Browse Device Recalls
3,276 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,276 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 3,276 FDA device recalls in 2024.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Feb 27, 2024 | Karl Storz SE & CO. KG, REF 723014, Uvula Retractor, For Veterinary Use Only,... | Inadequate reprocessing validation evidence | Class II | Karl Storz Endoscopy |
| Feb 27, 2024 | ConvaTec CarboFlex, 15cm x 20cm, 6 in. x 8 in., Order No. 403204, Odor Contro... | The product does not meet sterility assurance level. | Class II | ConvaTec, Inc |
| Feb 27, 2024 | TRIDENTII PSL CLUSTER52E- Indicated for use in primary and revision patients ... | The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of t... | Class II | Howmedica Osteonics Corp. |
| Feb 27, 2024 | TRIDENTII HEMI CLUSTER48D-indicated for use in primary and revision patients ... | The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of t... | Class II | Howmedica Osteonics Corp. |
| Feb 27, 2024 | TRIDENTII HEMI CLUSTER66H- Indicated for use in primary and revision patient... | The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of t... | Class II | Howmedica Osteonics Corp. |
| Feb 27, 2024 | TRIDENTII PSL CLUSTER48D- Indicated for use in primary and revision patients... | The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of t... | Class II | Howmedica Osteonics Corp. |
| Feb 27, 2024 | TRIDENTII PSL CLUSTER58F-Indicated for use in primary and revision patients a... | The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of t... | Class II | Howmedica Osteonics Corp. |
| Feb 27, 2024 | Karl Storz SE & CO. KG, REF 115400S, Optical Scissor, CE | Inadequate reprocessing validation evidence | Class II | Karl Storz Endoscopy |
| Feb 26, 2024 | Blood Pressure Unit, Model (REF) Numbers: a) MDS4001, b) MDS4001LA, c) MDS40... | The firm provided a set of specifications for the device, but some units of the device were manuf... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 26, 2024 | NaviNetics Skull Anchor Key and Drill Kit, REF NN1215 | Defective Skull Anchor Key. After attachment of the single use Skull Anchor Key to the patient, t... | Class II | Navinetics Inc |
| Feb 26, 2024 | Medline Sub-G Endotracheal Tube with Subglottic Suctioning: (1) REF DYNJ18... | Complaints have been received that the device inflation tube detached and/or tore from the main t... | Class I | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 23, 2024 | ACUSON Juniper Diagnostic Ultrasound System, REF: 11335791, and ACUSON Junipe... | On ultrasound systems, when Cardiac DICOM SR feature is configured to display either minimum or m... | Class II | Siemens Medical Solutions USA, Inc. |
| Feb 23, 2024 | Centurion scalpel handle kits labeled as: a) STERILE # 3 SCALPEL HANDLE, Pro... | Product may have a weak seal which may result in a breach of sterility of the contents if the sea... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 23, 2024 | BD Pyxis MedStation Auxiliary ES REF: 324. Intended to securely store and di... | Retroactive-Due to increase in complaints, their is a potential for drawer and/or door failures o... | Class II | CareFusion 303, Inc. |
| Feb 23, 2024 | Centurion Curette kits labeled as: a) STERILE BUCK EAR CURETTE "00" (25697)... | Product may have a weak seal which may result in a breach of sterility of the contents if the sea... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 23, 2024 | 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 sea... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 23, 2024 | Centurion manual surgical kits labeled as: a) ST. VIRTUS SPLINTER FORCEP 6"... | Product may have a weak seal which may result in a breach of sterility of the contents if the sea... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 23, 2024 | Centurion manual surgical kits labeled as: a) SUTURE REMOVAL TRAY, Product ... | Product may have a weak seal which may result in a breach of sterility of the contents if the sea... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 23, 2024 | Centurion Manual surgical kits labeled as: a) HEGAR UTERINE DILATOR, 11-12... | Product may have a weak seal which may result in a breach of sterility of the contents if the sea... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 23, 2024 | Centurion STERILE ROUND EAR SPECULUM SET (3, 4, 5), Product Code I68505 | Product may have a weak seal which may result in a breach of sterility of the contents if the sea... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 23, 2024 | BD Pyxis MedStation ES (Med ES Main) REF: 323. Intended to securely store ... | Retroactive-Due to increase in complaints, their is a potential for drawer and/or door failures o... | Class II | CareFusion 303, Inc. |
| Feb 23, 2024 | Centurion manual surgical kits labeled as: a) STERILE TUBE OCCLUDING FORCEP... | Product may have a weak seal which may result in a breach of sterility of the contents if the sea... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 23, 2024 | Centurion Manual surgical kits labeled as: a) STERILE S/B WIRE SCISSOR, Pr... | Product may have a weak seal which may result in a breach of sterility of the contents if the sea... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 23, 2024 | Centurion kits: a) DENTAL INSTRUMENT KIT, Product Code DH760; b) STERILE C... | Product may have a weak seal which may result in a breach of sterility of the contents if the sea... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 23, 2024 | BD Pyxis MedStation Auxiliary 4000 REF: 306. Intended to securely store and ... | Retroactive-Due to increase in complaints, their is a potential for drawer and/or door failures o... | Class II | CareFusion 303, Inc. |
| Feb 23, 2024 | RayStation Software Version Numbers version numbers 8B, 9A, 9B, 10A, 10B, 11A... | A use error that has occurred with RayStation/RayPlan, where material override using Silicon, Si,... | Class II | RAYSEARCH LABORATORIES AB |
| Feb 23, 2024 | Centurion STERILE TRACH BRUSH, Product Code 6225ST | Product may have a weak seal which may result in a breach of sterility of the contents if the sea... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 23, 2024 | Centurion PICC LINE SECUREMENT KIT, Product Code IVS565 | Product may have a weak seal which may result in a breach of sterility of the contents if the sea... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 23, 2024 | MEDLINE 4.5 IN WIRE CUT SCISSORS, Product Code DYND04006 | Product may have a weak seal which may result in a breach of sterility of the contents if the sea... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 23, 2024 | Centurion Forcep kits labeled as: a) STERILE F/P SPLINTER FORCEP (SF6141), P... | Product may have a weak seal which may result in a breach of sterility of the contents if the sea... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 23, 2024 | Centurion FCP MAGILL CATH 7.5 IN PED (67575), Product Code 67575 | Product may have a weak seal which may result in a breach of sterility of the contents if the sea... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 23, 2024 | The LeadCare¿ II Blood Lead Test System relies on electrochemistry and a uniq... | Calibration Buttons being used in the kitting process were incorrectly labeled as Lot 2323M for l... | Class II | Magellan Diagnostics, Inc. |
| Feb 23, 2024 | Centurion STERILE BLOOD COLLECTION TUBE,10ML, Product Code 6430ST | Product may have a weak seal which may result in a breach of sterility of the contents if the sea... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 23, 2024 | Centurion STERILE #5 LARYNGEAL MIRROR(505709), Product Code 67830 | Product may have a weak seal which may result in a breach of sterility of the contents if the sea... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 23, 2024 | Centurion hook kits labeled as: a) STERILE SKIN HOOK FINE (EA3975F), Product... | Product may have a weak seal which may result in a breach of sterility of the contents if the sea... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 23, 2024 | Centurion manual surgical kits labeled as: a) STERILE ALLIS TISS FCP 10", P... | Product may have a weak seal which may result in a breach of sterility of the contents if the sea... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 23, 2024 | MEDLINE SWABSTICKS ALCOHOL 3PK, Product code DYNDA2723 | Product may have a weak seal which may result in a breach of sterility of the contents if the sea... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 23, 2024 | ACUSON Maple Diagnostic Ultrasound System, REF: 11711750, ACUSON Maple Select... | On ultrasound systems, when Cardiac DICOM SR feature is configured to display either minimum or m... | Class II | Siemens Medical Solutions USA, Inc. |
| Feb 23, 2024 | BD Pyxis MedStation 4000 REF: 303. Intended to securely store and dispense m... | Retroactive-Due to increase in complaints, their is a potential for drawer and/or door failures o... | Class II | CareFusion 303, Inc. |
| Feb 23, 2024 | Altair 330 lbs w/o Hanger Bar, REF: 55200H-NA, 55220H-NA, and Roomer S 220 kg... | Patient lift hanger bar may come loose, which could potentially pose risks to patients. | Class II | Human Care Hc Sweden Ab |
| Feb 23, 2024 | Agfa DX-D 100 system-Digital Radiography mobile X-ray System. A mobile X-Ray ... | Steel cable installed inside the mobile column which supports the weight of the telescopic arm wi... | Class II | Agfa N.V. |
| Feb 23, 2024 | 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 sea... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 23, 2024 | Centurion retractor kits labeled as: a) STERILE 6-1/2" SENN RETRACTOR (ST718... | Product may have a weak seal which may result in a breach of sterility of the contents if the sea... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 23, 2024 | Centurion STERILE #16 RUBBER BAND, Product Code EB16 | Product may have a weak seal which may result in a breach of sterility of the contents if the sea... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 23, 2024 | MEDLINE M1S0179 STRL TAPE/PEN PACK, Product Code P519582A | Product may have a weak seal which may result in a breach of sterility of the contents if the sea... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 23, 2024 | ACUSON Redwood 1.0 Diagnostic Ultrasound System, REF: 11503314, running softw... | On ultrasound systems, when Cardiac DICOM SR feature is configured to display either minimum or m... | Class II | Siemens Medical Solutions USA, Inc. |
| Feb 23, 2024 | MEDLINE SWABSTICKS PVP 3 PK, Product Code DYNDA2724 | Product may have a weak seal which may result in a breach of sterility of the contents if the sea... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 23, 2024 | Centurion Hemostat kits labeled as: a) STERILE CURV KELLY HEMOSTAT, Product... | Product may have a weak seal which may result in a breach of sterility of the contents if the sea... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 23, 2024 | Centurion STERILE COTTON DENTAL ROLLS 6/PK, Product Code 9125ST6 | Product may have a weak seal which may result in a breach of sterility of the contents if the sea... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 23, 2024 | Centurion DISP.UMBILICAL CORD CLAMP CUTTER(CTR300), Product Code 67335 | Product may have a weak seal which may result in a breach of sterility of the contents if the sea... | 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.