Browse Device Recalls
35,307 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 35,307 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 35,307 FDA device recalls, Class II.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| May 25, 2023 | Trilogy Evo, Evo Clinical Korean (1137823) and Evo Caregiver Korean (1137853)... | There are errors present in the Korean Instructions For Use where the word "invasive," was incorr... | Class II | Philips Respironics, Inc. |
| May 25, 2023 | Flexiva Pulse 242 ID Trac Single Use Fiber-intended to be used as a device th... | Manufactured with the incorrect component may result in lower power output and degradation or dim... | Class II | Boston Scientific Corporation |
| May 25, 2023 | Flexiva Pulse ID 242 TracTip single Use Fiber-intended to be used as a device... | Manufactured with the incorrect component may result in lower power output and degradation or dim... | Class II | Boston Scientific Corporation |
| May 25, 2023 | Flexiva Pulse 242 TracTip Single-Use Laser Fibers -intended to be used as a d... | Manufactured with the incorrect component may result in lower power output and degradation or dim... | Class II | Boston Scientific Corporation |
| May 25, 2023 | Pilling LOWSLEY PROSTATIC TRACTOR CVD, REF 243200; retractor | There are incomplete pre-cleaning instructions within the Instructions for Use (IFU). | Class II | TELEFLEX LLC |
| May 25, 2023 | Flexiva Pulse 242 TracTip Single-Use Laser Fibers - intended to be used as a ... | Manufactured with the incorrect component may result in lower power output and degradation or dim... | Class II | Boston Scientific Corporation |
| May 25, 2023 | Pilling O'REILLY ESOPHAGEAL RETRACTOR, REF 381801A; ENT retractor | There are incomplete pre-cleaning instructions within the Instructions for Use (IFU). | Class II | TELEFLEX LLC |
| May 25, 2023 | Flexiva Pulse ID-intended to be used as a device that transmits Ho:YAG laser ... | Manufactured with the incorrect component may result in lower power output and degradation or dim... | Class II | Boston Scientific Corporation |
| May 25, 2023 | Pilling LOWSLEY PROSTATIC TRACTOR STR, REF 243201; retractor | There are incomplete pre-cleaning instructions within the Instructions for Use (IFU). | Class II | TELEFLEX LLC |
| May 25, 2023 | Flexiva Pulse 242 Single-Use Laser Fibers-intended to be used as a device tha... | Manufactured with the incorrect component may result in lower power output and degradation or dim... | Class II | Boston Scientific Corporation |
| May 25, 2023 | Flexiva Pulse ID-intended to be used as a device that transmits Ho:YAG laser ... | Manufactured with the incorrect component may result in lower power output and degradation or dim... | Class II | Boston Scientific Corporation |
| May 24, 2023 | EliA GBM Wells, Material Number 14551401, for Phadia 250, 2500, and 5000. In ... | Complaints that specific samples produced false positive EliA GBM results. A positive signal was ... | Class II | Phadia Ab |
| May 24, 2023 | RET Proximal Probe. Used in Fluorescence in situ hybridization (FISH), a labo... | DNAs used during the manufacture of two affected models were accidentally inverted during manufac... | Class II | Cytocell Ltd. |
| May 24, 2023 | RET Distal Probe. Used in Fluorescence in situ hybridization (FISH), a labora... | DNAs used during the manufacture of two affected models were accidentally inverted during manufac... | Class II | Cytocell Ltd. |
| May 24, 2023 | NeuMoDx Cartridge-used for extraction, purification, amplification and detect... | Top label on some of the NeuMoDx cartridges within these lots may have been incorrectly applied d... | Class II | NeuMoDx Molecular Inc |
| May 24, 2023 | Power-PRO 2- A powered ambulance cot that consists of a platform, including a... | Base leg assembly may bend and result in difficulty engaging/disengaging from fastener, difficult... | Class II | Stryker Medical Division of Stryker Corporation |
| May 23, 2023 | SurgiMend 3.0; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes... | Possible out of specification endotoxin test results due to issues with in-process and finished g... | Class II | TEI Biosciences, Inc. |
| May 23, 2023 | SurgiMend 1.0; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes... | Possible out of specification endotoxin test results due to issues with in-process and finished g... | Class II | TEI Biosciences, Inc. |
| May 23, 2023 | PriMatrix Fenestrated; Dermal Repair Scaffold; Rx Only; Sizes 4x4 cm, 6x6 cm,... | Possible out of specification endotoxin test results due to issues with in-process and finished g... | Class II | TEI Biosciences, Inc. |
| May 23, 2023 | Centurion Sterile CirClamp with 1.45cm Bell Reprocessed, Reorder CR3145K, 1 p... | The kits incorrectly contain CirClamp subassembly 345CRSAK which results in the kits containing a... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 23, 2023 | SurgiMend 4.0; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes... | Possible out of specification endotoxin test results due to issues with in-process and finished g... | Class II | TEI Biosciences, Inc. |
| May 23, 2023 | PriMatrix Meshed; Dermal Repair Scaffold; Rx Only; Sizes 20x25 cm (1:1), 3x3 ... | Possible out of specification endotoxin test results due to issues with in-process and finished g... | Class II | TEI Biosciences, Inc. |
| May 23, 2023 | SurgiMend 2.0; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes... | Possible out of specification endotoxin test results due to issues with in-process and finished g... | Class II | TEI Biosciences, Inc. |
| May 23, 2023 | wDR 2.2 Mobile Digital Diagnostic X-Ray System | There is a software login in issue that may prevent the user from logging in. | Class II | SEDECAL SA |
| May 23, 2023 | TissueMend; Advanced Soft Tissue Repair Matrix; Rx Only; Sizes 5x6 cm, 6x10 c... | Possible out of specification endotoxin test results due to issues with in-process and finished g... | Class II | TEI Biosciences, Inc. |
| May 23, 2023 | SurgiMend PRS; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes... | Possible out of specification endotoxin test results due to issues with in-process and finished g... | Class II | TEI Biosciences, Inc. |
| May 23, 2023 | BencoDental iris 5% NaF varnish, WHITE MINT ITEM # 4323-635; cavity varnish | The Iris 5% Fluoride Varnish White Mint package lot 207540 may contain units of 5% Fluoride Varni... | Class II | Young Dental Manufacturing I, LLC |
| May 23, 2023 | SurgiMend; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 1.0... | Possible out of specification endotoxin test results due to issues with in-process and finished g... | Class II | TEI Biosciences, Inc. |
| May 23, 2023 | PriMatrix Ag; Dermal Repair Scaffold; Rx Only; Sizes 10x12 cm, 10x25 cm, 20x2... | Possible out of specification endotoxin test results due to issues with in-process and finished g... | Class II | TEI Biosciences, Inc. |
| May 23, 2023 | PriMatrix; Dermal Repair Scaffold; Rx Only; Sizes 0.2x26.5 cm (3 pack), 10x12... | Possible out of specification endotoxin test results due to issues with in-process and finished g... | Class II | TEI Biosciences, Inc. |
| May 23, 2023 | PriMatrix Ag Fenestrated; Dermal Repair Scaffold; Rx Only; Sizes 10x25 cm, 20... | Possible out of specification endotoxin test results due to issues with in-process and finished g... | Class II | TEI Biosciences, Inc. |
| May 23, 2023 | Revize; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 10x10 ... | Possible out of specification endotoxin test results due to issues with in-process and finished g... | Class II | TEI Biosciences, Inc. |
| May 23, 2023 | Revize-X; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 12x6... | Possible out of specification endotoxin test results due to issues with in-process and finished g... | Class II | TEI Biosciences, Inc. |
| May 23, 2023 | SurgiMend MP; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes ... | Possible out of specification endotoxin test results due to issues with in-process and finished g... | Class II | TEI Biosciences, Inc. |
| May 23, 2023 | PriMatrix Ag Meshed; Dermal Repair Scaffold; Rx Only; Sizes 10x12 cm (2:1), 1... | Possible out of specification endotoxin test results due to issues with in-process and finished g... | Class II | TEI Biosciences, Inc. |
| May 23, 2023 | SurgiMend PRS Meshed; Collagen Matrix for Soft Tissue Reconstruction; Rx Only... | Possible out of specification endotoxin test results due to issues with in-process and finished g... | Class II | TEI Biosciences, Inc. |
| May 22, 2023 | DiagnosUS SARS-CoV-2 Antibody (IgG/IgM) Test REF 555-10 | Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, Di... | Class II | Universal Meditech Inc. |
| May 22, 2023 | PrestiBio Rapid Detection Pregnancy Test Midstream REF 100-17 3 TESTS | Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, Di... | Class II | Universal Meditech Inc. |
| May 22, 2023 | PrestiBio URINALASYS TEST STRIP 10 PARAMETERS REF 900-10 | Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, Di... | Class II | Universal Meditech Inc. |
| May 22, 2023 | DiagnosUS hCG Pregnancy Urine Test Strip Format REF 100-12 | Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, Di... | Class II | Universal Meditech Inc. |
| May 22, 2023 | DiagnosUS Pregnancy Test Midstream REF 100-17 | Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, Di... | Class II | Universal Meditech Inc. |
| May 22, 2023 | PrestiBio KETONE TEST STRIPS REF 900-1KET 100 STRIPS/+50 FREE | Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, Di... | Class II | Universal Meditech Inc. |
| May 22, 2023 | Lem Fertility hCG Pregnancy Urine Test REF 100-12 | Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, Di... | Class II | Universal Meditech Inc. |
| May 22, 2023 | DeTec hCG Pregnancy Urine Test Cassette Format, REG Cat: 100-13 | Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, Di... | Class II | Universal Meditech Inc. |
| May 22, 2023 | OMTMO One Step Ovulation (LH) Test Strips REF 200-07 | Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, Di... | Class II | Universal Meditech Inc. |
| May 22, 2023 | One Step Pregnancy Test REF 100-01 | Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, Di... | Class II | Universal Meditech Inc. |
| May 22, 2023 | HealthyWiser pH-Aware pH 4.5 - 9.0 pH Test Strips REF 900-1P 120 STRIP | Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, Di... | Class II | Universal Meditech Inc. |
| May 22, 2023 | DiagnosUS Ovulation Predictor Midstream REF 200-17 | Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, Di... | Class II | Universal Meditech Inc. |
| May 22, 2023 | Lem Fertility LH Ovulation Test (Strip) REF 200-07 | Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, Di... | Class II | Universal Meditech Inc. |
| May 22, 2023 | One Step Ovulation Test REF 200-01 | Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, Di... | Class II | Universal Meditech 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.