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 13816

ModerateFDA (Devices)·Z-2645-2026·2026-07-08
Medela ENFit ExSet Enteral Extension Set Connector Compatibility Issue
Medela ENFit ExSet Strl 60 enteral extension sets may contain incorrect connectors that do not attach or misconnect to ENFit connections, potentially delaying delivery of nutritional fluids or medication.
Product
Brand Name: Medela Product Name: ENFit ExSet Strl 60 2.0ml PV 1ct EN Model/Catalog Number: ENF060182LD / 101033086 Software Version: N/A Product Description: Enteral Extension Set, Length 60 Orange-Striped Minibore Tubing, (Approx. Priming Vol. 2.00 mL), ENFit¿ Componen
Category
Medical Device
Distribution
18 states
ModerateFDA (Devices)·Z-2533-2026·2026-07-08
Medline arterial access and insertion kits with lidocaine ampules recalled
Medline Industries is recalling three arterial access and insertion kits nationwide because they contain lidocaine ampules subject to a quality issue recall by the manufacturer Huons Co., Ltd., identified during an FDA manufacturing inspection.
Product
Medline Convenience Kits: 1) ARTERIAL ACCESS TRAY W/LIDOCAINE, Model Number: ART1145; 2) Universal Central/Art Line Insertion Kit, Model Number: ART155A; 3) ARTERIAL LINE INSERTION TRAY, Model Number: ART1010B
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2543-2026·2026-07-08
Medline Convenience Kits recalled due to Lidocaine quality issues
Medline Industries is recalling two convenience kits (Arterial Line Kit and Ultrasound Guided IV Securement Set) due to quality issues with included Lidocaine Ampules identified during an FDA inspection.
Product
Medline Convenience Kits: 1) ARTERIAL LINE KIT, Model Number: ART890B; 2) ULTRASOUND GUIDED IV SECUREMENT SET, Model Number: IVS3350
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2666-2026·2026-07-08
PowerPICC Catheters recalled for deficient manufacturing practices
Bard Access Systems, Inc. is recalling multiple PowerPICC catheter models due to lidocaine ampoules being manufactured under deficient manufacturing practices by the supplier.
Product
1174108 PowerPICC Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741154935 1295108 PowerPICC SOLO Catheter 5 Fr Dual-Lumen UDI-DI Code: 00801741034602 1174108D3 PowerPICC Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741154935 1174108D4 PowerPICC Catheter 4 Fr Single-Lum
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2630-2026·2026-07-08
CRE Pro Wireguided Medical Device Recall for Sterile Packaging Breach
Boston Scientific is recalling the CRE Pro Wireguided 15-18mm 240cm device due to a potential sterile breach of the product pouches. The breach may compromise device sterility.
Product
CRE Pro Wireguided 15-18mm 240cm
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2667-2026·2026-07-08
Provena Midline Catheters recalled due to deficient manufacturing practices
Bard Access Systems is recalling Provena Midline Catheters because lidocaine ampoules used in manufacturing were produced under deficient manufacturing practices by a supplier.
Product
CK000880 Provena Midline Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741188770 S4153108BDP Provena Midline Catheter 3 Fr Single-Lumen UDI-DI Code: 00801741154003 S4153108BP Provena Midline Catheter 3 Fr Single-Lumen UDI-DI Code: 00801741153990 S4153108D Provena Midline
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2661-2026·2026-07-08
Power-Trialysis Slim-Cath Dialysis Catheters Recalled by Bard Access Systems
Bard Access Systems is recalling Power-Trialysis Slim-Cath short-term dialysis catheters due to lidocaine ampoules manufactured under deficient manufacturing practices. The recall affects multiple product models distributed nationwide and internationally.
Product
5855240 Power-Trialysis Slim-Cath Straight Short-Term Dialysis Catheter 12 Fr Triple-Lumen UDI-DI Code: 00801741107177 5855300 Power-Trialysis Slim-Cath Straight Short-Term Dialysis Catheter 12 Fr Triple-Lumen UDI-DI Code: 00801741107184 5865120 Power-Trialysis Slim-Cath
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2671-2026·2026-07-08
Radius VSM Disposable NIBP Cuff recalled for rough edges
Masimo Corporation is recalling Radius VSM Disposable NIBP Cuffs (blood pressure cuffs) with lot numbers 21G6S through 25ADF because they may contain rough edges that could cause skin irritation or redness.
Product
Radius VSM Disposable NIBP Cuff, REF: 4825, 4826
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2669-2026·2026-07-08
Solar GI System Water Perfusion Units Recalled Due to Moisture Accumulation
Laborie Medical Technologies is recalling Solar GI System (Water Perfusion) units worldwide because moisture may accumulate in internal tubing and filters under extended use, potentially affecting airflow and pressure measurement performance.
Product
Solar GI System (Water Perfusion); Product Name (Catalog Number): Solar GI LGI H2O, 12p, Trolley system (G3-6), Solar GI HRM H2O, 24p, Compact Pole system (G3-7), Solar GI HRM H2O, 24p, Trolley system (G3-8), Solar GI HRM H2O, 36p, Trolley system (G3-12), Solar GI HRAM H2O, 24p
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2546-2026·2026-07-08
Medline Circumcision Trays recalled due to Lidocaine quality issues
Medline Industries is recalling three models of circumcision trays containing Lidocaine ampules due to quality issues identified during an FDA inspection of the drug manufacturer.
Product
Medline Convenience Kits: 1) MERCY MEDICAL CIRCUMCISION TRAY, Model Number: CIT6780; 2) CIRCUMCISION TRAY W/1.1CM CIRCLAMP, Model Number: CIT3225A; 3) CIRCUMCISION TRAY, Model Number: CIT6325
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2539-2026·2026-07-08
Medline Convenience Kits with Lidocaine Ampules Recalled for Quality Issues
Medline Industries is recalling Imaging Biopsy Tray and Breast Biopsy Pack kits containing Huons Lidocaine HCL Injection USP due to quality issues identified during an FDA manufacturing inspection.
Product
Medline Convenience Kits: 1) IMAGING BIOPSY TRAY, Model Number: DYNDH1068; 2) BREAST BIOPSY PACK, Model Number: PHS234706I
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2633-2026·2026-07-08
CRE Wireguided 8-10mm 240cm Medical Device Recall Notice
Boston Scientific Corporation is recalling CRE Wireguided 8-10mm 240cm devices worldwide due to potential sterile breaches in the packaging pouches that could compromise device sterility.
Product
CRE Wireguided 8-10mm 240cm
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2541-2026·2026-07-08
Medline Convenience Kits Recalled Due to Lidocaine Quality Issues
Medline Industries is recalling multiple convenience kits containing Huons Lidocaine HCL Injection USP 1% due to quality issues identified during an FDA manufacturing inspection of Huons Co., Ltd.'s drug manufacturing site.
Product
Medline Convenience Kits: 1) PI CVC KIT 3L 7 FR 16 CM, Model Number: ECVC8520; 2) NO CATH CENTRAL LINE KIT, Model Number: CVI4880B; 3) 20G x 6" ARTERIAL CATHETER KIT, Model Number: ART356; 4) MULTIMED 7FR, 16CM, 3L CVC BUNDLE, Model Number: STCVC03; 5) A-LINE KIT, NO CATH, Mo
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2538-2026·2026-07-08
Medline Convenience Kits with Lidocaine Ampules Recalled for Quality Issues
Medline Industries is recalling Medline Convenience Kits containing Huons Lidocaine HCL Injection USP 1% due to quality issues identified during an FDA manufacturing inspection.
Product
Medline Convenience Kits: 1) STD, INTRO-FLEX INTRODUCER 6F, C, Model Number: I550BF6C; 2) STD, INTRO-FLEX INTRODUCER 9F, C, Model Number: I505BF9C
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2648-2026·2026-07-08
ARTIS icono ceiling medical imaging monitor suspension system
Siemens Medical Solutions is recalling ARTIS icono ceiling Model 11328100 because screws in the Display ceiling suspension (DCS Fix XL) that hold the monitor may gradually loosen over time, potentially causing the monitor to detach.
Product
ARTIS icono ceiling. Model Number: 11328100.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2653-2026·2026-07-08
Covidien Shiley Disposable Decannulation Plug product labeling error
Covidien LLC is recalling Shiley Disposable Decannulation Plug devices because the product labeling incorrectly indicates the product does not contain DEHP, when in fact the product contains 30 to 35% DEHP.
Product
Covidien Shiley Disposable Decannulation Plug REF DDCP UDI-DI code: 10884522004060 Product Codes that include the Covidien Shiley Disposable Decannulation Plug are: Product Number / UDI-DI code 4DCFN 10884522006576 4DCFS 10884522006583 4DFEN 10884522006606 6DCFN 10884
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2673-2026·2026-07-08
Sterile Tourniquet Hoses Recalled Due to Potential Sterility Breach
Zimmer Surgical Inc is recalling A.T.S. 4000 TS Tourniquet Systems Dual Hose with CPC Connectors due to a potential sterility breach in the sealing area of the sterile pouch. If used, the issue may result in moderate localized infection.
Product
Brand Name: Sterile Tourniquet Hoses Product Name: A.T.S¿ 4000 TS Tourniquet Systems Dual Hose with CPC Connectors Model/Catalog Number: 60-1812-101-00 Software Version: N/A Product Description: Dual Sterile Extension Hose with PLC Connector Component: N/A
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2656-2026·2026-07-08
Poly Midline Catheters recalled due to manufacturing defects
Bard Access Systems is recalling Poly Midline Catheters because lidocaine ampoules were manufactured under deficient manufacturing practices.
Product
CK000495A Poly Midline Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741121609 CK000566 Poly Midline Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741108051 CK000566 Poly Midline Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741108051 The Poly Per-Q-Cath Midline cathet
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2674-2026·2026-07-08
Sterile Tourniquet Hoses recalled for potential sterility breach
Zimmer Surgical Inc is recalling A.T.S 4000 TS Tourniquet Systems Single Hose units due to a potential sterility breach in the sealing area of the sterile pouch. If used, the compromised sterility may result in moderate localized infection.
Product
Brand Name: Sterile Tourniquet Hoses Product Name: A.T.S¿ 4000 TS Tourniquet Systems Single Hose with CPC Connectors Model/Catalog Number: 60-4009-101-00 Software Version: N/A Product Description: Single Sterile Extension Hose with PLC Connector Component: N/A
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2544-2026·2026-07-08
Medline Lumbar Puncture Kit recalled for Lidocaine quality issues
Medline Convenience Kits containing Huons Lidocaine HCL Injection USP 1% ampules are being recalled due to quality issues identified during an FDA manufacturing inspection. Affected kits have been distributed nationwide.
Product
Medline Convenience Kits: 1) LUMBAR PUNCTURE CHOICE, Model Number: DYNDH1215
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2635-2026·2026-07-08
CRE Wireguided Device Recall Due to Potential Sterile Packaging Breach
Boston Scientific Corporation is recalling CRE Wireguided 12-15mm 240cm devices due to a potential sterile breach in the pouches containing the devices. The breach could compromise device sterility.
Product
CRE Wireguided 12-15mm 240cm
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2658-2026·2026-07-08
PowerPICC SOLO HF Catheter 5 Fr Triple-Lumen Medical Device Recall
Bard Access Systems, Inc. is recalling PowerPICC SOLO HF Catheter 5 Fr Triple-Lumen devices due to lidocaine ampoules manufactured under deficient manufacturing practices by the supplier.
Product
CK000662 PowerPICC SOLO HF Catheter 5 Fr Triple-Lumen UDI-DI Code: 00801741129674 Catheter stylets provide internal reinforcement to aid in catheter placement.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2662-2026·2026-07-08
PowerMidline Catheters Recalled for Deficient Manufacturing Practices
Bard Access Systems is recalling PowerMidline Catheters due to lidocaine ampoules being manufactured under deficient manufacturing practices. The catheters are used for short-term peripheral intravenous access and have been distributed nationwide and internationally.
Product
CK000727 PowerMidline Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741138478 CK000729 PowerMidline Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741138713 P4153108D PowerMidline Catheter 3 Fr Single-lumen UDI-DI Code: 00801741108747 P4154108 PowerMidline Catheter 4 Fr
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2636-2026·2026-07-08
CRE Wireguided 15-18mm 240cm Medical Device Sterile Pouch Breach
Boston Scientific Corporation is recalling the CRE Wireguided 15-18mm 240cm device due to a potential sterile breach in the packaging pouches. The affected devices were distributed worldwide.
Product
CRE Wireguided 15-18mm 240cm
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2654-2026·2026-07-08
Medline 111 Gravity Set with Needle Free Y-Sites engineering sample recall
BD Switzerland SARL is recalling a Medline 111 Gravity Set with 3 Needle Free Y-Sites (Catalog Number SAM2461, Lot 25X445) because engineering samples labeled "Not for Human Use" were inadvertently shipped to the U.S. market.
Product
MEDLINE 111 GRAVITY SET W/3 Needle Free Y-Sites REF DYNDTN0555 Catalog Number: SAM2461 UDI code: N/A Engineering Sample/Not for Human Use
Category
Medical Device
Distribution
1 state

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51–75 of 13816