Browse Device Recalls
5,424 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 5,424 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 5,424 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Nov 17, 2022 | Non-sterile procedural trays labeled as CRANI, 2 per case | Potential for sterile blades, within non-sterile SPT kits containing the blades, to puncture the ... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 17, 2022 | Sterile Procedural Trays, labeled as the following: a. GYN LAPAROTOMY HA... | Sterile blades within sterile kits have the potential for the blade to puncture the outer foil la... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 17, 2022 | Sterile Procedural Tray, labeled as the following: a. PAIN SERVICE PACK-LF... | Sterile blades within sterile kits have the potential for the blade to puncture the outer foil la... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 17, 2022 | Sterile Procedural Trays, labeled as the following: a. CARDIAC CATH PACK-L... | Sterile blades within sterile kits have the potential for the blade to puncture the outer foil la... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 17, 2022 | Sterile Procedural Trays, labeled as the following: GENERAL ENDOSCOPY | Sterile blades within sterile kits have the potential for the blade to puncture the outer foil la... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 17, 2022 | Sterile Procedural Trays, labeled as the following: a. WOUND CLOSURE TRAY... | Sterile blades within sterile kits have the potential for the blade to puncture the outer foil la... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 17, 2022 | Sterile Procedural Trays, labeled as the following: a. GYN ABD CDS b. L... | Sterile blades within sterile kits have the potential for the blade to puncture the outer foil la... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 17, 2022 | Sterile Procedural Trays, labeled as the following: a. ORAL SURGERY PACK-L... | Sterile blades within sterile kits have the potential for the blade to puncture the outer foil la... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 17, 2022 | Non-sterile procedural trays labeled as ORTHO TRAUMA, 1 per case | Potential for sterile blades, within non-sterile SPT kits containing the blades, to puncture the ... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 17, 2022 | Sterile Procedural Trays, labeled as the following: MINOR BASIC PACK-LF | Sterile blades within sterile kits have the potential for the blade to puncture the outer foil la... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 17, 2022 | Sterile Procedural Trays, labeled as the following: a. MAJOR CDS-LF b. B... | Sterile blades within sterile kits have the potential for the blade to puncture the outer foil la... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 17, 2022 | Non-sterile procedural trays labeled as MAJOR/MINOR, 3 per case | Potential for sterile blades, within non-sterile SPT kits containing the blades, to puncture the ... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 17, 2022 | Sterile Procedural Trays, labeled as the following: a. UNIVERSAL PLASTIC ... | Sterile blades within sterile kits have the potential for the blade to puncture the outer foil la... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 17, 2022 | Sterile Procedural Trays, labeled as the following: a. BASIC EYE PACK-LF... | Sterile blades within sterile kits have the potential for the blade to puncture the outer foil la... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 17, 2022 | Sterile Procedural Trays, labeled as the following: a. RHINOPLASTY PACK b... | Sterile blades within sterile kits have the potential for the blade to puncture the outer foil la... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 17, 2022 | Sterile Procedural Trays, labeled as the following: a. LAPAROTOMY CDS-LF b. ... | Sterile blades within sterile kits have the potential for the blade to puncture the outer foil la... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 17, 2022 | Sterile Procedural Trays, labeled as the following: a. CELEBRATION ROBOT... | Sterile blades within sterile kits have the potential for the blade to puncture the outer foil la... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 17, 2022 | Sterile Procedural Trays, labeled as the following: a. EP LAB PACEMAKER PACK... | Sterile blades within sterile kits have the potential for the blade to puncture the outer foil la... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 17, 2022 | Sterile Procedural Trays, labeled as the following: a. C-SECTION OR 30 C... | Sterile blades within sterile kits have the potential for the blade to puncture the outer foil la... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 17, 2022 | Sterile Procedural Trays, labeled as the following: a. EAR CDS-LF b. SINUS C... | Sterile blades within sterile kits have the potential for the blade to puncture the outer foil la... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 17, 2022 | Sterile Procedural Trays, labeled as the following: AMBULATORY MINI PACK | Sterile blades within sterile kits have the potential for the blade to puncture the outer foil la... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 17, 2022 | Sterile Procedural Trays, labeled as the following: a. BREAST AUGMENTATIO... | Sterile blades within sterile kits have the potential for the blade to puncture the outer foil la... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 8, 2022 | Corin BIOLOX DELTA MOD HEAD,032mm, EX LONG +7mm, REF 104.3215 | The BIOLOX Delta Ceramic Head size 36XL is labelled as the size 32XL and vice-versa. | Class II | Corin Ltd |
| Nov 8, 2022 | Corin BIOLOX DELTA MOD HEAD, 036mm EX LONG +8mm, REF 104.3615 | The BIOLOX Delta Ceramic Head size 36XL is labelled as the size 32XL and vice-versa. | Class II | Corin Ltd |
| Nov 7, 2022 | R&D CBC-3D Hematology Control: (1) CBC-3D Normal Pack Hematology Control, ... | For one lot of CBC-3D Hematology Control, the Normal Level may exhibit hemolysis or deterioration... | Class III | R & D Systems, Inc. |
| Oct 27, 2022 | Southmedic SAFETY CARTRIDGE WITH SOUTHMEDIC PLUS SURGICAL BLADE, REF 73-8020,... | Upon review of its batch record, Southmedic identified that lot # W92761 was not sent out for ste... | Class II | Southmedic, Inc. |
| Oct 27, 2022 | CytoCell BCL11B Proximal in FITC Spectrum-LDT for investigation T-cell relate... | Device is mislabeled. The package insert for this ASR device contains a chromomap - an image show... | Class II | Cytocell Ltd. |
| Oct 21, 2022 | Propel Mini Mometasone Furoate Sinus Implant, with Straight Delivery System, ... | Sinus Implant product label displays incorrect product information including: "Straight Delivery ... | Class II | Intersect ENT, Inc. |
| Oct 18, 2022 | Hill-Rom Progressa Bed System | The compression links on impacted Progressa beds, listed in Appendix A, may bend when raising the... | Class II | Baxter Healthcare Corporation |
| Oct 14, 2022 | GentleWave System Posterior CleanFlow Procedure Instrument with Matrices (Sin... | Procedure Instruments with erroneous unit carton labels. | Class II | Sonendo Inc |
| Oct 14, 2022 | GentleWave System APM Procedure Instrument with Matrix REF GW-APM-PI02 | Procedure Instruments with erroneous unit carton labels. | Class II | Sonendo Inc |
| Oct 12, 2022 | BASIN SET, MEBS42K, general surgical kit | Basin Set labeling error: components within the kit are for the Single Basin Set. Therefore, the... | Class II | American Contract Systems, Inc. |
| Oct 12, 2022 | Medical Action Industries Inc. Port Access Kit, REF #76511B (on case label), ... | The Port Access Kits were incorrectly labeled as IV Start Kits on the kit label. The case label ... | Class II | Medical Action Industries, Inc. 306 |
| Oct 4, 2022 | NaturaLyte Liquid Acid concentrate, Part Number 08-0231-4, four (4) one-gallo... | The "Nominal Chemical Composition" section of the label incorrectly lists 5.62g/L KCL (potassium ... | Class II | Fresenius Medical Care Holdings, Inc. |
| Oct 3, 2022 | BD Trucount Tubes (Cat. No. 340334), used for determining absolute counts of ... | Due to partial label detachment on tubes. This can cause tubes to become stuck together in the po... | Class II | Becton, Dickinson and Company, BD Biosciences |
| Oct 3, 2022 | BD Trucount Tubes (Cat. No. 663028), used for determining absolute counts of ... | Due to partial label detachment on tubes. This can cause tubes to become stuck together in the po... | Class II | Becton, Dickinson and Company, BD Biosciences |
| Oct 3, 2022 | BD Multitest 6-Color TBNK with optional BD Trucount Tubes (Cat. No. 662995), ... | Due to partial label detachment on tubes. This can cause tubes to become stuck together in the po... | Class II | Becton, Dickinson and Company, BD Biosciences |
| Sep 28, 2022 | Zio AT Clinical Reference Manual, Part: ALB0031, and Zio AT Important Informa... | Ambulatory ECG monitoring system labeling update: 1) Clinically actionable arrhythmia notificatio... | Class II | iRhythm Technologies, Inc. |
| Sep 28, 2022 | Cardinal Health INSULATED GEL PACK REUSABLE, LARGE, Cat. 80104 | Users are being informed that the product should not be used on infants/neonates. A caution state... | Class II | Cardinal Health 200, LLC |
| Sep 28, 2022 | Cardinal Health HOT AND COLD GEL PACK REUSABLE, M, Cat. 70304 | Users are being informed that the product should not be used on infants/neonates. A caution state... | Class II | Cardinal Health 200, LLC |
| Sep 28, 2022 | Cardinal Health GEL PACK REUSABLE, EXTRA SMALL, Cat. 61115 | Users are being informed that the product should not be used on infants/neonates. A caution state... | Class II | Cardinal Health 200, LLC |
| Sep 28, 2022 | Cardinal Health INSULATED GEL PACK REUSABLE, MEDIUM, Cat. 80304A | Users are being informed that the product should not be used on infants/neonates. A caution state... | Class II | Cardinal Health 200, LLC |
| Sep 28, 2022 | Cardinal Health INSULATED GEL PACK REUSABLE, SMALL, Cat. 80204A | Users are being informed that the product should not be used on infants/neonates. A caution state... | Class II | Cardinal Health 200, LLC |
| Sep 28, 2022 | Cardinal Health Reusable Gel Pack, Hot/Cold Pack, 4.5 in. x 10 in., REF 70304A | Users are being informed that the product should not be used on infants/neonates. A caution state... | Class II | Cardinal Health 200, LLC |
| Sep 28, 2022 | Cardinal Health INSULATED GEL PACK REUSABLE, EXTRA LARGE, Cat. 80600 | Users are being informed that the product should not be used on infants/neonates. A caution state... | Class II | Cardinal Health 200, LLC |
| Sep 28, 2022 | Cardinal Health GEL PACK REUSABLE, SMALL, Cat. 70204 | Users are being informed that the product should not be used on infants/neonates. A caution state... | Class II | Cardinal Health 200, LLC |
| Sep 15, 2022 | B. Braun CARESITE Port Access Kit w/Tegaderm, REF 375214, Central Venous (car... | The kits were incorrectly labeled with an extended expiration date of 02/21/2024 instead of 02/10... | Class II | Medical Action Industries, Inc. 306 |
| Sep 14, 2022 | Y-CONNECTOR: 6" Small Kink Resistant Tubing Bifurcated Connector /2 Male Lue... | Sterile extension sets were distributed without an expiration date | Class II | Avanos Medical, Inc. |
| Sep 14, 2022 | ARROW Pressure Injectable Arrowg+ard Blue Advance Two-Lumen Midline Kit, 5.5 ... | Mislabeling: the corrugate label, lidstock, banner card, and peel sticker accompanying the affe... | Class II | ARROW INTERNATIONAL Inc. |
| Sep 7, 2022 | Optima Coil System Model Number OPTI0208CSS10, Model Number OPTI0308... | Product pouch label does not match up with carton label | Class II | BALT USA, 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.