Browse Device Recalls

3,306 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,306 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 3,306 FDA device recalls in IL.

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DateProductReasonClassFirm
May 15, 2023 Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound ... Potential for the labeled sterile ultrasound gel component within packs to not meet sterility spe... Class II MEDLINE INDUSTRIES, LP - Northfield
May 15, 2023 Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound ... Potential for the labeled sterile ultrasound gel component within packs to not meet sterility spe... Class II MEDLINE INDUSTRIES, LP - Northfield
May 15, 2023 Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound ... Potential for the labeled sterile ultrasound gel component within packs to not meet sterility spe... Class II MEDLINE INDUSTRIES, LP - Northfield
May 12, 2023 Medline O.R. Scissors, S/B, Sterile, 5.5, Model #DYND04000 The scissors were manufactured without a tip protector resulting in the scissors breaking through... Class II MEDLINE INDUSTRIES, LP - Northfield
May 5, 2023 bellavista 1000 Ventilator, Catalogue Number 301.100.030; Continuous Use Vent... Vyaire Medical identified two patient safety risks during the use of the bellavista 1000 and bell... Class II Vyaire Medical
May 5, 2023 bellavista 1000e Ventilator, Catalogue Number 301.100.130; Continuous Use Ven... Vyaire Medical identified two patient safety risks during the use of the bellavista 1000 and bell... Class II Vyaire Medical
May 3, 2023 MEDLINE THERAHONEY GEL, 100% LEPTOSPERMUM SCOPARIUM HONEY, a) REF MNK0005, b)... Medline issued a recall on TheraHoney Wound Gel due to the manufacturer notifying Medline of a st... Class II MEDLINE INDUSTRIES, LP - Northfield
Apr 21, 2023 Procedure packs: (1) Medline Sterile Arthroscopy Pack, REF: DYNJ64242B; (... The kits were damaged by water. Class II MEDLINE INDUSTRIES, LP - Northfield
Apr 6, 2023 Presource Kit, SMA21LPUHJ GYN Laparoscopy Pack. Convenience kit used for... Inadvertently released for distibution without sterility assurance. Class II Cardinal Health 200, LLC
Mar 31, 2023 Hill-Rom pro+ mattress, product codes (REF): a) 20877002S, b) 20877003S, c) ... There is a potential for mattress cover damage (delamination) which may result in fluid absorptio... Class II Baxter Healthcare Corporation
Mar 28, 2023 Centricity PACS-IW, Product ID Numbers: a) 2041037-001, b) 2042988-001, c) 2... GE HealthCare has become aware of an issue where information from two different patients can be m... Class II GE Healthcare
Mar 28, 2023 Centricity Universal Viewer, Centricity Universal Viewer 6.0, Model/Catalog ... GE HealthCare has become aware of an issue where information from two different patients can be m... Class II GE Healthcare
Mar 28, 2023 Centricity PACS-IW with Universal Viewer, Model/Catalog Numbers: a) 2066908-... GE HealthCare has become aware of an issue where information from two different patients can be m... Class II GE Healthcare
Mar 28, 2023 DYND3000xxP Series - Flexible Laryngeal Mask Airway Packs The case and each (i.e. packet) labels for the DYND3000xxP series do not include an expiration da... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 27, 2023 GEM NEUROTUBE, Absorbable Woven Polyglycolic Acid Mesh Tube, Product Codes: ... The product is brittle and potentially crumbling upon handling or when being removed from its pac... Class II Baxter Healthcare Corporation
Mar 22, 2023 Replacement Battery List Number SUB0000594 found in Plum A+ & Plum A+3 Infusi... Due to a manufacturing defect from the battery supplier, affected batteries may experience a loss... Class I ICU Medical Inc
Mar 22, 2023 ASM Replacement Battery, Component Number SUB0000594 Due to a manufacturing defect from the battery supplier, affected batteries may experience a loss... Class I ICU Medical Inc
Mar 22, 2023 ASM Replacement Battery, Component Number SUB0000864 Due to a manufacturing defect from the battery supplier, affected batteries may experience a loss... Class I ICU Medical Inc
Mar 22, 2023 Replacement Battery List Number SUB0000864, found in Plum 360 Infusion System... Due to a manufacturing defect from the battery supplier, affected batteries may experience a loss... Class I ICU Medical Inc
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

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.