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.

DateProductReasonClassFirm
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.