Browse Device Recalls
39,969 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 39,969 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 39,969 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Sep 6, 2023 | 2008T HD SYS. CDX W/BIBAG BLUESTAR | Potential PCBA leaching from tubing of hemodialysis machines. | Class I | Fresenius Medical Care Holdings, Inc. |
| Sep 6, 2023 | 2008T GEN 2 Bibag without CDX | Potential PCBA leaching from tubing of hemodialysis machines. | Class I | Fresenius Medical Care Holdings, Inc. |
| Sep 6, 2023 | 2008T Hemodialysis System w/Bibag | Potential PCBA leaching from tubing of hemodialysis machines. | Class I | Fresenius Medical Care Holdings, Inc. |
| Sep 6, 2023 | RX Daytona Plus (with ISE)-IVD Clinical Chemistry Analyser Catalog Number: R... | RX Parameter rerun settings (Sample Volume Low/High), and Dilutions used for Auto reruns, not mee... | Class II | Randox Laboratories Ltd. |
| Sep 6, 2023 | 2008T HD SYS. W/O CDX W/BIBAG BLUESTAR | Potential PCBA leaching from tubing of hemodialysis machines. | Class I | Fresenius Medical Care Holdings, Inc. |
| Sep 6, 2023 | RX Imola-IVD Clinical Chemistry Analyzer Catalog Number: RX4900. RX4900R (re... | RX Parameter rerun settings (Sample Volume Low/High), and Dilutions used for Auto reruns, not mee... | Class II | Randox Laboratories Ltd. |
| Sep 6, 2023 | Portex Pro-Vent Arterial Blood Sampling Kit with Dry Lithium Heparin for Gase... | The complaint involved the absence of a component called "ASM Filter-Pro ABG SYR CAP" from the pa... | Class II | Smiths Medical ASD Inc. |
| Sep 6, 2023 | RX Monaco-IVD Clinical Chemistry Analyser Catalog Number: RX5000 | RX Parameter rerun settings (Sample Volume Low/High), and Dilutions used for Auto reruns, not mee... | Class II | Randox Laboratories Ltd. |
| Sep 6, 2023 | 2008T Hemodialysis SYS, with CDX | Potential PCBA leaching from tubing of hemodialysis machines. | Class I | Fresenius Medical Care Holdings, Inc. |
| Sep 6, 2023 | 2008T HD SYS. W/O CDX BLUESTAR | Potential PCBA leaching from tubing of hemodialysis machines. | Class I | Fresenius Medical Care Holdings, Inc. |
| Sep 6, 2023 | RX Modena-IVD Clinical Chemistry Analyser Catalog Number: RX9000 | RX Parameter rerun settings (Sample Volume Low/High), and Dilutions used for Auto reruns, not mee... | Class II | Randox Laboratories Ltd. |
| Sep 6, 2023 | RSP Glenoid Baseplate, 30mm P2 Porous Coated REF 508-32-204. DJO Surgical sho... | Coating hex did not engage with the Straight Mod Hexdriver or with the Hex Head Screw Driver | Class II | Encore Medical, LP |
| Sep 6, 2023 | Venue Go Standard Carts Ref: (H45181VC and H45103VCW), used with Venue Go R2,... | Some Venue Go Standard Carts can develop an internal failure of the vertical/horizontal tilt adju... | Class II | GE MEDICAL SYSTEMS, ISRAEL LTD. |
| Sep 5, 2023 | Zimmer Dermatome Blades- 10-pack boxes of blades. Intended for use with the d... | Skin grafts thin and non-uniform when using the affected blades. The issue would be identified at... | Class II | Zimmer Surgical Inc |
| Sep 5, 2023 | Atrium Oasis Dry Suction Water Seal Chest Drain, Part Number: 3600-100, DRAIN... | Product was re-processed and re-sterilized by a third party using packaging configurations and a ... | Class II | Atrium Medical Corporation |
| Sep 5, 2023 | Atrium Oasis Dry Suction Water Seal Chest Drain, Part Number: 3650-100, DRAIN... | Product was re-processed and re-sterilized by a third party using packaging configurations and a ... | Class II | Atrium Medical Corporation |
| Sep 5, 2023 | MAZOR X robotic guidance system, Model TPL0059, with software versions 4.2.2 ... | Software update | Class II | Mazor Robotics Ltd |
| Sep 1, 2023 | Segmental Stem, Canal Filling, Bowed 152MM, 1 EACH. Model Numbers: FB-11152-0... | Potential for breach of Tyvek seals. | Class II | Onkos Surgical, Inc. |
| Sep 1, 2023 | Male-Female Midsection with the following sizes and model numbers. a. Male... | Potential for breach of Tyvek seals. | Class II | Onkos Surgical, Inc. |
| Sep 1, 2023 | Segmental Stem, Cemented, Bowed, 152MM, 1 EACH. Model Numbers: CB-11152-03M, ... | Potential for breach of Tyvek seals. | Class II | Onkos Surgical, Inc. |
| Sep 1, 2023 | General Pack, REF BBGP31C | During an internal investigation, ACS identified that the components, I.V. Cath (part number 4252... | Class II | American Contract Systems, Inc. |
| Sep 1, 2023 | Pediatric Urology Wolson Pack, REF BPPU55A | During an internal investigation, ACS identified that the components, I.V. Cath (part number 4252... | Class II | American Contract Systems, Inc. |
| Sep 1, 2023 | Breast Plastics Pack, REF BBPL20D | During an internal investigation, ACS identified that the components, I.V. Cath (part number 4252... | Class II | American Contract Systems, Inc. |
| Sep 1, 2023 | Sub Q Recorder Pack, REF BPRC87A | During an internal investigation, ACS identified that the components, I.V. Cath (part number 4252... | Class II | American Contract Systems, Inc. |
| Sep 1, 2023 | (1) Over-ear headphones used with the MAGNETOM Amira MAGNETOM Free.Star MAGNE... | In some cases, when lubricating grease is present within the headband of the over-ear headphones... | Class II | Siemens Medical Solutions USA, Inc |
| Sep 1, 2023 | Robotics Pack, REF SSRO22D | During an internal investigation, ACS identified that the components, I.V. Cath (part number 4252... | Class II | American Contract Systems, Inc. |
| Sep 1, 2023 | Brand Name: The Guardian System Product Name: The Guardian Model/Catalog Numb... | Device reaching End of Service prematurely. | Class II | Angel Medical Systems, Inc. |
| Sep 1, 2023 | Cath Cardiac Pack, REF IHCC03V | During an internal investigation, ACS identified that the components, I.V. Cath (part number 4252... | Class II | American Contract Systems, Inc. |
| Sep 1, 2023 | Pediatric Heart SJH, REF SJPH34K | During an internal investigation, ACS identified that the components, I.V. Cath (part number 4252... | Class II | American Contract Systems, Inc. |
| Sep 1, 2023 | CVS PCSU SJH, REF SJCV48J | During an internal investigation, ACS identified that the components, I.V. Cath (part number 4252... | Class II | American Contract Systems, Inc. |
| Sep 1, 2023 | Solea Models 2.0 and 3.0 Laser Surgical Instrument, Foot Pedal assembly SUB-0... | It has been found that potential unintended laser activation can occur without foot pedal depress... | Class II | Convergent Dental |
| Sep 1, 2023 | Vasc. Open CVOR SJH, REF SJVO56B | During an internal investigation, ACS identified that the components, I.V. Cath (part number 4252... | Class II | American Contract Systems, Inc. |
| Sep 1, 2023 | Segmental Stem, Canal Filling, Straight, 120MM, 1 EACH. Model Numbers: FS-111... | Potential for breach of Tyvek seals. | Class II | Onkos Surgical, Inc. |
| Sep 1, 2023 | Ethos Collar Stem, Cemented, Fluted, 100MM, 1 EACH. Model Numbers: HC-09100-0... | Potential for breach of Tyvek seals. | Class II | Onkos Surgical, Inc. |
| Sep 1, 2023 | Robotics Pack, REF SJVO56B | During an internal investigation, ACS identified that the components, I.V. Cath (part number 4252... | Class II | American Contract Systems, Inc. |
| Sep 1, 2023 | a. Segmental Stem, Cemented, Straight, 100MM, 1 EACH; Model Numbers: CS-09100... | Potential for breach of Tyvek seals. | Class II | Onkos Surgical, Inc. |
| Sep 1, 2023 | Robotics Pack SAH, REF SAR530M | During an internal investigation, ACS identified that the components, I.V. Cath (part number 4252... | Class II | American Contract Systems, Inc. |
| Sep 1, 2023 | LAVH, REF BBLV21C | During an internal investigation, ACS identified that the components, I.V. Cath (part number 4252... | Class II | American Contract Systems, Inc. |
| Aug 31, 2023 | EarlyVue VS30 Vital Signs Monitor, utilizing E01 (Oridion Microstream sidest... | A software issue prevents the monitor from alarming when the high/low acoustic respiration rate (... | Class II | Philips North America Llc |
| Aug 31, 2023 | smith&nephew LEGION OXINUM POSTERIOR STABILIZED NONPOROUS FERMOAL COMPONENT, ... | The firm conducting a recall due to a complaint received indicating that a package contained a LE... | Class II | Smith & Nephew Inc |
| Aug 31, 2023 | HydroPICC 5Fr Dual Lumen Maximal Barrier Kit, Product Model Number 80002004 | Specific lots of the Dual Lumen HydroPICC Kits were provided with the incorrect revision of the I... | Class II | Access Vascular, Inc |
| Aug 31, 2023 | HydroPICC 5Fr Dual Lumen, 80cm guidewire - Basic Kit, Product Model Number 80... | Specific lots of the Dual Lumen HydroPICC Kits were provided with the incorrect revision of the I... | Class II | Access Vascular, Inc |
| Aug 31, 2023 | EarlyVue VS30 Vitals Monitor, utilizing E01 (Oridion Microstream sidestream e... | A software issue prevents the monitor from alarming when the high/low acoustic respiration rate (... | Class II | Philips North America Llc |
| Aug 31, 2023 | Zephyr Endobronchial Valve (EBV) 5.5-LP, REF: EBV-TS-5.5-LP | Endobronchial implant devices may have been labeled with a shortened expiration date but they can... | Class II | Pulmonx, Corp. |
| Aug 30, 2023 | ProCuity bed series, model number 3009, item number: 3009PX-L-200 | Patient beds are missing test values for electrical safety tests presenting risk of tissue burn ... | Class II | Stryker Medical Division of Stryker Corporation |
| Aug 30, 2023 | Citrine QTRAP Mass Spectrometer, Part Number 5063685 | In rare occasions, the combination of a leak of a highly flammable solvent at the ion source prob... | Class II | AB Sciex, LLC |
| Aug 30, 2023 | ProCuity bed series, model number 3009, item number: 300900000000, | Patient beds are missing test values for electrical safety tests presenting risk of tissue burn ... | Class II | Stryker Medical Division of Stryker Corporation |
| Aug 30, 2023 | ProCuity bed series, model number 3009, item number: 3009PX-ZM-600. | Patient beds are missing test values for electrical safety tests presenting risk of tissue burn ... | Class II | Stryker Medical Division of Stryker Corporation |
| Aug 30, 2023 | ProCuity bed series, model number 3009, item number: 3009PX-LEX-450. | Patient beds are missing test values for electrical safety tests presenting risk of tissue burn ... | Class II | Stryker Medical Division of Stryker Corporation |
| Aug 30, 2023 | ProCuity bed series, model number 3009, item number: 3009PX-Z-450. | Patient beds are missing test values for electrical safety tests presenting risk of tissue burn ... | Class II | Stryker Medical Division of Stryker Corporation |
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.