Browse Device Recalls
3,419 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,419 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 3,419 FDA device recalls in MA.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Aug 6, 2013 | BIORAPTOR 2.9 mm Suture Anchor with DURABRAID" Suture; Part Number: 72200783 ... | Pinholes detected in a small number of primary pouches that may constitute a breach of the steril... | Class II | Smith & Nephew, Inc. Endoscopy Division |
| Aug 6, 2013 | RAPTORMITE" 3.7 mm PLLA with two ULTRABRAID" Sutures Size 0 and Needles; Part... | Pinholes detected in a small number of primary pouches that may constitute a breach of the steril... | Class II | Smith & Nephew, Inc. Endoscopy Division |
| Aug 6, 2013 | BIORAPTOR 2.9 mm Suture Anchor with 2 ULTRABRAID Suture; Part Number: 7220077... | Pinholes detected in a small number of primary pouches that may constitute a breach of the steril... | Class II | Smith & Nephew, Inc. Endoscopy Division |
| Aug 6, 2013 | TWINFIX Ultra HA 6.5 mm with 2 ULTRABRAID Suture, Blue / Black; Part Number: ... | Pinholes detected in a small number of primary pouches that may constitute a breach of the steril... | Class II | Smith & Nephew, Inc. Endoscopy Division |
| Aug 6, 2013 | TWINFIX Ultra PLLA/HA 6.5 mm with 3 ULTRABRAID Suture; Part Number: 72202610 ... | Pinholes detected in a small number of primary pouches that may constitute a breach of the steril... | Class II | Smith & Nephew, Inc. Endoscopy Division |
| Aug 6, 2013 | BIORAPTOR 2.9 mm Suture Anchor, pack of 1 ULTRABRAID Suture: 72200689 Biod... | Pinholes detected in a small number of primary pouches that may constitute a breach of the steril... | Class II | Smith & Nephew, Inc. Endoscopy Division |
| Aug 6, 2013 | BIORAPTOR 2.9 mm Suture Anchor with 1 ULTRABRAID Suture; Part Number: 7220077... | Pinholes detected in a small number of primary pouches that may constitute a breach of the steril... | Class II | Smith & Nephew, Inc. Endoscopy Division |
| Aug 6, 2013 | TWINFIX Ultra PLLA/HA 5.5 mm Suture Anchor with 2 ULTRABRAID Suture, White / ... | Pinholes detected in a small number of primary pouches that may constitute a breach of the steril... | Class II | Smith & Nephew, Inc. Endoscopy Division |
| Aug 6, 2013 | TWINFIX Ultra HA 5.5 mm Suture Anchor with 2 ULTRABRAID Suture, Blue / Black;... | Pinholes detected in a small number of primary pouches that may constitute a breach of the steril... | Class II | Smith & Nephew, Inc. Endoscopy Division |
| Aug 6, 2013 | TWINFIX ULTRA PLLA/HA 5.5 mm Suture Anchor with 3 ULTRABRAID Suture: Part Num... | Pinholes detected in a small number of primary pouches that may constitute a breach of the steril... | Class II | Smith & Nephew, Inc. Endoscopy Division |
| Aug 6, 2013 | OSTOSTEORAPTOR 2.9 mm Suture Anchor with 1 ULTRABRAID COBRAID Suture, Blue; P... | Pinholes detected in a small number of primary pouches that may constitute a breach of the steril... | Class II | Smith & Nephew, Inc. Endoscopy Division |
| Aug 6, 2013 | TWINFIX" Ultra PLLA/HA 6.5 mm with 2 ULTRABRAID" Suture, White / Black: Part ... | Pinholes detected in a small number of primary pouches that may constitute a breach of the steril... | Class II | Smith & Nephew, Inc. Endoscopy Division |
| Aug 6, 2013 | OSTEORAPTOR CURVED 2.3 mm Suture Anchor SA ULTRABRAID COBRAID Suture, Blue; P... | Pinholes detected in a small number of primary pouches that may constitute a breach of the steril... | Class II | Smith & Nephew, Inc. Endoscopy Division |
| Aug 6, 2013 | OSTEORAPTOR 2.9 mm Suture Anchor with 2 ULTRABRAID Suture, White / Blue ; Par... | Pinholes detected in a small number of primary pouches that may constitute a breach of the steril... | Class II | Smith & Nephew, Inc. Endoscopy Division |
| Aug 6, 2013 | TWINFIX Ultra 5.5 mm PLLA-HA Suture Anchor with two #2 ULTRABRAID Sutures (bl... | Pinholes detected in a small number of primary pouches that may constitute a breach of the steril... | Class II | Smith & Nephew, Inc. Endoscopy Division |
| Aug 6, 2013 | OSTEORAPTOR 2.9 mm Suture Anchor with 2 ULTRABRAID Suture, White / Black; Par... | Pinholes detected in a small number of primary pouches that may constitute a breach of the steril... | Class II | Smith & Nephew, Inc. Endoscopy Division |
| Aug 6, 2013 | BIORAPTOR 2.9 mm Suture Anchor Straight, pack of 2 ULTRABRAID Suture; Part Nu... | Pinholes detected in a small number of primary pouches that may constitute a breach of the steril... | Class II | Smith & Nephew, Inc. Endoscopy Division |
| Aug 6, 2013 | OSTEORAPTOR 2.9 mm Suture Anchor with 1 ULTRABRAID Suture, White; Part Numbe... | Pinholes detected in a small number of primary pouches that may constitute a breach of the steril... | Class II | Smith & Nephew, Inc. Endoscopy Division |
| Aug 6, 2013 | OSTEORAPTOR 2.3 mm Suture Anchor with 1 ULTRABRAID COBRAID Suture, Black; Par... | Pinholes detected in a small number of primary pouches that may constitute a breach of the steril... | Class II | Smith & Nephew, Inc. Endoscopy Division |
| Jul 31, 2013 | PIPELINE LS ACCESS SYSTEM, 4th Dilator, 18 mm, Insulated The PIPELINE LS D... | Dilators and Holding Clip are being used for a secondary function of neuromonitoring, for which i... | Class II | DePuy Spine, Inc. |
| Jul 31, 2013 | PIPELINE LS ACCESS SYSTEM, 2nd Dilator, 10 mm, Insulated The PIPELINE LS D... | Dilators and Holding Clip are being used for a secondary function of neuromonitoring, for which i... | Class II | DePuy Spine, Inc. |
| Jul 31, 2013 | PIPELINE LS ACCESS SYSTEM, 15 Dilator, 5 mm, Insulated The PIPLINE LS Dila... | Dilators and Holding Clip are being used for a secondary function of neuromonitoring, for which i... | Class II | DePuy Spine, Inc. |
| Jul 31, 2013 | PIPELINE LS ACCESS SYSTEM, Holding Clip The PIPELINE LS Dilators and Holdi... | Dilators and Holding Clip are being used for a secondary function of neuromonitoring, for which i... | Class II | DePuy Spine, Inc. |
| Jul 31, 2013 | PIPELINE LS ACCESS SYSTEM, 3rd Dilator, 14 mm Insulated The PIPELINE LS Di... | Dilators and Holding Clip are being used for a secondary function of neuromonitoring, for which i... | Class II | DePuy Spine, Inc. |
| Jul 30, 2013 | High Flow Irrigation Extender; Part Number 72201021. Arthroscopic accessor... | During arthroscopic surgery, when the scope is moved inside the cannula, the body of the irrigati... | Class II | Smith & Nephew, Inc., Endoscopy Div. |
| Jul 25, 2013 | ADVIA Centaur Folate (100 Tests), SMN 10310308, Cat No. 06367974 In vitro... | Calibration failures and/or significant negative shifts in quality control (QC) and patient results. | Class II | Siemens Healthcare Diagnostics, Inc |
| Jul 25, 2013 | ADVIA Centaur Folate (500 tests), REF SMN 10331250, Cat No. 00203473 In vi... | Calibration failures and/or significant negative shifts in quality control (QC) and patient results. | Class II | Siemens Healthcare Diagnostics, Inc |
| Jul 25, 2013 | ADVIA Centaur Folate (500 Tests) SMN 10325366, Cat No. 06891541 In vitro d... | Calibration failures and/or significant negative shifts in quality control (QC) and patient results. | Class II | Siemens Healthcare Diagnostics, Inc |
| Jul 25, 2013 | ADVIA Centaur Folate (2500 tests), REF SMN 10340209, Cat No. 09132781 In v... | Calibration failures and/or significant negative shifts in quality control (QC) and patient results. | Class II | Siemens Healthcare Diagnostics, Inc |
| Jul 25, 2013 | Medtronic O-arm Imaging System Mobile X-ray system. Model No. BI-700-00027 a... | Review of on-system electronic product labeling and Instructions for comply with applicable Use i... | Class II | Medtronic Navigation, Inc. |
| Jul 19, 2013 | ACL TOP 700 LAS; PN 0000280030 Bench top, fully automated, random access a... | Potential carryover issue that can can cause shortened APTT clotting times on the instrument. | Class II | Instrumentation Laboratory Co. |
| Jul 19, 2013 | ACL TOP 500 CTS; PN 0000280040 Bench top, fully automated, random access a... | Potential carryover issue that can can cause shortened APTT clotting times on the instrument. | Class II | Instrumentation Laboratory Co. |
| Jul 19, 2013 | ACL TOP 300 and ACL TOP 300 CTS (Japan); PN 0000280060 Bench top, fully au... | Potential carryover issue that can can cause shortened APTT clotting times on the instrument. | Class II | Instrumentation Laboratory Co. |
| Jul 19, 2013 | ACL TOP 700 CTS; PN 0000280050 Bench top, fully automated, random access a... | Potential carryover issue that can can cause shortened APTT clotting times on the instrument. | Class II | Instrumentation Laboratory Co. |
| Jul 19, 2013 | ACL TOP CTS; PN 0000280020 Bench top, fully automated, random access analy... | Potential carryover issue that can can cause shortened APTT clotting times on the instrument. | Class II | Instrumentation Laboratory Co. |
| Jul 19, 2013 | ACL TOP 700; PN 0000280010 Bench top, fully automated, random access analy... | Potential carryover issue that can can cause shortened APTT clotting times on the instrument. | Class II | Instrumentation Laboratory Co. |
| Jul 19, 2013 | ACL TOP (Base); PN 0000280000 Bench top, fully automated, random access an... | Potential carryover issue that can can cause shortened APTT clotting times on the instrument. | Class II | Instrumentation Laboratory Co. |
| Jul 15, 2013 | Nova Max Glucose Test Strips (50 Count Retail) Catalog Number: 43437 Prod... | Reports of false abnormally high glucose readings from test strips | Class I | Nova Biomedical Corporation |
| Jul 15, 2013 | Nova Max Glucose Test Strips (10 Count Boxed) Catalog Number: 43590 Produ... | Reports of false abnormally high glucose readings from test strips | Class I | Nova Biomedical Corporation |
| Jul 15, 2013 | Nova Max Glucose Test Strips (50 Count DME) Catalog Number: 43523 Product... | Reports of false abnormally high glucose readings from test strips | Class I | Nova Biomedical Corporation |
| Jul 15, 2013 | Nova Max Plus Monitor System (Kit w/10 Count Vials Canada) Catalog Number: 43... | Reports of false abnormally high glucose readings from test strips | Class I | Nova Biomedical Corporation |
| Jul 15, 2013 | Nova Max Plus Monitor System (Kit w/10 Count Vials) Catalog Number: 43435 ... | Reports of false abnormally high glucose readings from test strips | Class I | Nova Biomedical Corporation |
| Jul 15, 2013 | Nova Max Glucose Test Strips (10 Count Vials) Catalog Number: 43604 These s... | Reports of false abnormally high glucose readings from test strips | Class I | Nova Biomedical Corporation |
| Jul 15, 2013 | Nova Max Plus Monitor System (Kit w/10 Count Vials International) Catalog Nu... | Reports of false abnormally high glucose readings from test strips | Class I | Nova Biomedical Corporation |
| Jul 15, 2013 | Nova Max Glucose Test Strips (10 Count Canada)Catalog Number: 43877 Produc... | Reports of false abnormally high glucose readings from test strips | Class I | Nova Biomedical Corporation |
| Jul 15, 2013 | Nova Max Glucose Test Strips (50 Count International Catalog Number: 45512 ... | Reports of false abnormally high glucose readings from test strips | Class I | Nova Biomedical Corporation |
| Jul 15, 2013 | Nova Max Glucose Test Strips (100 Count Retail Canada)Catalog Number: 43955 ... | Reports of false abnormally high glucose readings from test strips | Class I | Nova Biomedical Corporation |
| Jul 8, 2013 | Radiohead Access Point 1.4 GHz Radiohead Access Point Firmware versions: C.... | IntelliVue Smart-hopping 1.4 GHz Access Point may experience unexpected signal loss of several m... | Class II | Philips Healthcare Inc. |
| Jun 28, 2013 | ADVIA Centaur Calibrator A. Cat. #04800735, SMN 10285904 (6 pack); Cat. # 04... | Calibrator A lot CA77 is under-recovering to the assigned target for the ADVIA Centaur Total T4 A... | Class III | Siemens Healthcare Diagnostics, Inc |
| Jun 25, 2013 | ADVIA Centaur HCY Diluent - 10mL Bottle Catalog number 09877493 (124533), SMN... | ADVIA Centaur Homocysteine dilution recovery on the diluent identified the percent recovery for t... | Class II | Siemens Healthcare Diagnostics, 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.