Browse Device Recalls

3,087 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,087 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 3,087 FDA device recalls in IL.

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DateProductReasonClassFirm
Mar 20, 2023 ExactaMed Oral Dispenser - 20 mL Clear Pharmacy Pack, REF H9387120; Oral medi... ExataMed 20 mL oral dispenser component of the Clear Pharmacy Pack may have particulate matter. Class II Baxter Healthcare Corporation
Mar 16, 2023 (1) Carefusion V. Mueller Graves Vaginal Speculum, Catalog #GL11, Medium Blad... A portion of the two products were incorrectly marked (etched) and packaged resulting in a produc... Class II Carefusion 2200 Inc
Mar 2, 2023 Centurion CirClamp with 1.3cm Bell & Insert Reprocessed, Reorder #CR230K, Ste... The CirClamp subassembly found in the kit was the incorrect size. Class II MEDLINE INDUSTRIES, LP - Northfield
Feb 22, 2023 Automated Peritoneal Dialysis System. Used for automatic control of dialysis... The electrical safety testing was not properly performed on the impacted devices and additional t... Class II Baxter Healthcare Corporation
Feb 14, 2023 Amicus MNC Apheresis Kit Double Needle. Component of Amicus Separator multi... Potential for centrifuge packs to develop a stress leak for certain lots of Amicus MNC Apheresis ... Class II Fenwal Inc
Feb 14, 2023 Amicus Exchange Kit Therapeutics. Component of Amicus Separator multiprocedur... Potential for centrifuge packs to develop a stress leak for certain lots of Amicus MNC Apheresis ... Class II Fenwal Inc
Feb 1, 2023 Baxter MiniCap Disconnect Cap with Povidone-Iodine Solution, 5C4466P; Accesso... MiniCap Disconnect Cap with Povidone-Iodine are packaged in foil pouches, which may have been inc... Class II Baxter Healthcare Corporation
Jan 30, 2023 CD5 Series of Genesis Reusable Rigid Sterilization Container Systems catalog ... Product did not meet shelf-life testing requirements resulting in a breach of the sterility of th... Class II Carefusion 2200 Inc
Jan 25, 2023 Life2000 Ventilator , REF MS-01-0118, ventilatory support for the care of ind... There is the potential for patient desaturation events to occur under certain scenarios when the ... Class I Baxter Healthcare Corporation
Jan 25, 2023 Life2000 Ventilator System, a) REF BT-20-0002, b) REF BT-20-0002A, ventilator... There is the potential for patient desaturation events to occur under certain scenarios when the ... Class I Baxter Healthcare Corporation
Jan 25, 2023 Life2000 Ventilator PKG, Hospital, a) REF BT20007, b) REF BT-20-0007, ventila... There is the potential for patient desaturation events to occur under certain scenarios when the ... Class I Baxter Healthcare Corporation
Jan 25, 2023 Life2000 Ventilator PKG, Hospital, a) REF BT200011, b) REF BT-20-0011, ventil... There is the potential for patient desaturation events to occur under certain scenarios when the ... Class I Baxter Healthcare Corporation
Jan 16, 2023 SIEMENS Biograph Horizon 3R Mobile; System, Tomography, Computed, Emission This is a potential problem with the locking mechanism that is used to secure the PET gantry in e... Class II Siemens Medical Solutions USA, Inc.
Jan 16, 2023 SIEMENS Biograph Vision: a) 450, b) 600, c) 600 Edge This is a potential problem with the locking mechanism that is used to secure the PET gantry in e... Class II Siemens Medical Solutions USA, Inc.
Jan 16, 2023 SIEMENS Biograph mCT: a) Flow 64-4R Seismic, b) S(40)-3R Seismic, c) S(64)-3... This is a potential problem with the locking mechanism that is used to secure the PET gantry in e... Class II Siemens Medical Solutions USA, Inc.
Dec 27, 2022 (1) Medline Sterile Maximum Barrier Pack-LF, Item DYNJ0248546C, 6 kits per ca... The convenience trays had improper placement of some of the components that were in the nonsteril... Class II MEDLINE INDUSTRIES, LP - Northfield
Dec 27, 2022 Medline Sterile Oncology Port Access Tray, Item #DYNDC2239, 20 sterile kits p... The convenience trays had improper placement of some of the components that were in the nonsteril... Class II MEDLINE INDUSTRIES, LP - Northfield
Dec 27, 2022 (1) Medline Sterile Hand Pack, Item DYNJ63380A, 3 kits per case, contains BD ... The convenience trays had improper placement of some of the components that were in the nonsteril... Class II MEDLINE INDUSTRIES, LP - Northfield
Dec 23, 2022 CENTURION MEDICAL PRODUCTS, SILVER ANTIMICROBIAL VAD DRIVE, REF DT18760 The kit contained an expired component. Class II MEDLINE INDUSTRIES, LP - Northfield
Dec 22, 2022 MEDLINE UNITE FOOT & ANKLE Screw, Polyaxial Locking, Mini T8 (2.0x8mm), REF M... The recall is due to observed intra-operative screw failure. When pre-drilled with ¿1.3mm drill b... Class II MEDLINE INDUSTRIES, LP - Northfield
Dec 22, 2022 MEDLINE UNITE FOOT & ANKLE Screw, Non-Locking, Mini T8 (2.0x8mm), REF MMSN2008 The recall is due to observed intra-operative screw failure. When pre-drilled with ¿1.3mm drill b... Class II MEDLINE INDUSTRIES, LP - Northfield
Dec 22, 2022 MEDLINE UNITE FOOT & ANKLE DRILL BIT, 1.3MM Solid Core, REF MPN10013 The recall is due to observed intra-operative screw failure. When pre-drilled with ¿1.3mm drill b... Class II MEDLINE INDUSTRIES, LP - Northfield
Dec 15, 2022 HCT CENTRAL LINE Insertion Tray, I2 per case. Distributed by Health Care Tech... Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in t... Class II Stradis Healthcare
Dec 15, 2022 HCT 500mL BAGS, 2 Port, Sterile, Triple Packaged, 10 EVA BAGS/Pack, 7 Packs P... Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in t... Class II Stradis Healthcare
Dec 15, 2022 Tacy Medical, Inc PORT ACCESS TRAY, Sterile, QTY 20. Manufactured for Tracy ... Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in t... Class II Stradis Healthcare
Dec 15, 2022 PICC KIT, 10/CS, ACCESS MEDICAL LABEL Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in t... Class II Stradis Healthcare
Dec 15, 2022 Henry Shein CYSTO SET UP PACK, 20 per case. Distributed by Henry Schein. Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in t... Class II Stradis Healthcare
Dec 15, 2022 Tacy Medical, Inc Fluid Filter Transfer Kit, Sterile, 60 kits per bag, 5 bags... Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in t... Class II Stradis Healthcare
Dec 15, 2022 Stradis Healthcare NEONATAL PICC Tray *PGBK* 20 trays per case. Manufacture... Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in t... Class II Stradis Healthcare
Dec 15, 2022 Henry Shein GLOVES, packaged in the following sizes and descriptions: a. G... Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in t... Class II Stradis Healthcare
Dec 15, 2022 HCT 50mL EVA BAGS, 2 Port, Sterile, Tripple Packaged, 20 EVA BAGS/Pack, 7 Pac... Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in t... Class II Stradis Healthcare
Dec 15, 2022 PHS Lacertaion Tray, Sterile, 20 per case, Manufactured for Professional Hosp... Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in t... Class II Stradis Healthcare
Dec 15, 2022 Vital Care Products NEONATAL PICC TRAY, Sterile, QTY 20. Manufactured for Vi... Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in t... Class II Stradis Healthcare
Dec 15, 2022 Stradis Healthcare Foley Catheter Insertion Tray with preconnected bag and ca... Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in t... Class II Stradis Healthcare
Dec 15, 2022 Tacy Medical, Inc Syringe Convenience Pack, IML L/L, Sterile, 60 packs per ba... Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in t... Class II Stradis Healthcare
Dec 15, 2022 HCT MAX BARRIER PICC INSERTION TRAY 12 per case. Distributed by Health Care T... Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in t... Class II Stradis Healthcare
Dec 15, 2022 Stradis Healthcare TCTR Convenience Kit. Manufactured by Stradis Healthcare. Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in t... Class II Stradis Healthcare
Dec 15, 2022 HCT 6 CC SYRINGE KIT, 25/TRAY, 4 TRAYS/BAG, 5 BAGS/CASE. Distributed by Heal... Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in t... Class II Stradis Healthcare
Dec 15, 2022 HCT 12 CC SYRINGE KIT, 20/TRAY,5 TRAYS/BAG, 5 BAGS /CASE HCT. Distributed by... Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in t... Class II Stradis Healthcare
Dec 15, 2022 McCormick Medical Distribution PORT TRAY, 25 trays per case. Distributed by ... Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in t... Class II Stradis Healthcare
Dec 14, 2022 Cardinal Health Jackson-Pratt Channel Drain, 15 Fr, REF JP-2188 Cardinal Health recently received multiple complaints regarding various performance issues with C... Class II Cardinal Health 200, LLC
Dec 14, 2022 Cardinal Health Jackson-Pratt Channel Drain, 10 mm, REF JP-2215 Cardinal Health recently received multiple complaints regarding various performance issues with C... Class II Cardinal Health 200, LLC
Dec 14, 2022 Cardinal Health Jackson-Pratt Channel Drain, 19 Fr, REF JP-2231 Cardinal Health recently received multiple complaints regarding various performance issues with C... Class II Cardinal Health 200, LLC
Dec 14, 2022 Cardinal Health Jackson-Pratt Channel Drain, 7 mm, REF JP-2210 Cardinal Health recently received multiple complaints regarding various performance issues with C... Class II Cardinal Health 200, LLC
Dec 14, 2022 Cardinal Health Jackson-Pratt Channel Drain, 24 Fr, REF JP-2234 Cardinal Health recently received multiple complaints regarding various performance issues with C... Class II Cardinal Health 200, LLC
Dec 14, 2022 Cardinal Health Jackson-Pratt Channel Drain, 7 mm, REF JP-2216 Cardinal Health recently received multiple complaints regarding various performance issues with C... Class II Cardinal Health 200, LLC
Dec 14, 2022 Cardinal Health Jackson-Pratt Channel Drain, 10 Fr, REF JP-2221 Cardinal Health recently received multiple complaints regarding various performance issues with C... Class II Cardinal Health 200, LLC
Dec 14, 2022 Cardinal Health Jackson-Pratt Channel Drain, 15 Fr, REF JP-2229 Cardinal Health recently received multiple complaints regarding various performance issues with C... Class II Cardinal Health 200, LLC
Dec 14, 2022 Cardinal Health Jackson-Pratt Channel Drain, 10 Fr, REF JP-2226 Cardinal Health recently received multiple complaints regarding various performance issues with C... Class II Cardinal Health 200, LLC
Dec 14, 2022 Cardinal Health Jackson-Pratt Channel Drain, 19 Fr, REF JP-2232 Cardinal Health recently received multiple complaints regarding various performance issues with C... Class II Cardinal Health 200, LLC

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.