Browse Device Recalls
3,037 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,037 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 3,037 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jul 1, 2024 | The Everest Bipolar Cutting Forceps are intended to be passed through a 5-mm ... | Fractures and breakages in packaging trays and Tyvek covers, which may result in a sterility breach | Class II | Olympus Corporation of the Americas |
| Jun 18, 2024 | ANESTHESIA TURNOVER KIT, Pack Number DYNJAA0377 | A non-sterile Mastisol component, which was not labeled as being sterile or non-sterile, was plac... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Jun 18, 2024 | KIT PEDI CRANI LAMI, Pack Number DYNJ907372A | A non-sterile Mastisol component, which was not labeled as being sterile or non-sterile, was plac... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Jun 18, 2024 | ANESTHESIA TURNOVER KIT, Pack Number DYNJAA0377A | A non-sterile Mastisol component, which was not labeled as being sterile or non-sterile, was plac... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Jun 18, 2024 | BD Nano 2nd Gen Pen Needles 32G X 4mm (5-count sample contained in Patient Co... | BD Nano 2nd Gen Pen Needle was shipped close to or after the labeled expiration date of February ... | Class II | Embecta Corp. |
| Jun 18, 2024 | CRANIOTOMY PACK, Pack Number DYNJ46552O | A non-sterile Mastisol component, which was not labeled as being sterile or non-sterile, was plac... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 10, 2024 | MONOCRYL Plus Antibacterial (poliglecaprone 25) Suture - Intended for use in ... | Issue on a specific packaging machine resulted in a hole in the primary packaging, product steril... | Class II | Ethicon, Inc. |
| May 10, 2024 | VICRYL Plus Antibacterial (polyglactin 910) Suture - Indicated for use in gen... | Issue on a specific packaging machine resulted in a hole in the primary packaging, product steril... | Class II | Ethicon, Inc. |
| May 10, 2024 | PDS II (polydioxanone) Suture - Intended for use in general soft tissue appro... | Issue on a specific packaging machine resulted in a hole in the primary packaging, product steril... | Class II | Ethicon, Inc. |
| May 10, 2024 | VICRYL (polyglactin 910) Suture - Indicated for use in general soft tissue ap... | Issue on a specific packaging machine resulted in a hole in the primary packaging, product steril... | Class II | Ethicon, Inc. |
| May 10, 2024 | MONOCRYL (poliglecaprone 25) Suture - Intended for use in general soft tissue... | Issue on a specific packaging machine resulted in a hole in the primary packaging, product steril... | Class II | Ethicon, Inc. |
| May 10, 2024 | PDS Plus Antibacterial (polydioxanone) Suture - Intended for use in general s... | Issue on a specific packaging machine resulted in a hole in the primary packaging, product steril... | Class II | Ethicon, Inc. |
| May 7, 2024 | CODMAN EVD BACTISEAL 1.9mm I.D. Catheter Set- indicated for gaining access to... | Defect in the external sterile packaging (pouch) leading to a gap or/and weakness of the seal may... | Class II | Integra LifeSciences Corp. |
| May 7, 2024 | CODMAN BACTISEAL Clear EVD Catheter 1.9mm I.D. Catheter Set- indicated for ga... | Defect in the external sterile packaging (pouch) leading to a gap or/and weakness of the seal may... | Class II | Integra LifeSciences Corp. |
| May 7, 2024 | CODMAN BACTISEAL EVD Catheter Set - Indicated for gaining access to the vent... | Defect in the external sterile packaging (pouch) leading to a gap or/and weakness of the seal tha... | Class II | Integra LifeSciences Corp. |
| May 6, 2024 | American Contract Systems Gyn Laparoscopy convenience kit | Product released with insufficient aeration time impacting the kits sterilized on the same cycle ... | Class II | American Contract Systems, Inc. |
| May 6, 2024 | American Contract Systems Extremity convenience kit, American Contract System... | Product released with insufficient aeration time impacting the kits sterilized on the same cycle ... | Class II | American Contract Systems, Inc. |
| May 6, 2024 | American Contract Systems Special Procedure Pack convenience kit | Product released with insufficient aeration time impacting the kits sterilized on the same cycle ... | Class II | American Contract Systems, Inc. |
| May 6, 2024 | American Contract Systems Laparoscopy Litho Std Pack convenience kit and Amer... | Product released with insufficient aeration time impacting the kits sterilized on the same cycle ... | Class II | American Contract Systems, Inc. |
| May 6, 2024 | American Contract Systems Biopsy Drape Pack convenience kit | Product released with insufficient aeration time impacting the kits sterilized on the same cycle ... | Class II | American Contract Systems, Inc. |
| May 6, 2024 | American Contract Systems Hand Pack convenience kit | Product released with insufficient aeration time impacting the kits sterilized on the same cycle ... | Class II | American Contract Systems, Inc. |
| May 1, 2024 | The D*Clot¿ HD Rotational Thrombectomy System is a percutaneous catheter-base... | Internal product testing failed bubble leak testing (ASTM F2096), which indicates the sterility b... | Class II | Mermaid Medical A/S |
| Apr 17, 2024 | Integra¿ Cranial access kit (without Prep solutions) Bit and Guard- Used duri... | Potential holes and tears in the sterile packaging (header bag) of the Cranial Access Kit may com... | Class II | Integra LifeSciences Corp. |
| Apr 2, 2024 | Sterile CoFlex NL: Latex Free Flexible Cohesive Bandage, Tan, 4INx5YD (5400S) | A packaging seal gap could impact the sterility of the product. | Class II | Andover Healthcare Inc. |
| Apr 1, 2024 | LASER Application Instrument, 23 cm, REF: 8694; LEUNIG-GREVERS LASER Applicat... | Laser surgical instruments have no specific evidence of a validated reprocessing method, therefor... | Class II | Karl Storz Endoscopy |
| Mar 15, 2024 | Elekta Disposable Biopsy Needle Kit for Leksell Stereotactic System, REF 9119... | Elekta has become aware that Disposable Biopsy Needles (911933) from one batch (837838839) can co... | Class I | Elekta Instrument AB |
| Mar 14, 2024 | Sterile surgical convenience kit: Medline Retrograde PK-22025203-LF, Pack ... | Surgical convenience kits containing Pure Pouch component that has weak seals which may result in... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 14, 2024 | Sterile convenience kit: Medline Birthing Room Pack, Pack #DYNJ38429D, con... | Surgical convenience kits containing Pure Pouch component that has weak seals which may result in... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 14, 2024 | Nonsterile convenience kits: a. Medline Delivery, Pack #DYNJ901130I, cont... | Surgical convenience kits containing Pure Pouch component that has weak seals which may result in... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 14, 2024 | Sterile surgical convenience kits: a. Medline Cath Lab Special Procedure,... | Surgical convenience kits containing Pure Pouch component that has weak seals which may result in... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 14, 2024 | Non-sterile convenience kits: Medline Open Heart CDS, Pack #CDS981759C, co... | Surgical convenience kits containing Pure Pouch component that has weak seals which may result in... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 14, 2024 | Non-sterile convenience kits: a. Medline CC Drawer 4 IV Circulation, Pack ... | Surgical convenience kits containing Pure Pouch component that has weak seals which may result in... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 14, 2024 | Sterile surgical convenience kit: Medline Neuro IR Pack, Pack #DYNJ56073C,... | Surgical convenience kits containing Pure Pouch component that has weak seals which may result in... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 14, 2024 | Non-sterile convenience kits: a. Medline Difficult Airway Tray W/O Cook, ... | Surgical convenience kits containing Pure Pouch component that has weak seals which may result in... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 14, 2024 | Sterile convenience kits: a. Medline Retrograde PK-22025203-LF, Pack #DYN... | Surgical convenience kits containing Pure Pouch component that has weak seals which may result in... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 12, 2024 | namic CONVENIENCE KIT, a) CAROTID MANIFOLD KIT, REF 60011045; b) 3V MANIF... | Products have a lack of sterility assurance. | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 12, 2024 | Namic FLUID DELIVERY SET, REF 91300040 | Products have a lack of sterility assurance. | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 11, 2024 | Ureteral dilator, REF RBD014 | A possible sterility issue (e.g. a breach in sterile packaging) was detected in Coloplast's facil... | Class II | Coloplast Manufacturing US, LLC |
| Mar 8, 2024 | STRATAFIX Spiral MONOCRYL Plus Bidirectional Knotless Tissue Control Device: ... | Degraded and unusable upon removal from the foil pouch due to exposed environmental conditions du... | Class II | Ethicon, Inc. |
| Mar 1, 2024 | Chiba Biopsy Needle - Used for aspiration biopsy. REFERENCE PART NUMBER (R... | Packaging may have low seal strength and not meet peel strength specifications, compromising devi... | Class II | Cook Incorporated |
| Mar 1, 2024 | Dilator With AQ Hydrophilic Coating - Intended to be used for dilating punctu... | Packaging may have low seal strength and not meet peel strength specifications, compromising devi... | Class II | Cook Incorporated |
| Mar 1, 2024 | Dilator - Coons Taper - Used for dilating puncture sites or catheter tracts f... | Packaging may have low seal strength and not meet peel strength specifications, compromising devi... | Class II | Cook Incorporated |
| Mar 1, 2024 | Trocar Needle - Used for dilating puncture sites or catheter tracts for percu... | Packaging may have low seal strength and not meet peel strength specifications, compromising devi... | Class II | Cook Incorporated |
| Mar 1, 2024 | Yueh Centesis Disposable Catheter Needle - Intended for use in percutaneous f... | Packaging may have low seal strength and not meet peel strength specifications, compromising devi... | Class II | Cook Incorporated |
| Mar 1, 2024 | Entuit Secure Adjustable Gastrointestinal Suture Anchor Set - Intended for an... | Packaging may have low seal strength and not meet peel strength specifications, compromising devi... | Class II | Cook Incorporated |
| Mar 1, 2024 | Dilator - Intended to be used for dilating puncture sites or catheter tracts ... | Packaging may have low seal strength and not meet peel strength specifications, compromising devi... | Class II | Cook Incorporated |
| Mar 1, 2024 | Peel-Away Introducer - Intended for the percutaneous introduction of balloon,... | Packaging may have low seal strength and not meet peel strength specifications, compromising devi... | Class II | Cook Incorporated |
| 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 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 | 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 |
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.