Browse Device Recalls
3,133 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,133 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 3,133 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| May 18, 2023 | QUADROX-i Adult, Oxygenator used during cardiopulmonary bypass Model ... | Product packaging may exhibit small pinholes which may not be visible to the unaided eye, comprom... | Class II | Maquet Medical Systems USA |
| May 18, 2023 | QUADROX -i Neonatal, Oxygenator used during cardiopulmonary bypass Model ... | 1. An accessory may be improperly placed during packaging, causing creases and damage to the acce... | Class II | Maquet Medical Systems USA |
| May 18, 2023 | BEQ-HMO 50000-USA/ QUADROX-i Small, Oxygenator used during cardiopulmonary by... | 1. An accessory may be improperly placed during packaging, causing creases and damage to the acce... | Class II | Maquet Medical Systems USA |
| May 18, 2023 | QUADROX-i Pediatric, Oxygenator used during cardiopulmonary bypass Model ... | 1. An accessory may be improperly placed during packaging, causing creases and damage to the acce... | Class II | Maquet Medical Systems USA |
| May 18, 2023 | MEDLINE NON-STERILE PVP SOLUTION, STERILE PACKAGING REF DYNDA2232A | Affected product lots were mislabeled as "STERILE PVP SLN" when they should have been titled "NON... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 18, 2023 | MEDLINE NON-STERILE PVP SOLUTION, packaged in kits as follows: TOTAL KNEE TH... | Affected product lots were mislabeled as "STERILE PVP SLN" when they should have been titled "NON... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 18, 2023 | MEDLINE NON-STERILE PVP SOLUTION, packaged in kits as follows: OISC HAND BEA... | Affected product lots were mislabeled as "STERILE PVP SLN" when they should have been titled "NON... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 18, 2023 | QUADROX-i Small Adult, Oxygenator used during cardiopulmonary bypass Model ... | Product packaging may exhibit small pinholes which may not be visible to the unaided eye, comprom... | Class II | Maquet Medical Systems USA |
| May 18, 2023 | QUADROX -i Neonatal, Oxygenator used during cardiopulmonary bypass Model ... | Product packaging may exhibit small pinholes which may not be visible to the unaided eye, comprom... | Class II | Maquet Medical Systems USA |
| May 15, 2023 | NeuMoDx SARS-CoV-2 Assay -IVD intended for the qualitative detection of SARS... | Potential for lot number discrepancies between the test strip packaging and the barcode label app... | Class III | NeuMoDx Molecular Inc |
| May 2, 2023 | Serrated Blade Applicator Kit (12 Sample), REF: 552687, For use with the Spif... | Packaging for a serrated blade applicator kit (12 Sample) may contain a serrated blade applicator... | Class II | Helena Laboratories, Corp. |
| Apr 25, 2023 | LINK SymphoKnee System L-Shaped Femoral Augment, Medial-Right/Lateral-Left, S... | Contains the incorrect implant in the packaging. The packaging incorrectly contains the opposite ... | Class II | Linkbio Corp. |
| Apr 24, 2023 | Aligned Medical Solutions Spine Pack, REF: AMS4599(C, containing P 2 Cover ... | Light handle covers may separate from the light handle (detach and fall off) during use, this cou... | Class II | Windstone Medical Packaging, Inc. |
| Apr 24, 2023 | Aligned Medical Solutions Minor Hand Pack, REF: AMS6539E, containing P 2 Co... | Light handle covers may separate from the light handle (detach and fall off) during use, this cou... | Class II | Windstone Medical Packaging, Inc. |
| Apr 24, 2023 | Aligned Medical Solutions Hand Pack, REF: AmS4601E, containing P 2 Cover Li... | Light handle covers may separate from the light handle (detach and fall off) during use, this cou... | Class II | Windstone Medical Packaging, Inc. |
| Apr 20, 2023 | Magic3 Go Intermittent Urinary Catheters, male Catalog Numbers: a) REF 50810G... | Some catheters had a manufacturing defect where the clear resealing label separating from the pro... | Class II | C.R. Bard Inc |
| Apr 20, 2023 | Magic3 Go Intermittent Urinary Catheters, pediatric Catalog Numbers: a) REF 5... | Some catheters had a manufacturing defect where the clear resealing label separating from the pro... | Class II | C.R. Bard Inc |
| Apr 20, 2023 | Magic3 Go Intermittent Urinary Catheters, Female Catalog Numbers: a) REF 5180... | Some catheters had a manufacturing defect where the clear resealing label separating from the pro... | Class II | C.R. Bard Inc |
| Apr 20, 2023 | HydroSil Go Intermittent Urinary Catheters, Catalog Numbers: a) REF 71808, b... | Some catheters had a manufacturing defect where the clear resealing label separating from the pro... | Class II | C.R. Bard Inc |
| Feb 20, 2023 | Mani Trocar Kit, Model MTK23S and Model MTK25S There are 3 kits contained ... | A packaging defect may compromise the sterile barrier. | Class II | Mani, Inc. - Kiyohara Facility |
| Feb 13, 2023 | BEQ-HLS 5050 USA; HLS Set Advanced 5.0, Product Code 70106.9077, BEQ-HLS ... | Firm has initiated a removal of the product due to insufficient evidence of packaging sterility. ... | Class II | Maquet Medical Systems USA |
| Feb 8, 2023 | Medtronic Grafton Flex: a) DBM S42090 GRAFTON 1.5CM X 1.5CM FLEX, REF S420... | Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch pack... | Class II | Medtronic Sofamor Danek USA Inc |
| Feb 8, 2023 | Medtronic Accelerate Grafton DBF a) ACCELERATE BG SET T50203 GRAFTON DBF 3C... | Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch pack... | Class II | Medtronic Sofamor Danek USA Inc |
| Feb 8, 2023 | Medtronic Grafton DBF: a) PUTTY T50101 GRAFTON DBF 1CC, REF T50101; b) ... | Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch pack... | Class II | Medtronic Sofamor Danek USA Inc |
| Feb 8, 2023 | Medtronic Grafton Putty: a) DBM S43101 GRAFTON 0.5CC PUTTY, REF S43101; ... | Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch pack... | Class II | Medtronic Sofamor Danek USA Inc |
| Feb 8, 2023 | Medtronic Grafton Matrix Strips: a) DBM S42275 8MMX1CMX10CM 2EA MATRIX STR... | Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch pack... | Class II | Medtronic Sofamor Danek USA Inc |
| Feb 8, 2023 | Medtronic Grafton Plus Paste a) DBM S45001 GRAFTON 1CC PASTE, REF S45001; ... | Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch pack... | Class II | Medtronic Sofamor Danek USA Inc |
| Feb 8, 2023 | Medtronic Grafton Orthoblend: a) DBM S44125 5CC ORTHOBLEND LARGE DEFECT, R... | Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch pack... | Class II | Medtronic Sofamor Danek USA Inc |
| Feb 8, 2023 | Medtronic Grafton Gel: a) DBM S41120 GRAFTON GEL 1CC, REF S41120; b) DBM ... | Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch pack... | Class II | Medtronic Sofamor Danek USA Inc |
| Feb 8, 2023 | Medtronic Grafton Matrix: a) DBM S42200 GRAFTON 2.5CMX10CM 2EA MATRIX, REF... | Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch pack... | Class II | Medtronic Sofamor Danek USA Inc |
| Feb 8, 2023 | Medtronic Grafton DBF Inject: a) GRAFTON T50303 DBF INJECT 3CC, REF T50303; ... | Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch pack... | Class II | Medtronic Sofamor Danek USA Inc |
| Feb 8, 2023 | Medtronic XPANSE Bone Insert: a) DBM T600106 XPANSE SMALL-C 6, REF T600106;... | Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch pack... | Class II | Medtronic Sofamor Danek USA Inc |
| Feb 8, 2023 | Medtronic Grafton Crunch a) DBM S44105 GRAFTON 5CC CRUNCH, REF S44105; b)... | Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch pack... | Class II | Medtronic Sofamor Danek USA Inc |
| Feb 7, 2023 | injeTAK Adjustable Tip Needles Needle Sheath diameter 6Fr with 35-50cm in le... | The packaging may be damaged, compromising the sterile barrier. | Class II | Labories Medical Technologies |
| Feb 2, 2023 | ORTHOLOC 3DSi CLAW II 4 HOLE Plate, Size 25MM, REF 402S0425, Bone fixation de... | Stryker has identified an issue that impacts two specific lots of CLAW" II plates. The plates wit... | Class II | Wright Medical Technology, Inc. |
| Feb 2, 2023 | ORTHOLOC 3DSi CLAW II 4 HOLE Plate, Size 25MM, REF 40241425, Bone fixation de... | Stryker has identified an issue that impacts two specific lots of CLAW" II plates. The plates wit... | Class II | Wright Medical Technology, Inc. |
| Dec 20, 2022 | CustomEyes kits | Device packaging may contain open seals, compromising product sterility. | Class II | Beaver Visitec International, Inc. |
| Dec 20, 2022 | Ultracell Wick with 80cc Collection Bag, 20/box | Device packaging may contain open seals, compromising product sterility. | Class II | Beaver Visitec International, Inc. |
| Dec 20, 2022 | RELAY PRO, THORACIC STENT-GRAFT SYSTEM, REF 28-N4-XX-XXX-XXX | The product may be shorter than packaging indicates | Class II | Bolton Medical Inc. |
| Dec 20, 2022 | RELAY PRO, THORACIC STENT-GRAFT SYSTEM, REF 28-M4-XX-XXX-XXX | The product may be shorter than packaging indicates | Class II | Bolton Medical Inc. |
| Dec 16, 2022 | Mammotome MammoStar Biopsy Site Identified, REF STAR1401 | The label incorrectly identifies the product as STAR1401, a 1x3mm Barbell shaped marker pre-loade... | Class II | Carbon Medical Technologies, Inc. |
| Dec 12, 2022 | DeRoyal ORGAN RECOVERY PACK PGYBK, a) REF 89-9004.09 and b) 89-9004.10 | DeRoyal is recalling certain lots of surgical procedure pack products that contain a Medtronic No... | Class II | DeRoyal Industries Inc |
| Dec 5, 2022 | Invisalign Express 10 REF 8512 Invisalign System Comprehensive REF 9000 ... | 3D orthodontic planning software has a defect that leads to an issue where incorrect number of al... | Class II | Align Technology Inc |
| Nov 30, 2022 | Beaver EdgeAhead Stiletto/MVR Knife .90mm Straight (20G)-for ocular paracente... | Packaging sterile barrier has been compromised. Open seals can lead to a loss of device sterility... | Class II | Beaver Visitec International, Inc. |
| Nov 18, 2022 | Medline CISION Sterile Blades. Labeled as follows with corresponding Item Nu... | Potential of the blade puncturing the outer foil layer causing a breach in the sterile packaging. | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 17, 2022 | Sterile Procedural Trays, labeled as the following: a. MINOR/BREAST BIOPSY... | 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. AV SHUNT CDS 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. BREAST BIOPSY 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. PORT/TRACH INSERTIO... | 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. ENDOSCOPY-LF b. S... | Sterile blades within sterile kits have the potential for the blade to puncture the outer foil la... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
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.