Browse Device Recalls
4,602 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 4,602 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 4,602 FDA device recalls in CA.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 | 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 12, 2023 | Driver Instrument, part of the Superion Indirect Decompression System, REF: 1... | Pending update to indirect decompression system instructions for use informing users that excessi... | Class II | Boston Scientific Neuromodulation Corporation |
| May 2, 2023 | LEGACY SMARTBASE, NE 3.0D 1MML, REF: 8730-81NE; LEGACY SMARTBASE, NE 3.0D 2M... | Non-engaging abutments were distributed without FDA clearance; the performance characteristics ha... | Class II | Implant Direct Sybron Manufacturing LLC |
| Apr 24, 2023 | Xpert Xpress Strep A, XPRSTREPA-10, P/N: 302-2294 IVD, Rx Only | pipettes packaged in Strep A test may fail to dispense an adequate sample volume which could resu... | Class II | Cepheid |
| Apr 24, 2023 | Xpert Xpress Strep A, REF:Xprstrepa-CE-10, CE IVD, | pipettes packaged in Strep A test may fail to dispense an adequate sample volume which could resu... | Class II | Cepheid |
| Apr 21, 2023 | Masimo LNOP TC-I SpO2, Reusable Ear Sensor, REF: 1794 | TC-I tip clip sensor may produce readings outside the accuracy specification. | Class II | Masimo Corporation |
| Apr 21, 2023 | Masimo LNCS TC-I SpO2, Reusable Ear Sensor, REF: 1895 | TC-I tip clip sensor may produce readings outside the accuracy specification. | Class II | Masimo Corporation |
| Apr 21, 2023 | Masimo RD Set TC-I SpO2 Adult Reusable Ear Sensor, REF: 4053 | TC-I tip clip sensor may produce readings outside the accuracy specification. | Class II | Masimo Corporation |
| Apr 21, 2023 | Masimo LNCS TC-I SpO2, Reusable Ear Sensor, REF: 2503 | TC-I tip clip sensor may produce readings outside the accuracy specification. | Class II | Masimo Corporation |
| Apr 6, 2023 | Metal Tray, 178 x 135 x 37 mm, REF: 11580A; Metal Tray, 275 x 178 x 35 mm, R... | Metal sterilization trays used to encase and protect medical devices during sterilization have a ... | Class II | Karl Storz Endoscopy |
| Apr 5, 2023 | Beckman Coulter Bicarbonate, REF: OSR6237, 4x50 mL | There is a potential for a decrease in calibration ODs for Bicarbonate reagent which could result... | Class II | Beckman Coulter Inc. |
| Apr 5, 2023 | BD Pyxis MedStation ES (Med ES Main), REF: 323; BD Pyxis MedStation ES (Med E... | Automated dispensing cabinet software is experiencing: 1) ES device download failure resulting in... | Class II | CareFusion 303, Inc. |
| Apr 5, 2023 | BD Pyxis MedStation ES (Med ES Main), REF: 323; and BD Pyxis MedStation ES ... | Due to an automated dispensing cabinet software issue, when a medication single order contains mo... | Class II | CareFusion 303, Inc. |
| Apr 5, 2023 | NextSeq 550Dx Instrument, Catalog # 20005715, contaning Universal Copy Servic... | Cybersecurity vulnerability concerning the software used for sequencing instruments. | Class II | Illumina, Inc. |
| Apr 5, 2023 | KARL STORZ Radel Sterilization Trays, Models: 27717A, 27717B, 39301A, 39301C,... | Plastic sterilization trays used to encase and protect medical devices during sterilization have ... | Class II | Karl Storz Endoscopy |
| Apr 5, 2023 | Beckman Coulter Bicarbonate, REF: OS6637, 4x173 mL | There is a potential for a decrease in calibration ODs for Bicarbonate reagent which could result... | Class II | Beckman Coulter Inc. |
| Apr 5, 2023 | Beckman Coulter Bicarbonate, REF: OSR6137, 4x25 mL | There is a potential for a decrease in calibration ODs for Bicarbonate reagent which could result... | Class II | Beckman Coulter Inc. |
| Apr 5, 2023 | MiSeq Dx Instrument, Catalog # M70101, containing Universal Copy Service (UCS... | Cybersecurity vulnerability concerning the software used for sequencing instruments. | Class II | Illumina, Inc. |
| Mar 20, 2023 | DERMLITE DL4W, REF: DL4W, Rx Only MD, CE | Incorrect labeling; Package labeling contains a different serial number then the serial number on... | Class II | DermLite LLC |
| Mar 2, 2023 | SafeLight Fiber Optic Cable: Clear, 5MM X 10FT 3.05M, REF: 0233-050-100; Gray... | Fiber optic cables assembled with not enough epoxy on the proximal end, creating light output iss... | Class II | Stryker Corporation |
| Feb 27, 2023 | RelieVR REF: RVX-2002, Rx Only. Virtual reality behavioral therapy device fo... | There is the potential for the program software to malfunction which will not allow it to move fo... | Class II | Appliedvr |
| Feb 21, 2023 | Biosense Webster Carto Vizigo Bi-Directional Guiding Sheath, 8.5F(Medium), RE... | Incorrect labeling; specifically, the product name, lot number and product code on the carton lab... | Class II | Biosense Webster, Inc. |
| Feb 21, 2023 | Biosense Webster Carto Vizigo Bi-Directional Guiding Sheath, 8.5F(Small), REF... | Incorrect labeling; specifically, the product name, lot number and product code on the carton lab... | Class II | Biosense Webster, Inc. |
| Feb 21, 2023 | Neodent GM X 6mm Engaging Titanium Base, REF: 9007162 | Engaging titanium base contains a dimensional condition that allows vertical movement of the tita... | Class II | Preat Corp |
| Feb 15, 2023 | KLS Martin Battery Pack, REF: KLS BP 001, and KLS BP 040 (bulk case of 40), u... | Battery packs used in surgical procedures where a surgeon uses a powered screwdriver and a right-... | Class II | Pro-Dex Inc |
| Feb 14, 2023 | BD Pyxis MedStation ES AUX, REF 324 | Drawer and/or door failures that may lead to a delay in access to medications. The following thre... | Class II | CareFusion 303, Inc. |
| Feb 14, 2023 | BD Pyxis MedStation 4000 AUX, REF 306 | Drawer and/or door failures that may lead to a delay in access to medications. The following thre... | Class II | CareFusion 303, Inc. |
| Feb 14, 2023 | BD Pyxis MedStation ES (Med ES Main), REF 323 | Drawer and/or door failures that may lead to a delay in access to medications. The following thre... | Class II | CareFusion 303, Inc. |
| Feb 14, 2023 | BD Pyxis MedStation 4000 Main, REF 303 | Drawer and/or door failures that may lead to a delay in access to medications. The following thre... | Class II | CareFusion 303, Inc. |
| Feb 14, 2023 | BD Pyxis MedStation ES AUX Tower REF 343 BD Pyxis " MedStation 4000 AUX To... | Due to an increase in complaints of door latch assembly failures that may cause the doors to be l... | Class II | CareFusion 303, Inc. |
| Feb 14, 2023 | BD Pyxis Anesthesia ES System (PAS ES), REF: 327; BP Pyxis MedStation ES (Med... | Automated dispensing cabinet drawer firmware may have inadvertently been downgraded to an earlier... | Class II | CareFusion 303, Inc. |
| Feb 14, 2023 | Edward Lifesciences, REF 777F8, Swan-Ganz CCOmbo V, CCO/SvO2/CEDV/VIP, Thermo... | There is a potential that the distal end of the catheter may be bent beyond its intended curvatur... | Class II | Edwards Lifesciences, LLC |
| Feb 14, 2023 | BD Pyxis Med 4000 Auxiliary (AUX), REF 314 | Drawer and/or door failures that may lead to a delay in access to medications. The following thre... | Class II | CareFusion 303, Inc. |
| Feb 14, 2023 | Edward Lifesciences, REF 774F75, Swan-Ganz CCOmbo V, CCO/SvO2/CEDV/VIP, Therm... | There is a potential that the distal end of the catheter may be bent beyond its intended curvatur... | Class II | Edwards Lifesciences, LLC |
| Feb 14, 2023 | BD Pyxis Med ES Auxiliary (AUX), REF 343 | Drawer and/or door failures that may lead to a delay in access to medications. The following thre... | Class II | CareFusion 303, Inc. |
| Feb 14, 2023 | KLS martin Group KLS E-COUPLING ADAPTER REF PDEC-1000-2 E-Coupling Adapter... | Incorrect Unique Device Identifier/GTIN code was used on product. | Class II | Pro-Dex Inc |
| Feb 13, 2023 | FreeStyle Libre Reader, REF: 71525-01, 71701-01, 71739-01 a component of the ... | Lithium-ion batteries in glucose monitoring system readers may swell, overheat, or pose fire haza... | Class I | Abbott Diabetes Care, Inc. |
| Feb 13, 2023 | FreeStyle Libre Reader, REF: 71936-01, 71937-01, 71938-01 a component of the ... | Lithium-ion batteries in glucose monitoring system readers may swell, overheat, or pose fire haza... | Class I | Abbott Diabetes Care, Inc. |
| Feb 13, 2023 | FreeStyle Libre Reader, REF: 71951-01, 71952-01, 71953-01 a component of the ... | Lithium-ion batteries in glucose monitoring system readers may swell, overheat, or pose fire haza... | Class I | Abbott Diabetes Care, Inc. |
| Feb 10, 2023 | da Vinci Xi Surgical System Model IS4000 da Vinci X Surgical System Model ... | Due to Universal Surgical Manipulator (USM) instrument carriage being loose as a result of the li... | Class II | Intuitive Surgical, Inc. |
| Feb 9, 2023 | FreeStyle Libre 3 App, part of Continuous Glucose Monitoring System, when use... | If using affected glucose monitoring app on Android 13 Operating System, extended periods of sign... | Class II | Abbott Diabetes Care, Inc. |
| Feb 1, 2023 | PREAT NOBIL GRIP, product numbers 0102000 and 01202000-3 (3 pack), 5-ml vials... | Product is labeled with an incorrect expiration date. | Class III | Preat Corp |
| Jan 30, 2023 | Simplexa Flu A/B & RSV Direct Gen II, REF: MOL2655; including Reaction Mix RE... | Direct amplification Discs , used with COVID-19 and Flu A/B & RSV assays, may leak and cause cont... | Class II | DiaSorin Molecular LLC |
| Jan 30, 2023 | Simplexa COVID-19 Direct, REF: MOL4150; including Reaction Mix, REF: MOL4150;... | Direct amplification Discs , used with COVID-19 and Flu A/B & RSV assays, may leak and cause cont... | Class II | DiaSorin Molecular LLC |
| Jan 24, 2023 | Outset Tablo Model Numbers (REF): PN-0006000 PN-0007001 Tablo is a ne... | An observed trend of high conductivity dialysate alarms in a hemodialysis system as a result of i... | Class II | Outset Medical, Inc. |
| Jan 24, 2023 | Patient Side Cart, REF: 380620, with instrument arms, used as part of the da ... | Preventative maintenance data was used to identify instrument Arms, part of surgical systems, tha... | Class II | Intuitive Surgical, Inc. |
| Jan 24, 2023 | Alaris PC Unit 8015 utilizing 802.11 b/g or 802.11 a/b/g wireless network car... | Infusion pump PCs with specific software/network cards/IP addresses can have network/wireless con... | Class II | CareFusion 303, Inc. |
| Jan 16, 2023 | Irvine Scientific Oil for Embryo Culture (Light Mineral Oil) REF Catalog # 9305 | Due to the detection of oil toxicity in several lots of Oil for Embryo Culture products. | Class II | Fujifilm Irvine Scientific, Inc. |
| Dec 22, 2022 | RipCord Syndesmosis Button, REF: STA001K | Overly aggressive tension on the pull suture, while passing the medial button through a bone/soft... | Class II | TriMed 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.