Hazard

Defective Device recalls

19 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total: 19
Critical: 0
Severe: 0
Most recent: 2024-09-18

Of the 19 defective device recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

Which agencies issued them

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all defective device recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

1–19 of 19

HighFDA (Devices)·Z-3041-2024·2024-09-18
Medline Medical Convenience Kits with Plastic Syringes Recalled Due to Leaks and Breakage
Medline Industries is recalling medical convenience kits containing plastic syringes with leaks, breakage, and other quality issues that may pose a risk to patient health.
Product
Medline Convenience kits labeled as: 1) CHEST TUBE INSERTION TRAY, Pack Number DYNDA2063; 2) PULL D/C PACK, Pack Number DYNDA2080; 3) STERILE 3CC SYR W/ 23GX1 NDL, Pack Number DYNDA2495; 4) STERILE 1CC SYR W/ 25GX5/8 NDL, Pack Number DYNDA2497; 5) ARTHROGRAM TRAY, Pack
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-2875-2024·2024-09-04
Beaver Visitec Recalls CustomEyes Procedure Packs with Sol-M Syringes
Beaver Visitec International is voluntarily recalling BVI CustomEyes Procedure Packs containing syringes manufactured by Sol-M. Approximately 1,338 units were distributed nationwide.
Product
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001486;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1671-2021·2021-06-02
Philips IntelliVue MX40 Patient Monitor Recalled for Manufacturing Defects
Philips is recalling three IntelliVue MX40 patient monitors because manufacturing process failures may have resulted in defective devices.
Product
IntelliVue MX40 Patient Monitor, Model Number: 865350 (US) 865352 (OUS) Software version number B.06.59 - Product Usage: Intended for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults and pediatrics in hospital environments and d
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0262-2020·2019-11-06
POM Medical Recalls Procedural Oxygen Masks Due to Defective Re-breather Bags
POM Medical LLC is recalling 5,610 procedural oxygen masks because the re-breather bag may not inflate or the oxygen line may pop off due to a clogged port.
Product
POM Procedural Oxygen Masks, Endoscopic, Conscious Sedation, Bronchoscopy Mask, as follows: (1) POM Medical, LLC, REF 1001-MM, High/Med Concentrations, Distributed by POM Medical, LLC, Moorpark, CA; (2) curaplex, REF 301-0318LT, Medium Concentration, Distributed by Sarnova HC, L
Category
Medical Device
Distribution
5 states
ModerateFDA (Devices)·Z-0245-2020·2019-11-06
A&E Medical Thorecon Plating System Kits Recalled for Molding Defect
Alto Development Corp is recalling 209 Thorecon Plating System Kits because a molding defect renders the tensioners inoperable.
Product
A&E Medical Thorecon Plating System Kits Model No. 94-1500-04-S. For fracture fixation or reconstruction of the sternum.
Category
Medical Device
Distribution
16 states
HighFDA (Devices)·Z-0851-2018·2018-03-14
Bausch & Lomb Recalls LaserEdge Ophthalmic Knives Due to Dull Blades
Bausch & Lomb Inc is voluntarily recalling 1,236,749 LaserEdge ophthalmic knives because an atypical volume of complaints indicates dull blades. The recall affects products lacking specific electro-polish and penetration force testing.
Product
LASEREDGE Knives, CRESCENT BLADE STRAIGHT BEVEL UP STR (6/BOX), REF/PRODUCT CODE E7500, STERILE, Rx Only Product Usage: The LaserEdge Knives are intended for ophthalmic surgery. There is no therapeutic use and they are available to surgeons for use in procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2243-2017·2017-06-14
ConvaTec Recalls Pediatric Non-Rebreather Oxygen Masks Due to Defects
ConvaTec is voluntarily recalling specific lots of pediatric non-rebreather oxygen masks with tubing. The recall was initiated by the firm and is currently terminated.
Product
Non-Rebreather Oxygen Mask, Pediatric with Tubing, Product Code 86-3226E, Product Code PMD06009, Product Code PMD06106
Category
Medical Device
Distribution
14 states
HighFDA (Devices)·Z-2245-2017·2017-06-14
ConvaTec Recalls Pediatric High Concentration Non-Rebreather Oxygen Tubing
ConvaTec is voluntarily recalling specific lots of pediatric non-rebreather oxygen tubing due to a Class II defect. The recall covers units distributed across the US and multiple international countries.
Product
Pediatric, High Conc. Non-Rebreather, 7 ft. (2.1 m) Oxygen Tubing w/FITS-ALL Oxygen Connector 50 Check Valve, One Side Valve, Product Code 9226-E
Category
Medical Device
Distribution
14 states
HighFDA (Devices)·Z-2231-2017·2017-06-14
ConvaTec Recalls Adult High Concentration Non-Rebreather Oxygen Masks
ConvaTec, Inc. is voluntarily recalling specific lots of Adult High Concentration Non-Rebreather Oxygen Masks due to a Class II defect.
Product
Oxygen Mask, Adult High Concentration Non-Rebreather 2.1 m (7) Oxygen Tubing, Product Code 106MM
Category
Medical Device
Distribution
14 states
HighFDA (Devices)·Z-2232-2017·2017-06-14
ConvaTec Recalls Elongated Oxygen Masks Due to Defect
ConvaTec is voluntarily recalling elongated oxygen masks in the US and 27 other countries. The recall was initiated by the firm and is classified as FDA Class II.
Product
Oxygen Masks, Elongated (Under Chin), Adult High Conc., Non-Rebreather, 7ft O2 Tubing, Check Valve, Two Side Valve, Product Code 108-E
Category
Medical Device
Distribution
14 states
HighFDA (Devices)·Z-2236-2017·2017-06-14
ConvaTec Recalls Rebreather Oxygen Masks Due to Defect
ConvaTec is voluntarily recalling specific lots of Rebreather Oxygen Masks. The recall was initiated by the firm and is classified as Class II by the FDA.
Product
Rebreather Oxygen Mask, Adult 7 (2.1 m) Tubing, Product Code 3104MM, Product Code 9104-E, Product Code PMD06001
Category
Medical Device
Distribution
14 states
HighFDA (Devices)·Z-1287-2016·2016-04-06
Ossur Recalls NecLoc Extrication Collars and Other Medical Devices
Ossur Americas is recalling NecLoc Extrication Collars and other medical devices due to a defect described as 'the p'.
Product
NecLoc Extrication Collar Product Usage: Necloc collars are applied to patients afflicted with cervical injuries to ensure immobilization.
Category
Medical Device
Distribution
48 states
HighFDA (Devices)·Z-1291-2016·2016-04-06
Ossur Recalls Rebound Air Walkers and Other Medical Devices
Ossur Americas is recalling Rebound Air Walkers and other medical devices due to a defect described as 'the p'.
Product
Rebound Air Walker Product Usage: Rebound Air Walkers are indicated for grade 2 and grade 3 ankle sprains, to stabilize fractures, post-operative use, and trauma or rehab use.
Category
Medical Device
Distribution
48 states
HighFDA (Devices)·Z-1609-2014·2014-05-21
FDA Recalls Defective Ultrasound Needles That May Leak at Hub
RM Temena GmbH is recalling ultrasound needles that may leak at the hub. The recall involves 7,370 needles distributed in the US.
Product
Ultrasound USB needles, with 30 degree bevel, packaged individually, 10 needles/box, item number REF USB050-22. Needles for peripheral nerve blocking under ultrasound guidance
Category
Medical Device
Distribution
2 states
ModerateFDA (Drugs)·D-1291-2014·2014-05-07
AbbVie Recalls Lupron Depot Kits Due to Defective Needle Protection Device
AbbVie is recalling 2,915 Lupron Depot kits because the syringe needle protection device may be defective. The recall covers nationwide distribution and Puerto Rico.
Product
LUPRON DEPOT — LUPRON DEPOT (LEUPROLIDE ACETATE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1290-2014·2014-05-07
AbbVie Recalls Lupron Depot Kits With Defective Needle Protection
AbbVie is recalling 1,530 Lupron Depot kits because some may contain a syringe with a defective needle stick protection device.
Product
LUPRON DEPOT — LUPRON DEPOT (LEUPROLIDE ACETATE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1287-2014·2014-05-07
AbbVie Recalls Lupron Depot Kits Due to Defective Needle Protection
AbbVie is recalling 7,362 Lupron Depot kits because some may contain a syringe with a defective needle stick protection device.
Product
LUPRON DEPOT — LUPRON DEPOT (LEUPROLIDE ACETATE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0711-2014·2014-01-22
Boston Scientific Recalls Extractor Pro XL Retrieval Balloon Catheters
Boston Scientific is recalling 38 units of Extractor Pro XL Retrieval Balloon Catheters due to potential defects in skive hole location or balloon size.
Product
Boston Scientific Extractor Pro XL Retrieval Balloon Catheter 12-15 mm Injects Above UPN: M00547110
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2261-2013·2013-10-02
Terumo Pall AL6X Arterial Blood Line Filter Recall for Defective Device
Terumo is recalling 15,817 arterial blood line filters used in cardiovascular procedures because the devices are defective.
Product
Terumo Pall AL6X Arterial Blood Line Filter, labeled in part Terumo Cardiovascular Systems Corporation, packaged as part of a Terumo Cardiovascular Procedure Kit or as a single, sterile filter unit Single/Sterile Terumo Pall AL6X Arterial Filter: The Terumo Pall AL6X Arterial
Category
Medical Device
Distribution
Distributed nationwide