Browse Device Recalls
2,601 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,601 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 2,601 FDA device recalls in 2023.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Sep 29, 2023 | EVO+VISIAN Implantable Collamer Lens, REF:VICM5_12.1. Phakic Intraocular lens. | Their is a potential that intraocular implant devices may not meet specifications. | Class II | Staar Surgical Company |
| Sep 29, 2023 | LIFEPAK 15, REF: 99577-000055, Part Number V15-2-000061 | Their is a potential for battery pins to become loose within the defibrillator resulting in power... | Class II | Physio-Control, Inc. |
| Sep 29, 2023 | EVO VISIAN Implantable Collamer Lens, REF: VICMO12.1. Phakic Intraocular lens. | Their is a potential that intraocular implant devices may not meet specifications. | Class II | Staar Surgical Company |
| Sep 29, 2023 | EVO+VISIAN Implantable Collamer Lens, REF: VTICM5_12.6. Phakic Toric Intraocu... | Their is a potential that intraocular implant devices may not meet specifications. | Class II | Staar Surgical Company |
| Sep 29, 2023 | LIFEPAK 15, REF: 99577-001255, Part Number V15-2-001602 | Their is a potential for battery pins to become loose within the defibrillator resulting in power... | Class II | Physio-Control, Inc. |
| Sep 29, 2023 | EVO+VISIAN Implantable Collamer Lens, REF:VTICM5_13.7. Phakic Toric Intraocul... | Their is a potential that intraocular implant devices may not meet specifications. | Class II | Staar Surgical Company |
| Sep 29, 2023 | LIFEPAK 15, REF: 99577-001956, Part Number V15-7-000021 | Their is a potential for battery pins to become loose within the defibrillator resulting in power... | Class II | Physio-Control, Inc. |
| Sep 29, 2023 | IRON assay, Reference Numbers 6K95-41 and 6K95-30 | A high recovery of Iron assay has been observed at some customer sites. Internal studies confirm... | Class II | Sentinel CH SpA |
| Sep 29, 2023 | LIFEPAK 15, REF: 99577-001373, Part Number V15-7-000002 | Their is a potential for battery pins to become loose within the defibrillator resulting in power... | Class II | Physio-Control, Inc. |
| Sep 29, 2023 | EVO+VISIAN Implantable Collamer Lens, REF: VICM5_12.6. Phakic Intraocular lens. | Their is a potential that intraocular implant devices may not meet specifications. | Class II | Staar Surgical Company |
| Sep 29, 2023 | EVO+VISIAN Implantable Collamer Lens, REF: VICM5_13.2. Phakic Intraocular lens. | Their is a potential that intraocular implant devices may not meet specifications. | Class II | Staar Surgical Company |
| Sep 29, 2023 | LIFEPAK 15, REF: 99577-001960, Part Number: V15-7-000026 | Their is a potential for battery pins to become loose within the defibrillator resulting in power... | Class II | Physio-Control, Inc. |
| Sep 29, 2023 | GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Part Numbers 00024307504, 00024330... | Internal testing identified that the GEM Premier PAKs (cartridges) may exhibit an over-recovery (... | Class II | Instrumentation Laboratory |
| Sep 29, 2023 | Atrium Firm PVC Thoracic Catheter 36FR Straight, part number 15036. | A sterilization nonconformance prematurely aged the product, resulting in an inaccurate labeled e... | Class II | Atrium Medical Corporation |
| Sep 29, 2023 | DJO EMPOWR Knee Punch Handle, REF: 801-05-040 | Knee punch handle tip is breaking during surgery due to the lack of heat treatment, which may lea... | Class II | Encore Medical, LP |
| Sep 29, 2023 | LIFEPAK 15, REF: 99577-001957, Part Number V15-5-000586 and V15-7-000022 | Their is a potential for battery pins to become loose within the defibrillator resulting in power... | Class II | Physio-Control, Inc. |
| Sep 29, 2023 | GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Na+, K+, Ca++, Part Numbers 000243... | Internal testing identified that the GEM Premier PAKs (cartridges) may exhibit an over-recovery (... | Class II | Instrumentation Laboratory |
| Sep 29, 2023 | EVO VISIAN Implantable Collamer Lens REF: VICMO13.2. Phakic Intraocular lens. | Their is a potential that intraocular implant devices may not meet specifications. | Class II | Staar Surgical Company |
| Sep 29, 2023 | LIFEPAK 15, REF: 99577-000061, Part Number V15-2-000067 | Their is a potential for battery pins to become loose within the defibrillator resulting in power... | Class II | Physio-Control, Inc. |
| Sep 29, 2023 | LIFEPAK 15, REF: 99577-000046, Part Number V15-2-000051 | Their is a potential for battery pins to become loose within the defibrillator resulting in power... | Class II | Physio-Control, Inc. |
| Sep 29, 2023 | EVO +VISIAN Implantable Collamer Lens, REF: VICM5_13.7.Phakic Intraocular lens. | Their is a potential that intraocular implant devices may not meet specifications. | Class II | Staar Surgical Company |
| Sep 29, 2023 | EVO VISIAN Implantable Collamer Lens, REF: VICMO12.6. Phakic Intraocular lens. | Their is a potential that intraocular implant devices may not meet specifications. | Class II | Staar Surgical Company |
| Sep 28, 2023 | Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000 | Defective video laryngoscopes that did not pass quality tests established for the product, that w... | Class I | Covidien |
| Sep 28, 2023 | TRACHEAL INTUBATION FIBERSCOPE OLYMPUS LF-GP, Model Number: LF-GP | Fiberscopes do not have adequate data to support that the suction flow rate meets the device spec... | Class II | Olympus Corporation of the Americas |
| Sep 28, 2023 | Abbott NT2000iX Radiofrequency (RF) generator, REF RFG-NT-2000, lesioning gen... | Certain NT2000iX RF generators were serviced using a tool that was subsequently found to be out o... | Class II | Abbott |
| Sep 27, 2023 | StealthStation S8 Application version 2.0 and 2.0.1 (Part 9735762) The Ste... | Due to a software anomaly which potentially could result in the surgical planning data shifting t... | Class I | Medtronic Navigation, Inc. |
| Sep 27, 2023 | JOURNEY II BCS ARTICULAR INSERT, LEFT 10 MM SIZE 5-6, REF 74027262; knee pros... | The JRNY II BCS XLPE ART ISRT SZ 5-6 LT 10MM was laser etched, labeled and packaged as a JRNY II ... | Class II | Smith & Nephew, Inc. |
| Sep 27, 2023 | JOURNEY II BCS CONSTRAINED ARTICULAR INSERT Size 5-6, 10 MM Left, REF 7402926... | The JRNY II BCS XLPE ART ISRT SZ 5-6 LT 10MM was laser etched, labeled and packaged as a JRNY II ... | Class II | Smith & Nephew, Inc. |
| Sep 27, 2023 | EXALT Model D Single-Use Duodenoscope, 2 pack: Outer box UPN# M00542421, Inne... | Poor image quality due to fluid ingress in the lens. | Class II | Boston Scientific Corporation |
| Sep 27, 2023 | EXALT Model D Single-Use Duodenoscope: Outer box UPN# M00542420 & Outer box U... | Poor image quality due to fluid ingress in the lens. | Class II | Boston Scientific Corporation |
| Sep 26, 2023 | Grafton DBM Crunch, Model Numbers: T44115, Demineralized Bone Matrix | Specific serial numbers of GraftonTM DBM product due to the potential that a step during the insp... | Class II | Medtronic Sofamor Danek USA Inc |
| Sep 26, 2023 | AuDX PRO, mobile medical devices for hearing examinations, Model Number SOH10... | Affected lots of product may experience technical distortions to a greater extent than expected. | Class II | PATH |
| Sep 26, 2023 | BULK LARGEBORE MALE LL FITTING, Article No. M4341750SN. IV administration com... | Devices may leak as a result of a manufacturing issue. Leakage may result in a delay of therapy, ... | Class II | B. Braun Medical, Inc. |
| Sep 26, 2023 | SA3000 VENTED MICRO SPIKE ADAPTER, REF No. 418121, for intravenous use. | Devices may leak as a result of a manufacturing issue. Leakage may result in a delay of therapy, ... | Class II | B. Braun Medical, Inc. |
| Sep 26, 2023 | FT1000S FLUID TRANSFER SET, REF No. 356048. For direct transfer of fluids bet... | Devices may leak as a result of a manufacturing issue. Leakage may result in a delay of therapy, ... | Class II | B. Braun Medical, Inc. |
| Sep 26, 2023 | ALLERGAN UNIVERSAL FILL KIT, REF No. 7M2804. for tissue expander inflation. | Devices may leak as a result of a manufacturing issue. Leakage may result in a delay of therapy, ... | Class II | B. Braun Medical, Inc. |
| Sep 26, 2023 | 30ML BURETTE ASSY WITH STOPCOCK, BNS, Article No. 7A3970. used in a contrast... | Devices may leak as a result of a manufacturing issue. Leakage may result in a delay of therapy, ... | Class II | B. Braun Medical, Inc. |
| Sep 26, 2023 | Cordis ANGIOGRAPHIC CATHETERIZATION SETS, INFINITI THRULEMEN, 5F, REF CO0208,... | Non-sterile product labeled as sterile was distributed. | Class I | Cordis US Corp |
| Sep 26, 2023 | Grafton DBM Matrix Strips, Model Numbers: a) T42275, b) T42280; Demineralized... | Specific serial numbers of GraftonTM DBM product due to the potential that a step during the insp... | Class II | Medtronic Sofamor Danek USA Inc |
| Sep 26, 2023 | AMO ADMINISTRATION SET, Article No. 7A3817, REF OM2505191, for ophthalmologic... | Devices may leak as a result of a manufacturing issue. Leakage may result in a delay of therapy, ... | Class II | B. Braun Medical, Inc. |
| Sep 26, 2023 | RAPIDPOINT 500e Blood Gas System | There are potential drug interferences from Perhexiline Maleate or Atomoxetine Hydrochloride that... | Class II | Siemens Healthcare Diagnostics Inc |
| Sep 26, 2023 | 30 ML 2PORT BURETTE ASSEMBLY, Article No. 7A3950, used in a contrast manageme... | Devices may leak as a result of a manufacturing issue. Leakage may result in a delay of therapy, ... | Class II | B. Braun Medical, Inc. |
| Sep 26, 2023 | SENTIERO, mobile medical devices for hearing examinations, Model Number SOH10... | Affected lots of product may experience technical distortions to a greater extent than expected. | Class II | PATH |
| Sep 26, 2023 | THERASPHERE ADMIN SET, Article No. 7M2650. Canada only. Sterile, single use ... | Devices may leak as a result of a manufacturing issue. Leakage may result in a delay of therapy, ... | Class II | B. Braun Medical, Inc. |
| Sep 26, 2023 | SENTIERO Screening2, mobile medical devices for hearing examinations, Model N... | Affected lots of product may experience technical distortions to a greater extent than expected. | Class II | PATH |
| Sep 26, 2023 | RAPIDPOINT 500 Blood Gas System | There are potential drug interferences from Perhexiline Maleate or Atomoxetine Hydrochloride that... | Class II | Siemens Healthcare Diagnostics Inc |
| Sep 26, 2023 | Grafton DBM Putty, Model Numbers: a) T43102, b) T43102INT, c) T43103INT, d) T... | Specific serial numbers of GraftonTM DBM product due to the potential that a step during the insp... | Class II | Medtronic Sofamor Danek USA Inc |
| Sep 26, 2023 | TERUMO 60" TUBE SET W/HIGH CRACK CHK VLV, Article No. 7S3070. Singapore only.... | Devices may leak as a result of a manufacturing issue. Leakage may result in a delay of therapy, ... | Class II | B. Braun Medical, Inc. |
| Sep 26, 2023 | Grafton Plus DBM Paste, Model Numbers: a) T45001, b) T45005, c) T45010; Demin... | Specific serial numbers of GraftonTM DBM product due to the potential that a step during the insp... | Class II | Medtronic Sofamor Danek USA Inc |
| Sep 26, 2023 | Grafton DBM Orthoblend, Model Numbers: a) T44125INT, b) T44135, c) T44145, d)... | Specific serial numbers of GraftonTM DBM product due to the potential that a step during the insp... | Class II | Medtronic Sofamor Danek USA Inc |
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.