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1800-2026·2026-04-22

    B. Braun StreamLine Fresenius bloodlines may accumulate arterial air bubbles

    B. Braun is recalling StreamLine Fresenius bloodlines supplied for DaVita because small air bubbles can accumulate in the arterial line under negative pressure. 1,174,271 units are affected.

    Product
    B. Braun Hemodialysis Bloodlines, STREAMLINE FRESENIUS FOR DAVITA. Model Number: SL-2000M2095DA.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1798-2026·2026-04-22

    B. Braun StreamLine Dialog DR bloodlines may accumulate arterial air bubbles

    B. Braun is recalling StreamLine Bloodline Sets for Dialog DR because small air bubbles can accumulate in the arterial line under negative pressure. 3,158,104 units are affected.

    Product
    B. Braun Hemodialysis Bloodlines, STREAMLINE BLOODLINE SET FOR DIALOG DR. Model Number: SL-2010M2096A.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1801-2026·2026-04-22

    B. Braun StreamLine long bloodlines may accumulate arterial air bubbles

    B. Braun is recalling StreamLine Bloodline Long Version sets because small air bubbles can accumulate in the arterial line under negative pressure. 328,640 units are affected.

    Product
    B. Barun Hemodialysis Bloodlines, StreamLine Bloodline Long Version, FMC. Model Number: SL-2000M2095L.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1803-2026·2026-04-22

    B. Braun 4.8 mm hemodialysis bloodlines may accumulate arterial air bubbles

    B. Braun is recalling hemodialysis bloodlines with a 4.8 mm pump segment because small air bubbles can accumulate in the arterial line under negative pressure. 4,884 units are affected.

    Product
    B Braun Hemodialysis Bloodlines, LOW VOL, NO CHAMBER 4.8MM PUMP SEGMENT. Model Number: B3-4630M4705.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1797-2026·2026-04-22

    Omnipod 5 insulin pods from 49 lots have torn internal cannulas

    Omnipod 5 Pods from 49 lots have an internal soft cannula tear that lets insulin leak inside the Pod instead of being delivered. 1,240,115 units are affected.

    Product
    Omnipod 5 Pods. Model/Catalog number: PT-001662 ASM 5PK Pod STRL OPS G6G7
    Category
    Medical Device
    Distribution
    Distributed nationwide