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.
DeRoyal Industries recalled 28 SHOULDER KIT units due to an unspecified Class II device defect. The affected lot numbers were distributed across 23 U.S. states between November 2022 and April 2025.
DeRoyal Industries Inc recalled 16 kits of DeRoyal TOTAL HIP PACK (Lot 56042728, expiring May 1, 2026) distributed across 23 U.S. states. The specific reason for the recall was not provided in available agency documentation.
DeRoyal Industries is recalling 264 units of the ORTHO SPINE BACK PACK orthopedic device across 23 U.S. states as a voluntary, Class II recall. The specific reason for the recall is not provided in the available notice.
DeRoyal Industries is recalling 190 cataract procedure packs that contain 3M Health Care Steri Drapes which have been recalled. The affected packs were distributed across 22 US states.
DeRoyal Industries voluntarily recalled 159 kits of the NEURO PACK medical device. The specific reason for the recall was not disclosed in the FDA filing.
DeRoyal Industries initiated a voluntary recall of 552 units of its CATARACT PACK due to an unspecified defect. The FDA classified this Class II recall on December 15, 2022.
DeRoyal Industries Inc recalled 243 SPINE PACK medical device kits distributed across 23 US states as a Class II FDA recall. The specific reason for the recall is not detailed in the available notice.
DeRoyal Industries has voluntarily recalled 75 DeRoyal UNIVERSAL PACK kits (Ref 89-9558.03) distributed across 23 US states. The specific reason for the recall has not been disclosed in available documentation.
DeRoyal Industries initiated a voluntary recall of 363 shoulder arthroscopy surgical packs. The specific reason for the recall was not disclosed in the notice.
DeRoyal Industries Inc voluntarily recalled 45 units of the DeRoyal TOTAL HIP KIT (Lot 57686947, expiration 5/1/2025), distributed across 23 US states. The FDA classified this as a Class II recall, initiated November 3, 2022.
DeRoyal Industries Inc is voluntarily recalling the DeRoyal CUSTOM NEURO PACK (Lot 57745880) distributed across multiple U.S. states. The specific reason for the recall is not disclosed.
DeRoyal Industries voluntarily recalled 2,280 myelogram pack kits across 23 U.S. states. No specific reason for the recall was provided in the official notice.
DeRoyal Industries Inc is recalling 180 kits of the NEURO SPINE BACK PACK PGYBK distributed across multiple U.S. states. The specific reason for the recall is not documented in the agency filing.
DeRoyal is recalling 18 EMERGENT TRAUMA PACK units distributed to 23 states. The specific reason for recall is not documented in available source materials.
The FDA is recalling 403 kits of DeRoyal lapinectomy packs distributed across 23 US states. The specific reason for the recall is not provided in the source documentation.
DeRoyal Industries is recalling 135 surgical procedure kits containing recalled 3M Health Care Steri Drapes. The affected kits were distributed to 23 U.S. states.
Remel Inc. is recalling Sensititre HPB1 diagnostic plates that may produce false susceptible results for specific bacteria when tested with seven antibiotics. This could lead to inaccurate susceptibility information affecting clinical treatment decisions.
Caire, Inc. is recalling 10 CAIRE Liberator 45 liquid oxygen system units due to inconsistencies in weld penetration on the inner bottle discovered during an FDA audit.
Sensititre MDRGN3F antibiotic test device may return false susceptible results for certain gram-negative bacteria, risking inappropriate antibiotic treatment. FDA Class I recall issued.
Caire, Inc. is recalling CAIRE Liberator 20 liquid oxygen system units due to weld penetration inconsistencies discovered during an FDA audit. The manufacturing defect affects 3 units.
The FDA recalled Sensititre GN6F Gram Negative antimicrobial susceptibility test plates (2,471 units) because they may report false results indicating bacteria are susceptible to certain antibiotics when they are actually resistant.
Dewei DNA/RNA Preservation Kits (catalog DW-80005-1B) were distributed in the U.S. without FDA authorization or clearance. Approximately 1,348,000 units were distributed to California, Florida, Kentucky, and Michigan.
Thermo Scientific Sensititre CMC7AFLF Gram Negative diagnostic tests may produce false susceptible results for certain bacteria, potentially leading to ineffective antibiotic treatment decisions. The FDA has classified this as a Class I recall.
Remel Inc is recalling 588 units of the Sensititre Gram Negative IVD AST diagnostic plate due to false susceptible test results for certain bacteria when tested with specific antibiotics. The defect could lead to incorrect treatment decisions.
Sensititre diagnostic plates may give false antibiotic susceptibility results for certain bacteria species, potentially affecting treatment decisions. The FDA issued a Class I recall for approximately 1,917 units distributed nationwide.
Looking for a different category? Browse all recalls.