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

51–75 of 12223

SevereFDA (Devices)·Z-2585-2026·2026-07-01
Medline 10mL Polycarbonate Syringes in Medical Procedure Kits Recalled
Medline Industries is recalling convenience kits containing 10mL polycarbonate colored syringes due to unapproved design changes made outside of FDA clearance. The recall affects 113,843 kits distributed nationwide and in Barbados.
Product
Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. AAA DYNJ905651B ARTERIOGRAM TRAY 00-402001S AV SHUNT PACK-LF DYNJ0842516F BASIC IR PACK-LF PHS463660F CATH PROCEDURAL TRAY DYNJ43580C CONGENITAL ADD-ON KIT DYN
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2599-2026·2026-07-01
Abiomed Impella CP Introducer Kit recalled for thrombus formation risk
Abiomed is recalling 3 units of the 14 Fr x 13 cm Low Profile Introducer Kit for Impella CP due to potential for blood clot formation during prolonged use.
Product
Abiomed 14 Fr x 13 cm Low Profile Introducer Kit for Impella CP. Impella Set Product Code: 1000434. Introducer Product Code: 1000434.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2525-2026·2026-07-01
VOCSN+Pro Respiratory System Backup Battery Alarm Failure Recall
Ventec Life Systems is recalling VOCSN+Pro respiratory systems due to a damaged backup battery that may prevent the backup alarm from activating during power loss, delaying caregiver awareness of a hazardous condition.
Product
VOCSN+Pro package, REF: PRT-00853-000; VOCSN+Pro unit, REF: PRT-00490-001
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2582-2026·2026-07-01
Medline 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 clearance.
Product
Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. ANGIO CATH COMBINED PACK DYNJ43609S ANGIO PACK DYNJ67987D DYNJ80317A ANGIO SPECIAL PROCEDURE-LF DYNJ38412C ANGIOGRAM SET UP PACK DYNJ66260A ANGIOGRAPHY PACK DYNJ44293I ANGIOGRA
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2601-2026·2026-07-01
Abiomed Impella CP Set with SmartAssist 10th Generation Introducer Kits Recalled
Abiomed is recalling certain Impella CP Set with SmartAssist (10th Generation) units with affected 14Fr Low Profile Introducer Kits due to potential for thrombus (blood clot) formation during prolonged use.
Product
Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Profile Introducer Kits. Product Codes: 1000413, 1000834.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2592-2026·2026-07-01
Medline Polycarbonate Syringes in Convenience Kits Recalled for Unapproved Design Changes
Medline Industries recalled multiple convenience kits containing 10mL polycarbonate colored syringes due to unapproved design changes made outside of FDA clearance. The company identified these modifications and notified the FDA of the deviation from the approved 510(k) design.
Product
Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. ANGIO DRAPE PACK (ADLUG)642-LF DYNJ47665D ANGIO PACK DYNJ30565D ANGIOGRAPHY PACK-LF DYNJ0854485V ARTERIOGRAM DYNJ28082D DYNJ28082F CARDIAC CATH DYNJ67349 CARDIA
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2453-2026·2026-07-01
Medline Convenience Kits with Lidocaine and Bupivacaine Injections Recalled
Medline Industries is recalling 22 models of Convenience Kits that contain Lidocaine Hydrochloride Injection and Bupivacaine Hydrochloride in Dextrose Injection due to quality issues found during an FDA inspection of the supplier.
Product
Medline Convenience Kits: 1) OPEN HEART CDS, Model Number: CDS840144Q; 2) OPEN HEART, Model Number: CDS840150W; 3) OPEN HEART ADULT, Model Number: CDS840396AA; 4) CABG A CDS, Model Number: CDS982269N; 5) OPEN HEART ANESTHESIA PACK, Model Number: CDS983849G; 6) OPEN HE
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2602-2026·2026-07-01
Abiomed Impella CP Set with SmartAssist 10th Generation Introducer Kit Recall
Abiomed is recalling Impella CP Set with SmartAssist (10th Generation) containing 14Fr Low Profile Introducer Kits due to potential thrombus (blood clot) formation during prolonged use of the introducer.
Product
Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Profile Introducer Kits 13 and 25 cm Japan. Product Code: 1000542.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2574-2026·2026-07-01
Dexcom G7 Continuous Glucose Monitoring System sensors recalled
Dexcom is recalling two lots of G7 glucose sensors that were stolen during destruction and sold through unauthorized channels. These sensors were designated for destruction due to improper sterilization, increased infection risk, and potential for inaccurate or missing readings.
Product
Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 US Retail Sensor/Transmitter 1-pack Model/Catalog Number: STP-AT-012 Software Version: N/A Product Description: Dexcom G7 US Retail Sensor/Transmitter 1-pack Component: Dexcom G7 Continuous Gl
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-2591-2026·2026-07-01
Medline angiography and radiology convenience 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 clearance. The recall affects 113,843 kits distributed nationwide and to Barbados.
Product
Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. ANGIO PACK DYNJ30565C DYNJ32555B ANGIO PACK-LF DYNJ0774765U ANGIO TRAY DYNJ46153A ANGIOGRAM TRAY DYNJ33638K ANGIOGRAPHY DRAPE PK QVH-LF DYNJ35110D ANGIOGRAPHY P
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2593-2026·2026-07-01
Medline convenience kits recalled for unapproved syringe design changes
Medline Industries recalls convenience kits containing 10mL polycarbonate colored syringes because design changes were made outside of FDA-cleared specifications. The recall affects approximately 113,843 kits distributed nationwide.
Product
Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. ABDOMINAL VASCULAR-LF DYNJ905291B DYNJ905291C ARTERIOGRAM DYNJ28082G CVICU HEART BAG DYKM2130A ENDOVASCULAR PACK DYNJ0678934J EP PACK DYNJ23456J GENERAL ENDO PA
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2558-2026·2026-07-01
Surgify Halo 4.0mm Extendable Surgical Burr Recall for Breakage Risk
Surgify Medical is recalling Surgify Halo 4.0 mm Extendable surgical burrs due to potential breakage during bi-portal endoscopic spinal surgery. The breakage could create a safety hazard during the procedure.
Product
Surgify Halo, 4.0 mm, Extendable, Model/Catalog Number: 40.000.SEE.H1; drills, burrs, trephines & accessories (simple, powered)
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2583-2026·2026-07-01
Medical Device Surgical Kits with Syringes Recalled for Unapproved Design Changes
Medline Industries is recalling convenience kits containing 10mL polycarbonate colored syringes used in surgical procedures. The manufacturer identified unapproved design changes to the products that were not cleared by the FDA through the 510(k) process.
Product
Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. BARIATRIC DYNJ905153J DYNJ905153K DYNJ905153L GYNE LAPAROTOMY PACK-LF DYNJ49593A LAPAROSCOPY DYNJ905157G DYNJ905157I DYNJ905157J LAPAROSCOPY PACK DYNJ56930B MAJOR PLUS
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2521-2026·2026-07-01
Da Vinci surgical system operative components with E-brake retainer pin defect
Intuitive Surgical recalls certain Da Vinci surgical system operative components due to a defective E-brake retainer pin that may fail to engage the E-brake, potentially causing uncontrolled motion and patient injury.
Product
Da Vinci ASSY, PSS, SP1098, Part Number: 380601
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2455-2026·2026-07-01
Medline Convenience Kits Medical Devices Recalled for Quality Issues
Medline Industries is recalling four models of Convenience Kits containing Lidocaine and Bupivacaine injections due to quality issues identified during an FDA inspection of the supplier.
Product
Medline Convenience Kits: 1) DRAWER 6A ADULT CENTRAL LINE, Model Number: ACC010890; 2) OPEN HEART A OVERHEAD, Model Number: DYNJ910066; 3) OPEN HEART, Model Number: DYNJ9855016V; 4) OPEN HEART, Model Number: DYNJ9855016X
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2587-2026·2026-07-01
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 FDA-cleared specifications.
Product
Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. CRANIOTOMY PACK-LF DYNJ0101292F DYNJ0101292G HYBRID PACK DYNJ65925A LAMINECTOMY DYNJ905156L DYNJ905156M DYNJ905156N DYNJ905156O DYNJ905156P MAJOR EXTREMITY DYNJ905
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2532-2026·2026-07-01
Acumed Hexalob Screws Recalled for Risk of Fracture During Use
Acumed LLC is recalling Hexalob Screws of various sizes used with wrist fixation systems due to a manufacturing error that may cause the screws to break during use.
Product
Acumed Hexalob Screw various sizes: REF Numbers: : 3070-27008 2.7mm x 8mm NL Hexalobe Screw; 3070-27009 2.7mm x 9mm NL Hexalobe Screw; 3070-27010 2.7mm x 10mm NL Hexalobe Screw; 3070-27011 2.7mm x 11mm NL Hexalobe Screw; 3070-27012 2.7mm x 12mm NL Hexalobe Screw; 3070-27013
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2561-2026·2026-07-01
Surgify Halo 4.0 mm Spinal Surgery Burrs May Break During Use
Surgify Halo 4.0 mm Short burrs may break during bi-portal endoscopic spinal surgery, creating a potential hazard during the procedure. The FDA has classified this as a Class II recall affecting devices nationwide.
Product
Surgify Halo, 4.0 mm, Short, Model/Catalog Number: 40.070.NVG.U1; drills, burrs, trephines & accessories (simple, powered)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2568-2026·2026-07-01
Surgify Halo Surgical Burr Breakage Risk During Spinal Surgery
Surgify Medical is recalling Surgify Halo 5.4 mm Medium surgical burrs due to potential burr breakage during bi-portal endoscopic spinal surgery. The device poses a risk of fragmentation that could complicate surgical procedures.
Product
Surgify Halo, 5.4 mm, Medium, Model/Catalog Number: 54.085.SHD.H1; burrs, trephines & accessories (simple, powered)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2562-2026·2026-07-01
Surgify Halo surgical drill may break during spinal surgery procedures
Surgify Halo 4.0 mm surgical drills are being recalled because the burr may break during bi-portal endoscopic spinal surgery. The defect could interfere with the surgical procedure.
Product
Surgify Halo, 4.0 mm, Short, Model/Catalog Number: 40.125.NVG.H1; drills, burrs, trephines & accessories (simple, powered)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2531-2026·2026-07-01
Zimmer Off-Axis Alliance Glenoid Reamer Guide recalled for breakage
Zimmer is recalling the Off-Axis Alliance Glenoid Right 4-Peg Augment Reamer Guide (Model 110040476) after five complaints that plastic guides broke during reaming.
Product
Off-Axis Alliance Glenoid, Right, 4-Peg, Augment, Reamer Guide, Model/Catalog Number: 110040476
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2564-2026·2026-07-01
Surgify Halo Surgical Burrs Recalled Due to Breakage Risk
SURGIFY MEDICAL OY is recalling Surgify Halo 5.4 mm Extendable surgical burrs (Model 54.000.SEE.H1) due to potential for burr breakage during bi-portal endoscopic spinal surgery. The device has been distributed nationwide.
Product
Surgify Halo, 5.4 mm, Extendable, Model/Catalog Number: 54.000.SEE.H1; drills, burrs, trephines & accessories (simple, powered)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2559-2026·2026-07-01
Surgify Halo spinal surgery burr tool potential breakage recall
Surgify Halo 4.0 mm extendable surgical burrs may break during bi-portal endoscopic spinal surgery. The device is being recalled to prevent patient injury from burr fragments.
Product
Surgify Halo, 4.0 mm, Extendable, Model/Catalog Number: 40.000.SEE.U1; drills, burrs, trephines & accessories (simple, powered)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2567-2026·2026-07-01
Surgify Halo surgical burrs recalled for potential breakage
Surgify Halo 5.4 mm Short surgical burrs may break during bi-portal endoscopic spinal surgery. FDA Class II recall affects multiple U.S. states.
Product
Surgify Halo, 5.4 mm, Short, Model/Catalog Number: 54.070.NVG.U1; drills, burrs, trephines & accessories (simple, powered)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2523-2026·2026-07-01
Philips Avalon Fetal Monitor FM 30 Speaker Connector Assembly
Philips is recalling 169 units of the Avalon Fetal Monitor FM 30 due to incorrect speaker connector assembly that can cause device cables to disconnect, resulting in loss of speaker output.
Product
Philips Avalon Fetal Monitor, FM 30 Part numberM2703A
Category
Medical Device
Distribution
Distributed nationwide

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51–75 of 12223