Recalls in South Dakota (page 16)
3823 recalls.
- A M S recall (Windstone Medical Packaging, Inc.)
Medical deviceClass IReported July 8, 2026 · Kits contain Webcol Large Alcohol Prep Pad which were recalled by Cardinal Health following the discovery of a contaminant (Paenibacillus phoenicis) during a... - A M S recall (Windstone Medical Packaging, Inc.)
Medical deviceClass IReported July 8, 2026 · Kits contain Webcol Large Alcohol Prep Pad which were recalled by Cardinal Health following the discovery of a contaminant (Paenibacillus phoenicis) during a... - Short Monobloc Stem Broaches recall (Medacta Usa Inc)
Medical deviceClass IIReported July 8, 2026 · Surgical instruments used during shoulder arthroplasty procedures does not progressively translate to replicate implant geometry, so the reaming guide and the... - Reprocessed Electrophysiology Catheters and Ultrasound Catheters Item no. 401206RH recall (Medline Industries, LP)
Medical deviceClass IReported July 8, 2026 · Expansion of RES 98277. Specific lots of reprocessed catheters may contain small particles of residual material. If devices with residual particulates on... - Medline Convenience kits containing recalled Swan-Ganz Catheters CABG A CDS ... recall (Medline Industries, LP)
Medical deviceClass IIReported July 8, 2026 · Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of leaks/breakage involving failures of the (blue) proximal... - Medline Convenience kits containing recalled Swan-Ganz Catheters RIGHT HEART CATH... recall (Medline Industries, LP)
Medical deviceClass IIReported July 8, 2026 · Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of leaks/breakage involving failures of the (blue) proximal... - Medline Convenience kits containing recalled Swan-Ganz Catheters OPEN HEART ... recall (Medline Industries, LP)
Medical deviceClass IIReported July 8, 2026 · Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of leaks/breakage involving failures of the (blue) proximal... - Medline Convenience kits containing recalled Swan-Ganz Catheters CV ANESTHESIA -... recall (Medline Industries, LP)
Medical deviceClass IIReported July 8, 2026 · Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of leaks/breakage involving failures of the (blue) proximal... - Medline Convenience kits containing recalled Swan-Ganz Catheters KIT GERMANTOWN... recall (Medline Industries, LP)
Medical deviceClass IIReported July 8, 2026 · Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of leaks/breakage involving failures of the (blue) proximal... - Medline Convenience kits containing recalled Swan-Ganz Catheters CENTRAL AND... recall (Medline Industries, LP)
Medical deviceClass IIReported July 8, 2026 · Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of leaks/breakage involving failures of the (blue) proximal... - Medline Convenience kits containing recalled Swan-Ganz Catheters CARDIAC MAJOR ... recall (Medline Industries, LP)
Medical deviceClass IIReported July 8, 2026 · Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of leaks/breakage involving failures of the (blue) proximal... - Medline Convenience kits containing recalled Swan-Ganz Catheters RIGHT HEART CATH... recall (Medline Industries, LP)
Medical deviceClass IIReported July 8, 2026 · Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of leaks/breakage involving failures of the (blue) proximal... - Omnipod recall (Insulet Corporation)
Medical deviceClass IReported July 8, 2026 · External soft cannula damage during manufacturing that results in insulin leaking around the Pod instead of being delivered to the user regardless of basal or... - Omnipod DASH Pod. Includes the below Model/REF Numbers: 1. POD-BLE-I1-525 recall (Insulet Corporation)
Medical deviceClass IReported July 8, 2026 · External soft cannula damage during manufacturing that results in insulin leaking around the Pod instead of being delivered to the user regardless of basal or... - Omnipod 5 Pods. Includes the below Model/REF Numbers: 1. POD-OMNI-I1-6720. 2.... recall (Insulet Corporation)
Medical deviceClass IReported July 8, 2026 · External soft cannula damage during manufacturing that results in insulin leaking around the Pod instead of being delivered to the user regardless of basal or... - Hillrom VOLARA System P.CIRCUIT 5KIT AC recall (Baxter Healthcare Corporation)
Medical deviceClass IReported July 8, 2026 · There have been reports of air and medication leakage from the nebulizer cup during therapy of Volara system patient circuits. The leakage can lead to an... - Hillrom VOLARA System P.CIRCUIT KIT AC recall (Baxter Healthcare Corporation)
Medical deviceClass IReported July 8, 2026 · There have been reports of air and medication leakage from the nebulizer cup during therapy of Volara system patient circuits. The leakage can lead to an... - Hillrom VOLARA P.CIRCUIT 5KIT recall (Baxter Healthcare Corporation)
Medical deviceClass IReported July 8, 2026 · There have been reports of air and medication leakage from the nebulizer cup during therapy of Volara system patient circuits. The leakage can lead to an... - Hillrom VOLARA System P.CIRCUIT KIT recall (Baxter Healthcare Corporation)
Medical deviceClass IReported July 8, 2026 · There have been reports of air and medication leakage from the nebulizer cup during therapy of Volara system patient circuits. The leakage can lead to an... - Medline Convenience Kits: 1) OPHTHALMIC PACK W/LIDO recall (Medline Industries, LP)
Medical deviceClass IIReported July 8, 2026 · The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for... - Medline Convenience Kits: 1) MERCY MEDICAL CIRCUMCISION TRAY recall (Medline Industries, LP)
Medical deviceClass IIReported July 8, 2026 · The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for... - Medline Convenience Kits: 1) L&D CONTINUOUS EPIDURAL TRAY recall (Medline Industries, LP)
Medical deviceClass IIReported July 8, 2026 · The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for... - Medline Convenience Kits: 1) LUMBAR PUNCTURE CHOICE recall (Medline Industries, LP)
Medical deviceClass IIReported July 8, 2026 · The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for... - Medline Convenience Kits: 1) ARTERIAL LINE KIT recall (Medline Industries, LP)
Medical deviceClass IIReported July 8, 2026 · The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for... - Medline Convenience Kits: 1) SUTURE TRAY recall (Medline Industries, LP)
Medical deviceClass IIReported July 8, 2026 · The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for... - Medline Convenience Kits: 1) PI CVC KIT 3L 7 FR 16 CM recall (Medline Industries, LP)
Medical deviceClass IIReported July 8, 2026 · The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for... - Medline Convenience Kits: 1) SUTURING SET recall (Medline Industries, LP)
Medical deviceClass IIReported July 8, 2026 · The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for... - Medline Convenience Kits: 1) IMAGING BIOPSY TRAY recall (Medline Industries, LP)
Medical deviceClass IIReported July 8, 2026 · The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for... - Medline Convenience Kits: 1) STD recall (Medline Industries, LP)
Medical deviceClass IIReported July 8, 2026 · The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for... - Medline Convenience Kits: 1) DYNJ0621189X recall (Medline Industries, LP)
Medical deviceClass IIReported July 8, 2026 · The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for... - Medline Convenience Kits: 1) MULTIMED recall (Medline Industries, LP)
Medical deviceClass IIReported July 8, 2026 · The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for... - Medline Convenience Kits: 1) BLOCK TRAY recall (Medline Industries, LP)
Medical deviceClass IIReported July 8, 2026 · The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for... - Medline Convenience Kits: 1) PAIN MGMT/ PREF W. MED NDL recall (Medline Industries, LP)
Medical deviceClass IIReported July 8, 2026 · The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for... - Medline Convenience Kits: 1) ARTERIAL ACCESS TRAY W/LIDOCAINE recall (Medline Industries, LP)
Medical deviceClass IIReported July 8, 2026 · The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for... - Winco Fireworks International Recalls Roman Candles 8 Shot Fireworks Due to Risk of Serious Injury from Explosion and Burn Hazards
Consumer productReported July 3, 2026 · The recalled fireworks can malfunction, and shots can blow out the side of the tube, posing a risk of serious injury from explosion and burn hazards. - Winco Fireworks International Recalls Unity 7 Shot 200 Gram Aerial Cake Fireworks Due to Risk of Serious Injury from Explosion and Burn Hazards
Consumer productReported July 3, 2026 · The recalled fireworks can tip over, posing a risk of serious injury from explosion and burn hazards. - Conair Recalls Over One Million Cuisinart Grill Brushes Due to Ingestion Hazard
Consumer productReported July 3, 2026 · Small metal wire bristles can detach from the brushes and stick to the grill or food, posing an ingestion hazard and risk of serious internal injuries that... - Junpower CR2032 Lithium Coin Batteries Recalled Due to Risk of Serious Injury or Death from Battery Ingestion Hazard; Violate Federal Statute for Child-Resistant Packaging of Coin Batteries; Sold on Amazon by JSNJ_Tech Store
Consumer productReported July 3, 2026 · The lithium coin batteries are not sold in child-resistant packaging and do not bear the warning labels as required under Reese's Law. When button cell or coin... - Cooper Lighting Recalls Metalux Optimized High Bay LED Light Fixtures Due to Fire Hazard
Consumer productReported July 3, 2026 · The LED's board can overheat or come into contact with the lens or nearby combustible materials, posing a fire hazard. - Target Recalls Gigglescape™ Under the Sea Popping Toy Due to Choking Hazard
Consumer productReported July 3, 2026 · The clear plastic dome can detach from the blue plastic base, making the small plastic balls inside the toy accessible to children, posing a choking hazard. - AMASKY Nursing Pillows Recalled Due to Risk of Serious Injury or Death from Suffocation; Violate Mandatory Standards for Nursing Pillows and Infant Support Cushions; Sold on Amazon by Pretty-Life
Consumer productReported July 3, 2026 · The recalled nursing pillows advertised for infant feeding and tummy time violate the mandatory safety standards for nursing pillows and infant support... - Rowenta Recalls Cordless Vacuum Cleaners Due to Risk of Serious Injury from Fire and Burn Hazards
Consumer productReported July 3, 2026 · The recalled lithium-ion battery in the vacuum cleaner can overheat and ignite, posing a risk of serious injury from fire and burn hazards. - Projecting LED Finger Light Toys Recalled Due to Risk of Serious Injury Death from Battery Ingestion; Violate Mandatory Standard for Toys; Sold on Amazon by POPOOO
Consumer productReported July 3, 2026 · The recalled LED finger lights violate the mandatory safety standard for toys because they contain button cell batteries that can be easily accessed by... - Diamond Wipes International Recalls CVS Health Medicated Hemorrhoidal Wipes Due to Risk of Serious Injury or Death from Child Poisoning; Violate Mandatory Standard for Child-Resistant Packaging
Consumer productReported July 3, 2026 · The recalled medicated wipes contain lidocaine, which must be in child-resistant packaging, as required by the Poison Prevention Packaging Act. The packaging... - Topyond Pool Drain Ports with Covers Recalled Due to Risk of Serious Injury or Death from Entrapment and Drowning Hazards; Violate Virginia Graeme Baker Pool & Spa Safety Act; Sold by Jialyduu
Consumer productReported July 3, 2026 · The recalled drain ports with covers violate the entrapment protection standards of the Virginia Graeme Baker Pool and Spa Safety Act (VGBA), posing deadly... - Vevor Recalls Baby Loungers Due to Risk of Serious Injury or Death from Entrapment and Fall Hazards; Violate Mandatory Standard for Infant Sleep Products
Consumer productReported July 3, 2026 · The recalled baby loungers violate the mandatory safety standard for infant sleep products. The sides are too low to contain an infant and the enclosed... - Philips Telemetry Monitor 5500 1.4 GHz. Model Number: 867232. Includes the following... recall (Philips North America Llc)
Medical deviceClass IIReported July 1, 2026 · Potential for device reset to default "NEW_DEVICE" state, which may lead to a to loss of device configuration and the equipment label, resulting in a failure... - INZONE DETACHMENT SYSTEM recall (Stryker Neurovascular)
Medical deviceClass IIReported July 1, 2026 · Embolization coil detachment system devices may experience premature battery drain causing devices to: 1) Not power on; 2) Power on with faint audible and... - Da Vinci ASSY recall (Intuitive Surgical, Inc.)
Medical deviceClass IIReported July 1, 2026 · Operative components of surgical systems potentially distributed with E-brake retainer pin, so in event of a structural column failure, the E-brake pin would... - Spring & Mulberry Blood Orange Date-Sweetened Chocolate recall (Spring & Mulberry Inc.)
FoodClass IReported July 1, 2026 · Potential Salmonella contamination - Spring & Mulberry Coffee Date-Sweetened Chocolate recall (Spring & Mulberry Inc.)
FoodClass IReported July 1, 2026 · Potential Salmonella contamination - Spring & Mulberry Sea Salt Date-Sweetened Chocolate recall (Spring & Mulberry Inc.)
FoodClass IReported July 1, 2026 · Potential Salmonella contamination - 1) Spring & Mulberry Pure Dark Date-Sweetened Chocolate recall (Spring & Mulberry Inc.)
FoodClass IReported July 1, 2026 · Potential Salmonella contamination - Spring & Mulberry Pecan Date Date-Sweetened Chocolate recall (Spring & Mulberry Inc.)
FoodClass IReported July 1, 2026 · Potential Salmonella contamination. - Spring & Mulberry Mulberry Fennel Date-Sweetened Chocolate recall (Spring & Mulberry Inc.)
FoodClass IReported July 1, 2026 · Potential Salmonella contamination. - Spring & Mulberry Mango Chili Date-Sweetened Chocolate recall (Spring & Mulberry Inc.)
FoodClass IReported July 1, 2026 · Potential Salmonella contamination - Spring & Mulberry Lavender Rose Date-Sweetened Chocolate recall (Spring & Mulberry Inc.)
FoodClass IReported July 1, 2026 · Potential Salmonella contamination - Spring & Mulberry Earl Grey Date-Sweetened Chocolate recall (Spring & Mulberry Inc.)
FoodClass IReported July 1, 2026 · Potential Salmonella contamination - Spring & Mulberry Mixed Berry Date-Sweetened Chocolate recall (Spring & Mulberry Inc.)
FoodClass IReported July 1, 2026 · Potential Salmonella contamination - Spring & Mulberry Mint Leaf Date-Sweetened Chocolate recall (Spring & Mulberry Inc.)
FoodClass IReported July 1, 2026 · Potential Salmonella contamination - Motor City Pizza Co. 5 Cheese Bread Single retail pack recall (Champion Foods, LLC)
FoodClass IIReported July 1, 2026 · potential salmonella contamination - Perampanel CIII Tablets recall (SUN PHARMACEUTICAL INDUSTRIES INC)
DrugClass IIReported July 1, 2026 · Labeling: Label Mix-up: 10mg Perampanel CIII tablet was found in a Perampanel CIII bottle labeled Perampanel 6 mg tablets. - Povi-One recall (Elevate Oral Care)
DrugClass IIReported July 1, 2026 · sub potency - Lacosamide Tablets recall (Annora Pharma Private Limited)
DrugClass IIReported July 1, 2026 · Presence of a Foreign Tablets: Complaint received, possible mix-up of Selexipag 1000 mcg tablet in a bottle of Lacosamide Tablets USP, 100mg. - BD ChloraPrep FREPP Clear recall (CareFusion 213, LLC)
DrugClass IReported July 1, 2026 · Non-Sterility: Due to presence of Aspergillus penicillioides. And Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the... - BD ChloraPrep Clear recall (CareFusion 213, LLC)
DrugClass IReported July 1, 2026 · Non-Sterility: Due to presence of Aspergillus penicillioides. - BD ChloraPrep FREPP Clear recall (CareFusion 213, LLC)
DrugClass IIReported July 1, 2026 · Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area. - BD ChloraPrep Clear recall (CareFusion 213, LLC)
DrugClass IIReported July 1, 2026 · Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area. - hydrOXYzine Hydrochloride Oral Solution recall (ANI Pharmaceuticals, Inc.)
DrugClass IIIReported July 1, 2026 · Presence of foreign substance - DULOXETINE D/R recall (Direct Rx)
DrugClass IIReported July 1, 2026 · CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit - Sensipar recall (Amgen, Inc.)
DrugClass IIReported July 1, 2026 · CGMP Deviations - Corlanor recall (Amgen, Inc.)
DrugClass IIReported July 1, 2026 · Presence of Foreign Substance. - Sensipar recall (Amgen, Inc.)
DrugClass IIReported July 1, 2026 · CGMP Deviations - Sensipar recall (Amgen, Inc.)
DrugClass IIReported July 1, 2026 · CGMP Deviations - Corlanor recall (Amgen, Inc.)
DrugClass IIReported July 1, 2026 · Presence of Foreign Substance. - Fenofibrate Capsules recall (Ajanta Pharma USA Inc)
DrugClass IIReported July 1, 2026 · CGMP Deviations - Carton Label: MAJOR recall (The Harvard Drug Group LLC)
DrugClass IIReported July 1, 2026 · Subpotent Drug - Abiomed Impella CP Set with SmartAssist recall (Abiomed, Inc.)
Medical deviceClass IReported July 1, 2026 · Potential for thrombus formation during prolonged use of the introducer. - Abiomed Impella CP Set with SmartAssist recall (Abiomed, Inc.)
Medical deviceClass IReported July 1, 2026 · Potential for thrombus formation during prolonged use of the introducer. - Abiomed 14 Fr x 25 cm Low Profile Introducer Kit for Impella CP. Impella Set Product... recall (Abiomed, Inc.)
Medical deviceClass IReported July 1, 2026 · Potential for thrombus formation during prolonged use of the introducer. - Abiomed 14 Fr x 13 cm Low Profile Introducer Kit for Impella CP. Impella Set Product... recall (Abiomed, Inc.)
Medical deviceClass IReported July 1, 2026 · Potential for thrombus formation during prolonged use of the introducer. - Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. ... recall (Medline Industries, LP)
Medical deviceClass IIReported July 1, 2026 · Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601. - Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. ... recall (Medline Industries, LP)
Medical deviceClass IIReported July 1, 2026 · Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601. - Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. ... recall (Medline Industries, LP)
Medical deviceClass IIReported July 1, 2026 · Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601. - Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. ... recall (Medline Industries, LP)
Medical deviceClass IIReported July 1, 2026 · Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601. - Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. ... recall (Medline Industries, LP)
Medical deviceClass IIReported July 1, 2026 · Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601. - Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. ... recall (Medline Industries, LP)
Medical deviceClass IIReported July 1, 2026 · Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601. - Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. ... recall (Medline Industries, LP)
Medical deviceClass IIReported July 1, 2026 · Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601. - Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. KIT... recall (Medline Industries, LP)
Medical deviceClass IIReported July 1, 2026 · Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601. - Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. ... recall (Medline Industries, LP)
Medical deviceClass IIReported July 1, 2026 · Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601. - Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. ... recall (Medline Industries, LP)
Medical deviceClass IIReported July 1, 2026 · Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601. - Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. ... recall (Medline Industries, LP)
Medical deviceClass IIReported July 1, 2026 · Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601. - Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. ... recall (Medline Industries, LP)
Medical deviceClass IIReported July 1, 2026 · Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601. - Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. DR... recall (Medline Industries, LP)
Medical deviceClass IIReported July 1, 2026 · Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601. - Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. ... recall (Medline Industries, LP)
Medical deviceClass IIReported July 1, 2026 · Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601. - Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. ... recall (Medline Industries, LP)
Medical deviceClass IIReported July 1, 2026 · Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601. - Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. ... recall (Medline Industries, LP)
Medical deviceClass IIReported July 1, 2026 · Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601. - Intera Oncology INTERA 3000 Hepatic Artery Infusion Pump recall (Boston Scientific Corporation)
Medical deviceClass IIReported July 1, 2026 · There is the potential for leakage along the drug pathway from the pump through the end of the catheter. - Octopus 4 Tissue Stabilizer recall (Medtronic Perfusion Systems)
Medical deviceClass IIReported July 1, 2026 · During the manufacturing process, Medtronic personnel identified an assembly issue where the tubing was incorrectly positioned. The short tube was attached to... - Octopus Evolution AS Tissue Stabilizer recall (Medtronic Perfusion Systems)
Medical deviceClass IIReported July 1, 2026 · During the manufacturing process, Medtronic personnel identified an assembly issue where the tubing was incorrectly positioned. The short tube was attached to...