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.

Agency

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

276–300 of 713

CriticalFDA (Devices)·Z-1935-2026·2026-05-13
Aurous Centimeter Sizing Catheter Recalled for Marker Band Cracking Risk
Cook Incorporated is recalling Aurous Centimeter Sizing Catheters due to risk of marker band cracking or breakage during angiographic procedures. Potential complications include device fragmentation, vessel injury, and in worst-case scenarios, life-threatening harm or death.
Product
Aurous Centimeter Sizing Catheter RPN N5.0-35-100-P-10S-PIG-CSC-20-01 GPN G47308 Sizing catheters are single-use, sterile catheters with gold marker bands. These catheters are for use in angiographic procedures and available in a variety of lengths (70 and 100 cm) and tip co
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2114-2026·2026-05-13
Medline Surgical Convenience Kits recalled for sterilization calibration defect
Medline Industries is recalling multiple surgical convenience kits because equipment used to sterilize and package the devices had calibration issues that may have affected sterility assurance. The devices were processed through validated sterilization cycles but the calibration problems could impact their sterility.
Product
See RES for complete list. Medline Convenience Kits: 1) SPINAL CDS, Model Number: CDS940087AG; 2) SPINAL CDS, Model Number: CDS940087AI; 3) TOTAL HIP CDS-LF, Model Number: CDS980832Q; 4) TOTAL HIP CDS-LF, Model Number: CDS980832R; 5) TOTAL HIP CDS-LF, Model Number: CDS980832S; 6)
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0523-2026·2026-05-13
Naproxen Oral Suspension Recalled for Lead and Lithium Contamination
Acella Pharmaceuticals is recalling Naproxen oral suspension due to the presence of lead and lithium above specification levels. The recall affects 6,336 bottles distributed nationwide.
Product
NAPROXEN — NAPROXEN (NAPROXEN)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2064-2026·2026-05-13
Endoscopy Pump Tubing/Cap Set water aspiration risk recall
Erbe Medical is recalling ERBEFLO 2 Endoscopy Pump Tubing/Cap Sets due to a connector design that may allow unintended water flow, potentially leading to water aspiration and serious respiratory conditions.
Product
ERBEFLO 2, Endoscopy Pump Tubing/Cap Set, REF: 20325-222
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0519-2026·2026-05-13
Octreotide Acetate Injectable Suspension Recalled Due to Sterility Assurance
Teva Pharmaceuticals USA, Inc. is recalling 2,200 kits of Octreotide Acetate for Injectable Suspension (30 mg) due to quality system deficiencies that affect sterility assurance. The recall affects all lots nationwide.
Product
OCTREOTIDE ACETATE — OCTREOTIDE ACETATE (OCTREOTIDE ACETATE)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1977-2026·2026-05-13
Halyard PERC TRAY Kit Syringe Adaptor Connection Risk Recall
The Halyard PERC TRAY kit (models SLPC34-01 and SLPC34-02) is being recalled due to risk that a Medline syringe rotating adaptor may unwind during use, causing a loose or full disconnection between the syringe and manifold.
Product
Halyard PERC TRAY kit. Model Numbers: SLPC34-01, SLPC34-02.
Category
Medical Device
Distribution
7 states
SevereFDA (Devices)·Z-2091-2026·2026-05-13
Medline Convenience Kits Recalled for Sterilization Calibration Issues
Medline is recalling multiple convenience kits used in catheterization labs and surgical procedures due to calibration issues with sterilization equipment that may affect sterility assurance. The affected kits were distributed nationwide.
Product
Medline Convenience Kits: 1) ANGIO PROCEDURE PACK, Model Number:00-401824AA; 2) ENDO KIT W/SYRINGE, Model Number:DYKE1743; 3) BGMC ANGIOGRAPHY PACK-LF, Model Number:DYNJ0800934D; 4) GENERAL ENDO PACK-LF, Model Number:DYNJ0842873J; 5) ANGIO PROCEDURE PACK, Model Number:DY
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0513-2026·2026-05-13
DELFLEX Peritoneal Dialysis Solution Recall Due to Potential Sterility Issues
Fresenius Medical Care is recalling DELFLEX Dextrose Peritoneal Dialysis Solution bags due to potential leaks from bag perforations that could compromise sterility. Affected patients should contact their healthcare provider immediately.
Product
DELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-safe Exchange Set for Intraperitoneal Dialysis Only, 2.5% DEX. LM/LC, 2L 5PK, Part Number 054-20222, Fresenius Medical Care North America, 920 Winter Street, Waltham, MA 02451.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0524-2026·2026-05-13
TPN Bag Recalled for Missing Insulin Formulation Error
Central Admixture Pharmacy Services is recalling a patient-specific TPN bag because it did not contain insulin as listed on the label. Patients relying on this product for the labeled insulin dosage may face serious health risks.
Product
TPN bag (patient specific), Rx# 11-4909703-0-1, Compound Volume 1660 mL per bag, Rx only, Single Dose Injection, Refrigerated Injection, Central Admixture Pharmacy Services, Los Angeles, 13128 Imperial Hwy, Santa Fe Spr., CA 90670
Category
Drug
Distribution
1 state
SevereFDA (Devices)·Z-1972-2026·2026-05-13
Halyard Cardiac Catheterization Tray Kits Recalled for Connection Risk
AVID Medical is recalling Halyard CARDIAC CATH TRAY SHANDS JAX kits due to a defect in the Medline syringe rotating adaptor that may unwind during use, causing a loose or full disconnection between the syringe and manifold.
Product
Halyard CARDIAC CATH TRAY SHANDS JAX kit. Model Number: SHND401-04, SHND401-05.
Category
Medical Device
Distribution
7 states
SevereFDA (Devices)·Z-2118-2026·2026-05-13
Medline Convenience Kits recalled for potential sterility assurance defects
Medline Industries is recalling six models of medical device convenience kits due to calibration issues with sterilization and packaging equipment that may have reduced sterility assurance levels. The recall affects 553 units distributed nationwide.
Product
Medline Convenience Kits: 1) PICC CATHETER INSERTION TRAY, Model Number: CVI4300; 2) OSC SHERMAN KNEE ARTHRO BASIC, Model Number: DYKM1977C; 3) KIT ACES INSERT PEG, Model Number: DYKMBNDL130; 4) KIT ACES INSERT PEG, Model Number: DYKMBNDL130A; 5) KIT ACES INSERT PERCUTAN
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2062-2026·2026-05-13
ERBEFLO CleverCap CO2 Tubing and Cap Sets for Endoscopes
Erbe Medical is recalling ERBEFLO CleverCap CO2 hybrid tubing and cap sets used with endoscopes because the distal connector may allow unintended water flow, potentially leading to water aspiration and serious respiratory complications.
Product
ERBEFLO CleverCap CO2: Hybrid CO2 Tubing/Cap Set for Olympus Scopes & CO2 Sources, REF: 20325-239; Hybrid CO2 Tubing/Cap Set for Olympus Scopes & UCR, REF: 20325-240; Hybrid CO2 Tubing/Cap Set for Olympus Scopes, REF: 20325-206; Hybrid CO2 Tubing/Cap Set for Pentax Scopes, REF: 2
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0540-2026·2026-05-13
Lactated Ringers Injection Recalled for Particulate Matter Contamination
B. Braun Medical Inc. is recalling Lactated Ringer's Injection USP (1000 mL containers) due to the presence of particulate matter. The recall affects 95,412 containers distributed nationwide.
Product
LACTATED RINGERS — LACTATED RINGERS (SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDE)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1979-2026·2026-05-13
Halyard VA Detroit Cath Lab Pack Kit Syringe Adaptor Disconnection Risk
Halyard VA Detroit Cath Lab Pack kits (Model VMCD029) are being recalled due to a potential risk that the Medline syringe rotating adaptor may unwind during use, causing a loose or full disconnection between the syringe and manifold.
Product
Halyard VA DETROIT CATH LAB PACK kit. Model Numbers: VMCD029.
Category
Medical Device
Distribution
7 states
SevereFDA (Devices)·Z-1970-2026·2026-05-13
Halyard Cardiac Cath Pack Kit Syringe Adapter Unwinding Risk
AVID Medical recalls Halyard Cardiac Cath Pack kits (Models EAMC1000-05, WAFB208-02) due to risk that a Medline syringe rotating adapter may unwind during use, causing loose or full disconnection between the syringe and manifold.
Product
Halyard CARDIAC CATH PACK kit. Model Number: EAMC1000-05, WAFB208-02.
Category
Medical Device
Distribution
7 states
SevereFDA (Devices)·Z-1855-2026·2026-05-13
Intuitive 8 mm SureForm 30 Gray Reloads Incomplete Staple Defect
Intuitive Surgical is recalling Intuitive 8 mm SureForm 30 Gray Reloads (Reference Numbers 48230M-05 and 48230M-06) because they may produce an incomplete staple line during curved-tipped stapler operations.
Product
Intuitive 8 mm SureForm 30 Gray Reloads Reference Numbers: 48230M-05 and 48230M-06
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-1974-2026·2026-05-13
Halyard CATH LAB Kit Due to Syringe Adapter Disconnection Risk
AVID Medical is recalling the Halyard CATH LAB kit (Model SACL75-01) due to risk that a Medline syringe rotating adaptor may unwind during use, causing loose or complete disconnection between the syringe and manifold.
Product
Halyard CATH LAB kit. Model Number: SACL75-01.
Category
Medical Device
Distribution
7 states
SevereFDA (Devices)·Z-2106-2026·2026-05-13
Medline Convenience Kits recalled due to sterilization equipment calibration issues
Medline Industries is recalling four Convenience Kit models (892 units) nationwide because sterilization and packaging equipment calibration issues may have compromised the sterility assurance level of the devices.
Product
Medline Convenience Kits: 1) CHEST TUBE INSERTION TRAY, Model Number: DYNDA2941A; 2) CHEST/BREAST-LF, Model Number: DYNJ83950; 3) HERNIA REPAIR TOTE, Model Number: DYNJ908337A; 4) HERNIA REPAIR TOTE, Model Number: DYNJ908337C
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1936-2026·2026-05-13
Beacon Tip Centimeter Sizing Catheter recalled for cracking marker bands
Cook Incorporated is recalling Beacon Tip Centimeter Sizing Catheters because marker bands may crack or break, which could lead to device fragmentation, prolonged procedures, vessel injury, and in worst-case scenarios, life-threatening harm or death.
Product
Beacon Tip Centimeter Sizing Catheter RPN/GPN NR5.0-35-70-P-10S-0-CSC-20 G31213 NR5.0-35-100-P-10S-0-CSC-20 G31214 NR5.0-35-100-P-10S-PIG-CSC-20 G31216 NR5.0-35-70-P-10S-VCF-CSC-20 G31220 NR5.0-35-100-P-10S-VCF-CSC-20 G31221 Sizing catheters are single-use, sterile
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0518-2026·2026-05-13
BD PurPrep Povidone-Iodine Topical Solution Sterility Assurance Recall
CareFusion 213, LLC is recalling BD PurPrep (povidone-iodine 8.3% with isopropyl alcohol 72.5%) due to lack of assurance of sterility and potential product contamination. Affected lots are distributed nationwide.
Product
PURPREP — PURPREP (POVIDONE IODINE AND ISOPROPYL ALCOHOL)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2108-2026·2026-05-13
Medline Labor and Delivery Kits Recalled for Sterilization Calibration Issues
Medline Industries is recalling approximately 29,192 labor and delivery kits and OB packs due to calibration issues in sterilization equipment that may impact sterility assurance. The products were exposed to validated sterilization cycles, but the calibration problems potentially compromise sterile status.
Product
Medline Convenience Kits: 1) OB KIT, Model Number: DYKM2326; 2) KIT LABOR DELIVERY TUBAL LIGAT, Model Number: DYKMBNDL165; 3) KIT LABOR & DELIVERY D&C/D&E, Model Number: DYKMBNDL31; 4) KIT LABOR & DELIVERY CERCLAGE, Model Number: DYKMBNDL38; 5) KIT LABOR & DELIVERY CERCL
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1971-2026·2026-05-13
Halyard CARDIAC CATH PACK SAN23CARDQ Kit Syringe Adapter Risk
AVID Medical is recalling Halyard CARDIAC CATH PACK SAN23CARDQ kits (Model DRCC36) due to a Medline syringe rotating adapter that may unwind during use, potentially causing loose or full disconnection between the syringe and manifold.
Product
Halyard CARDIAC CATH PACK SAN23CARDQ kit. Model Number: DRCC36.
Category
Medical Device
Distribution
7 states
SevereFDA (Devices)·Z-1976-2026·2026-05-13
Halyard NEURO IR PERIPHERAL kit syringe adapter may disconnect
AVID Medical is recalling the Halyard NEURO IR PERIPHERAL (PS 64405) kit because the Medline syringe rotating adapter may unwind during use, causing a loose or full disconnection between the syringe and manifold.
Product
Halyard NEURO IR PERIPHERAL (PS 64405) kit. Model Number: UINR44-01.
Category
Medical Device
Distribution
7 states
SevereFDA (Devices)·Z-1975-2026·2026-05-13
Halyard HEART CATH SELF REGIONAL kit syringe adapter disconnection hazard
AVID Medical is recalling the Halyard HEART CATH SELF REGIONAL kit (Model SELF131-05) because the Medline syringe rotating adaptor may unwind during use, causing a loose or full disconnection between the syringe and manifold.
Product
Halyard HEART CATH, SELF REGIONAL kit. Model Number: SELF131-05.
Category
Medical Device
Distribution
7 states
SevereFDA (Devices)·Z-1973-2026·2026-05-13
Halyard CATH LAB Kit Recalled for Syringe Adapter Disconnection Risk
AVID Medical is recalling the Halyard CATH LAB kit (Model SACL75AM) because the syringe rotating adapter may unwind during use, causing a loose or full disconnection between the syringe and manifold.
Product
Halyard CATH LAB kit. Model Number: SACL75AM.
Category
Medical Device
Distribution
7 states

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