Medical devices, 2024
Shortlist up to four to read them side by side.
3,394 medical device recalls FDA’s Enforcement Report published in 2024, newest first; 40,450 in all since 2012.
FDA’s medical device recalls, as its Enforcement Report classifies them, from June 2012. Lists of FDA’s records can’t be saved for alerts: openFDA asks that its data not be used to alert the public (openFDA); FDA’s own emails do that. Copied Nov 7, 2026.
3,394of 3,394 medical device recallsshown with your filters
The list
- Medical device recall Exactech Equinoxe GLENOID,POSTERIOR AUGMENT, PEGGED, 16o, LEFT, FOR CEMENTED USE ONLY, Mates with: a) 38, 41,… The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. Class IIFDA’s classApr 10, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 10, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Exactech Equinoxe GLENOID,POSTERIOR AUGMENT, PEGGED, 16o, RIGHT, FOR CEMENTED USE ONLY, Mates with: a) 38,… The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. Class IIFDA’s classApr 10, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 10, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Exactech Equinoxe CAGE GLENOID, CEMENTED, alpha curvature, Mates with: a) 38, 41, 44 head, Small The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. Class IIFDA’s classApr 10, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 10, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 47, 50, 53 head, Medium The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. Class IIFDA’s classApr 10, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 10, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Left, Mates with: a) 38, 41, 44, 47 head, Small The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. Class IIFDA’s classApr 10, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 10, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Right, Mates with: a) 38, 41, 44, 47 head, Small The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. Class IIFDA’s classApr 10, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 10, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. Class IIFDA’s classApr 10, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 10, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Exactech Equinoxe REVERSE SHOULDER,36mm Constrained Humeral Liner: a) +0mm The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. Class IIFDA’s classApr 10, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 10, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Exactech Equinoxe REVERSE SHOULDER, 38mm Humeral Liner: a) +0mm The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. Class IIFDA’s classApr 10, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 10, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. Class IIFDA’s classApr 10, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 10, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Exactech Equinoxe Humeral Liner The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. Class IIFDA’s classApr 10, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 10, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Exactech Equinoxe Constrained Humeral Liner The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. Class IIFDA’s classApr 10, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 10, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Exactech Equinoxe REVERSE SHOULDER,42mm Humeral Liner, a) +0mm The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. Class IIFDA’s classApr 10, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 10, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. Class IIFDA’s classApr 10, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 10, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Exactech Equinoxe REVERSE SHOULDER,46mm Humeral Liner, a) +0mm The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. Class IIFDA’s classApr 10, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 10, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Exactech Equinoxe REVERSE SHOULDER,46mmConstrained Humeral Liner, a) +0mm The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. Class IIFDA’s classApr 10, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 10, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Torrent Suite Dx Software versions 5.14 and earlier used in connection with Ion PGM DX Systems-IVD intended… Torrent Suite Dx Software versions 5.14 and earlier used in connection with Ion PGM DX Systems exploitation of the vulnerability by a threat actor may allow… Class IIFDA’s classApr 10, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedApr 10, 2024ClassClass IIStatusOngoingWhereNationwide, and California, Indiana, North Carolina, Oregon and Tennessee named
- Medical device recall Centurion STERILE TRACH BRUSH Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. Class IIFDA’s classApr 10, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 10, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Centurion FCP MAGILL CATH 7.5 IN PED Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. Class IIFDA’s classApr 10, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 10, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Centurion STERILE COTTON DENTAL ROLLS 6/PK Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. Class IIFDA’s classApr 10, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 10, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Centurion STERILE BLOOD COLLECTION TUBE,10ML Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. Class IIFDA’s classApr 10, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 10, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Centurion kits: a) DENTAL INSTRUMENT KIT Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. Class IIFDA’s classApr 10, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 10, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Centurion STERILE #5 LARYNGEAL MIRROR(505709) Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. Class IIFDA’s classApr 10, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 10, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Centurion STERILE ROUND EAR SPECULUM SET Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. Class IIFDA’s classApr 10, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 10, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Centurion retractor kits labeled as: a) STERILE 6-1/2” SENN RETRACTOR (ST7185) Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. Class IIFDA’s classApr 10, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 10, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Centurion hook kits labeled as: a) STERILE SKIN HOOK FINE (EA3975F) Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. Class IIFDA’s classApr 10, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 10, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Centurion scalpel handle kits labeled as: a) STERILE # 3 SCALPEL HANDLE Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. Class IIFDA’s classApr 10, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 10, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Centurion Forcep kits labeled as: a) STERILE F/P SPLINTER FORCEP (SF6141) Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. Class IIFDA’s classApr 10, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 10, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Centurion Hemostat kits labeled as: a) STERILE CURV KELLY HEMOSTAT Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. Class IIFDA’s classApr 10, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 10, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Centurion Curette kits labeled as: a) STERILE BUCK EAR CURETTE “00” Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. Class IIFDA’s classApr 10, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 10, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Centurion Clamp kits labeled as: a) STERILE BACKHAUS TOWEL CLAMP (BTC173) Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. Class IIFDA’s classApr 10, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 10, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Centurion manual surgical kits labeled as: a) STERILE TUBE OCCLUDING FORCEP (TO8256) Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. Class IIFDA’s classApr 10, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 10, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Centurion manual surgical kits labeled as: a) ST Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. Class IIFDA’s classApr 10, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 10, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Centurion manual surgical kits labeled as: a) STERILE ALLIS TISS FCP 10” Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. Class IIFDA’s classApr 10, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 10, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Centurion manual surgical kits labeled as: a) STERILE 4-1/2” S/S SCISSOR (SS5031) Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. Class IIFDA’s classApr 10, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 10, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Centurion manual surgical kits labeled as: a) SUTURE REMOVAL TRAY Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. Class IIFDA’s classApr 10, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 10, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Centurion STERILE #16 RUBBER BAND Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. Class IIFDA’s classApr 10, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 10, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Centurion PICC LINE SECUREMENT KIT Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. Class IIFDA’s classApr 10, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 10, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Centurion Manual surgical kits labeled as: a) 15ML SAMPLING TUBE WITH CAP Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. Class IIFDA’s classApr 10, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 10, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Centurion Manual surgical kits labeled as: a) STERILE S/B WIRE SCISSOR Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. Class IIFDA’s classApr 10, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 10, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Centurion Manual surgical kits labeled as: a) HEGAR UTERINE DILATOR, 11-12MM, STERILE Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. Class IIFDA’s classApr 10, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 10, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Centurion DISP.UMBILICAL CORD CLAMP CUTTER(CTR300) Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. Class IIFDA’s classApr 10, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 10, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MEDLINE M1S0179 STRL TAPE/PEN PACK Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. Class IIFDA’s classApr 10, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 10, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MEDLINE SWABSTICKS PVP 3 PK Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. Class IIFDA’s classApr 10, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 10, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MEDLINE 4.5 IN WIRE CUT SCISSORS Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. Class IIFDA’s classApr 10, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 10, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MEDLINE SWABSTICKS ALCOHOL 3PK Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. Class IIFDA’s classApr 10, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 10, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ATTUNE AFFIXIUM Cementless Fixed Bearing Knee with 3DP Technology, Size 6 Product incorrectly labelled. Class IIFDA’s classApr 10, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedApr 10, 2024ClassClass IIStatusOngoingWhereNationwide, and California, Illinois, New Jersey and Wisconsin named
- Medical device recall Signia” Small Diameter Curved Tip Intelligent Reload Under certain firing conditions, reloads were found to articulate in an uncontrolled manner potentially causing disruption to the staple line. Class IIFDA’s classApr 10, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 10, 2024ClassClass IIStatusOngoingWhereNationwide
Nothing matches all of these.
Remove a filter to see more. Each one is a fact FDA’s record publishes, so a recall can be left out because its record is silent on it.
Source:
FDA, Device recall enforcement reports. Released Nov 3, 2026. Updated weekly.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.”
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