Browse Device Recalls
35,290 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 35,290 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 35,290 FDA device recalls, Class II.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jan 2, 2025 | Socrates 38 Aspiration Catheter 127 cm length REF SC038-127-001 The Socra... | Due to manufacturing non-conformance that resulted in channels in the seal on the packaging pouch... | Class II | Scientia Vascular, Inc. |
| Jan 2, 2025 | Brasseler ESR Rotary/Reciprocating Endodontic File Device SKU AP120213PK ... | Due to devices being irradiated above the established specification which my result in package in... | Class II | US Endodontics, LLC |
| Jan 2, 2025 | ARTIS One Angiographic X-Ray System | A potential issue with ARTIS One systems was identified. In very rare situations, the first x-ra... | Class II | SIEMENS MEDICAL SOLUTIONS USA, INC |
| Jan 2, 2025 | Access PCT Reagent Pack, Catalog Number C53987, when used on Access 2 and Uni... | Identified reagent lots are experiencing a high rate of calibration failures with failure code of... | Class II | Beckman Coulter Inc. |
| Dec 31, 2024 | AcuMatch XLE Item Number / Product Description: 140-28-27 AM EHXL 0¿ LNR G ... | Due to the lack of the Ethylene Vinyl Alcohol (EVOH) barrier layer. | Class II | Exactech, Inc. |
| Dec 31, 2024 | Novation XLE Item Number / Product Description: 140-22-70 NV EHXL NTL LNR G... | Due to the lack of the Ethylene Vinyl Alcohol (EVOH) barrier layer. | Class II | Exactech, Inc. |
| Dec 31, 2024 | Alteon XLE Item Number / Product Description: 140-22-70 NV EHXL NTL LNR G... | Due to the lack of the Ethylene Vinyl Alcohol (EVOH) barrier layer. | Class II | Exactech, Inc. |
| Dec 28, 2024 | NeiMed NasoGel for DRY NOSES UDI-DI/UPC code: 00705928045309 SKU GSP30-2R-48-... | Due to nasal spray stability failure for bioburden. | Class II | Neilmed Pharmaceuticals Inc |
| Dec 23, 2024 | AnchorFast Guard, Oral Endotracheal Tube Fastener, REF 9800, | Hollister received reports of decreased skin barrier wear time which could can lead to tube migra... | Class II | Hollister Incorporated |
| Dec 23, 2024 | MEDLINE ARTERIAL LINE PACK, REF DYNJ65208B, medical convenience kit containi... | Certain lots Sterile Infusion Catheters which were mislabeled as having a heparin coating were ei... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Dec 23, 2024 | AnchorFast SlimFit, Oral Endotracheal Tube Fastener, REF 9787, | Hollister received reports of decreased skin barrier wear time which could can lead to tube migra... | Class II | Hollister Incorporated |
| Dec 23, 2024 | AnchorFast, Oral Endotracheal Tube Fastener, REF 9799, | Hollister received reports of decreased skin barrier wear time which could can lead to tube migra... | Class II | Hollister Incorporated |
| Dec 23, 2024 | CENTURION Infusion Catheter, 7F, 17cm (DO), Reorder MIC17F7; Infusion Cathete... | Certain lots Sterile Infusion Catheters which were mislabeled as having a heparin coating were ei... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Dec 23, 2024 | Lev5, REF CT1587B, 50 Susceptibility discs Levofloxacin 5 ug, IVD, CE 2797 | Mislabeling; Levofloxacin Antimicrobial susceptibility disc packaging may contain Norfloxacin A... | Class II | Oxoid Limited |
| Dec 23, 2024 | CyberKnife Treatment Delivery System, REF 0660000 The CyberKnife System ma... | Snap rings may become partially or completed detached from the shafts within the internal mechani... | Class II | Accuray Incorporated |
| Dec 23, 2024 | AnchorFast Guard Select, Oral Endotracheal Tube Fastener, REF 9700, | Hollister received reports of decreased skin barrier wear time which could can lead to tube migra... | Class II | Hollister Incorporated |
| Dec 20, 2024 | ETHIBOND EXCEL Polyester Suture, REF: 6664H, X425H, X872H, EH7491H. Not so... | Sutures may have an open seal on the primary packaging, due to a manufacturing issue on a specifi... | Class II | Ethicon, LLC |
| Dec 20, 2024 | AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx10mm UPN: M... | Reported Outer sheath distal black tip detaching from the device can remain around the stent sadd... | Class II | Boston Scientific Corporation |
| Dec 20, 2024 | AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx15mm UPN: M005... | Reported Outer sheath distal black tip detaching from the device can remain around the stent sadd... | Class II | Boston Scientific Corporation |
| Dec 20, 2024 | Randox Lipoprotein (a) - In vitro diagnostic (IVD) use as Randox Lipoprotein ... | Lipoprotein (a) on Roche Cobas c501 with nmol/l claims does not have a 510(k) or PMA. | Class II | Randox Laboratories, Limited |
| Dec 20, 2024 | AXIOS Stent and Electrocautery- Enhanced Delivery System 6mmx8mm UPN: M00553680 | Reported Outer sheath distal black tip detaching from the device can remain around the stent sadd... | Class II | Boston Scientific Corporation |
| Dec 20, 2024 | AXIOS Stent and Electrocautery- Enhanced Delivery System 10mmx10mm UPN: M005... | Reported Outer sheath distal black tip detaching from the device can remain around the stent sadd... | Class II | Boston Scientific Corporation |
| Dec 20, 2024 | HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx10mm UPN: ... | Reported Outer sheath distal black tip detaching from the device can remain around the stent sadd... | Class II | Boston Scientific Corporation |
| Dec 20, 2024 | AXIOS Stent and Delivery System 10mmx10mm UPN: M00553740 | Reported Outer sheath distal black tip detaching from the device can remain around the stent sadd... | Class II | Boston Scientific Corporation |
| Dec 20, 2024 | PROLENE Polypropylene Suture, REF: EH7585H, 8706H, 8833H, 8963H, 8935H PROLEN... | Sutures may have an open seal on the primary packaging, due to a manufacturing issue on a specifi... | Class II | Ethicon, LLC |
| Dec 20, 2024 | HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 10mmx10mm UPN: ... | Reported Outer sheath distal black tip detaching from the device can remain around the stent sadd... | Class II | Boston Scientific Corporation |
| Dec 20, 2024 | HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 20mmx10mm UPN: ... | Reported Outer sheath distal black tip detaching from the device can remain around the stent sadd... | Class II | Boston Scientific Corporation |
| Dec 20, 2024 | Baxter Continu-Flo Solution Set with Duo-Vent Spike, REF UC8519 | Specific lots of Solution Sets with Duo-Vent Spike have the potential for inverted side clamps ca... | Class II | Baxter Healthcare Corporation |
| Dec 20, 2024 | AXIOS Stent and Electrocautery- Enhanced Delivery System 8mmx8mm UPN: M00553690 | Reported Outer sheath distal black tip detaching from the device can remain around the stent sadd... | Class II | Boston Scientific Corporation |
| Dec 20, 2024 | Baxter Clearlink System Solution Set with Duo-Vent Spike, REF 2R8538 | Specific lots of Solution Sets with Duo-Vent Spike have the potential for inverted side clamps ca... | Class II | Baxter Healthcare Corporation |
| Dec 20, 2024 | HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 8mmx8mm UPN: M0... | Reported Outer sheath distal black tip detaching from the device can remain around the stent sadd... | Class II | Boston Scientific Corporation |
| Dec 20, 2024 | HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx15mm UPN: ... | Reported Outer sheath distal black tip detaching from the device can remain around the stent sadd... | Class II | Boston Scientific Corporation |
| Dec 20, 2024 | HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 6mmx8mm UPN: M0... | Reported Outer sheath distal black tip detaching from the device can remain around the stent sadd... | Class II | Boston Scientific Corporation |
| Dec 20, 2024 | AXIOS Stent and Delivery System 15mmx10mm UPN: M00553750 | Reported Outer sheath distal black tip detaching from the device can remain around the stent sadd... | Class II | Boston Scientific Corporation |
| Dec 20, 2024 | Brand Name: N/A Product Name: Repeater Bone Tamp Model/Catalog Number: ASY-... | Due to incompatibility of bone tamp (Rev A) and bone funnels (Rev C). | Class II | Integrity Implants Inc. |
| Dec 20, 2024 | PERMA-HAND Silk Suture, REF: K872H, W723H, 623H, K833H; Perma-hand Silk Sutur... | Sutures may have an open seal on the primary packaging, due to a manufacturing issue on a specifi... | Class II | Ethicon, LLC |
| Dec 20, 2024 | AXIOS Stent and Electrocautery- Enhanced Delivery System 20mmx10mm UPN: M005... | Reported Outer sheath distal black tip detaching from the device can remain around the stent sadd... | Class II | Boston Scientific Corporation |
| Dec 20, 2024 | Randox Lipoprotein (a) - In vitro diagnostic (IVD) use as Randox Lipoprotein... | Lipoprotein (a) on Roche Cobas c501 with nmol/l claims does not have a 510(k) or PMA. | Class II | Randox Laboratories, Limited |
| Dec 20, 2024 | Baxter Solution Set with Duo-Vent Spike, REF 2R8404 | Specific lots of Solution Sets with Duo-Vent Spike have the potential for inverted side clamps ca... | Class II | Baxter Healthcare Corporation |
| Dec 19, 2024 | 8MM,LARGE SUTURECUT NEEDLE DRIVER,IS4000 REF 471296 | Due to increased complaints regarding frayed or broken grip cables on reusable instruments with j... | Class II | Intuitive Surgical, Inc. |
| Dec 19, 2024 | 8MM,CURVED BIPOLAR DISSECTOR,IS4000 REF 471344 | Due to increased complaints regarding frayed or broken grip cables on reusable instruments with j... | Class II | Intuitive Surgical, Inc. |
| Dec 19, 2024 | KARL STORZ - ENDOSKOPE, REF: 27002K, Ureteroscope, 9.5 Fr., 6¿, 34 cm, NON ST... | Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safe... | Class II | Karl Storz Endoscopy |
| Dec 19, 2024 | KARL STORZ - ENDOSKOPE, REF: 27010L, Uretero-Renoscope, 7 Fr., 43cm, NON STER... | Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safe... | Class II | Karl Storz Endoscopy |
| Dec 19, 2024 | 8MM,HORIZON SMALL CLIP APPLIER,IS4000¿ REF 470401 | Due to increased complaints regarding frayed or broken grip cables on reusable instruments with j... | Class II | Intuitive Surgical, Inc. |
| Dec 19, 2024 | KARL STORZ - ENDOSKOPE, REF: 27003L, MICHEL Uretero-Renoscope, 9.5 Fr., 43cm,... | Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safe... | Class II | Karl Storz Endoscopy |
| Dec 19, 2024 | 8MM,MEGA SUTURECUT ND,IS4000 REF 471309 | Due to increased complaints regarding frayed or broken grip cables on reusable instruments with j... | Class II | Intuitive Surgical, Inc. |
| Dec 19, 2024 | 8MM, LARGE NEEDLE DRIVER, IS4000 REF 470006 | Due to increased complaints regarding frayed or broken grip cables on reusable instruments with j... | Class II | Intuitive Surgical, Inc. |
| Dec 19, 2024 | 8MM,PROGRASP FORCEPS,IS4000 REF 471093 | Due to increased complaints regarding frayed or broken grip cables on reusable instruments with j... | Class II | Intuitive Surgical, Inc. |
| Dec 19, 2024 | KARL STORZ - ENDOSKOPE, REF: 27030KA, Cysto-Urethroscope, NON STERILE, CE | Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safe... | Class II | Karl Storz Endoscopy |
| Dec 19, 2024 | Integra Miltex Cryosolutions Cartridges 4 Pack (23.5g N2O each), Model: C-CA-... | During the assembly of the cartridge to its connecting body part, the valve may open prematurely ... | Class II | New Medical Technologies Gmbh |
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.