Safety Recalls

17,395 recalls across FDA food, drug, and medical device recalls, CPSC consumer products, and NHTSA vehicles.

Showing 1,151–1,200 of 17,395

• Drug Recall · June 11, 2026

  CareFusion 213, LLC

  BD ChloraPrep Clear, (2% w/v chlorhexidine gluconate (CHG), and 70% v/v isopropyl alcohol (IPA), Packaged as a) 100 x 3ml applicators/case, NDC 54365-400-32, catalog 930400NS; b) 250 x 3ml applicators

  Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel

  Class II

• Medical Device Recall · June 11, 2026

  PHILIPS MEDICAL SYSTEMS

  Ingenuity CT CT5000 Ingenuity Plus CT5000 Ingenuity Pro CT5000 Ingenuity Premium Ingenuity CT Upgrades Ingenuity CT China Ingenuity Core 128 Elite Brazil

  The clinical CT scan may not automatically trigger after the Bolus Tracking scan and may need to be triggered manually. Additional Bolus Tracking shots may occur. This may result in the clinical acquisition being inadequate for diagnosis, causing a potential for patient rescan and receiving additional radiation.

  Class II

• Medical Device Recall · June 11, 2026

  Abiomed, Inc.

  ABIOMED Impella CP Set, Pump Set Code 0048-0014; containing Introducer Product Code 0052-3046. heart pump and accessories

  A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set.

  Class I

• Medical Device Recall · June 11, 2026

  Boston Scientific Corporation

  FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401; Percutaneous Cardiac Ablation Catheter

  Boston Scientific is replacing specific FARASTAR PFA generators which have a configuration that is not compatible for use with the FARAPOINT PFA catheter.

  Class II

• Drug Recall · June 11, 2026

  CareFusion 213, LLC

  BD ChloraPrep CLear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol) 100 x 10.5 mL Applicators/case, STERILE SOLUTION, CareFusion 123, LLC, El Paso, TX, subsidiary of Beckton, Dic

  Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel

  Class II

• Drug Recall · June 11, 2026

  CareFusion 213, LLC

  BD ChloraPrep CLear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol),500 x 1 mL applicators/case, STERILE SOLUTION, CareFusion 123, LLC, El Paso, TX, subsidiary of Beckton, Dicks

  Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel

  Class II

• Medical Device Recall · June 11, 2026

  Abiomed, Inc.

  ABIOMED Impella 5.5 SmartAssist S2 Set, JP, Pump Set Codes 1000459, 1000460; containing Introducer Product Code 0052-3006-JP. heart pump and accessories

  A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set.

  Class I

• Medical Device Recall · June 11, 2026

  Boston Scientific Corporation

  FARADRIVE STEERABLE SHEATH CLEAR, used to facilitate access to the vasculature and into the chambers of the heart, Material Number 21M402, IFU Reference Number LBL1062

  Boston Scientific's complaint investigations have identified that a subset of air ingress complaints are associated with hemostatic valve damage related to dilator insertion orientation during device preparation. Valve damage may result in air ingress, potential air embolism, and associated patient harm. This risk can be mitigated by inserting the dilator straight through the center of the valve and fully advancing it into the sheath body.

  Class II

• Medical Device Recall · June 11, 2026

  Abiomed, Inc.

  ABIOMED Impella CP Introducer Kit 14 Fr, 13 and 25 cm, Pump Set Code 1000550, containing Kit, 14Fr Introducer, 13cm&25cm, Sterile, Introducer Product Code 0052-3046. heart pump and accessories

  A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set.

  Class I

• Drug Recall · June 11, 2026

  CareFusion 213, LLC

  BD ChloraPrep Scrub Teal, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol) packaged as a) 100 x 10.5 mL Applicators/case, NDC 54365-400-36, catalog number 930725NS; b) 100 x 10.5 m

  Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel

  Class II

• Food Recall · June 11, 2026

  Wondermade LLC

  Alabama Banana Pudding Marshmallow, 4 ounce 16 pieces of individual marshmallows packaged in a sealed plastic bag inside a printed cardboard box

  Foreign material: small metal pieces

  Class II

• Medical Device Recall · June 11, 2026

  Abiomed, Inc.

  ABIOMED Impella CP Introducer Kit 14 Fr, 13 cm, Pump Set Code 0052-0038, containing Kit, 14Fr Introducer, 13cm, Long Taper, Introducer Product Code 0052-3052. heart pump and accessories

  A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set.

  Class I

• Medical Device Recall · June 11, 2026

  Boston Scientific Corporation

  FARASTAR Pulsed Field Ablation Generator, Product ID M004PFCE61M401; Percutaneous Cardiac Ablation Catheter

  Labeling discrepancy: Devices distributed with Instructions For Use (IFU) did not include FARAPOINT PFA catheter information.

  Class II

• Medical Device Recall · June 10, 2026

  Oscor Inc.

  Abiomed REF: 0052-3006, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 23F. heart pump and accessories.

  Due to manufacturing issues, there is a potential for the 14Fr and 23Fr introducer sheaths to leak from the sidearm, under the sheath cap, and along the hub score lines in the hub region.

  Class I

• Medical Device Recall · June 10, 2026

  Oscor Inc.

  Abiomed REF: 0052-3021, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 14F, 23F. heart pump and accessories.

  Due to manufacturing issues, there is a potential for the 14Fr and 23Fr introducer sheaths to leak from the sidearm, under the sheath cap, and along the hub score lines in the hub region.

  Class I

• Medical Device Recall · June 10, 2026

  Orthofix U.S. LLC

  Orthofix ARTICULATED MINIRAIL FIXATOR HORIZONTAL AXIS REF: M111, Unilateral orthopedic/trauma external fixation device

  Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103, Minirail M103 was labeled as M101, and Minirail M122 was labeled as M111

  Class II

• Medical Device Recall · June 10, 2026

  ICU Medical, Inc.

  ICU Medical Plum Solo Precision IV Pump, v1.0.3, Item Number 400010401; infusion pump

  In a specific scenario, the pump will not decrement the Volume to be Infused (VTBI) displayed on the Delivery screen and may deliver up to twice the VTBI at the programmed rate.

  Class II

• Medical Device Recall · June 10, 2026

  Medline Industries, LP

  Medline Kits containing Zimmer Biomet mixing bowls and spatulas TOTAL KNEE PACK DYNJT6267

  Kits contain Zimmer Biomet mixing bowls and spatulas, which were recalled due to seal nonconformities which present risk of sterility breach. Health consequences from use of product include clinically insignificant extension of surgery to find another readily available device.

  Class II

• Medical Device Recall · June 10, 2026

  Orthofix U.S. LLC

  Orthofix MINIRAIL, ARTICULATED, FIXATOR, VERTICAL AXIS REF: M122, Unilateral orthopedic/trauma external fixation device

  Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103, Minirail M103 was labeled as M101, and Minirail M122 was labeled as M111

  Class II

• Medical Device Recall · June 10, 2026

  Orthofix U.S. LLC

  Orthofix MINIRAIL, SHORT, LENGTHENER REF: M103, Unilateral orthopedic/trauma external fixation device

  Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103, Minirail M103 was labeled as M101, and Minirail M122 was labeled as M111

  Class II

• Medical Device Recall · June 10, 2026

  Medline Industries, LP

  Medline Kits containing Zimmer Biomet mixing bowls and spatulas TOTAL KNEE PACK-LF DYNJ61651J

  Kits contain Zimmer Biomet mixing bowls and spatulas, which were recalled due to seal nonconformities which present risk of sterility breach. Health consequences from use of product include clinically insignificant extension of surgery to find another readily available device.

  Class II

• Medical Device Recall · June 10, 2026

  ICU Medical, Inc.

  ICU Medical Plum Duo Infusion Pump, v1.2.3: 1) Item Number 400020401 and 2) Item Number 400020403; infusion pump

  In a specific scenario, the pump will not decrement the Volume to be Infused (VTBI) displayed on the Delivery screen and may deliver up to twice the VTBI at the programmed rate.

  Class II

• Medical Device Recall · June 10, 2026

  Orthofix U.S. LLC

  Orthofix MINIRAIL, STANDARD LENGTHENER Model/Catalog Number: M101, Unilateral orthopedic/trauma external fixation device

  Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103, Minirail M103 was labeled as M101, and Minirail M122 was labeled as M111

  Class II

• Food Recall · June 10, 2026

  Fry Pie Factory LLC

  Pepperoni Rolls, Net Wt. 5 oz (141g), individually packaged in a clear plastic bag, UPC 601959803041

  Undeclared allergen (milk) and process deviation (product not held under refrigeration as required)

  Class II

• Medical Device Recall · June 10, 2026

  Foundation Medicine, Inc.

  Hamilton Microlab STAR Liquid Handler; Protocol Configuration Tool (PCT) v2.0.0. Used to conduct F1CDx and F1LCDx.

  Software issue that can cause an increase in spontaneous software closures.

  Class II

• Drug Recall · June 10, 2026

  McKesson

  Gemcitabine Injection, 1 g per 26.3 mL (38 mg/mL), 26.3 mL Single-Dose Vial, For Intravenous Infusion ONLY, Rx only, Manufactured by: THYMOORGAN PHARMAZIE GmbH, Schiffgraben 23, 38690 Goslar, Germany;

  Temperature Abuse: Product was stored incorrectly in a controlled room temperature environment instead of a refrigerated environment.

  Class II

• Medical Device Recall · June 10, 2026

  Oscor Inc.

  Abiomed REF: 0052-3025, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 14F 13cm and 25cm. heart pump and accessories.

  Due to manufacturing issues, there is a potential for the 14Fr and 23Fr introducer sheaths to leak from the sidearm, under the sheath cap, and along the hub score lines in the hub region.

  Class I

• Drug Recall · June 10, 2026

  ACCORD BIOPHARMA INC

  IMULDOSA, (ustekinumab-srlf) Injection, 130 mg/26 mL (5mg/mL), Rx only, Single dose vial, Manufactured by Accord BioPharma Inc., 8041 Arco corporate Drive, Suite 200, Raleigh, NC 27617, USA, Manufactu

  Lack of assurance of Sterility:

  Class II

• Food Recall · June 10, 2026

  Wells Enterprises, Inc.

  Plastic 1-gallon clear pail blue label which reads in part as "BLUE RIBBON CLASSICS FRENCH VANILLA, MFD. BY WELLS ENTERPRISES, INC. D/B/A WELLS DAIRY, INC., P.O. BOX 1310 LE MARS, IA 51031

  Elevated coliforms

  Class II

• Medical Device Recall · June 9, 2026

  Zimmer Surgical Inc

  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:

  Potential sterility breach in sealing area of sterile pouch. If used, issue may result in moderate localized infection. If discovered prior to use, may result in clinically insignificant extension of surgery to find another readily available device.

  Class II

• Vehicle Recall · June 9, 2026

  Ford Motor Company

  2023 FORD EXPEDITION, 2024 FORD EXPEDITION

  Vehicle occupants may contact the center console's sharp edges, increasing the risk of injury.

  Unclassified

• Medical Device Recall · June 9, 2026

  Zimmer Surgical Inc

  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: D

  Potential sterility breach in sealing area of sterile pouch. If used, issue may result in moderate localized infection. If discovered prior to use, may result in clinically insignificant extension of surgery to find another readily available device.

  Class II

• Vehicle Recall · June 9, 2026

  Ford Motor Company

  2024 FORD EXPLORER

  A park system that is damaged may not shift into "PARK," resulting in a vehicle rollaway and increasing the risk of injury or crash.

  Unclassified

• Food Recall · June 9, 2026

  GREENWORLD FOOD EXPRESS (USA) LLC

  Al Yaman Halawa Extra Pistachio 907g (31.994 oz) plastic jars, UPC 5 287000 098083, 12 retail units per case

  Product may be contaminated with Salmonella

  Class I

• Vehicle Recall · June 9, 2026

  Alliance RV, LLC

  2026 MIDWEST AUTOMOTIVE DESIGN LUXE CRUISER

  The undersized ground cable may overheat, increasing the risk of a fire.

  Unclassified

• Medical Device Recall · June 9, 2026

  CMR SURGICAL LIMITED

  Brand Name: Versius Surgical System US Product Name: Vesius Surgeon Console US Model/Catalog Number: V-SS-1020 Software Version: Pratchett 1 version 62.1 Product Description: The Versius Surgical

  Secure Boot was mistakenly not enabled at manufacturing time, which presents a potential cybersecurity risk.

  Class II

• Medical Device Recall · June 8, 2026

  Siemens Healthcare Diagnostics, Inc.

  Atellica CH Enzymatic Hemoglobin A1c (A1c_E). Material Number: 11097536.

  The potential for intermittent well-to-well bias on the A1c_E assay on the Atellica CH and Atellica CI analyzer which could cause falsely depressed or falsely elevated HbA1c patient results.

  Class II

• Medical Device Recall · June 8, 2026

  Medline Industries, LP

  Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16, 18, 20) 5cc balloons. RR-DAVINCI PROSTATE ACCESSORY DYNJ63392F

  Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increased amount of raw material present on the surface of the catheter. Issue may result in the use of urinary catheters that exhibit staining on the catheter surface; raw material present in increased amounts may be harmful.

  Class II

• Medical Device Recall · June 8, 2026

  Siemens Medical Solutions USA, Inc

  ARTIS icono ceiling. Model Number: 11328100.

  Potential issue with the Display ceiling suspension (DCS Fix XL) that holds the monitor in place. Over time some screws that keep the monitor attached to the suspension may gradually loosen.

  Class II

• Medical Device Recall · June 8, 2026

  Windstone Medical Packaging, Inc.

  AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) ENT Pack, Part Number AMS10411B; 2) ENT Pack, Part Number AMS10411C; 3) Rhinoplasty Pack, Part Number AMS11963A; 4) Spine

  The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalling specific lots of Ritmed¿ Neurological Sponges Non-Sterile Models 55992C to 55998C due to potential for unexpected variability of endotoxin levels on the products.

  Class II

• Medical Device Recall · June 8, 2026

  Stryker Corporation

  STRYKER AHTO TUBE SET PACKAGING, Catalog Number 0250070600

  There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use.

  Class II

• Medical Device Recall · June 8, 2026

  Stryker Corporation

  STRYKER PKG., SINGLE SPIKE TUBE SET, Catalog Number 0250070530

  There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use.

  Class II

• Medical Device Recall · June 8, 2026

  Medline Industries, LP

  MEDLINE medical procedure convenience kit labeled as: 1) TOTAL KNEE-LF, Medline kit SKU CDSOPT590T; 2) TOTAL KNEE-LF, Medline kit SKU CDSOPT590U; 3) TOTAL KNEE CDS, Medline kit SKU CDS983930J; 4)

  The procedure kits contain ICU Medical, Inc. pain management kits containing Bupivacaine Hydrochloride in Dextrose Injection, USP, which were recalled due to quality issues that could result in drug ineffectiveness.

  Class I

• Medical Device Recall · June 8, 2026

  Medline Industries, LP

  Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16, 18, 20) 5cc balloons. NON MB DAVINCI LITHOTOMY SM PK DYNJT6105

  Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increased amount of raw material present on the surface of the catheter. Issue may result in the use of urinary catheters that exhibit staining on the catheter surface; raw material present in increased amounts may be harmful.

  Class II

• Medical Device Recall · June 8, 2026

  Klowen Braces

  KL Owen Custom Orthodontic Solution, model/catalog number CIAS-800033,

  A product error defect may cause incorrect bracket placement.

  Class II

• Medical Device Recall · June 8, 2026

  Medline Industries, LP

  MEDLINE medical procedure convenience kit labeled as: HIP CDS-LF, Medline kit SKU CDS984556N

  The procedure kits contain ICU Medical, Inc. pain management kits containing Bupivacaine Hydrochloride in Dextrose Injection, USP, which were recalled due to quality issues that could result in drug ineffectiveness.

  Class I

• Medical Device Recall · June 8, 2026

  Medline Industries, LP

  Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16, 18, 20) 5cc balloons. PROSTATE ROBOTIC DYNJ901822B

  Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increased amount of raw material present on the surface of the catheter. Issue may result in the use of urinary catheters that exhibit staining on the catheter surface; raw material present in increased amounts may be harmful.

  Class II

• Drug Recall · June 8, 2026

  Asclemed USA Inc.

  Accucaine, Kit contains: Lidocaine HCl Injection USP, 1% (10 mg/mL), 5 mL single dose ampule, Rx Only, Distributed by Enovachem Pharmaceuticals, Torrance, CA 90501, NDC: 76420-715-01.

  Lack of Assurance of Sterility

  Class II

• Medical Device Recall · June 8, 2026

  Stryker Corporation

  STRYKER AHTO TUBE SET WITH TIP PACKAGING, Catalog Number 0250070620

  There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use.

  Class II

• Medical Device Recall · June 8, 2026

  ConvaTec, Inc

  Aquacel Ag Surgical SP REF: 413556 9cm x 15cm/3.5 in. x 6 in., Sterile R

  Surgical dressing manufactured out of specification (greater thickness).

  Class II