Browse Device Recalls
5,424 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 5,424 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 5,424 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Dec 19, 2023 | EndoVive Replacement Button Kit w/ ENFIT 28F 2.8 CM, Outer Box UPN M00509500 ... | Affected batches of the kit contain Stoma Measuring Devices sized to measure for an 18/24F replac... | Class II | Boston Scientific Corporation |
| Dec 13, 2023 | Spectral CT on Rails: Software Version 5.1.0.X, model 728334. | A software issue that can incorrectly label all captured images that may lead to misdiagnosis and... | Class II | PHILIPS MEDICAL SYSTEMS |
| Dec 13, 2023 | Spectral CT 7500: Software Version 5.0, Model 728333 and Spectral CT 7500 Chi... | A software issue that can incorrectly label all captured images that may lead to misdiagnosis and... | Class II | PHILIPS MEDICAL SYSTEMS |
| Dec 11, 2023 | Olympus/Gyrus Paparrela-Type Vent Tube 1.02MM, Silicone, Sterile- to ventilat... | The expiration date is missing from the primary (inner) packaging. The secondary (outer) box labe... | Class II | Olympus Corporation of the Americas |
| Dec 4, 2023 | Soltive SuperPulsed Laser System TFL FIBER CLEAVER, Model Number TFL-AFC | The strippers and cleavers are provided non-sterile and labelled as reusable/autoclavable. Olympu... | Class II | Olympus Corporation of the Americas |
| Dec 4, 2023 | Soltive SuperPulsed Laser System TFL Fiber Stripper, Model Numbers TFL-AFS150... | The strippers and cleavers are provided non-sterile and labelled as reusable/autoclavable. Olympu... | Class II | Olympus Corporation of the Americas |
| Nov 30, 2023 | Link Patella Glide Resection Guide- For the implantation of the Endo-Model Kn... | Mislabeled: Angle and height of the device marked as L(large) corresponds to the small/medium dim... | Class II | Waldemar Link GmbH & Co. KG (Mfg Site) |
| Nov 29, 2023 | Custom procedural convenience kits and trays, Othopedic use, labeled as: a... | During an internal investigation, ACS identified that several components were "piggybacked" to AC... | Class II | American Contract Systems, Inc. |
| Nov 29, 2023 | Custom procedural convenience kits and trays, Ophthalmic use, labeled as: ... | During an internal investigation, ACS identified that several components were "piggybacked" to AC... | Class II | American Contract Systems, Inc. |
| Nov 29, 2023 | Custom procedural convenience kits and trays, anesthesia, labeled as: a) H... | During an internal investigation, ACS identified that several components were "piggybacked" to AC... | Class II | American Contract Systems, Inc. |
| Nov 29, 2023 | Custom procedural convenience kits and trays, urological, labeled as: a) U... | During an internal investigation, ACS identified that several components were "piggybacked" to AC... | Class II | American Contract Systems, Inc. |
| Nov 29, 2023 | Custom procedural convenience kits and trays, Obstetrical & Gynecological use... | During an internal investigation, ACS identified that several components were "piggybacked" to AC... | Class II | American Contract Systems, Inc. |
| Nov 29, 2023 | Custom procedural convenience kits and trays, general & plastic surgery, labe... | During an internal investigation, ACS identified that several components were "piggybacked" to AC... | Class II | American Contract Systems, Inc. |
| Nov 29, 2023 | Custom procedural convenience kits and trays, gastroenterological & urologica... | During an internal investigation, ACS identified that several components were "piggybacked" to AC... | Class II | American Contract Systems, Inc. |
| Nov 29, 2023 | Custom procedural convenience kits and trays, general hospital use, labeled a... | During an internal investigation, ACS identified that several components were "piggybacked" to AC... | Class II | American Contract Systems, Inc. |
| Nov 29, 2023 | Custom procedural convenience kits and trays, cardiac, labeled as: a) HEAR... | During an internal investigation, ACS identified that several components were "piggybacked" to AC... | Class II | American Contract Systems, Inc. |
| Nov 29, 2023 | Custom procedural convenience kits and trays, Obstetrical & Gynecological use... | During an internal investigation, ACS identified that several components were "piggybacked" to AC... | Class II | American Contract Systems, Inc. |
| Nov 29, 2023 | Custom procedural convenience kits and trays, Obstetrical & Gynecological use... | During an internal investigation, ACS identified that several components were "piggybacked" to AC... | Class II | American Contract Systems, Inc. |
| Nov 29, 2023 | Custom procedural convenience kits and trays, general hospital use, labeled a... | During an internal investigation, ACS identified that several components were "piggybacked" to AC... | Class II | American Contract Systems, Inc. |
| Nov 29, 2023 | Custom procedural convenience kits and trays, gastroenterological & urologica... | During an internal investigation, ACS identified that several components were "piggybacked" to AC... | Class II | American Contract Systems, Inc. |
| Nov 29, 2023 | Custom procedural convenience kits and trays, general & plastic surgery, labe... | During an internal investigation, ACS identified that several components were "piggybacked" to AC... | Class II | American Contract Systems, Inc. |
| Nov 29, 2023 | Custom procedural convenience kits and trays, cardiac, labeled as: a) CENT... | During an internal investigation, ACS identified that several components were "piggybacked" to AC... | Class II | American Contract Systems, Inc. |
| Nov 29, 2023 | Custom procedural convenience kits and trays, Obstetrical & Gynecological use... | During an internal investigation, ACS identified that several components were "piggybacked" to AC... | Class II | American Contract Systems, Inc. |
| Nov 29, 2023 | Custom procedural convenience kits and trays, ear, nose & throat, labeled as:... | During an internal investigation, ACS identified that several components were "piggybacked" to AC... | Class II | American Contract Systems, Inc. |
| Nov 29, 2023 | Procedural convenience kits and trays, cardiac, labeled as: a) EP LAB BI V... | During an internal investigation, ACS identified that several components were "piggybacked" to AC... | Class II | American Contract Systems, Inc. |
| Nov 28, 2023 | MYNXGRIP 6F/7F, REF MX6721, Vascular Closure Device (VCD). Used to seal femor... | Cordis became aware that the label for the carton box containing 10 units is incorrect for some b... | Class II | Cordis US Corp |
| Nov 28, 2023 | MYNXGRIP 5F, REF MX5021, Vascular Closure Device (VCD). Used to seal femoral ... | Cordis became aware that the label for the carton box containing 10 units is incorrect for some b... | Class II | Cordis US Corp |
| Nov 28, 2023 | Cortera Spinal Fixation System, REF: 150100-85050. Spinal fixation screws lab... | Spinal fixation screws labeled as 8.5 mm diameter, 50 mm length were manufactured using an incorr... | Class II | XTANT Medical Holdings, Inc |
| Nov 15, 2023 | Centurion Kits, trays, and packs labeled as follows: LACERATION TRAY, REF ... | Medline Industries, LP is recalling certain kits and trays that were manufactured using specific ... | Class I | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 15, 2023 | Medline Kits, trays, and packs labeled as follows: a) BREAST PACK, REF DY... | Medline Industries, LP is recalling certain kits and trays that were manufactured using specific ... | Class I | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 15, 2023 | MEDLINE Kits, trays, and packs labeled as follows: a) Description, REF DYN... | Medline Industries, LP is recalling certain kits and trays that were manufactured using specific ... | Class I | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 15, 2023 | MEDLINE kits and trays, labeled as: a) SUCTION CATH 10FR KIT W/SALINE, REF ... | Medline Industries, LP is recalling certain kits and trays that were manufactured using specific ... | Class I | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 15, 2023 | Centurion Kits, trays, and packs labeled as follows: a) BASIC PROCEDURE TR... | Medline Industries, LP is recalling certain kits and trays that were manufactured using specific ... | Class I | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 15, 2023 | MEDLINE Kits, trays, and packs labeled as follows: a) CATH LAB CDS, REF CD... | Medline Industries, LP is recalling certain kits and trays that were manufactured using specific ... | Class I | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 15, 2023 | Centurion Kits, trays, and packs labeled as follows: a) DIALYSIS ACCESSOR... | Medline Industries, LP is recalling certain kits and trays that were manufactured using specific ... | Class I | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 15, 2023 | Medline Kits, trays, and packs labeled as follows: a) ANTERIOR PACK, REF D... | Medline Industries, LP is recalling certain kits and trays that were manufactured using specific ... | Class I | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 15, 2023 | Centurion Kits, trays, and packs labeled as follows: MAINTENANCE FLUSH KIT/B... | Medline Industries, LP is recalling certain kits and trays that were manufactured using specific ... | Class I | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 15, 2023 | Medline Kits, trays, and packs labeled as follows: a) PORT ACCESS TRAY, RE... | Medline Industries, LP is recalling certain kits and trays that were manufactured using specific ... | Class I | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 15, 2023 | Medline Kits, trays, and packs labeled as follows: a) D&C CDS, REF CDS9839... | Medline Industries, LP is recalling certain kits and trays that were manufactured using specific ... | Class I | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 15, 2023 | Centurion Kits, trays, and packs labeled as follows: LATEX FREE TRACHEOSTO... | Medline Industries, LP is recalling certain kits and trays that were manufactured using specific ... | Class I | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 15, 2023 | MEDLINE Kits, trays, and packs labeled as follows: DIALYSIS ON/OFF BNDLE -... | Medline Industries, LP is recalling certain kits and trays that were manufactured using specific ... | Class I | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 15, 2023 | Centurion Kits, trays, and packs labeled as follows: a) A C DAILY WET KIT,... | Medline Industries, LP is recalling certain kits and trays that were manufactured using specific ... | Class I | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 15, 2023 | Medline Kits, trays, and packs labeled as follows: WOUND CARE TRAY - LATEX... | Medline Industries, LP is recalling certain kits and trays that were manufactured using specific ... | Class I | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 15, 2023 | Centurion Kits, trays, and packs labeled as follows: a) DIALYSIS ACCESSORY... | Medline Industries, LP is recalling certain kits and trays that were manufactured using specific ... | Class I | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 15, 2023 | Centurion Kits, trays, and packs labeled as follows: BREAST BIOPSY KIT, RE... | Medline Industries, LP is recalling certain kits and trays that were manufactured using specific ... | Class I | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 15, 2023 | Spectranetics Turbo-Elite Laser Atherectomy Catheter 2.0 RX REF 420-159 Sp... | Incorrect product labeling. Exterior product box label does not match internal pouch label. | Class II | Spectranetics Corporation |
| Nov 15, 2023 | Centurion Kits, trays, and packs labeled as follows: EYE PREP KIT, REF ET1010 | Medline Industries, LP is recalling certain kits and trays that were manufactured using specific ... | Class I | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 15, 2023 | Medline Kits, trays, and packs labeled as follows: a) NUR 105, REF EDUC050... | Medline Industries, LP is recalling certain kits and trays that were manufactured using specific ... | Class I | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 15, 2023 | Medline Kits, trays, and packs labeled as follows: CHP WOUND IRRIGATION KI... | Medline Industries, LP is recalling certain kits and trays that were manufactured using specific ... | Class I | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 15, 2023 | MEDLINE Kits, trays, and packs labeled as follows: SERUM TEAR KIT, REF DYNDA... | Medline Industries, LP is recalling certain kits and trays that were manufactured using specific ... | Class I | 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.