Category
FDA recalls of medical devices including diagnostics, implants, and consumer health hardware.
Medical device recalls are the FDA's highest-volume stream. They cover implantable devices like pacemakers and joint replacements, hospital diagnostics and lab analyzers, surgical instruments, software-as-a-medical-device, and consumer-facing hardware like CPAP machines, blood-pressure cuffs, and glucose monitors. The volume comes from the wide range of products in scope and from the FDA's broad definition of 'corrective action' — software updates, IFU revisions, and labeling corrections all show up as recalls.
For Class I device recalls, the device's defect creates a reasonable risk of serious injury or death — these are the urgent ones. Class II covers issues that may cause temporary or medically reversible harm, often around accuracy or calibration. Class III is for products that don't comply with FDA rules but pose no real safety risk; in practice many software-update letters are Class III.
If you depend on a recalled device for ongoing care, don't disconnect or stop using it before talking to the prescribing clinician — interrupting therapy for a CPAP or a continuous glucose monitor can be more dangerous than the recall it's responding to. Almost every device recall offers a remedy that doesn't require you to surrender the device first.
Materialise USA LLC is recalling ProPlan CMF Anatomical Model units where packages labeled MU22-INA-DUQ contained the wrong anatomical model inside. Recipients should verify their package contents match the label.
McKesson is recalling Medefil Normal Saline IV Flush Syringes (Models MIS-1130 and 191-MIS-1130) due to facility temperature excursions between June and August 2021. Products received through September 30, 2021 may have impaired effectiveness from temperature exposure prior to delivery.
McKesson is recalling Fischer Cone Biopsy Excisor Model 900-157 units because temperature excursions during storage may have compromised product effectiveness.
McKesson and Metrex Research are recalling glutaraldehyde disinfectants due to facility temperature excursions from June to August 2021 that may have reduced product effectiveness. Affected lots were distributed nationwide between June 1 and September 30, 2021.
Mckesson is recalling Dynarex DynaLube lubricating jelly due to facility temperature excursions from June-August 2021 that may have degraded product effectiveness. Recall affects 17.5 boxes distributed nationwide between June-September 2021.
Mckesson Medical-Surgical Inc. is recalling Excelsior Heparin Sodium prefilled syringes that may have been damaged by temperature excursions during manufacturing, potentially affecting their effectiveness. The recall covers lots received between June and September 2021.
Wright Medical Technology is recalling 17 Stryker SWANSON Finger Joint Implants (size 00) due to incorrect sizing labels applied to carton packaging. Devices with lot numbers 1728375 and 1728376 were distributed across multiple US states and internationally.
Mckesson Medical-Surgical Inc. is recalling Dynarex Nail Polish Remover Pads due to facility temperature excursions in summer 2021 that may have reduced product effectiveness. All lots received between June 1 and September 30, 2021, nationwide are affected.
Baxter Healthcare is recalling DISCPAC Syringe Tip Caps due to potential packaging defects that may not maintain sterile barriers. The recall affects approximately 63,190 units distributed worldwide.
B. Braun Medical Inc. is recalling Anesthesia Support Trays distributed between June and September 2021 due to temperature excursions during storage that may have affected product effectiveness.
Multiple Strep A diagnostic test kits are being recalled due to temperature exposure during manufacturing and storage that may have compromised test accuracy. All lots received between June 1 and September 30, 2021 are affected.
The Vanta Clinician Programmer Application may fail to connect with Vanta neurostimulators when a patient has multiple devices implanted. This prevents programming of pain therapy settings in patients with multiple implants.
Merit Medical Systems Aspira Dressing and Drainage Kits recalled due to facility temperature excursions from June to August 2021. Exposure to higher temperatures may have reduced product effectiveness; no illnesses reported.
Mckesson Medical-Surgical Inc. is recalling Fisherbrand laboratory swabs due to facility temperature excursions from June through August 2021 that may have impacted product effectiveness. All affected lots distributed between June 1 and September 30, 2021 are included.
Mckesson is recalling a Total-Fix stool collection parasitology kit due to temperature exposure that may have reduced its effectiveness. All lots received between June 1 and September 30, 2021 are affected.
Mckesson Medical-Surgical initiated a voluntary nationwide recall of Fisherbrand SWAB TRANS STUARTS swabs. The specific reason for the recall is not documented in the FDA notice.
Revital-Ox Resert hydrogen peroxide disinfectant 4-liter containers may have reduced effectiveness due to temperature exposure during storage. McKesson is recalling affected lots distributed June-September 2021.
Mckesson Medical-Surgical is recalling Medline catheter insertion trays (Model DYND10160) due to temperature excursions at the manufacturing facility that may have affected product effectiveness. Affected units were distributed nationwide between June and September 2021.
Mizuho OSI is recalling one batch of regular femoral hooks that were etched with an incorrect model designation. The recalled batch contains 13 devices distributed in the United States and Canada.
BD Vacutainer blood collection tubes are recalled due to potential temperature damage during storage from June to August 2021. Affected tubes received between June 1 and September 30, 2021 may have reduced effectiveness.
McKesson recalls hCG pregnancy test kits nationwide due to facility temperature excursions that may have compromised product effectiveness. Affected lots were received between June and September 2021.
Merit Medical Systems Temno soft tissue biopsy devices may have lost effectiveness due to storage temperature excursions between June and August 2021. The recall affects all lots received between June 1 and September 30, 2021.
HeartWare HVAD System Batteries are being recalled due to electrical faults that may prevent the battery from powering the device controller, accepting charges, or maintaining charge. Approximately 19,616 batteries distributed worldwide are affected.
Family Dollar is recalling CURAD First Aid Kits (SKU 999037) that were improperly stored without temperature control from April 30 to June 10, 2022. The temperature exposure may have degraded medications or compromised medical devices within the kits.
ASO LLC is recalling 274,458 retail packages of three wound care products that fall apart during handling after removal from packaging, compromising their sterility and usability.
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