Hazard

Sterility Compromise recalls

2,228 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total: 2,228
Critical: 3
Severe: 255
Most recent: 2026-08-19

Of the 2,228 sterility compromise recalls we have scored against our rubric, 3 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 255 (11%) 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 sterility compromise 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.

2076–2100 of 2228

HighFDA (Devices)·Z-0724-2014·2014-01-22
Boston Scientific Recalls TWISTER PLUS Retrieval Devices Due to Seal Integrity
Boston Scientific is recalling 3,300 TWISTER PLUS 26mm Rotatable Retrieval Devices because the pouch seal integrity may be compromised, potentially affecting sterility.
Product
TWISTER PLUS 26mm Rotatable Retrieval Device (Box of 10 configuration) Intended to be used in flexible endoscopes as a retrieval device for foreign body objects, such as polyps and food boluses. Universal Product Number (UPN):M00561422 Distributed by: Boston Scientific, Nat
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0721-2014·2014-01-22
Boston Scientific Recalls TWISTER PLUS Retrieval Devices Due to Seal Integrity
Boston Scientific is recalling TWISTER PLUS 22mm Rotatable Retrieval Devices because the pouch seal integrity may be compromised, potentially affecting sterility.
Product
TWISTER PLUS 22mm Rotatable Retrieval Device (Box of 10 configuration) Universal Product Number (UPN):M00561412. Distributed by: Boston Scientific, Natick, MA. Manufactured by: Horizons International Corp., Costa Rica Intended to be used in flexible endoscopes as a retrieval d
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0772-2014·2014-01-22
Becton Dickinson Recalls BD Interlink Threaded Lock Cannula Due to Seal Defects
Becton Dickinson is recalling BD Interlink Threaded Lock Cannulas because some units may have open seals, compromising sterility.
Product
BD Interlink threaded lock cannula This is a locking blunt plastic cannula specifically designed for IV connection to an Interlink¿ injection site. It is screwed down over the Interlink¿ injection site and a blunt plastic cannula inside the housing enters the Interlink¿ injectio
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0719-2014·2014-01-22
Boston Scientific Recalls TWISTER PLUS Retrieval Devices Due to Seal Integrity Issues
Boston Scientific is recalling TWISTER PLUS 22mm Rotatable Retrieval Devices because the pouch seal integrity may be compromised, potentially affecting sterility.
Product
TWISTER PLUS 22mm Rotatable Retrieval Device (Box of 1 configuration) Universal Product Number (UPN): M00561410. Distributed by: Boston Scientific. Manufactured by: Horizons International Corp. Intended to be used in flexible endoscopes as a retrieval device for foreign b
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0638-2014·2014-01-15
Sandel Weighted Safety Scalpels Recalled Due to Exposed Blades
Ansell Sandel Medical Industries is recalling Sandel Weighted Safety Scalpels because the blades may be exposed, compromising sterility and causing injury.
Product
Sandel Healthcare Safety Devices Weighted Safety Scalpel #3 Disposable Safety Handle with #11 Blade Manufactured for: Ansell Sandel Medical Solutions LLC 19736 Dearborn St. Chatsworth, CA 91311 USA Emergo Europe Molenstraat 15 2513 BH The Hague The Netherlands Made in China
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0636-2014·2014-01-15
Sandel Weighted Safety Scalpels Recalled for Exposed Blades
Ansell Sandel Medical Industries LLC is recalling Sandel Weighted Safety Scalpels because the blade may be exposed beyond the safety shield, compromising sterility and causing injury.
Product
Sandel Healthcare Safety Devices Weighted Safety Scalpel #3 Disposable Safety Handle with #11 Blade Manufactured for: Ansell Sandel Medical Solutions LLC 19736 Dearborn St. Chatsworth, CA 91311 USA Emergo Europe Molenstraat 15 2513 BH The Hague The Netherlands Made in China
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0640-2014·2014-01-15
Sandel Weighted Safety Scalpels Recalled for Exposed Blades
Ansell Sandel Medical Industries is recalling Sandel Weighted Safety Scalpels because the blades are exposed beyond the safety shield, potentially compromising sterility and causing injury.
Product
Sandel Healthcare Safety Devices Weighted Safety Scalpel #3 Long Disposable Safety Handle with #15 Blade Manufactured for: Ansell Sandel Medical Solutions LLC 19736 Dearborn St. Chatsworth, CA 91311 USA Emergo Europe Molenstraat 15 2513 BH The Hague The Netherlands Made in C
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0641-2014·2014-01-15
Sandel Weighted Safety Scalpels Recalled for Exposed Blades
Ansell Sandel Medical Industries is recalling Sandel Weighted Safety Scalpels because the blade may be exposed beyond the safety shield, compromising sterility and causing injury.
Product
Sandel Healthcare Safety Devices Weighted Safety Scalpel 4# Disposable Safety Handle with #20 Blade Manufactured for: Ansell Sandel Medical Solutions LLC 19736 Dearborn St. Chatsworth, CA 91311 USA Emergo Europe Molenstraat 15 2513 BH The Hague The Netherlands Made in China
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0635-2014·2014-01-15
Sandel Weighted Safety Scalpels Recalled Due to Exposed Blades
Ansell Sandel Medical Industries is recalling specific lots of Sandel Weighted Safety Scalpels because the blades are exposed beyond the safety shield, potentially compromising sterility and causing injury.
Product
Sandel Healthcare Safety Devices Weighted Safety Scalpel #3 Disposable Safety Handle with #10 Blade Manufactured for: Ansell Sandel Medical Solutions LLC 19736 Dearborn St. Chatsworth, CA 91311 USA Emergo Europe Molenstraat 15 2513 BH The Hague The Netherlands Made in China
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-388-2014·2014-01-01
GlaxoSmithKline Recalls Sumatriptan Injection Cartridges Due to Sterility Concerns
GlaxoSmithKline is recalling 9,743 cartridges of Sumatriptan Succinate Injection because some may have needles protruding through the shield, compromising sterility.
Product
Sumatriptan Succinate Injection, 6 mg, 0.5 mL For subcutaneous injection only, Rx only, 2 Single-Dose Syringe Cartridges for use with sumatriptan Autoinjector Pen, Manufactured by GlaxoSmithKline, Research Triangle Park, NC 27709 for Sandoz Inc., Princeton, NJ 08540, Made in Sing
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0447-2014·2013-12-11
Smith & Nephew Recalls Genesis II Knee Inserts Due to Sealing Defect
Smith & Nephew is recalling 32 Genesis II knee inserts because the Tyvek lid may not be adequately sealed, potentially compromising sterility.
Product
GENESIS(R) II, PS HIGH FLEXION ARTICULAR INSERT, SIZE 5-6, 9 MM QTY: (1), REF 71421515, STERILE EO, Smith & Nephew, Inc. Memphis, TN 38116 USA Orthopedic
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-0445-2014·2013-12-11
Smith & Nephew Recalls Genesis II Knee Inserts Due to Seal Defect
Smith & Nephew is recalling 45 units of Genesis II knee inserts because the Tyvek lid may not be adequately sealed, potentially compromising sterility.
Product
GENESIS(R) II, PS HIGH FLEXION ARTICULAR INSERT, SIZE 3-4, 13 MM QTY: (1), REF 71420820, STERILE EO, Smith & Nephew, Inc. Memphis, TN 38116 USA Orthopedic
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-0449-2014·2013-12-11
Smith & Nephew Recalls Genesis II Knee Inserts Due to Seal Defect
Smith & Nephew is recalling 8 units of Genesis II mobile bearing articular inserts because the Tyvek lid may not be adequately sealed.
Product
GENESIS(R) II, MOBILE BEARING ARTICULAR INSERT RIGHT, SIZE 5, 9 MM QTY: (1), REF 71621509, STERILE EO, Smith & Nephew, Inc. Memphis, TN 38116 USA Orthopedic
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-0446-2014·2013-12-11
Smith & Nephew Recalls Genesis II Knee Inserts Due to Seal Defect
Smith & Nephew is recalling 80 Genesis II knee inserts because the Tyvek lid may not be adequately sealed, potentially compromising sterility.
Product
GENESIS(R) II, PS HIGH FLEXION ARTICULAR INSERT, SIZE 3-4, 9 MM QTY: (1), REF 71421508, STERILE EO, Smith & Nephew, Inc. Memphis, TN 38116 USA Orthopedic
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-0392-2014·2013-12-04
Baxter Recalls VIAL-MATE Adaptors Due to Incomplete Foil Seal
Baxter Healthcare is recalling 38,400 units of VIAL-MATE Adaptors because an incomplete foil seal may compromise sterility.
Product
Baxter, VIAL-MATE Adaptor, 2B8071, Rx Only, STERILE R, Baxter Healthcare Corporation, Deerfield, IL 30015 USA The VIAL-MATE is reconstitution device labeled for use with 20 mm drug vials and 50mL, 100mL, and 250mL Single Pack Mini Bags.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0109-2014·2013-11-06
Baxter Recalls Vented Spike Adapters Due to Potential Pouch Tears
Baxter Healthcare is recalling 49,344 units of Vented Spike Adapters because potential tears in the pouch could compromise sterility.
Product
Vented Spike Adapter Product Code 2C0471, Sterile, nopyrogenic. Manufactured by an affiliate of Baxter Healthcare Corporation, Clintec Nutrition Division, Deerfield IL 60015 USA. An IV transfer device, used to transfer fluids in pharmacy compounding system.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0005-2014·2013-10-09
PhotoMedex Recalls SLT Fiber Delivery Systems Due to Sterility Concerns
PhotoMedex is recalling 549 units of SLT Fiber Delivery Systems because some may not have been sealed appropriately, compromising the sterile barrier.
Product
The product is labeled in part "***Surgical Laser Technologies, Inc. Montgomeryville, PA***SLT Fiber Delivery System***Sterile***Non-Pyrogenic***. The product is packaged in a flexible pouch and includes the following laser surgery accessories - SLT-SSRH 8, Catalog/Product N
Category
Medical Device
Distribution
3 states
ModerateFDA (Devices)·Z-2315-2013·2013-10-09
Atrium Medical Recalls Advanta VS Grafts Due to Label Adhesion
Atrium Medical Corporation is recalling Advanta VS Grafts because the inner tray label may adhere to the outer tray, making it difficult to remove the tray onto the sterile field.
Product
Advanta VS Grafts >or= 6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2260-2013·2013-09-25
Integra Recalls Cranial Access Kits Due to Potential Sterile Seal Compromise
Integra LifeSciences is recalling specific lots of Cranial Access Kits because the sterile package seal may become compromised during shipping.
Product
Cranial Access (CRAK) Kits, Product / Catalogue No.s: INSHITH, INSHITHND, INSHITHRZN The kits allow for access to the subarachnoid space or the lateral ventricles of the brain. The kits are intended to be used with an external drainage and monitoring system in selected patient
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-996-2013·2013-09-18
Beacon Hill Medical Pharmacy Recalls Selenium Injectable Due to Sterility Concerns
Beacon Hill Medical Pharmacy is recalling Selenium 400 mcg/mL injectable because FDA inspections raised concerns about quality control and sterility assurance.
Product
SELENIUM 400 MCG/ML INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2189-2013·2013-09-18
Edwards Lifesciences Recalls FloTrac Sensor Due to Packaging Error
Edwards Lifesciences is recalling 35 units of the FloTrac Sensor Model MHD85 because incorrect packaging configuration prevents validation of the product's sterility.
Product
"***Flo Trac Sensor Model MHD85***" Sterile, single use kit that monitors pressures when attached to pressure monitoring catheters.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2159-2013·2013-09-11
MicroAire Kirschner-Wire Recall Due to Defective Sterile Pouch Seals
MicroAire Surgical Instruments is recalling Kirschner-Wires because defective pouch seals may compromise sterility. The recall affects 15,786 units distributed worldwide.
Product
Kirschner-Wire (K-Wire), packed in a clear tube with end caps, tubes packed in a sterile barrier pouch, 6 pouches/sales unit. Pouches are labeled in part ***MicroAire Surgical Instruments 3590 Grand Forks Blvd Charlottesville, VA LLC 22911*** Models: 1620-109 1636-
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2158-2013·2013-09-11
MicroAire Steinmann Pins Recalled Due to Potential Sterility Compromise
MicroAire Surgical Instruments is recalling Steinmann Pins because defective pouch seals may compromise sterility. The recall affects 15,786 units distributed worldwide.
Product
Steinmann Pin, packed in a clear tube with end caps, tubes packed in a sterile barrier pouch, 6 pouches/sales unit. Pouches are labeled in part ***MicroAire Surgical Instruments 3590 Grand Forks Blvd Charlottesville, VA LLC 22911*** Models: 1620-109 1636-509 162
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2091-2013·2013-09-04
Zimmer Free Lock Femoral Hip Fixation System Recalled for Sterility Failure
Zimmer, Inc. is recalling Free Lock Femoral Hip Fixation System Compression Tubes/Plates because a packaging configuration failed a leak test, compromising product sterility.
Product
Free Lock Femoral Hip Fixation System Compression Tube/Plate, different length (59, 75, 91, 107, 123 mm), holes (2, 3, 4, 5, 6) and degree angles (130, 135, 140, 145 and 150). Item codes starting with 00-1181-130, 00-1181-135, 00-1181-140, 00-1181-145, 00-1181-150). ZIMMER Co
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2092-2013·2013-09-04
Zimmer Recalls VERSA-FX Femoral Fixation System Due to Sterility Failure
Zimmer, Inc. is recalling VERSA-FX Femoral Fixation System compression lag screws because a packaging failure compromised sterility. The recall affects 85,794 units distributed worldwide.
Product
VERSA-FX FEMORAL FIXATION SYSTEM COMPRESSION LAG SCREW, several length (55 mm to 155 mm), diameters (12.7 mm and 15.8 mm) and short thread, standard thread and large thread. Item codes starting with 00-1193-005, 00-1193-010 and 00-1193-015. orthopedic implant.
Category
Medical Device
Distribution
Distributed nationwide