Browse Device Recalls

5,543 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 5,543 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Medical Device Recalls

Browse 5,543 FDA device recalls.

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DateProductReasonClassFirm
Oct 9, 2024 MEDLINE convenience kits labeled as: 1) TRACH TOTE, REF DYNJ85691; 2) TR... Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuat... Class II MEDLINE INDUSTRIES, LP - Northfield
Oct 9, 2024 MEDLINE convenience kits labeled as: 1) CIRCUMCISION PACK, REF DYNJ16826O;... Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuat... Class II MEDLINE INDUSTRIES, LP - Northfield
Oct 9, 2024 MEDLINE convenience kits labeled as: 1) GYN LAPAROSCOPY-LF, REF CDS760059I... Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuat... Class II MEDLINE INDUSTRIES, LP - Northfield
Oct 9, 2024 MEDLINE convenience kits labeled as: 1) LAKELAND SINGLE BASIN PACK-LF, REF... Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuat... Class II MEDLINE INDUSTRIES, LP - Northfield
Oct 9, 2024 MEDLINE convenience kits labeled as: 1) BURN, REF CDS983465M; 2) BURN, R... Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuat... Class II MEDLINE INDUSTRIES, LP - Northfield
Oct 9, 2024 MEDLINE convenience kits labeled as: 1) BASIC NEURO PACK, REF CDS780202P; ... Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuat... Class II MEDLINE INDUSTRIES, LP - Northfield
Oct 9, 2024 MEDLINE convenience kits labeled as: 1) MAJOR VASCULAR-LF, REF CDS840232L; ... Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuat... Class II MEDLINE INDUSTRIES, LP - Northfield
Oct 9, 2024 MEDLINE convenience kits labeled as: COLON WOUND CLOSURE PACK, REF DYNJ52141B Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuat... Class II MEDLINE INDUSTRIES, LP - Northfield
Oct 9, 2024 MEDLINE convenience kits labeled as: 1) C-SECTION OR 30 CDS, REF CDS820075V... Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuat... Class II MEDLINE INDUSTRIES, LP - Northfield
Oct 9, 2024 MEDLINE convenience kits labeled as: L&D MINOR PACK, REF DYNJ82672 Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuat... Class II MEDLINE INDUSTRIES, LP - Northfield
Oct 9, 2024 MEDLINE convenience kits labeled as: 1) ANGIO PACK #2, REFDYNJ39185D; 2)... Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuat... Class II MEDLINE INDUSTRIES, LP - Northfield
Oct 9, 2024 MEDLINE medical convenience kits labeled as: 1) ACETABULAR PACK-LF, REF DY... Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuat... Class II MEDLINE INDUSTRIES, LP - Northfield
Oct 9, 2024 MEDLINE convenience kits labeled as: PORT INSERTION PACK, REF DYNJ81597 Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuat... Class II MEDLINE INDUSTRIES, LP - Northfield
Oct 8, 2024 Approach CTO Micro Wire Guide, Guide Wire, Catalog Prefix CMW; Reference P... Affected device lots have labels that state the incorrect expiration dates. Class II Cook Incorporated
Oct 8, 2024 Approach Hydro ST Micro Wire Guide; Catalog prefix HMW Reference Part Numb... Affected device lots have labels that state the incorrect expiration dates. Class II Cook Incorporated
Oct 2, 2024 smith&nephew LEIGON OXINIUM CONSTRAINED NONPOROUS FEMORAL COMPONENT, SIZE 3 L... Complaint received indicating that a package contained a LGN OX CONSTRAINED FEM 3 LT implant inst... Class II Smith & Nephew Inc
Oct 2, 2024 smith&nephew GENESIS II NONPOROUS POSTERIOR STABILIZED FEMORAL COMPONENT, SIZ... Complaint received indicating that a package contained a LEGION NARROW PS OXIN SZ 5N RIGHT implan... Class II Smith & Nephew Inc
Oct 2, 2024 smith&nephew LEGION OXINIUM POSTERIOR STABILIZED NONPOROUS FEMORAL COMPONENT,... Complaint received indicating that a package contained a LEGION NARROW PS OXIN SZ 5N RIGHT implan... Class II Smith & Nephew Inc
Oct 2, 2024 smith&nephew LEIGON OXINIUM CONSTRAINED NONPOROUS FEMORAL COMPONENT, SIZE 4 L... Complaint received indicating that a package contained a LGN OX CONSTRAINED FEM 3 LT implant inst... Class II Smith & Nephew Inc
Sep 25, 2024 Elekta Disposable Biopsy Needle Kit for Leksell Stereotactic System, REF 9119... Elekta has become aware that Disposable Biopsy Needles can contain some microscopic debris on the... Class I Elekta Instrument AB
Sep 19, 2024 AD-TECH Spencer Probe Depth Electrode, REF SD06R-AP58X-000 6-Contact 1.12mm (... Ad-Tech is recalling these A-Style SD Depth Electrodes because a label discrepancy was identified... Class II Ad-Tech Medical Instrument Corporation
Sep 19, 2024 NovoHip Biolox Ball Head 32mmL Ref: 1345-2803 NovoHip Total Hip System - ... Mislabeled: Packaged in a box labeled as 32 long but containing a 28 long head by physical markin... Class II Novosource, LLC
Sep 19, 2024 AD-TECH Spencer Probe Depth Electrode, REF SD04R-AP58X-000 4-Contact 1.12mm (... Ad-Tech is recalling these A-Style SD Depth Electrodes because a label discrepancy was identified... Class II Ad-Tech Medical Instrument Corporation
Sep 19, 2024 AD-TECH Spencer Probe Depth Electrode, REF SD08R-AP58X-000 8-Contact 1.12mm (... Ad-Tech is recalling these A-Style SD Depth Electrodes because a label discrepancy was identified... Class II Ad-Tech Medical Instrument Corporation
Sep 17, 2024 MEGA 7.5Fr. 40cc Intra-Aortic Balloon with Accessories, Model Number 0684-00-... There is discrepant labeling on the inner and outer packaging of the device. Class II Datascope Corp.
Sep 13, 2024 EZDilate Wire Guided Balloon- Indicated for use in adult and adolescent (> 12... Mislabeled Glo Cath Label (attached to the device) states: 11 mm, 12 mm, 13 mm however the balloo... Class II Olympus Corporation of the Americas
Sep 13, 2024 17-OH Progesterone ELISA 96 well kit- An enzyme immunoassay for the quantitat... The High and Low Control acceptance ranges in the Certificate of Analysis (CofA) did not match th... Class III DRG International, Inc.
Sep 9, 2024 iCast Covered Stent, 6MMx16MMx120CM, Model Number 42616 There is an error in the Unique Device Identifier (UDI) printed on the product's distribution label. Class II Atrium Medical Corporation
Sep 4, 2024 Medline brand medical procedure convenience kits, labeled as: a) CONE BIOP... It has been determined that certain Convenience kits that were packaged in breather pouch lot 323... Class II MEDLINE INDUSTRIES, LP - Northfield
Sep 4, 2024 Centurion brand, medical procedure convenience kits, labeled as: a) FLOOR ... It has been determined that certain Convenience kits that were packaged in breather pouch lot 323... Class II MEDLINE INDUSTRIES, LP - Northfield
Sep 4, 2024 Medline brand medical procedure convenience kits, labeled as: a) OB PACK-L... It has been determined that certain Convenience kits that were packaged in breather pouch lot 323... Class II MEDLINE INDUSTRIES, LP - Northfield
Sep 4, 2024 Medline brand medical procedure convenience kits, labeled as: a) KIT LINE ... It has been determined that certain Convenience kits that were packaged in breather pouch lot 323... Class II MEDLINE INDUSTRIES, LP - Northfield
Sep 4, 2024 Medline brand medical procedure convenience kits, labeled as: a) NEURO PAC... It has been determined that certain Convenience kits that were packaged in breather pouch lot 323... Class II MEDLINE INDUSTRIES, LP - Northfield
Sep 4, 2024 Medline brand medical procedure convenience kits, labeled as: 1) T&A CDS-L... It has been determined that certain Convenience kits that were packaged in breather pouch lot 323... Class II MEDLINE INDUSTRIES, LP - Northfield
Sep 4, 2024 Medline brand, medical procedure convenience kits, labeled as: a) SET UP PAC... It has been determined that certain Convenience kits that were packaged in breather pouch lot 323... Class II MEDLINE INDUSTRIES, LP - Northfield
Sep 4, 2024 Medline brand medical procedure convenience kits, labeled as: 1) CYSTO CDS... It has been determined that certain Convenience kits that were packaged in breather pouch lot 323... Class II MEDLINE INDUSTRIES, LP - Northfield
Sep 4, 2024 Medline brand medical procedure convenience kits, labeled as: 1) L&D/OB PACK... It has been determined that certain Convenience kits that were packaged in breather pouch lot 323... Class II MEDLINE INDUSTRIES, LP - Northfield
Sep 4, 2024 Medline brand medical procedure convenience kits, labeled as: a) ABDOMINAL... It has been determined that certain Convenience kits that were packaged in breather pouch lot 323... Class II MEDLINE INDUSTRIES, LP - Northfield
Sep 4, 2024 Medline brand medical procedure convenience kits, labeled as: a) UNIVERSAL... It has been determined that certain Convenience kits that were packaged in breather pouch lot 323... Class II MEDLINE INDUSTRIES, LP - Northfield
Sep 4, 2024 Medline brand, medical procedure convenience kits, labeled as: a) RADIOLOG... It has been determined that certain Convenience kits that were packaged in breather pouch lot 323... Class II MEDLINE INDUSTRIES, LP - Northfield
Sep 4, 2024 Leica Biosystems Cryostat Model Number CM1950, Material Numbers: a) 14047742... As part of our post market surveillance, we recognized that some customers are using flammable fr... Class II LEICA BIOSYSTEMS NUSSLOCH GMBH
Sep 4, 2024 Leica Biosystems Cryostat Model Number CM1510 S, Material Numbers: a) 491510... As part of our post market surveillance, we recognized that some customers are using flammable fr... Class II LEICA BIOSYSTEMS NUSSLOCH GMBH
Sep 4, 2024 Medline brand medical procedure convenience kits, labeled as: 1) THORACENTESI... XXX Class II MEDLINE INDUSTRIES, LP - Northfield
Sep 4, 2024 Leica Biosystems Cryostat Model Number CM3050 S, Material Numbers: a) 140470... As part of our post market surveillance, we recognized that some customers are using flammable fr... Class II LEICA BIOSYSTEMS NUSSLOCH GMBH
Sep 4, 2024 Leica Biosystems Cryostat Model Number CM1850, Material Numbers: a) 14047131... As part of our post market surveillance, we recognized that some customers are using flammable fr... Class II LEICA BIOSYSTEMS NUSSLOCH GMBH
Sep 4, 2024 Medline brand medical procedure convenience kit, labeled as: a) PAIN PROCEDU... It has been determined that certain Convenience kits that were packaged in breather pouch lot 323... Class II MEDLINE INDUSTRIES, LP - Northfield
Sep 4, 2024 Medline brand medical procedure convenience kits, labeled as: 1) EYE PACK, ... It has been determined that certain Convenience kits that were packaged in breather pouch lot 323... Class II MEDLINE INDUSTRIES, LP - Northfield
Sep 4, 2024 Medline brand medical procedure convenience kits, labeled as: 1) NEW LONDO... It has been determined that certain Convenience kits that were packaged in breather pouch lot 323... Class II MEDLINE INDUSTRIES, LP - Northfield
Sep 4, 2024 Leica Biosystems Cryostat Model Number CM1100, Material Number 14046931130, f... As part of our post market surveillance, we recognized that some customers are using flammable fr... Class II LEICA BIOSYSTEMS NUSSLOCH GMBH
Sep 4, 2024 Medline brand, medical procedure convenience kits, labeled as: a) CUH OPEN... It has been determined that certain Convenience kits that were packaged in breather pouch lot 323... Class II MEDLINE INDUSTRIES, LP - Northfield

Frequently Asked Questions

When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.

All types, from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.

Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.