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.

Agency

All agencies FDA (Food)FDA (Drugs)FDA (Devices)USDA FSIS CPSC NHTSA EPA

1251–1275 of 39948

ModerateFDA (Devices)·Z-1881-2026·2026-04-29
Medline Convenience Kits with Polycarbonate Syringes Unapproved Design Changes
Medline Industries is recalling select Convenience Kits containing 10mL polycarbonate colored syringes due to unapproved design changes made outside of FDA 510(k) clearance.
Product
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes BARIATRIC DYNJ905153M, DYNJ905153N GENERAL LAPAROSCOPY PACK DYNJ81602 LAPAROSCOPY DYNJ905157K, DYNJ905157L LAPAROTOMY PACK DYNJ46675G MAJOR LITHOTOMY PACK DYNJ81607 MAJ
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1838-2026·2026-04-29
Medline Heart Transplant Biopsy Kit regulatory clearance rescinded
Medline Industries is recalling Heart Transplant Biopsy Kit (Model DYNJ37543A) after the FDA rescinded regulatory clearances for certain Control Syringes, Guidewires, and High-Pressure Tubing used in the kit.
Product
Medline Kits: 1) HEART TRANSPLANT BIOPSY, Model Number: DYNJ37543A
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1898-2026·2026-04-29
OER-ELITE Endoscope Reprocessor Connecting Tubes Lock Lever Failure
Olympus is recalling OER-ELITE Endoscope Reprocessor Connecting Tubes (Model MAJ-2110) because the Version 2 reprocessor connecting tube lock levers may fail prematurely. The tubes are used to reprocess endoscopes.
Product
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2110. May be included with the Olympus OER-ELITE.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1840-2026·2026-04-29
Medline General Laparoscopy Kit regulatory clearance rescinded
The FDA has rescinded the 510(k) regulatory clearances for certain Control Syringes, Guidewires, and High-Pressure Tubing components in Medline's General Laparoscopy Kit (Model CDS930027Y). Affected units should not be used.
Product
Medline Kits: 1) GENERAL LAPAROSCOPY, Model Number: CDS930027Y
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1905-2026·2026-04-29
Olympus OER-ELITE Endoscope Reprocessor Connecting Tubes Recall
Olympus Corporation of the Americas is recalling OER-ELITE Endoscope Reprocessor Connecting Tubes (Model MAJ-2117) because the Version 2 reprocessor connecting tube lock levers may fail prematurely.
Product
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2117.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1888-2026·2026-04-29
Medline Convenience Kits with Polycarbonate 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.
Product
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes ARTHROSCOPY PACK DYNJ45173D
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1924-2026·2026-04-29
Flamingo Funnel Small surgical device recalled for sterilization defect
SurgiSmoke Solutions is recalling certain lots of the Flamingo Funnel Small (Model SQ20012-01) due to a manufacturing issue involving use of a non-gamma sterilization compatible drape.
Product
Flamingo Funnel Small, Model Number SQ20012-01
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1885-2026·2026-04-29
Medline 10mL Polycarbonate Colored Syringes Kits 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 syringes distributed worldwide, including the US, Canada, Panama, and Barbados.
Product
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes GU DAVINCI PACK - LF DYNJ909398A ROBOTIC PACK DYNJ908706D
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1911-2026·2026-04-29
Arrow Radial Artery Catheterization Kit recalled for incorrect adhesive
Arrow International is recalling Arrow Radial Artery Catheterization Kits due to incorrect manufacturing of the liquid adhesive by a supplier. The recall affects 675 units distributed nationwide.
Product
ARROW RADIAL ARTERY CATHETERIZATION KIT REF ASK-04220-UCL1 UDI code: (01)10801902159127(17)270331(11)251203(10)33F25J0352 REF ASK-04020-EUH2 UDI code: (01)10801902213379(17)270731(11)251218(10)33F25J0869 REF ASK-04020-FMC UDI code: (01)10801902212099(17)270731(11)25121
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1918-2026·2026-04-29
Rover Mobile X-ray System may malfunction and become inoperable
Micro-X Ltd. is recalling certain Rover Mobile X-ray Systems (models MXU-RV35 and MXU-RV71) because the X-ray generator may malfunction, rendering the device inoperable.
Product
Rover Mobile X-ray System Model/Catalog Number: MXU-RV35 and MXU-RV71
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1841-2026·2026-04-29
Medline Breast Pack Kit regulatory clearance rescinded by FDA
The FDA has rescinded the regulatory clearance for Medline's Breast Pack Kit (Model DYNJ66777D) because certain Control Syringes, Guidewires, and High-Pressure Tubing components no longer meet regulatory standards.
Product
Medline Kits: 1) BREAST PACK, Model Number: DYNJ66777D
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1828-2026·2026-04-29
CUSA Clarity C7000 Ultrasonic Surgical Aspirator Touch Screen Unresponsiveness
Integra LifeSciences is recalling the CUSA Clarity C7000 Console (Software Version 2.1.1.909) due to a software issue that renders the touch screen unresponsive during surgical use.
Product
CUSA Clarity C7000 Console, Software Version: 2.1.1.909. Ultrasonic surgical aspirator system.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1833-2026·2026-04-29
Medline Medical Device Kits With Rescinded FDA Clearances
FDA has rescinded the 510(k) clearances for certain Medline medical device kits including control syringes, guidewires, and high-pressure tubing. Medline is recalling approximately 58,836 units distributed nationwide.
Product
Medline Kits: 1) SYR CNTRL 10ML RING W/ROT NB, Model Number: DYNJSYR10CWRB; 2) MANIFOLD KIT LOW PRESSURE OFF, Model Number: VASCSLPOFF1; 3) EP MANIFOLD KIT, Model Number: VASC1018A
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1914-2026·2026-04-29
Arrow Pressure Injectable Central Venous Catheters Recalled
Arrow International is recalling 395 pressure injectable central venous catheters across nine U.S. states due to incorrect manufacturing of the liquid adhesive by a supplier.
Product
ARROW, ARROWG+ARD AND ARROWG+ARD BLUE PLUS PRESSURE INJECTABLE CENTRAL VENOUS CATHETER REF ASK-42802-PLH UDI code: (01)10801902133110(17)261231(11)251211(10)33F25L0140 REF ASK-45703-MGH UDI code: (01)10801902223675(17)261231(11)251209(10)33F25L0143 REF ASK-42854-MGH
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1910-2026·2026-04-29
Arrow Echogenic Introducer Needle REF ASK-04001-BWK2 Medical Device Recall
Arrow International is recalling 85 units of the Arrow Echogenic Introducer Needle due to incorrect manufacturing of the liquid adhesive used in the device.
Product
Arrow Echogenic Introducer Needle REF ASK-04001-BWK2 UDI code: (01)10801902220315(17)261231(11)251210(10)33F25J0347 This device is intended for injection or aspiration of fluids. The needle protection device covers the needle after use to help prevent needle sticks.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1846-2026·2026-04-29
Medline GYN Laparoscopy Pack regulatory clearance rescinded
Medline Industries has recalled the GYN Laparoscopy Pack (Model DYNJ41257F, Lot 25GBL423) because its regulatory clearances for certain components—including Control Syringes, Guidewires, and High-Pressure Tubing—have been rescinded.
Product
Medline Kits: 1) GYN LAPAROSCOPY PACK, Model Number: DYNJ41257F
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-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-1802-2026·2026-04-22
B. Braun hemodialysis bloodlines may accumulate air bubbles in the arterial line
B. Braun is recalling one model of hemodialysis bloodline because small air bubbles can accumulate in the arterial line when blood gases adhere to the tubing under negative pressure.
Product
B. Braun Hemodialysis Bloodlines, LOW VOL, NO CHAMBER 2.6MM PUMP SEGMENT. Model Number: B3-3632M3705.
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
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-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-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
HighFDA (Devices)·Z-1806-2026·2026-04-22
Yeastone Broth recalled because it may report incorrect susceptibility results
Yeastone Broth is being recalled because the product may report incorrect antifungal susceptibility results during quality control, which could delay treatment or force a change of agent.
Product
Yeastone Broth, 11ML, 10/BOX YY3462
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1822-2026·2026-04-22
Cellex photopheresis kit centrifuge bowls may dislodge and break
Cellex Photopheresis Kits are being recalled because the centrifuge bowl is harder to install and, if fitted improperly, may dislodge and break during priming or treatment.
Product
Brand Name: Cellex Photopheresis System Product Name: CELLEX Photopheresis Kit Model/Catalog Number: CLXUSA Software Version: Not Applicable Product Description: THERAKOS Photopheresis or extracorporeal photopheresis (ECP) is a photoimmune therapy where leukocytes are separa
Category
Medical Device
Distribution
Distributed nationwide

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1251–1275 of 39948