Medical DeviceNov 15, 2023
Family Dollar Stores, LLC AT HOME MARIJUANA TEST STRIP, SKU 900752 recall — FDA Z-0262-2024
Products were stored outside of labeled temperature requirements.
Class IIFDA: OngoingFamily Dollar Stores, LLC.
November 2023 recalls — page 9
These records include useful source details for the selected month.
Medical DeviceNov 15, 2023
Baxter Healthcare Novum IQ Syringe infusion system, Product Code 40800BAXUS recall — FDA Z-0151-2024
Baxter is issuing an Urgent Medical Device Correction for the Novum IQ Syringe Pump. Baxter identified that after multiple downstream occlusion alarms, the pump may display an Infusion…
Class IFDA: OngoingBaxter Healthcare Corporation
Medical DeviceNov 15, 2023
Philips Zenition 50 & 70 Mobile Surgery C-arm recall — FDA Z-0226-2024
Philips has become aware of an issue with the Philips Integris-Allura, Allura Xper and Azurion systems that have been delivered to Puerto Rico without a warning label and the Source-to-Skin…
Class IIFDA: OngoingPhilips North America
Medical DeviceNov 15, 2023
B. Braun Medical AMO ADMINISTRATION SET, Article No. 7A3817, REF OM2505191, for recall — FDA Z-0130-2024
Devices may leak as a result of a manufacturing issue. Leakage may result in a delay of therapy, increase risk of bloodstream infection (BSI), and may expose both patients and healthcare…
Class IIFDA: OngoingB. Braun Medical, Inc.
Medical DeviceNov 15, 2023
Olympus Corporation of the Americas EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Model recall — FDA Z-0190-2024
There is a risk of endobronchial combustion if high-frequency cauterization is performed while supplying oxygen [and/or] the electrode section of the electrosurgical accessory is too close…
Class IFDA: OngoingOlympus Corporation of the Americas
Medical DeviceNov 15, 2023
Family Dollar Stores, LLC GOODSENSE DENTURE CLEANSER GRN TAB 40CT, SKU 906312 GOODSENSE recall — FDA Z-0267-2024
Products were stored outside of labeled temperature requirements.
Class IIFDA: OngoingFamily Dollar Stores, LLC.
Medical DeviceNov 15, 2023
B. Braun Medical 30 ML 2PORT BURETTE ASSEMBLY, Article No. 7A3950, used in a contrast recall — FDA Z-0131-2024
Devices may leak as a result of a manufacturing issue. Leakage may result in a delay of therapy, increase risk of bloodstream infection (BSI), and may expose both patients and healthcare…
Class IIFDA: OngoingB. Braun Medical, Inc.
Medical DeviceNov 15, 2023
Securitas Healthcare Arial Water Resistant Pendant with Neck Lanyard, Models: 59360 and recall — FDA Z-0220-2024
Premature battery depletion presents a risk that alarms will not be received by the Arial Wireless Emergency Call System.
Class IIFDA: OngoingSecuritas Healthcare LLC
Medical DeviceNov 15, 2023
Stryker Disposable Spetzler-Malis Bipolar forceps, 23CM SM DISP BAYONET 0.5MM TIP, Catalog recall — FDA Z-0242-2024
An error was identified on the expiration date of the product label. The shelf life for the products impacted is 36 months (3 years) however the product label represents a 54 month (4.5…
Class IIFDA: OngoingStryker Corporation
Medical DeviceNov 15, 2023
Stryker Disposable Spetzler-Malis Bipolar forceps, 23CM SLM DISP BAYONET 0.5MM, Catalog recall — FDA Z-0255-2024
An error was identified on the expiration date of the product label. The shelf life for the products impacted is 36 months (3 years) however the product label represents a 54 month (4.5…
Class IIFDA: OngoingStryker Corporation
Medical DeviceNov 15, 2023
Stryker Disposable Spetzler-Malis Bipolar forceps, 20CM SM DISP BAYONET 0.5MM TIP, Catalog recall — FDA Z-0241-2024
An error was identified on the expiration date of the product label. The shelf life for the products impacted is 36 months (3 years) however the product label represents a 54 month (4.5…
Class IIFDA: OngoingStryker Corporation
Medical DeviceNov 15, 2023
Stryker Disposable Spetzler-Malis Bipolar forceps, 23CM IM DISP BAYONET 1.0MM TIP, Catalog recall — FDA Z-0251-2024
An error was identified on the expiration date of the product label. The shelf life for the products impacted is 36 months (3 years) however the product label represents a 54 month (4.5…
Class IIFDA: OngoingStryker Corporation
Medical DeviceNov 15, 2023
Olympus Corporation of the Americas EVIS EXERA III BRONCHOVIDEOSCOPE Model Numbers recall — FDA Z-0192-2024
There is a risk of endobronchial combustion if high-frequency cauterization is performed while supplying oxygen [and/or] the electrode section of the electrosurgical accessory is too close…
Class IFDA: OngoingOlympus Corporation of the Americas
Medical DeviceNov 15, 2023
Stryker Disposable Spetzler-Malis Bipolar forceps, 20CM SLM DISP BAYONET 1.0MM, Catalog recall — FDA Z-0253-2024
An error was identified on the expiration date of the product label. The shelf life for the products impacted is 36 months (3 years) however the product label represents a 54 month (4.5…
Class IIFDA: OngoingStryker Corporation
Medical DeviceNov 15, 2023
Olympus Corporation of the Americas EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Model recall — FDA Z-0191-2024
There is a risk of endobronchial combustion if high-frequency cauterization is performed while supplying oxygen [and/or] the electrode section of the electrosurgical accessory is too close…
Class IFDA: OngoingOlympus Corporation of the Americas
Medical DeviceNov 15, 2023
St. Jude Medical CardioMEMS Patient Electronic System (PES), Model Number CM1100 recall — FDA Z-0218-2024
Potential for damaged and frayed power connector plug with repeated bending or manipulation beyond 90 degrees.
Class IIFDA: OngoingSt. Jude Medical
Medical DeviceNov 15, 2023
Securitas Healthcare Arial Water Resistant Pendant with Wristband, Models: 59361 and recall — FDA Z-0221-2024
Premature battery depletion presents a risk that alarms will not be received by the Arial Wireless Emergency Call System.
Class IIFDA: OngoingSecuritas Healthcare LLC
Medical DeviceNov 15, 2023
Stryker Disposable Spetzler-Malis Bipolar forceps, 23CM SM DISP BAYONET 1.0MM TIP, Catalog recall — FDA Z-0243-2024
An error was identified on the expiration date of the product label. The shelf life for the products impacted is 36 months (3 years) however the product label represents a 54 month (4.5…
Class IIFDA: OngoingStryker Corporation
Medical DeviceNov 15, 2023
B. Braun Medical THERASPHERE ADMIN SET, Article No. 7M2650 recall — FDA Z-0133-2024
Devices may leak as a result of a manufacturing issue. Leakage may result in a delay of therapy, increase risk of bloodstream infection (BSI), and may expose both patients and healthcare…
Class IIFDA: OngoingB. Braun Medical, Inc.
Medical DeviceNov 15, 2023
Medical DeviceNov 15, 2023
Stryker Disposable Spetzler-Malis Bipolar forceps, 23CM IM DISP BAYONET 0.5MM TIP, Catalog recall — FDA Z-0250-2024
An error was identified on the expiration date of the product label. The shelf life for the products impacted is 36 months (3 years) however the product label represents a 54 month (4.5…
Class IIFDA: OngoingStryker Corporation
Medical DeviceNov 15, 2023
Encore Medical RSP Humeral Socket Insert Size 36mm Semi-Constrained +4 mm, REF: 509-01-436 recall — FDA Z-0282-2024
Two different humeral socket Insert devices were swapped during packaging, which could result in surgeons not having the correct device for surgery, which could cause a delay in surgery.
Class IIFDA: OngoingEncore Medical, LP
Medical DeviceNov 15, 2023
Family Dollar Stores, LLC CLEARBLUE SMART COUNTDOWN PRGNCY TST 1CT, SKU 900260 recall — FDA Z-0261-2024
Products were stored outside of labeled temperature requirements.
Class IIFDA: OngoingFamily Dollar Stores, LLC.
Medical DeviceNov 15, 2023
Stryker Disposable Spetzler-Malis Bipolar forceps, 20CM IM DISP BAYONET 1.5MM TIP, Catalog recall — FDA Z-0249-2024
An error was identified on the expiration date of the product label. The shelf life for the products impacted is 36 months (3 years) however the product label represents a 54 month (4.5…
Class IIFDA: OngoingStryker Corporation
How to use this monthly recall archive
Use this page to compare the recalls reported during the month, then open an individual record for the exact reason, classification, company, remedy or distribution information available from the official source. Monthly counts are descriptive, not a safety rating.