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FDA Recalls
›Device Recalls

FDA Device Recalls

Recalls of medical devices, diagnostic equipment, implants, and surgical instruments.

Classification

All Class I Class II Class III

Status

All Ongoing Completed Terminated

Date

All time Past 30 days Past 12 months

Showing 621–640 of 39,430 recalls

Class IIOngoing

OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2111

Olympus Corporation of the Americas

Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.

March 25, 2026 · DeviceView details →

Class IIOngoing

DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff End Grasping Forceps, Model/Catalog Number: DVF4022-25-S

Katalyst Surgical, LLC

Field Safety Corrective Action for IFU in DEX Forceps and Scissors.

March 25, 2026 · DeviceView details →

Class IIOngoing

DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Maculorhexis Forceps, Model/Catalog Number: DVF4019-25-S

Katalyst Surgical, LLC

Field Safety Corrective Action for IFU in DEX Forceps and Scissors.

March 25, 2026 · DeviceView details →

Class IIOngoing

OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2116.

Olympus Corporation of the Americas

Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.

March 25, 2026 · DeviceView details →

Class IIOngoing

Oxoid Agglutinating Sera, Salmonella 9-0 R30957301

Remel Europe Ltd.

Affected lots are not performing to IFU criteria showing cross reactions with 2-0 within 60 seconds. Cross-reactivity may result in the misidentification of a Salmonella 9-O serotype as a 2-O serotype.

March 25, 2026 · DeviceView details →

Class IIOngoing

DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Serrated Forceps, Model/Catalog Number: DVF4016-25-S

Katalyst Surgical, LLC

Field Safety Corrective Action for IFU in DEX Forceps and Scissors.

March 25, 2026 · DeviceView details →

Class IIOngoing

OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2330.

Olympus Corporation of the Americas

Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.

March 25, 2026 · DeviceView details →

Class IIOngoing

DEX Ophthalmic Tissue Forceps, 27ga DEX Stiff Maculorhexis Forceps, Model/Catalog Number: DVF4019-27

Katalyst Surgical, LLC

Field Safety Corrective Action for IFU in DEX Forceps and Scissors.

March 25, 2026 · DeviceView details →

Medline medical convenience kits, containing Namic Manifold, Labeled as: HEART CATH PACK-LF, Medline Kit Number/SKU DYNJ36478B

Medline Industries, LP

Medline has identified the presence of particulate within the fluid path of the Manifolds.

March 24, 2026 · DeviceView details →

Class IIOngoing

Yeastone Broth, 11ML, 10/BOX YY3462

Remel, Inc

Products may report incorrect AST results during quality control. Health consequences may include delayed response or the need to change to another antifungal agent if laboratory ignores Quality Control test result.

March 24, 2026 · DeviceView details →

Namic Preceptor Manifold, custom, Medline Product Number/SKU 64037107; Extravascular blood pressure transducer

Medline Industries, LP

Medline has identified the presence of particulate within the fluid path of the Manifolds.

March 24, 2026 · DeviceView details →

Medline medical convenience kits, containing Namic Manifold, Labeled as: TAVI, Medline Kit Number/SKU DYNJ904981C

Medline Industries, LP

Medline has identified the presence of particulate within the fluid path of the Manifolds.

March 24, 2026 · DeviceView details →

Class IIOngoing

Protocol Configuration Tool (PCT) software v1.3.0 for Hamilton AutoLys STAR used within FoundationOneCDx (F1CDx) installed on Research Triangle Park laboratory Equipment IDs 01342, 01591, 01989, 01990, 01994, 01995.

Foundation Medicine, Inc.

Potential for spontaneous closures of Hamilton HxRunControl software during execution of Autolys protocols after deployment of the PCT software for AutoLys Hamilton STAR.

March 24, 2026 · DeviceView details →

Medline medical convenience kits, containing Namic Manifold, Labeled as: 1. ANGIOGRAPHY CATH LAB, Medline Kit Number/SKUDYNJ23532C; 2. CATH LAB PACK, Medline Kit Number/SKUDYNJ65185; 3. ANGIO KIT, Medline Kit Number/SKUVASC1057.

Medline Industries, LP

Medline has identified the presence of particulate within the fluid path of the Manifolds.

March 24, 2026 · DeviceView details →

1. 3 VALVE MAN KIT, Medline Kit SKU Number: 65101544; 2. 3V MANIFOLD KIT, Medline Kit SKU Number: 65110351; 3. HEART CATH PACK-LF, Medline Kit SKU Number: DYNJ0373285M; 4. ANGIO DRAPE CARDIAC PACK, Medline Kit SKU Number: DYNJ51615P; 5. ANGIO DRAPE CARDIAC PACK, Medline Kit SKU Number: DYNJ51615R; 6. HEART RADIAL LAB PACK, Medline Kit SKU Number: DYNJ61982C; 7. HEART RADIAL LAB PACK, Medline Kit SKU Number: DYNJ61982D; 8. HEART ABLATION DRAPE PACK, Medline Kit SKU Number: DYNJ61984C; 9. TAVR PACK, Medline Kit SKU Number: DYNJ62310B; 10. HEART TAVR PACK, Medline Kit SKU Number: DYNJ65174G; 11. FEMORAL CARDIAC CATH, Medline Kit SKU Number: DYNJ66343A; 12. CARDIAC CATH PACK, Medline Kit SKU Number: DYNJ66693C; 13. TAVR PACK, Medline Kit SKU Number: DYNJ67225C; 14. AFIB TRAY, Medline Kit SKU Number: DYNJ85069; 15. AFIB TRAY, Medline Kit SKU Number: DYNJ85069A; 16. AFIB TRAY, Medline Kit SKU Number: DYNJ85069B; 17. MTO,LEFT HEART,KIT, Medline Kit SKU Number: VASC1811. Namic medical convenience kits, containing Namic Manifold, Labeled as: 1. DBD-MTS,3V,MAN,KIT, Medline Kit Number/SKU 60010195; 2. MTS,4 VALVE,LFT,HRT,KIT, Medline Kit Number/SKU 60010468; 3. MTO,ADD,ON,KIT, Medline Kit Number/SKU 60010469; 4. MTS,RT,HANDED/LFT,HRT,KIT, Medline Kit Number/SKU 60010508; 5. MTS,LFT,HRT,KIT, Medline Kit Number/SKU 60012911; 6. MTO,RIGHT HEART,KIT, Medline Kit Number/SKU 60012912; 7. DBD-MTS,LEFT HEART,KIT, Medline Kit Number/SKU 60013001; 8. MTS,LEFT HEART,KIT, Medline Kit Number/SKU 60013101; 9. MTS,LFT,HRT,W/WIRE, Medline Kit Number/SKU 60013112; 10. MTS,-,3V,KIT, Medline Kit Number/SKU 60020608; 11. MTO,ANGIO,KIT, Medline Kit Number/SKU 60032681; 12. MTS-LEFT HEART,KIT, Medline Kit Number/SKU 60033123; 13. MTS,RIGHT HEART,KIT, Medline Kit Number/SKU 60033124; 14. MTO,LEFT HEART,KIT, Medline Kit Number/SKU 60034644; 15. MTS,LEFT HEART,KIT, Medline Kit Number/SKU 60040273; 16. MTO,2V,LEFT HEART,KIT, Medline Kit Number/SKU 60040424; 17. MTS,3,VAVLE,KIT, Medline Kit Number/SKU 60041082; 18. MTS,2V,KIT, Medline Kit Number/SKU 60042453; 19. MTO,3V,KIT, Medline Kit Number/SKU 60042454; 20. MTS,LEFT HEART,KIT, Medline Kit Number/SKU 60042721; 21. MTS,3 VALVE,KIT, Medline Kit Number/SKU 60050183; 22. MTS,3 VALVE,MANIFOLD,KIT, Medline Kit Number/SKU 60060268; 23. MTO,RT,HRT,KIT, Medline Kit Number/SKU 60060564; 24. MTO,LEFT HEART,KIT, Medline Kit Number/SKU 60060569; 25. MTS, Medline Kit Number/SKU 60062021; 26. MTS,LEFT HEART,KIT, Medline Kit Number/SKU 60071232; 27. MTO,CATH,LAB,KIT, Medline Kit Number/SKU 60080221; 28. MTO,RIGHT, Medline Kit Number/SKU 60080347; 29. MTS,LEFT HEART,KIT, Medline Kit Number/SKU 60080349; 30. MTS,MANIFOLD,KIT, Medline Kit Number/SKU 60080716; 31. MTS,LEFT,HRT,KIT, Medline Kit Number/SKU 60081001; 32. MTS,RIGHT HEART,KIT, Medline Kit Number/SKU 60081002; 33. MTO,LEFT,HRT(RT,HANDED), Medline Kit Number/SKU 60081168; 34. MTO,RIGHT HEART,KIT, Medline Kit Number/SKU 60090123; 35. MTS,LEFT HEART,KIT, Medline Kit Number/SKU 60091111; 36. MTS,EP,KIT, Medline Kit Number/SKU 60100056; 37. MTS,3 VALVE,LEFT HEART,KIT, Medline Kit Number/SKU 60100338; 38. MTO,RIGHT HEART,KIT, Medline Kit Number/SKU 60100339; 39. DBD-MTO,LEFT HEART,KIT, Medline Kit Number/SKU 60110273; 40. MTO,RIGHT HEART,KIT, Medline Kit Number/SKU 60110701; 41. MTS,3 VALVE,KIT, Medline Kit Number/SKU 60120693; 42. MTS,LEFT HEART,KIT, Medline Kit Number/SKU 60121817; 43. MTO,CATH,KIT, Medline Kit Number/SKU 60130124; 44. MTO,LEFT HEART,KIT, Medline Kit Number/SKU 60130318; 45. DBD-MTS,3 VALVE,KIT, Medline Kit Number/SKU 60130506; 46. MTO,RT HEART,KIT, Medline Kit Number/SKU 60131323; 47. MTS,LEFT,HRT,KIT, Medline Kit Number/SKU 60131324; 48. DBD-MTS,LEFT HEART,KIT, Medline Kit Number/SKU 60131554; 49. MTS,LEFT HEART,KIT, Medline Kit Number/SKU 60131815; 50. MTO,RT,HRT,KIT, Medline Kit Number/SKU 60

Medline Industries, LP

Medline has identified the presence of particulate within the fluid path of the Manifolds.

March 24, 2026 · DeviceView details →

1. DBD-MTS,3V,MAN,KIT, Medline Kit Number/SKU 60010195; 2. MTS-LEFT HEART,KIT, Medline Kit Number/SKU 60033123; 3. MTS,3 VALVE,KIT, Medline Kit Number/SKU 60050183; 4. MTS,LEFT HEART,KIT, Medline Kit Number/SKU 60080349; 5. MTS,3 VALVE,LEFT HEART,KIT, Medline Kit Number/SKU 60100338; 6. MTS LHK, Medline Kit Number/SKU 60101017; 7. DBD-MTS,3 VALVE,KIT, Medline Kit Number/SKU 60130506; 8. MTS,LEFT,HRT,KIT, Medline Kit Number/SKU 60131324; 9. MTS,LEFT HEART,KIT, Medline Kit Number/SKU 60132238; 10. MTS,3,PORT,KIT, Medline Kit Number/SKU 60138301; 11. MTS,LEFT HEART,KIT, Medline Kit Number/SKU 60140589; 12. MTS,3 VALVE,W/, Medline Kit Number/SKU 60192012; 13. DBD-MTS,4V,MANIFOLD,KIT, Medline Kit Number/SKU 60220488; 14. MTS,LHK, Medline Kit Number/SKU 60232091; 15. MTO,3 VALVE,MANIFOLD,KIT, Medline Kit Number/SKU 65010037; 16. MTO,LEFT HEART,KIT, Medline Kit Number/SKU 65012819; 17. DBD-MTO,2V,LEFT HEART,KIT, Medline Kit Number/SKU 65040421; 18. DBD-MTO,LEFT HEART,KIT, Medline Kit Number/SKU 65183482; 19. MTS KIM, Medline Kit Number/SKU 65660872; 20. LHK,-, Medline Kit Number/SKU 601006269; 21. DBD-MTS,MANIFOLD,KIT, Medline Kit Number/SKU 601203616; 22. MTO,4V,KIT, Medline Kit Number/SKU 650104611; 23. MTO,MANIFOLD,KIT, Medline Kit Number/SKU 651304116; 24. KIMAL 3 PORT RH OFF WITH CC PG, Medline Kit Number/SKU 656206837; 25. KIM MANIFOLD SET VER ONE - PG, Medline Kit Number/SKU 656608724; 26. CARDIAC MAN PG, Medline Kit Number/SKU 656608737; 27. MTO MANIFOLD, Medline Kit Number/SKU 656608739; 28. CARDIAC MANIFOLD SET, Medline Kit Number/SKU 656608749; 29. CARDIAC MAN SET, Medline Kit Number/SKU 656608753; 30. KIMAL 3 PORT MAN KIT, Medline Kit Number/SKU 656608755; 31. DBD-MTS,LHK, Medline Kit Number/SKU 6010236231; 32. LHK, Medline Kit Number/SKU 6561068101; 33. LHK, Medline Kit Number/SKU 60022681B; 34. CARDIAC CATH PACK-LF, Medline Kit Number/SKU DYNJ0376288O; 35. CARDIAC CATH PACK-LF, Medline Kit Number/SKU DYNJ0376288P; 36. CARDIAC CATH PACK, Medline Kit Number/SKU DYNJ04636M; 37. CATH LAB PACK-LF, Medline Kit Number/SKU DYNJ0771922AA; 38. CATH LAB PACK-LF, Medline Kit Number/SKU DYNJ0771922Y; 39. CATH PACK, Medline Kit Number/SKU DYNJ21810L; 40. CATH PACK, Medline Kit Number/SKU DYNJ21810M; 41. CATH PACK, Medline Kit Number/SKU DYNJ21810N; 42. CARDIAC CATH PACK W/ADD ON, Medline Kit Number/SKU DYNJ22553F; 43. CATH LAB TRAY, Medline Kit Number/SKU DYNJ24250F; 44. HEART CATH, Medline Kit Number/SKU DYNJ27274J; 45. HEART CATH, Medline Kit Number/SKU DYNJ27274K; 46. HEART CATH, Medline Kit Number/SKU DYNJ27274L; 47. CARDIAC CATH PACK, Medline Kit Number/SKU DYNJ32376G; 48. CARDIAC CATH PACK, Medline Kit Number/SKU DYNJ32376I; 49. CATH/ANGIO PACK, Medline Kit Number/SKU DYNJ38087G; 50. CATH LAB PACK-LF, Medline Kit Number/SKU DYNJ38333C; 51. CATH PACK, Medline Kit Number/SKU DYNJ44473C; 52. CATH PACK, Medline Kit Number/SKU DYNJ44473D; 53. CATH LAB ANGIOGRAPHY PACK, Medline Kit Number/SKU DYNJ50779F; 54. ANGIO DRAPE CARDIAC PACK, Medline Kit Number/SKU DYNJ51615N; 55. ANGIO DRAPE CARDIAC PACK, Medline Kit Number/SKU DYNJ51615O; 56. ANGIO DRAPE CARDIAC PACK, Medline Kit Number/SKU DYNJ51615Q; 57. CARDIAC CATH IMF 86040- LF, Medline Kit Number/SKU DYNJ53947I; 58. CARDIAC CATH IMF 86040- LF, Medline Kit Number/SKU DYNJ53947J; 59. CARDIAC CATH LAB, Medline Kit Number/SKU DYNJ57748B; 60. PK CUST CATH LAB, Medline Kit Number/SKU DYNJ60584F; 61. PK CUST CATH LAB, Medline Kit Number/SKU DYNJ60584G; 62. PK CUST CATH LAB, Medline Kit Number/SKU DYNJ60584I; 63. HEART ABLATION DRAPE PACK, Medline Kit Number/SKU DYNJ61984B; 64. ANGIOGRAPHY PACK, Medline Kit Number/SKU DYNJ64525B; 65. HMSL ANGIOGRAPHY PACK, Medline Kit Number/SKU DYNJ64525C; 66. CATH LAB PACK, Medline Kit Number/SKU DYNJ64548D; 67. CATH LAB PACK, Medline Kit Number/SKU DYNJ64548F; 68. CATH LAB & E. P. PACK, Medline Kit Number/SKU DYNJ646

Medline Industries, LP

Medline has identified the presence of particulate within the fluid path of the Manifolds.

March 24, 2026 · DeviceView details →

Class IIOngoing

Hintermann Series Talar Implant, Left, Size 2 REF 302112

DT MedTech, LLC

Through customer complaints, the ankle replacement system was found to contain incorrect devices: Left implant packaging and labeling bears a right implant device.

March 24, 2026 · DeviceView details →

Namic Angiographic Manifold, custom, Medline Product Number/SKU 64038301; Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting.

Medline Industries, LP

Medline has identified the presence of particulate within the fluid path of the Manifolds.

March 24, 2026 · DeviceView details →

Namic Angiographic Manifold, custom, Medline Product Number/SKU 64038200; Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting.

Medline Industries, LP

Medline has identified the presence of particulate within the fluid path of the Manifolds.

March 24, 2026 · DeviceView details →

Class IIOngoing

Oncology Kit w/60" (152 cm) Appx 2.2 ml, Smallbore Ext Set w/ChemoLock Port, Clamp, Anti-Siphon Valve, Spiros; ChemoLock; Syringe Transfer Set w/MicroClave, ChemoLock Port, REF: CL3960

ICU Medical, Inc.

Oncology sets/closed system transfer devices with extension sets may leak resulting in therapy delayed if noticed and corrected during setup, but if the leak occurs during therapy this may result in therapy interruption with the potential for the patient to receive less infusion solution than intended. Exposure of hazardous substances to the patient, caregiver, or pharmacy technician is possible.

March 24, 2026 · DeviceView details →

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