Browse Device Recalls
3,133 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,133 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 3,133 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 | Medline ReNewal Reprocessed Ethicon Harmonic ACE+7 Shears w/ Adv. Hemostasis ... | Potential for an incomplete seal on the packaging tray. | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| 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 7, 2024 | Medline ReNewal Reprocessed Covidien LigaSure Impact, Sealer/Divider, Nano-Co... | Potential for an incomplete seal on the packaging tray. | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 7, 2024 | Medline ReNewal Reprocessed Covidien LigaSure Blunt Tip, Sealer/Divider, Nano... | Potential for an incomplete seal on the packaging tray. | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 7, 2024 | Medline ReNewal Reprocessed Covidien LigaSure Maryland Jaw Sealer/Divider, Na... | Potential for an incomplete seal on the packaging tray. | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 3, 2024 | EVOLUTION¿ MP Femoral CS/CR Non-Porous Non-porous MicroPort total knee rep... | One confirmed incident has been received that EFSRN4PR, lot number MP1982170, Size 4 Evolution MP... | Class II | MicroPort Orthopedics Inc. |
| Apr 26, 2024 | Acumatch L-Series BIPOLAR LINER, 22mm (BIPOLAR ENDOPROSTHESIS-Hip), Item Numb... | The AcuMatch L-Series 22mm Inner Diameter Bipolar Hip Liner lots were packaged without the specif... | Class II | Exactech, Inc. |
| Apr 24, 2024 | smith&nephew OXINIUM Femoral Head 12/14 Taper, REF 71343204, 32 MM OD +4, Ste... | Packaging contained the incorrect size of femoral head from what was displayed on the label. | Class II | Smith & Nephew Inc |
| 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 5, 2024 | WishFIX Growth Control Plating System, Model Number: TEFCS28-080US. Orthopedi... | The products in this lot are incorrectly packed with a Stainless-Steel implant instead of a Titan... | Class II | Wishbone Medical, Inc. |
| 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. |
| Mar 13, 2024 | Vanguard Knee System AS Tibial Bearing / DCM ArCom, 12 MM X 75 MM; Model Numb... | Possible damage to the Vanguard Knee System AS Tibial Bearing caused during the manufacturing pro... | Class II | Biomet, Inc. |
| 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 6, 2024 | Exactech Equinoxe GLENOID,POSTERIOR AUGMENT, PEGGED, 16o, RIGHT, FOR CEMENTED... | The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do n... | Class II | Exactech, Inc. |
| Mar 6, 2024 | Exactech Equinoxe GLENOID,POSTERIOR AUGMENT, PEGGED, 16o, LEFT, FOR CEMENTED ... | The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do n... | Class II | Exactech, Inc. |
| Mar 6, 2024 | Exactech Equinoxe REVERSE SHOULDER,46mm Humeral Liner, a) +0mm, Item number 3... | The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do n... | Class II | Exactech, Inc. |
| Mar 6, 2024 | Exactech Equinoxe CAGE GLENOID, CEMENTED, alpha curvature, Mates with: a) ... | The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do n... | Class II | Exactech, Inc. |
| Mar 6, 2024 | Exactech Equinoxe GLENOID, POSTERIOR AUGMENT,PEGGED, CEMENTED, 8o, LEFT, Mate... | The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do n... | Class II | Exactech, Inc. |
| Mar 6, 2024 | Exactech Equinoxe REVERSE SHOULDER, 38mm Humeral Liner: a) +0mm, Item Number... | The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do n... | Class II | Exactech, Inc. |
| Mar 6, 2024 | Exactech Equinoxe REVERSE SHOULDER,42mm Humeral Liner, a) +0mm, Item number 3... | The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do n... | Class II | Exactech, Inc. |
| Mar 6, 2024 | 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 n... | Class II | Exactech, Inc. |
| Mar 6, 2024 | Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, I... | The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do n... | Class II | Exactech, Inc. |
| Mar 6, 2024 | Exactech Equinoxe GLENOID,KEELED, CEMENTED, Mates with 38, 41, 44 head, alpha... | The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do n... | Class II | Exactech, Inc. |
| Mar 6, 2024 | Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number ... | The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do n... | Class II | Exactech, Inc. |
| Mar 6, 2024 | Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 4... | The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do n... | Class II | Exactech, Inc. |
| Mar 6, 2024 | Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Left, Mates with:... | The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do n... | Class II | Exactech, Inc. |
| Mar 6, 2024 | Exactech Equinoxe GLENOID,POSTERIOR AUGMENT, PEGGED, 12o, LEFT, FOR CEMENTED ... | The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do n... | Class II | Exactech, Inc. |
| Mar 6, 2024 | Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta ... | The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do n... | Class II | Exactech, Inc. |
| Mar 6, 2024 | 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 n... | Class II | Exactech, Inc. |
| Mar 6, 2024 | Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta ... | The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do n... | Class II | Exactech, Inc. |
| Mar 6, 2024 | Exactech Equinoxe GLENOID,KEELED, CEMENTED,47, 50, 53 head, beta curvature, S... | The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do n... | Class II | Exactech, Inc. |
| Mar 6, 2024 | Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Right, Mates with... | The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do n... | Class II | Exactech, Inc. |
| Mar 6, 2024 | Exactech Equinoxe Humeral Liner: Item Numbers: a) 320-40-00, b) 320-40-03; ... | The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do n... | Class II | Exactech, Inc. |
| Mar 6, 2024 | Exactech Equinoxe REVERSE SHOULDER,46mmConstrained Humeral Liner, a) +0mm, It... | The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do n... | Class II | Exactech, Inc. |
| Mar 6, 2024 | Exactech Equinoxe Constrained Humeral Liner: Item Numbers: a) 320-40-10, b)... | The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do n... | Class II | Exactech, Inc. |
| Mar 6, 2024 | Exactech Equinoxe GLENOID, POSTERIOR AUGMENT,PEGGED, CEMENTED, 8o, RIGHT, Mat... | The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do n... | Class II | Exactech, Inc. |
| Mar 6, 2024 | Exactech Equinoxe GLENOID,POSTERIOR AUGMENT, PEGGED, 12o, RIGHT, FOR CEMENTED... | The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do n... | Class II | Exactech, 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 |
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.